Trial Outcomes & Findings for Elotuzumab, Lenalidomide and Dexamethasone in Treatment of Transplant-Eligible Newly Diagnosed Multiple Myeloma Patients (NCT NCT02843074)

NCT ID: NCT02843074

Last Updated: 2023-12-05

Results Overview

Defined as the percentage of patients who successfully complete four 28-day cycles of induction therapy with elotuzumab, lenalidomide and dexamethasone (ERd) and start autologous stem cell transplantation (ASCT).

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 53 participants
• Primary outcome timeframe: approximately 22 weeks (16 weeks of treatment and 6 weeks allowance for planning and scheduling mobilization and ASCT).
• Results posted on: 2023-12-05

Participant Flow

One participant withdrew consent before the study treatment assignment.

Participant milestones

Measure	ERd Therapy INDUCTION: Cycles 1-2: elotuzumab 10mg/kg IV days 1, 8, 15, 22; lenalidomide (len) 25mg orally (PO), once daily (QD) on days 1-21; dexamethasone (dex) 28 mg PO (3-24 hrs before elotuzumab IV) and 8mg IV (45-90 minutes before elotuzumab) days 1, 8, 15, 22. Cycles 3-4: elotuzumab 10mg/kg IV days 1 and 15; len 25mg PO QD days 1-21; dex 8mg PO (3-24 hrs before elotuzumab IV) and 8mg IV (45-90 minutes before elotuzumab) days 1 and 15; dex 40mg PO days 8 and 22. CONSOLIDATION: Four 28-day cycles: elotuzumab 10mg/kg IV days 1 and 15; len 15mg PO QD days 1-21; dex 28mg PO (3-24 hrs before elotuzumab) and 8mg IV (45-90 minutes before elotuzumab) days 1 and 15; dex 40mg PO days 8 and 22. MAINTENANCE: After completing consolidation therapy patients without progressive disease will receive, for up to 24 months, 28-day cycles of elotuzumab 20mg/kg IV day 1; len 10mg +/- 5mg PO QD days 1-21; dex 28mg PO (3-24 hrs before elotuzumab) and 8mg IV (45-90 minutes prior to elotuzumab) day 1. elotuzumab: Given intravenously (IV) Lenalidomide: Given by IV Dexamethasone: Given orally (PO) or by IV autologous stem cell transplantation
Overall Study STARTED	52
Overall Study COMPLETED	35
Overall Study NOT COMPLETED	17

Reasons for withdrawal

Measure	ERd Therapy INDUCTION: Cycles 1-2: elotuzumab 10mg/kg IV days 1, 8, 15, 22; lenalidomide (len) 25mg orally (PO), once daily (QD) on days 1-21; dexamethasone (dex) 28 mg PO (3-24 hrs before elotuzumab IV) and 8mg IV (45-90 minutes before elotuzumab) days 1, 8, 15, 22. Cycles 3-4: elotuzumab 10mg/kg IV days 1 and 15; len 25mg PO QD days 1-21; dex 8mg PO (3-24 hrs before elotuzumab IV) and 8mg IV (45-90 minutes before elotuzumab) days 1 and 15; dex 40mg PO days 8 and 22. CONSOLIDATION: Four 28-day cycles: elotuzumab 10mg/kg IV days 1 and 15; len 15mg PO QD days 1-21; dex 28mg PO (3-24 hrs before elotuzumab) and 8mg IV (45-90 minutes before elotuzumab) days 1 and 15; dex 40mg PO days 8 and 22. MAINTENANCE: After completing consolidation therapy patients without progressive disease will receive, for up to 24 months, 28-day cycles of elotuzumab 20mg/kg IV day 1; len 10mg +/- 5mg PO QD days 1-21; dex 28mg PO (3-24 hrs before elotuzumab) and 8mg IV (45-90 minutes prior to elotuzumab) day 1. elotuzumab: Given intravenously (IV) Lenalidomide: Given by IV Dexamethasone: Given orally (PO) or by IV autologous stem cell transplantation
Overall Study Withdrawal by Subject	5
Overall Study Progressive disease	1
Overall Study Physician Decision	1
Overall Study Lost to Follow-up	1
Overall Study Death	9

Baseline Characteristics

Elotuzumab, Lenalidomide and Dexamethasone in Treatment of Transplant-Eligible Newly Diagnosed Multiple Myeloma Patients

Baseline characteristics by cohort

Measure	ERd Therapy n=52 Participants INDUCTION: Cycles 1-2: elotuzumab 10mg/kg IV days 1, 8, 15, 22; lenalidomide (len) 25mg orally (PO), once daily (QD) on days 1-21; dexamethasone (dex) 28 mg PO (3-24 hrs before elotuzumab IV) and 8mg IV (45-90 minutes before elotuzumab) days 1, 8, 15, 22. Cycles 3-4: elotuzumab 10mg/kg IV days 1 and 15; len 25mg PO QD days 1-21; dex 8mg PO (3-24 hrs before elotuzumab IV) and 8mg IV (45-90 minutes before elotuzumab) days 1 and 15; dex 40mg PO days 8 and 22. CONSOLIDATION: Four 28-day cycles: elotuzumab 10mg/kg IV days 1 and 15; len 15mg PO QD days 1-21; dex 28mg PO (3-24 hrs before elotuzumab) and 8mg IV (45-90 minutes before elotuzumab) days 1 and 15; dex 40mg PO days 8 and 22. MAINTENANCE: After completing consolidation therapy patients without progressive disease will receive, for up to 24 months, 28-day cycles of elotuzumab 20mg/kg IV day 1; len 10mg +/- 5mg PO QD days 1-21; dex 28mg PO (3-24 hrs before elotuzumab) and 8mg IV (45-90 minutes prior to elotuzumab) day 1. elotuzumab: Given intravenously (IV) Lenalidomide: Given by IV Dexamethasone: Given orally (PO) or by IV autologous stem cell transplantation
Age, Continuous	60.7 years STANDARD_DEVIATION 9.11 • n=5 Participants
Sex: Female, Male Female	29 Participants n=5 Participants
Sex: Female, Male Male	23 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	11 Participants n=5 Participants
Race (NIH/OMB) White	41 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	52 participants n=5 Participants

PRIMARY outcome

Timeframe: approximately 22 weeks (16 weeks of treatment and 6 weeks allowance for planning and scheduling mobilization and ASCT).

Population: Four participants who completed four 28-day cycles of induction therapy refused transplantation (ASCT). These 4 participants were excluded from the IFR analysis.

Defined as the percentage of patients who successfully complete four 28-day cycles of induction therapy with elotuzumab, lenalidomide and dexamethasone (ERd) and start autologous stem cell transplantation (ASCT).

Outcome measures

Measure

ERd Therapy n=48 Participants INDUCTION: Cycles 1-2: elotuzumab 10mg/kg IV days 1, 8, 15, 22; lenalidomide (len) 25mg orally (PO), once daily (QD) on days 1-21; dexamethasone (dex) 28 mg PO (3-24 hrs before elotuzumab IV) and 8mg IV (45-90 minutes before elotuzumab) days 1, 8, 15, 22. Cycles 3-4: elotuzumab 10mg/kg IV days 1 and 15; len 25mg PO QD days 1-21; dex 8mg PO (3-24 hrs before elotuzumab IV) and 8mg IV (45-90 minutes before elotuzumab) days 1 and 15; dex 40mg PO days 8 and 22. CONSOLIDATION: Four 28-day cycles: elotuzumab 10mg/kg IV days 1 and 15; len 15mg PO QD days 1-21; dex 28mg PO (3-24 hrs before elotuzumab) and 8mg IV (45-90 minutes before elotuzumab) days 1 and 15; dex 40mg PO days 8 and 22. MAINTENANCE: After completing consolidation therapy patients without progressive disease will receive, for up to 24 months, 28-day cycles of elotuzumab 20mg/kg IV day 1; len 10mg +/- 5mg PO QD days 1-21; dex 28mg PO (3-24 hrs before elotuzumab) and 8mg IV (45-90 minutes prior to elotuzumab) day 1. elotuzumab: Given intravenously (IV) Lenalidomide: Given by IV Dexamethasone: Given orally (PO) or by IV autologous stem cell transplantation

Induction Feasibility Rate (IFR)

33 Participants

SECONDARY outcome

Timeframe: every 4 weeks until end of treatment visit, and every 3 months thereafter up to 3 years

Population: Participants who completed at least one cycle of treatment were included in the analysis. One participant didn't complete cycle 1 due to adverse events; therefore, excluded from the analysis.

Defined as the percentage of patients who achieve a complete response (CR) or near complete response (nCR) to treatment at each stage of the study (induction, ASCT, consolidation, end of study) per International Myeloma Working Group (IMWG) and European Group for Blood and Marrow Transplantation (EBMT) criteria.CR=bone marrow contains ≤5% plasma cells; negative immunofixation on serum and urine; disappearance of soft tissue plasmacytomas. nCR = the absence of myeloma protein on electrophoresis, with positive immunofixation, stable bone disease, and a normal serum calcium concentration. Patient must have completed at least 1 cycle to be included in analysis.

Outcome measures

Measure

ERd Therapy n=51 Participants INDUCTION: Cycles 1-2: elotuzumab 10mg/kg IV days 1, 8, 15, 22; lenalidomide (len) 25mg orally (PO), once daily (QD) on days 1-21; dexamethasone (dex) 28 mg PO (3-24 hrs before elotuzumab IV) and 8mg IV (45-90 minutes before elotuzumab) days 1, 8, 15, 22. Cycles 3-4: elotuzumab 10mg/kg IV days 1 and 15; len 25mg PO QD days 1-21; dex 8mg PO (3-24 hrs before elotuzumab IV) and 8mg IV (45-90 minutes before elotuzumab) days 1 and 15; dex 40mg PO days 8 and 22. CONSOLIDATION: Four 28-day cycles: elotuzumab 10mg/kg IV days 1 and 15; len 15mg PO QD days 1-21; dex 28mg PO (3-24 hrs before elotuzumab) and 8mg IV (45-90 minutes before elotuzumab) days 1 and 15; dex 40mg PO days 8 and 22. MAINTENANCE: After completing consolidation therapy patients without progressive disease will receive, for up to 24 months, 28-day cycles of elotuzumab 20mg/kg IV day 1; len 10mg +/- 5mg PO QD days 1-21; dex 28mg PO (3-24 hrs before elotuzumab) and 8mg IV (45-90 minutes prior to elotuzumab) day 1. elotuzumab: Given intravenously (IV) Lenalidomide: Given by IV Dexamethasone: Given orally (PO) or by IV autologous stem cell transplantation

Complete Response Rate (CRR) for Complete Time on Study

25 Participants

SECONDARY outcome

Timeframe: every 4 weeks until end of treatment visit, and every 3 months thereafter up to 3 years

Population: Participants who completed at least one cycle of treatment were included in the analysis. One participant didn't complete cycle 1 due to adverse events; therefore, excluded from the analysis.

Defined as percentage of patients receiving at least 1 cycle with confirmed complete response, very good partial response, or partial response (CR, VGPR, or PR) to treatment at each stage of the study (induction, ASCT, consolidation, end of study) per IMWG and EBMT criteria. CR=bone marrow contains ≤5% plasma cells; negative fixation on serum and urine; the disappearance of soft tissue plasmacytomas. VGPR=serum and urine M-protein detectable by immunofixation but not by electrophoresis or ≥90% reduction from baseline serum and urine M-protein level <100mg for 24h and In case of presence of soft tissue plasmacytoma(s) at baseline, the disappearance of any soft tissue plasmacytomas. PR=≥50% reduction from baseline in serum M-protein and ≥90% reduction from baseline in 24h urinary M-protein or urine M-protein <200 mg/24 hours and In case of presence of soft tissue plasmacytoma(s) at baseline, a reduction in the sum of products of the two longest perpendicular diameters (SPD) by >50%.

Outcome measures

Measure

ERd Therapy n=51 Participants INDUCTION: Cycles 1-2: elotuzumab 10mg/kg IV days 1, 8, 15, 22; lenalidomide (len) 25mg orally (PO), once daily (QD) on days 1-21; dexamethasone (dex) 28 mg PO (3-24 hrs before elotuzumab IV) and 8mg IV (45-90 minutes before elotuzumab) days 1, 8, 15, 22. Cycles 3-4: elotuzumab 10mg/kg IV days 1 and 15; len 25mg PO QD days 1-21; dex 8mg PO (3-24 hrs before elotuzumab IV) and 8mg IV (45-90 minutes before elotuzumab) days 1 and 15; dex 40mg PO days 8 and 22. CONSOLIDATION: Four 28-day cycles: elotuzumab 10mg/kg IV days 1 and 15; len 15mg PO QD days 1-21; dex 28mg PO (3-24 hrs before elotuzumab) and 8mg IV (45-90 minutes before elotuzumab) days 1 and 15; dex 40mg PO days 8 and 22. MAINTENANCE: After completing consolidation therapy patients without progressive disease will receive, for up to 24 months, 28-day cycles of elotuzumab 20mg/kg IV day 1; len 10mg +/- 5mg PO QD days 1-21; dex 28mg PO (3-24 hrs before elotuzumab) and 8mg IV (45-90 minutes prior to elotuzumab) day 1. elotuzumab: Given intravenously (IV) Lenalidomide: Given by IV Dexamethasone: Given orally (PO) or by IV autologous stem cell transplantation

Overall Response Rate (ORR) for Complete Time on Study

47 Participants

SECONDARY outcome

Timeframe: every 4 weeks until end of treatment visit, and every 3 months thereafter up to 3 years

Population: Participants who completed at least one cycle of treatment were included in the analysis. One participant didn't complete cycle 1 due to adverse events; therefore, excluded from the analysis.

The time from start of induction treatment to documented progressive disease (PD) or death from any cause up to 3 years post first study treatment. PD is defined as an increase of ≥ 25% from the nadir in at least one of the following criteria: serum M-protein (absolute increase must be ≥0.5 g/dL); urine M-protein (absolute increase must be ≥200 mg/24h) ; only in patients with non-measurable serum and urine M-protein levels: difference in involved and uninvolved FLC levels (absolute increase must be >10 mg/dL); only in patients with non-measurable serum and urine M-protein levels and non-measurable disease by FLC levels, bone marrow plasma cell % (absolute % must be ≥10%) OR Definite development of new bone lesions or soft tissue plasmacytomas OR definite increase in the size of existing bone lesions or soft tissue plasmacytomas OR Development of hypercalcemia (corrected serum Ca >11.5mg/dL) for patients without hypercalcemia at baseline. Must have completed 1 cycle to be included.

Outcome measures

Measure

ERd Therapy n=51 Participants INDUCTION: Cycles 1-2: elotuzumab 10mg/kg IV days 1, 8, 15, 22; lenalidomide (len) 25mg orally (PO), once daily (QD) on days 1-21; dexamethasone (dex) 28 mg PO (3-24 hrs before elotuzumab IV) and 8mg IV (45-90 minutes before elotuzumab) days 1, 8, 15, 22. Cycles 3-4: elotuzumab 10mg/kg IV days 1 and 15; len 25mg PO QD days 1-21; dex 8mg PO (3-24 hrs before elotuzumab IV) and 8mg IV (45-90 minutes before elotuzumab) days 1 and 15; dex 40mg PO days 8 and 22. CONSOLIDATION: Four 28-day cycles: elotuzumab 10mg/kg IV days 1 and 15; len 15mg PO QD days 1-21; dex 28mg PO (3-24 hrs before elotuzumab) and 8mg IV (45-90 minutes before elotuzumab) days 1 and 15; dex 40mg PO days 8 and 22. MAINTENANCE: After completing consolidation therapy patients without progressive disease will receive, for up to 24 months, 28-day cycles of elotuzumab 20mg/kg IV day 1; len 10mg +/- 5mg PO QD days 1-21; dex 28mg PO (3-24 hrs before elotuzumab) and 8mg IV (45-90 minutes prior to elotuzumab) day 1. elotuzumab: Given intravenously (IV) Lenalidomide: Given by IV Dexamethasone: Given orally (PO) or by IV autologous stem cell transplantation

Progression-free Survival (PFS)

29.7002 months Interval 20.53 to The upper limit of the 99% CI is not estimable by Kaplan-Meier method based on the data and events collected.

SECONDARY outcome

Timeframe: every 4 weeks until end of treatment visit, and up to 3 years thereafter

Population: Participants who completed at least one cycle of treatment were included in the analysis. One participant didn't complete cycle 1 due to adverse events; therefore, excluded from the analysis.

Defined as the time from start of induction treatment to 3 years post first study treatment or death from any cause, whichever comes first. Patient must have completed at least 1 cycle to be included in analysis.

Outcome measures

Measure

ERd Therapy n=51 Participants INDUCTION: Cycles 1-2: elotuzumab 10mg/kg IV days 1, 8, 15, 22; lenalidomide (len) 25mg orally (PO), once daily (QD) on days 1-21; dexamethasone (dex) 28 mg PO (3-24 hrs before elotuzumab IV) and 8mg IV (45-90 minutes before elotuzumab) days 1, 8, 15, 22. Cycles 3-4: elotuzumab 10mg/kg IV days 1 and 15; len 25mg PO QD days 1-21; dex 8mg PO (3-24 hrs before elotuzumab IV) and 8mg IV (45-90 minutes before elotuzumab) days 1 and 15; dex 40mg PO days 8 and 22. CONSOLIDATION: Four 28-day cycles: elotuzumab 10mg/kg IV days 1 and 15; len 15mg PO QD days 1-21; dex 28mg PO (3-24 hrs before elotuzumab) and 8mg IV (45-90 minutes before elotuzumab) days 1 and 15; dex 40mg PO days 8 and 22. MAINTENANCE: After completing consolidation therapy patients without progressive disease will receive, for up to 24 months, 28-day cycles of elotuzumab 20mg/kg IV day 1; len 10mg +/- 5mg PO QD days 1-21; dex 28mg PO (3-24 hrs before elotuzumab) and 8mg IV (45-90 minutes prior to elotuzumab) day 1. elotuzumab: Given intravenously (IV) Lenalidomide: Given by IV Dexamethasone: Given orally (PO) or by IV autologous stem cell transplantation

Overall Survival (OS)

NA months Since only a few patients died, the median survival was not estimable by Kaplan-Meier method nor the 90% confidence interval.

SECONDARY outcome

Timeframe: weekly for 8 weeks, then every 2 weeks till the start of mobilization for Induction and 70-120 days post-ASCT, every 2 weeks during 16 weeks of Consolidation, and monthly for 24 months of Maintenance, up to 30 days after last dose of study drugs.

Population: All treated patients

Safety data and abnormal lab values and abnormal vital signs were collected and assessed using National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE V4.03).

Outcome measures

Measure

ERd Therapy n=52 Participants INDUCTION: Cycles 1-2: elotuzumab 10mg/kg IV days 1, 8, 15, 22; lenalidomide (len) 25mg orally (PO), once daily (QD) on days 1-21; dexamethasone (dex) 28 mg PO (3-24 hrs before elotuzumab IV) and 8mg IV (45-90 minutes before elotuzumab) days 1, 8, 15, 22. Cycles 3-4: elotuzumab 10mg/kg IV days 1 and 15; len 25mg PO QD days 1-21; dex 8mg PO (3-24 hrs before elotuzumab IV) and 8mg IV (45-90 minutes before elotuzumab) days 1 and 15; dex 40mg PO days 8 and 22. CONSOLIDATION: Four 28-day cycles: elotuzumab 10mg/kg IV days 1 and 15; len 15mg PO QD days 1-21; dex 28mg PO (3-24 hrs before elotuzumab) and 8mg IV (45-90 minutes before elotuzumab) days 1 and 15; dex 40mg PO days 8 and 22. MAINTENANCE: After completing consolidation therapy patients without progressive disease will receive, for up to 24 months, 28-day cycles of elotuzumab 20mg/kg IV day 1; len 10mg +/- 5mg PO QD days 1-21; dex 28mg PO (3-24 hrs before elotuzumab) and 8mg IV (45-90 minutes prior to elotuzumab) day 1. elotuzumab: Given intravenously (IV) Lenalidomide: Given by IV Dexamethasone: Given orally (PO) or by IV autologous stem cell transplantation

Number of Participants With Treatment-emergent Adverse Events as a Measure of Safety

52 Participants

SECONDARY outcome

Timeframe: approximately 55 weeks (16 weeks of induction treatment, 6 weeks allowance for planning and scheduling mobilization and ASCT, 17 weeks pause in treatment after ASCT, 16 weeks of consolidation treatment).

Population: All patients starting induction treatment

defined as the percentage of patients starting induction treatment with ERd successfully completing treatment to end of consolidation

Outcome measures

Measure

ERd Therapy n=52 Participants INDUCTION: Cycles 1-2: elotuzumab 10mg/kg IV days 1, 8, 15, 22; lenalidomide (len) 25mg orally (PO), once daily (QD) on days 1-21; dexamethasone (dex) 28 mg PO (3-24 hrs before elotuzumab IV) and 8mg IV (45-90 minutes before elotuzumab) days 1, 8, 15, 22. Cycles 3-4: elotuzumab 10mg/kg IV days 1 and 15; len 25mg PO QD days 1-21; dex 8mg PO (3-24 hrs before elotuzumab IV) and 8mg IV (45-90 minutes before elotuzumab) days 1 and 15; dex 40mg PO days 8 and 22. CONSOLIDATION: Four 28-day cycles: elotuzumab 10mg/kg IV days 1 and 15; len 15mg PO QD days 1-21; dex 28mg PO (3-24 hrs before elotuzumab) and 8mg IV (45-90 minutes before elotuzumab) days 1 and 15; dex 40mg PO days 8 and 22. MAINTENANCE: After completing consolidation therapy patients without progressive disease will receive, for up to 24 months, 28-day cycles of elotuzumab 20mg/kg IV day 1; len 10mg +/- 5mg PO QD days 1-21; dex 28mg PO (3-24 hrs before elotuzumab) and 8mg IV (45-90 minutes prior to elotuzumab) day 1. elotuzumab: Given intravenously (IV) Lenalidomide: Given by IV Dexamethasone: Given orally (PO) or by IV autologous stem cell transplantation

Consolidation Feasibility Rate (CFR)

34 Participants

SECONDARY outcome

Timeframe: approximately 159 weeks (16 weeks of induction treatment, 6 weeks allowance for planning and scheduling mobilization and ASCT, 17 weeks pause in treatment after ASCT, 16 weeks of consolidation treatment, 104 weeks/2 years of maintenance treatment)

Population: All patients starting induction treatment

defined as the percentage of patients starting induction treatment with ERd successfully completing treatment to end of maintenance

Outcome measures

Measure

ERd Therapy n=52 Participants INDUCTION: Cycles 1-2: elotuzumab 10mg/kg IV days 1, 8, 15, 22; lenalidomide (len) 25mg orally (PO), once daily (QD) on days 1-21; dexamethasone (dex) 28 mg PO (3-24 hrs before elotuzumab IV) and 8mg IV (45-90 minutes before elotuzumab) days 1, 8, 15, 22. Cycles 3-4: elotuzumab 10mg/kg IV days 1 and 15; len 25mg PO QD days 1-21; dex 8mg PO (3-24 hrs before elotuzumab IV) and 8mg IV (45-90 minutes before elotuzumab) days 1 and 15; dex 40mg PO days 8 and 22. CONSOLIDATION: Four 28-day cycles: elotuzumab 10mg/kg IV days 1 and 15; len 15mg PO QD days 1-21; dex 28mg PO (3-24 hrs before elotuzumab) and 8mg IV (45-90 minutes before elotuzumab) days 1 and 15; dex 40mg PO days 8 and 22. MAINTENANCE: After completing consolidation therapy patients without progressive disease will receive, for up to 24 months, 28-day cycles of elotuzumab 20mg/kg IV day 1; len 10mg +/- 5mg PO QD days 1-21; dex 28mg PO (3-24 hrs before elotuzumab) and 8mg IV (45-90 minutes prior to elotuzumab) day 1. elotuzumab: Given intravenously (IV) Lenalidomide: Given by IV Dexamethasone: Given orally (PO) or by IV autologous stem cell transplantation

Maintenance Feasibility Rate (MFR)

19 Participants

Adverse Events

ERd Therapy

Serious events: 20 serious events

Other events: 52 other events

Deaths: 9 deaths

Serious adverse events

Measure	ERd Therapy n=52 participants at risk INDUCTION: Cycles 1-2: elotuzumab 10mg/kg IV days 1, 8, 15, 22; lenalidomide (len) 25mg orally (PO), once daily (QD) on days 1-21; dexamethasone (dex) 28 mg PO (3-24 hrs before elotuzumab IV) and 8mg IV (45-90 minutes before elotuzumab) days 1, 8, 15, 22. Cycles 3-4: elotuzumab 10mg/kg IV days 1 and 15; len 25mg PO QD days 1-21; dex 8mg PO (3-24 hrs before elotuzumab IV) and 8mg IV (45-90 minutes before elotuzumab) days 1 and 15; dex 40mg PO days 8 and 22. CONSOLIDATION: Four 28-day cycles: elotuzumab 10mg/kg IV days 1 and 15; len 15mg PO QD days 1-21; dex 28mg PO (3-24 hrs before elotuzumab) and 8mg IV (45-90 minutes before elotuzumab) days 1 and 15; dex 40mg PO days 8 and 22. MAINTENANCE: After completing consolidation therapy patients without progressive disease will receive, for up to 24 months, 28-day cycles of elotuzumab 20mg/kg IV day 1; len 10mg +/- 5mg PO QD days 1-21; dex 28mg PO (3-24 hrs before elotuzumab) and 8mg IV (45-90 minutes prior to elotuzumab) day 1. elotuzumab: Given intravenously (IV) Lenalidomide: Given by IV Dexamethasone: Given orally (PO) or by IV autologous stem cell transplantation
Blood and lymphatic system disorders Anaemia	1.9% 1/52 • Number of events 1 • weekly for 8 weeks, then every 2 weeks till the start of mobilization for Induction treatment and 70-120 days post-ASCT, every 2 weeks during 16 weeks of Consolidation treatment, and monthly for 24 months of Maintenance treatment up to 30 days after last dose of study drugs. Assessments will be made through analysis of the reported incidence of treatment-emergent Serious Adverse Events (SAEs) and non-serious adverse events (AEs).
Blood and lymphatic system disorders Febrile neutropenia	1.9% 1/52 • Number of events 1 • weekly for 8 weeks, then every 2 weeks till the start of mobilization for Induction treatment and 70-120 days post-ASCT, every 2 weeks during 16 weeks of Consolidation treatment, and monthly for 24 months of Maintenance treatment up to 30 days after last dose of study drugs. Assessments will be made through analysis of the reported incidence of treatment-emergent Serious Adverse Events (SAEs) and non-serious adverse events (AEs).
Blood and lymphatic system disorders Neutropenia	1.9% 1/52 • Number of events 1 • weekly for 8 weeks, then every 2 weeks till the start of mobilization for Induction treatment and 70-120 days post-ASCT, every 2 weeks during 16 weeks of Consolidation treatment, and monthly for 24 months of Maintenance treatment up to 30 days after last dose of study drugs. Assessments will be made through analysis of the reported incidence of treatment-emergent Serious Adverse Events (SAEs) and non-serious adverse events (AEs).
Cardiac disorders Cardiac failure congestive	1.9% 1/52 • Number of events 2 • weekly for 8 weeks, then every 2 weeks till the start of mobilization for Induction treatment and 70-120 days post-ASCT, every 2 weeks during 16 weeks of Consolidation treatment, and monthly for 24 months of Maintenance treatment up to 30 days after last dose of study drugs. Assessments will be made through analysis of the reported incidence of treatment-emergent Serious Adverse Events (SAEs) and non-serious adverse events (AEs).
Cardiac disorders Cardiac perforation	1.9% 1/52 • Number of events 1 • weekly for 8 weeks, then every 2 weeks till the start of mobilization for Induction treatment and 70-120 days post-ASCT, every 2 weeks during 16 weeks of Consolidation treatment, and monthly for 24 months of Maintenance treatment up to 30 days after last dose of study drugs. Assessments will be made through analysis of the reported incidence of treatment-emergent Serious Adverse Events (SAEs) and non-serious adverse events (AEs).
Gastrointestinal disorders Constipation	1.9% 1/52 • Number of events 1 • weekly for 8 weeks, then every 2 weeks till the start of mobilization for Induction treatment and 70-120 days post-ASCT, every 2 weeks during 16 weeks of Consolidation treatment, and monthly for 24 months of Maintenance treatment up to 30 days after last dose of study drugs. Assessments will be made through analysis of the reported incidence of treatment-emergent Serious Adverse Events (SAEs) and non-serious adverse events (AEs).
General disorders Pyrexia	1.9% 1/52 • Number of events 1 • weekly for 8 weeks, then every 2 weeks till the start of mobilization for Induction treatment and 70-120 days post-ASCT, every 2 weeks during 16 weeks of Consolidation treatment, and monthly for 24 months of Maintenance treatment up to 30 days after last dose of study drugs. Assessments will be made through analysis of the reported incidence of treatment-emergent Serious Adverse Events (SAEs) and non-serious adverse events (AEs).
Infections and infestations Bronchitis	1.9% 1/52 • Number of events 1 • weekly for 8 weeks, then every 2 weeks till the start of mobilization for Induction treatment and 70-120 days post-ASCT, every 2 weeks during 16 weeks of Consolidation treatment, and monthly for 24 months of Maintenance treatment up to 30 days after last dose of study drugs. Assessments will be made through analysis of the reported incidence of treatment-emergent Serious Adverse Events (SAEs) and non-serious adverse events (AEs).
Infections and infestations Cellulitis	1.9% 1/52 • Number of events 1 • weekly for 8 weeks, then every 2 weeks till the start of mobilization for Induction treatment and 70-120 days post-ASCT, every 2 weeks during 16 weeks of Consolidation treatment, and monthly for 24 months of Maintenance treatment up to 30 days after last dose of study drugs. Assessments will be made through analysis of the reported incidence of treatment-emergent Serious Adverse Events (SAEs) and non-serious adverse events (AEs).
Infections and infestations Clostridium difficile infection	1.9% 1/52 • Number of events 1 • weekly for 8 weeks, then every 2 weeks till the start of mobilization for Induction treatment and 70-120 days post-ASCT, every 2 weeks during 16 weeks of Consolidation treatment, and monthly for 24 months of Maintenance treatment up to 30 days after last dose of study drugs. Assessments will be made through analysis of the reported incidence of treatment-emergent Serious Adverse Events (SAEs) and non-serious adverse events (AEs).
Infections and infestations Enterocolitis bacterial	1.9% 1/52 • Number of events 1 • weekly for 8 weeks, then every 2 weeks till the start of mobilization for Induction treatment and 70-120 days post-ASCT, every 2 weeks during 16 weeks of Consolidation treatment, and monthly for 24 months of Maintenance treatment up to 30 days after last dose of study drugs. Assessments will be made through analysis of the reported incidence of treatment-emergent Serious Adverse Events (SAEs) and non-serious adverse events (AEs).
Infections and infestations Influenza	1.9% 1/52 • Number of events 1 • weekly for 8 weeks, then every 2 weeks till the start of mobilization for Induction treatment and 70-120 days post-ASCT, every 2 weeks during 16 weeks of Consolidation treatment, and monthly for 24 months of Maintenance treatment up to 30 days after last dose of study drugs. Assessments will be made through analysis of the reported incidence of treatment-emergent Serious Adverse Events (SAEs) and non-serious adverse events (AEs).
Infections and infestations Pneumonia	5.8% 3/52 • Number of events 3 • weekly for 8 weeks, then every 2 weeks till the start of mobilization for Induction treatment and 70-120 days post-ASCT, every 2 weeks during 16 weeks of Consolidation treatment, and monthly for 24 months of Maintenance treatment up to 30 days after last dose of study drugs. Assessments will be made through analysis of the reported incidence of treatment-emergent Serious Adverse Events (SAEs) and non-serious adverse events (AEs).
Infections and infestations Pneumonia parainfluenzae viral	1.9% 1/52 • Number of events 1 • weekly for 8 weeks, then every 2 weeks till the start of mobilization for Induction treatment and 70-120 days post-ASCT, every 2 weeks during 16 weeks of Consolidation treatment, and monthly for 24 months of Maintenance treatment up to 30 days after last dose of study drugs. Assessments will be made through analysis of the reported incidence of treatment-emergent Serious Adverse Events (SAEs) and non-serious adverse events (AEs).
Injury, poisoning and procedural complications Hip fracture	1.9% 1/52 • Number of events 1 • weekly for 8 weeks, then every 2 weeks till the start of mobilization for Induction treatment and 70-120 days post-ASCT, every 2 weeks during 16 weeks of Consolidation treatment, and monthly for 24 months of Maintenance treatment up to 30 days after last dose of study drugs. Assessments will be made through analysis of the reported incidence of treatment-emergent Serious Adverse Events (SAEs) and non-serious adverse events (AEs).
Metabolism and nutrition disorders Dehydration	1.9% 1/52 • Number of events 1 • weekly for 8 weeks, then every 2 weeks till the start of mobilization for Induction treatment and 70-120 days post-ASCT, every 2 weeks during 16 weeks of Consolidation treatment, and monthly for 24 months of Maintenance treatment up to 30 days after last dose of study drugs. Assessments will be made through analysis of the reported incidence of treatment-emergent Serious Adverse Events (SAEs) and non-serious adverse events (AEs).
Metabolism and nutrition disorders Hypercalcaemia	1.9% 1/52 • Number of events 1 • weekly for 8 weeks, then every 2 weeks till the start of mobilization for Induction treatment and 70-120 days post-ASCT, every 2 weeks during 16 weeks of Consolidation treatment, and monthly for 24 months of Maintenance treatment up to 30 days after last dose of study drugs. Assessments will be made through analysis of the reported incidence of treatment-emergent Serious Adverse Events (SAEs) and non-serious adverse events (AEs).
Musculoskeletal and connective tissue disorders Back pain	3.8% 2/52 • Number of events 2 • weekly for 8 weeks, then every 2 weeks till the start of mobilization for Induction treatment and 70-120 days post-ASCT, every 2 weeks during 16 weeks of Consolidation treatment, and monthly for 24 months of Maintenance treatment up to 30 days after last dose of study drugs. Assessments will be made through analysis of the reported incidence of treatment-emergent Serious Adverse Events (SAEs) and non-serious adverse events (AEs).
Nervous system disorders Ataxia	1.9% 1/52 • Number of events 1 • weekly for 8 weeks, then every 2 weeks till the start of mobilization for Induction treatment and 70-120 days post-ASCT, every 2 weeks during 16 weeks of Consolidation treatment, and monthly for 24 months of Maintenance treatment up to 30 days after last dose of study drugs. Assessments will be made through analysis of the reported incidence of treatment-emergent Serious Adverse Events (SAEs) and non-serious adverse events (AEs).
Nervous system disorders Syncope	3.8% 2/52 • Number of events 2 • weekly for 8 weeks, then every 2 weeks till the start of mobilization for Induction treatment and 70-120 days post-ASCT, every 2 weeks during 16 weeks of Consolidation treatment, and monthly for 24 months of Maintenance treatment up to 30 days after last dose of study drugs. Assessments will be made through analysis of the reported incidence of treatment-emergent Serious Adverse Events (SAEs) and non-serious adverse events (AEs).
Psychiatric disorders Substance-induced psychotic disorder	1.9% 1/52 • Number of events 1 • weekly for 8 weeks, then every 2 weeks till the start of mobilization for Induction treatment and 70-120 days post-ASCT, every 2 weeks during 16 weeks of Consolidation treatment, and monthly for 24 months of Maintenance treatment up to 30 days after last dose of study drugs. Assessments will be made through analysis of the reported incidence of treatment-emergent Serious Adverse Events (SAEs) and non-serious adverse events (AEs).
Respiratory, thoracic and mediastinal disorders Dyspnoea	1.9% 1/52 • Number of events 1 • weekly for 8 weeks, then every 2 weeks till the start of mobilization for Induction treatment and 70-120 days post-ASCT, every 2 weeks during 16 weeks of Consolidation treatment, and monthly for 24 months of Maintenance treatment up to 30 days after last dose of study drugs. Assessments will be made through analysis of the reported incidence of treatment-emergent Serious Adverse Events (SAEs) and non-serious adverse events (AEs).
Vascular disorders Deep vein thrombosis	1.9% 1/52 • Number of events 1 • weekly for 8 weeks, then every 2 weeks till the start of mobilization for Induction treatment and 70-120 days post-ASCT, every 2 weeks during 16 weeks of Consolidation treatment, and monthly for 24 months of Maintenance treatment up to 30 days after last dose of study drugs. Assessments will be made through analysis of the reported incidence of treatment-emergent Serious Adverse Events (SAEs) and non-serious adverse events (AEs).

Other adverse events

Measure	ERd Therapy n=52 participants at risk INDUCTION: Cycles 1-2: elotuzumab 10mg/kg IV days 1, 8, 15, 22; lenalidomide (len) 25mg orally (PO), once daily (QD) on days 1-21; dexamethasone (dex) 28 mg PO (3-24 hrs before elotuzumab IV) and 8mg IV (45-90 minutes before elotuzumab) days 1, 8, 15, 22. Cycles 3-4: elotuzumab 10mg/kg IV days 1 and 15; len 25mg PO QD days 1-21; dex 8mg PO (3-24 hrs before elotuzumab IV) and 8mg IV (45-90 minutes before elotuzumab) days 1 and 15; dex 40mg PO days 8 and 22. CONSOLIDATION: Four 28-day cycles: elotuzumab 10mg/kg IV days 1 and 15; len 15mg PO QD days 1-21; dex 28mg PO (3-24 hrs before elotuzumab) and 8mg IV (45-90 minutes before elotuzumab) days 1 and 15; dex 40mg PO days 8 and 22. MAINTENANCE: After completing consolidation therapy patients without progressive disease will receive, for up to 24 months, 28-day cycles of elotuzumab 20mg/kg IV day 1; len 10mg +/- 5mg PO QD days 1-21; dex 28mg PO (3-24 hrs before elotuzumab) and 8mg IV (45-90 minutes prior to elotuzumab) day 1. elotuzumab: Given intravenously (IV) Lenalidomide: Given by IV Dexamethasone: Given orally (PO) or by IV autologous stem cell transplantation
Blood and lymphatic system disorders Anaemia	19.2% 10/52 • Number of events 29 • weekly for 8 weeks, then every 2 weeks till the start of mobilization for Induction treatment and 70-120 days post-ASCT, every 2 weeks during 16 weeks of Consolidation treatment, and monthly for 24 months of Maintenance treatment up to 30 days after last dose of study drugs. Assessments will be made through analysis of the reported incidence of treatment-emergent Serious Adverse Events (SAEs) and non-serious adverse events (AEs).
Blood and lymphatic system disorders Febrile neutropenia	1.9% 1/52 • Number of events 2 • weekly for 8 weeks, then every 2 weeks till the start of mobilization for Induction treatment and 70-120 days post-ASCT, every 2 weeks during 16 weeks of Consolidation treatment, and monthly for 24 months of Maintenance treatment up to 30 days after last dose of study drugs. Assessments will be made through analysis of the reported incidence of treatment-emergent Serious Adverse Events (SAEs) and non-serious adverse events (AEs).
Blood and lymphatic system disorders Increased tendency to bruise	1.9% 1/52 • Number of events 1 • weekly for 8 weeks, then every 2 weeks till the start of mobilization for Induction treatment and 70-120 days post-ASCT, every 2 weeks during 16 weeks of Consolidation treatment, and monthly for 24 months of Maintenance treatment up to 30 days after last dose of study drugs. Assessments will be made through analysis of the reported incidence of treatment-emergent Serious Adverse Events (SAEs) and non-serious adverse events (AEs).
Blood and lymphatic system disorders Neutropenia	17.3% 9/52 • Number of events 22 • weekly for 8 weeks, then every 2 weeks till the start of mobilization for Induction treatment and 70-120 days post-ASCT, every 2 weeks during 16 weeks of Consolidation treatment, and monthly for 24 months of Maintenance treatment up to 30 days after last dose of study drugs. Assessments will be made through analysis of the reported incidence of treatment-emergent Serious Adverse Events (SAEs) and non-serious adverse events (AEs).
Blood and lymphatic system disorders Thrombocytopenia	13.5% 7/52 • Number of events 15 • weekly for 8 weeks, then every 2 weeks till the start of mobilization for Induction treatment and 70-120 days post-ASCT, every 2 weeks during 16 weeks of Consolidation treatment, and monthly for 24 months of Maintenance treatment up to 30 days after last dose of study drugs. Assessments will be made through analysis of the reported incidence of treatment-emergent Serious Adverse Events (SAEs) and non-serious adverse events (AEs).
Cardiac disorders Acute myocardial infarction	1.9% 1/52 • Number of events 1 • weekly for 8 weeks, then every 2 weeks till the start of mobilization for Induction treatment and 70-120 days post-ASCT, every 2 weeks during 16 weeks of Consolidation treatment, and monthly for 24 months of Maintenance treatment up to 30 days after last dose of study drugs. Assessments will be made through analysis of the reported incidence of treatment-emergent Serious Adverse Events (SAEs) and non-serious adverse events (AEs).
Cardiac disorders Atrial fibrillation	3.8% 2/52 • Number of events 2 • weekly for 8 weeks, then every 2 weeks till the start of mobilization for Induction treatment and 70-120 days post-ASCT, every 2 weeks during 16 weeks of Consolidation treatment, and monthly for 24 months of Maintenance treatment up to 30 days after last dose of study drugs. Assessments will be made through analysis of the reported incidence of treatment-emergent Serious Adverse Events (SAEs) and non-serious adverse events (AEs).
Ear and labyrinth disorders Deafness	1.9% 1/52 • Number of events 1 • weekly for 8 weeks, then every 2 weeks till the start of mobilization for Induction treatment and 70-120 days post-ASCT, every 2 weeks during 16 weeks of Consolidation treatment, and monthly for 24 months of Maintenance treatment up to 30 days after last dose of study drugs. Assessments will be made through analysis of the reported incidence of treatment-emergent Serious Adverse Events (SAEs) and non-serious adverse events (AEs).
Ear and labyrinth disorders Ear pain	3.8% 2/52 • Number of events 2 • weekly for 8 weeks, then every 2 weeks till the start of mobilization for Induction treatment and 70-120 days post-ASCT, every 2 weeks during 16 weeks of Consolidation treatment, and monthly for 24 months of Maintenance treatment up to 30 days after last dose of study drugs. Assessments will be made through analysis of the reported incidence of treatment-emergent Serious Adverse Events (SAEs) and non-serious adverse events (AEs).
Ear and labyrinth disorders Tinnitus	13.5% 7/52 • Number of events 7 • weekly for 8 weeks, then every 2 weeks till the start of mobilization for Induction treatment and 70-120 days post-ASCT, every 2 weeks during 16 weeks of Consolidation treatment, and monthly for 24 months of Maintenance treatment up to 30 days after last dose of study drugs. Assessments will be made through analysis of the reported incidence of treatment-emergent Serious Adverse Events (SAEs) and non-serious adverse events (AEs).
Eye disorders Ectropion	1.9% 1/52 • Number of events 1 • weekly for 8 weeks, then every 2 weeks till the start of mobilization for Induction treatment and 70-120 days post-ASCT, every 2 weeks during 16 weeks of Consolidation treatment, and monthly for 24 months of Maintenance treatment up to 30 days after last dose of study drugs. Assessments will be made through analysis of the reported incidence of treatment-emergent Serious Adverse Events (SAEs) and non-serious adverse events (AEs).
Eye disorders Eye irritation	1.9% 1/52 • Number of events 1 • weekly for 8 weeks, then every 2 weeks till the start of mobilization for Induction treatment and 70-120 days post-ASCT, every 2 weeks during 16 weeks of Consolidation treatment, and monthly for 24 months of Maintenance treatment up to 30 days after last dose of study drugs. Assessments will be made through analysis of the reported incidence of treatment-emergent Serious Adverse Events (SAEs) and non-serious adverse events (AEs).
Eye disorders Eye pruritus	1.9% 1/52 • Number of events 1 • weekly for 8 weeks, then every 2 weeks till the start of mobilization for Induction treatment and 70-120 days post-ASCT, every 2 weeks during 16 weeks of Consolidation treatment, and monthly for 24 months of Maintenance treatment up to 30 days after last dose of study drugs. Assessments will be made through analysis of the reported incidence of treatment-emergent Serious Adverse Events (SAEs) and non-serious adverse events (AEs).
Eye disorders Vision blurred	5.8% 3/52 • Number of events 3 • weekly for 8 weeks, then every 2 weeks till the start of mobilization for Induction treatment and 70-120 days post-ASCT, every 2 weeks during 16 weeks of Consolidation treatment, and monthly for 24 months of Maintenance treatment up to 30 days after last dose of study drugs. Assessments will be made through analysis of the reported incidence of treatment-emergent Serious Adverse Events (SAEs) and non-serious adverse events (AEs).
Eye disorders Visual impairment	3.8% 2/52 • Number of events 2 • weekly for 8 weeks, then every 2 weeks till the start of mobilization for Induction treatment and 70-120 days post-ASCT, every 2 weeks during 16 weeks of Consolidation treatment, and monthly for 24 months of Maintenance treatment up to 30 days after last dose of study drugs. Assessments will be made through analysis of the reported incidence of treatment-emergent Serious Adverse Events (SAEs) and non-serious adverse events (AEs).
Gastrointestinal disorders Abdominal discomfort	3.8% 2/52 • Number of events 4 • weekly for 8 weeks, then every 2 weeks till the start of mobilization for Induction treatment and 70-120 days post-ASCT, every 2 weeks during 16 weeks of Consolidation treatment, and monthly for 24 months of Maintenance treatment up to 30 days after last dose of study drugs. Assessments will be made through analysis of the reported incidence of treatment-emergent Serious Adverse Events (SAEs) and non-serious adverse events (AEs).
Gastrointestinal disorders Abdominal distension	3.8% 2/52 • Number of events 2 • weekly for 8 weeks, then every 2 weeks till the start of mobilization for Induction treatment and 70-120 days post-ASCT, every 2 weeks during 16 weeks of Consolidation treatment, and monthly for 24 months of Maintenance treatment up to 30 days after last dose of study drugs. Assessments will be made through analysis of the reported incidence of treatment-emergent Serious Adverse Events (SAEs) and non-serious adverse events (AEs).
Gastrointestinal disorders Abdominal pain	7.7% 4/52 • Number of events 6 • weekly for 8 weeks, then every 2 weeks till the start of mobilization for Induction treatment and 70-120 days post-ASCT, every 2 weeks during 16 weeks of Consolidation treatment, and monthly for 24 months of Maintenance treatment up to 30 days after last dose of study drugs. Assessments will be made through analysis of the reported incidence of treatment-emergent Serious Adverse Events (SAEs) and non-serious adverse events (AEs).
Gastrointestinal disorders Abdominal pain lower	3.8% 2/52 • Number of events 2 • weekly for 8 weeks, then every 2 weeks till the start of mobilization for Induction treatment and 70-120 days post-ASCT, every 2 weeks during 16 weeks of Consolidation treatment, and monthly for 24 months of Maintenance treatment up to 30 days after last dose of study drugs. Assessments will be made through analysis of the reported incidence of treatment-emergent Serious Adverse Events (SAEs) and non-serious adverse events (AEs).
Gastrointestinal disorders Abdominal pain upper	3.8% 2/52 • Number of events 2 • weekly for 8 weeks, then every 2 weeks till the start of mobilization for Induction treatment and 70-120 days post-ASCT, every 2 weeks during 16 weeks of Consolidation treatment, and monthly for 24 months of Maintenance treatment up to 30 days after last dose of study drugs. Assessments will be made through analysis of the reported incidence of treatment-emergent Serious Adverse Events (SAEs) and non-serious adverse events (AEs).
Gastrointestinal disorders Constipation	38.5% 20/52 • Number of events 31 • weekly for 8 weeks, then every 2 weeks till the start of mobilization for Induction treatment and 70-120 days post-ASCT, every 2 weeks during 16 weeks of Consolidation treatment, and monthly for 24 months of Maintenance treatment up to 30 days after last dose of study drugs. Assessments will be made through analysis of the reported incidence of treatment-emergent Serious Adverse Events (SAEs) and non-serious adverse events (AEs).
Gastrointestinal disorders Diarrhoea	48.1% 25/52 • Number of events 39 • weekly for 8 weeks, then every 2 weeks till the start of mobilization for Induction treatment and 70-120 days post-ASCT, every 2 weeks during 16 weeks of Consolidation treatment, and monthly for 24 months of Maintenance treatment up to 30 days after last dose of study drugs. Assessments will be made through analysis of the reported incidence of treatment-emergent Serious Adverse Events (SAEs) and non-serious adverse events (AEs).
Gastrointestinal disorders Diverticulum	1.9% 1/52 • Number of events 1 • weekly for 8 weeks, then every 2 weeks till the start of mobilization for Induction treatment and 70-120 days post-ASCT, every 2 weeks during 16 weeks of Consolidation treatment, and monthly for 24 months of Maintenance treatment up to 30 days after last dose of study drugs. Assessments will be made through analysis of the reported incidence of treatment-emergent Serious Adverse Events (SAEs) and non-serious adverse events (AEs).
Gastrointestinal disorders Dry mouth	3.8% 2/52 • Number of events 2 • weekly for 8 weeks, then every 2 weeks till the start of mobilization for Induction treatment and 70-120 days post-ASCT, every 2 weeks during 16 weeks of Consolidation treatment, and monthly for 24 months of Maintenance treatment up to 30 days after last dose of study drugs. Assessments will be made through analysis of the reported incidence of treatment-emergent Serious Adverse Events (SAEs) and non-serious adverse events (AEs).
Gastrointestinal disorders Epigastric discomfort	1.9% 1/52 • Number of events 2 • weekly for 8 weeks, then every 2 weeks till the start of mobilization for Induction treatment and 70-120 days post-ASCT, every 2 weeks during 16 weeks of Consolidation treatment, and monthly for 24 months of Maintenance treatment up to 30 days after last dose of study drugs. Assessments will be made through analysis of the reported incidence of treatment-emergent Serious Adverse Events (SAEs) and non-serious adverse events (AEs).
Gastrointestinal disorders Flatulence	1.9% 1/52 • Number of events 1 • weekly for 8 weeks, then every 2 weeks till the start of mobilization for Induction treatment and 70-120 days post-ASCT, every 2 weeks during 16 weeks of Consolidation treatment, and monthly for 24 months of Maintenance treatment up to 30 days after last dose of study drugs. Assessments will be made through analysis of the reported incidence of treatment-emergent Serious Adverse Events (SAEs) and non-serious adverse events (AEs).
Gastrointestinal disorders Gastrointestinal toxicity	1.9% 1/52 • Number of events 1 • weekly for 8 weeks, then every 2 weeks till the start of mobilization for Induction treatment and 70-120 days post-ASCT, every 2 weeks during 16 weeks of Consolidation treatment, and monthly for 24 months of Maintenance treatment up to 30 days after last dose of study drugs. Assessments will be made through analysis of the reported incidence of treatment-emergent Serious Adverse Events (SAEs) and non-serious adverse events (AEs).
Gastrointestinal disorders Gastrooesophageal reflux disease	13.5% 7/52 • Number of events 8 • weekly for 8 weeks, then every 2 weeks till the start of mobilization for Induction treatment and 70-120 days post-ASCT, every 2 weeks during 16 weeks of Consolidation treatment, and monthly for 24 months of Maintenance treatment up to 30 days after last dose of study drugs. Assessments will be made through analysis of the reported incidence of treatment-emergent Serious Adverse Events (SAEs) and non-serious adverse events (AEs).
Gastrointestinal disorders Glossodynia	1.9% 1/52 • Number of events 1 • weekly for 8 weeks, then every 2 weeks till the start of mobilization for Induction treatment and 70-120 days post-ASCT, every 2 weeks during 16 weeks of Consolidation treatment, and monthly for 24 months of Maintenance treatment up to 30 days after last dose of study drugs. Assessments will be made through analysis of the reported incidence of treatment-emergent Serious Adverse Events (SAEs) and non-serious adverse events (AEs).
Gastrointestinal disorders Haematochezia	3.8% 2/52 • Number of events 2 • weekly for 8 weeks, then every 2 weeks till the start of mobilization for Induction treatment and 70-120 days post-ASCT, every 2 weeks during 16 weeks of Consolidation treatment, and monthly for 24 months of Maintenance treatment up to 30 days after last dose of study drugs. Assessments will be made through analysis of the reported incidence of treatment-emergent Serious Adverse Events (SAEs) and non-serious adverse events (AEs).
Gastrointestinal disorders Haemorrhoids	1.9% 1/52 • Number of events 2 • weekly for 8 weeks, then every 2 weeks till the start of mobilization for Induction treatment and 70-120 days post-ASCT, every 2 weeks during 16 weeks of Consolidation treatment, and monthly for 24 months of Maintenance treatment up to 30 days after last dose of study drugs. Assessments will be made through analysis of the reported incidence of treatment-emergent Serious Adverse Events (SAEs) and non-serious adverse events (AEs).
Gastrointestinal disorders Hypoaesthesia oral	1.9% 1/52 • Number of events 1 • weekly for 8 weeks, then every 2 weeks till the start of mobilization for Induction treatment and 70-120 days post-ASCT, every 2 weeks during 16 weeks of Consolidation treatment, and monthly for 24 months of Maintenance treatment up to 30 days after last dose of study drugs. Assessments will be made through analysis of the reported incidence of treatment-emergent Serious Adverse Events (SAEs) and non-serious adverse events (AEs).
Gastrointestinal disorders Inguinal hernia	3.8% 2/52 • Number of events 3 • weekly for 8 weeks, then every 2 weeks till the start of mobilization for Induction treatment and 70-120 days post-ASCT, every 2 weeks during 16 weeks of Consolidation treatment, and monthly for 24 months of Maintenance treatment up to 30 days after last dose of study drugs. Assessments will be made through analysis of the reported incidence of treatment-emergent Serious Adverse Events (SAEs) and non-serious adverse events (AEs).
Gastrointestinal disorders Nausea	42.3% 22/52 • Number of events 31 • weekly for 8 weeks, then every 2 weeks till the start of mobilization for Induction treatment and 70-120 days post-ASCT, every 2 weeks during 16 weeks of Consolidation treatment, and monthly for 24 months of Maintenance treatment up to 30 days after last dose of study drugs. Assessments will be made through analysis of the reported incidence of treatment-emergent Serious Adverse Events (SAEs) and non-serious adverse events (AEs).
Gastrointestinal disorders Oesophagitis	1.9% 1/52 • Number of events 1 • weekly for 8 weeks, then every 2 weeks till the start of mobilization for Induction treatment and 70-120 days post-ASCT, every 2 weeks during 16 weeks of Consolidation treatment, and monthly for 24 months of Maintenance treatment up to 30 days after last dose of study drugs. Assessments will be made through analysis of the reported incidence of treatment-emergent Serious Adverse Events (SAEs) and non-serious adverse events (AEs).
Gastrointestinal disorders Oral pain	1.9% 1/52 • Number of events 1 • weekly for 8 weeks, then every 2 weeks till the start of mobilization for Induction treatment and 70-120 days post-ASCT, every 2 weeks during 16 weeks of Consolidation treatment, and monthly for 24 months of Maintenance treatment up to 30 days after last dose of study drugs. Assessments will be made through analysis of the reported incidence of treatment-emergent Serious Adverse Events (SAEs) and non-serious adverse events (AEs).
Gastrointestinal disorders Poor dental condition	1.9% 1/52 • Number of events 1 • weekly for 8 weeks, then every 2 weeks till the start of mobilization for Induction treatment and 70-120 days post-ASCT, every 2 weeks during 16 weeks of Consolidation treatment, and monthly for 24 months of Maintenance treatment up to 30 days after last dose of study drugs. Assessments will be made through analysis of the reported incidence of treatment-emergent Serious Adverse Events (SAEs) and non-serious adverse events (AEs).
Gastrointestinal disorders Rectal haemorrhage	1.9% 1/52 • Number of events 1 • weekly for 8 weeks, then every 2 weeks till the start of mobilization for Induction treatment and 70-120 days post-ASCT, every 2 weeks during 16 weeks of Consolidation treatment, and monthly for 24 months of Maintenance treatment up to 30 days after last dose of study drugs. Assessments will be made through analysis of the reported incidence of treatment-emergent Serious Adverse Events (SAEs) and non-serious adverse events (AEs).
Gastrointestinal disorders Stomatitis	1.9% 1/52 • Number of events 1 • weekly for 8 weeks, then every 2 weeks till the start of mobilization for Induction treatment and 70-120 days post-ASCT, every 2 weeks during 16 weeks of Consolidation treatment, and monthly for 24 months of Maintenance treatment up to 30 days after last dose of study drugs. Assessments will be made through analysis of the reported incidence of treatment-emergent Serious Adverse Events (SAEs) and non-serious adverse events (AEs).
Gastrointestinal disorders Toothache	1.9% 1/52 • Number of events 1 • weekly for 8 weeks, then every 2 weeks till the start of mobilization for Induction treatment and 70-120 days post-ASCT, every 2 weeks during 16 weeks of Consolidation treatment, and monthly for 24 months of Maintenance treatment up to 30 days after last dose of study drugs. Assessments will be made through analysis of the reported incidence of treatment-emergent Serious Adverse Events (SAEs) and non-serious adverse events (AEs).
Gastrointestinal disorders Vomiting	19.2% 10/52 • Number of events 15 • weekly for 8 weeks, then every 2 weeks till the start of mobilization for Induction treatment and 70-120 days post-ASCT, every 2 weeks during 16 weeks of Consolidation treatment, and monthly for 24 months of Maintenance treatment up to 30 days after last dose of study drugs. Assessments will be made through analysis of the reported incidence of treatment-emergent Serious Adverse Events (SAEs) and non-serious adverse events (AEs).
General disorders Asthenia	13.5% 7/52 • Number of events 7 • weekly for 8 weeks, then every 2 weeks till the start of mobilization for Induction treatment and 70-120 days post-ASCT, every 2 weeks during 16 weeks of Consolidation treatment, and monthly for 24 months of Maintenance treatment up to 30 days after last dose of study drugs. Assessments will be made through analysis of the reported incidence of treatment-emergent Serious Adverse Events (SAEs) and non-serious adverse events (AEs).
General disorders Chest discomfort	1.9% 1/52 • Number of events 1 • weekly for 8 weeks, then every 2 weeks till the start of mobilization for Induction treatment and 70-120 days post-ASCT, every 2 weeks during 16 weeks of Consolidation treatment, and monthly for 24 months of Maintenance treatment up to 30 days after last dose of study drugs. Assessments will be made through analysis of the reported incidence of treatment-emergent Serious Adverse Events (SAEs) and non-serious adverse events (AEs).
General disorders Chills	19.2% 10/52 • Number of events 12 • weekly for 8 weeks, then every 2 weeks till the start of mobilization for Induction treatment and 70-120 days post-ASCT, every 2 weeks during 16 weeks of Consolidation treatment, and monthly for 24 months of Maintenance treatment up to 30 days after last dose of study drugs. Assessments will be made through analysis of the reported incidence of treatment-emergent Serious Adverse Events (SAEs) and non-serious adverse events (AEs).
General disorders Fatigue	59.6% 31/52 • Number of events 48 • weekly for 8 weeks, then every 2 weeks till the start of mobilization for Induction treatment and 70-120 days post-ASCT, every 2 weeks during 16 weeks of Consolidation treatment, and monthly for 24 months of Maintenance treatment up to 30 days after last dose of study drugs. Assessments will be made through analysis of the reported incidence of treatment-emergent Serious Adverse Events (SAEs) and non-serious adverse events (AEs).
General disorders Feeling abnormal	1.9% 1/52 • Number of events 1 • weekly for 8 weeks, then every 2 weeks till the start of mobilization for Induction treatment and 70-120 days post-ASCT, every 2 weeks during 16 weeks of Consolidation treatment, and monthly for 24 months of Maintenance treatment up to 30 days after last dose of study drugs. Assessments will be made through analysis of the reported incidence of treatment-emergent Serious Adverse Events (SAEs) and non-serious adverse events (AEs).
General disorders Feeling cold	1.9% 1/52 • Number of events 1 • weekly for 8 weeks, then every 2 weeks till the start of mobilization for Induction treatment and 70-120 days post-ASCT, every 2 weeks during 16 weeks of Consolidation treatment, and monthly for 24 months of Maintenance treatment up to 30 days after last dose of study drugs. Assessments will be made through analysis of the reported incidence of treatment-emergent Serious Adverse Events (SAEs) and non-serious adverse events (AEs).
General disorders Feeling jittery	1.9% 1/52 • Number of events 1 • weekly for 8 weeks, then every 2 weeks till the start of mobilization for Induction treatment and 70-120 days post-ASCT, every 2 weeks during 16 weeks of Consolidation treatment, and monthly for 24 months of Maintenance treatment up to 30 days after last dose of study drugs. Assessments will be made through analysis of the reported incidence of treatment-emergent Serious Adverse Events (SAEs) and non-serious adverse events (AEs).
General disorders Influenza like illness	11.5% 6/52 • Number of events 12 • weekly for 8 weeks, then every 2 weeks till the start of mobilization for Induction treatment and 70-120 days post-ASCT, every 2 weeks during 16 weeks of Consolidation treatment, and monthly for 24 months of Maintenance treatment up to 30 days after last dose of study drugs. Assessments will be made through analysis of the reported incidence of treatment-emergent Serious Adverse Events (SAEs) and non-serious adverse events (AEs).
General disorders Infusion site bruising	1.9% 1/52 • Number of events 1 • weekly for 8 weeks, then every 2 weeks till the start of mobilization for Induction treatment and 70-120 days post-ASCT, every 2 weeks during 16 weeks of Consolidation treatment, and monthly for 24 months of Maintenance treatment up to 30 days after last dose of study drugs. Assessments will be made through analysis of the reported incidence of treatment-emergent Serious Adverse Events (SAEs) and non-serious adverse events (AEs).
General disorders Malaise	1.9% 1/52 • Number of events 1 • weekly for 8 weeks, then every 2 weeks till the start of mobilization for Induction treatment and 70-120 days post-ASCT, every 2 weeks during 16 weeks of Consolidation treatment, and monthly for 24 months of Maintenance treatment up to 30 days after last dose of study drugs. Assessments will be made through analysis of the reported incidence of treatment-emergent Serious Adverse Events (SAEs) and non-serious adverse events (AEs).
General disorders Mucosal inflammation	7.7% 4/52 • Number of events 5 • weekly for 8 weeks, then every 2 weeks till the start of mobilization for Induction treatment and 70-120 days post-ASCT, every 2 weeks during 16 weeks of Consolidation treatment, and monthly for 24 months of Maintenance treatment up to 30 days after last dose of study drugs. Assessments will be made through analysis of the reported incidence of treatment-emergent Serious Adverse Events (SAEs) and non-serious adverse events (AEs).
General disorders Non-cardiac chest pain	3.8% 2/52 • Number of events 2 • weekly for 8 weeks, then every 2 weeks till the start of mobilization for Induction treatment and 70-120 days post-ASCT, every 2 weeks during 16 weeks of Consolidation treatment, and monthly for 24 months of Maintenance treatment up to 30 days after last dose of study drugs. Assessments will be made through analysis of the reported incidence of treatment-emergent Serious Adverse Events (SAEs) and non-serious adverse events (AEs).
General disorders Oedema	1.9% 1/52 • Number of events 1 • weekly for 8 weeks, then every 2 weeks till the start of mobilization for Induction treatment and 70-120 days post-ASCT, every 2 weeks during 16 weeks of Consolidation treatment, and monthly for 24 months of Maintenance treatment up to 30 days after last dose of study drugs. Assessments will be made through analysis of the reported incidence of treatment-emergent Serious Adverse Events (SAEs) and non-serious adverse events (AEs).
General disorders Oedema peripheral	19.2% 10/52 • Number of events 10 • weekly for 8 weeks, then every 2 weeks till the start of mobilization for Induction treatment and 70-120 days post-ASCT, every 2 weeks during 16 weeks of Consolidation treatment, and monthly for 24 months of Maintenance treatment up to 30 days after last dose of study drugs. Assessments will be made through analysis of the reported incidence of treatment-emergent Serious Adverse Events (SAEs) and non-serious adverse events (AEs).
General disorders Pain	11.5% 6/52 • Number of events 6 • weekly for 8 weeks, then every 2 weeks till the start of mobilization for Induction treatment and 70-120 days post-ASCT, every 2 weeks during 16 weeks of Consolidation treatment, and monthly for 24 months of Maintenance treatment up to 30 days after last dose of study drugs. Assessments will be made through analysis of the reported incidence of treatment-emergent Serious Adverse Events (SAEs) and non-serious adverse events (AEs).
General disorders Peripheral swelling	11.5% 6/52 • Number of events 7 • weekly for 8 weeks, then every 2 weeks till the start of mobilization for Induction treatment and 70-120 days post-ASCT, every 2 weeks during 16 weeks of Consolidation treatment, and monthly for 24 months of Maintenance treatment up to 30 days after last dose of study drugs. Assessments will be made through analysis of the reported incidence of treatment-emergent Serious Adverse Events (SAEs) and non-serious adverse events (AEs).
General disorders Pyrexia	34.6% 18/52 • Number of events 33 • weekly for 8 weeks, then every 2 weeks till the start of mobilization for Induction treatment and 70-120 days post-ASCT, every 2 weeks during 16 weeks of Consolidation treatment, and monthly for 24 months of Maintenance treatment up to 30 days after last dose of study drugs. Assessments will be made through analysis of the reported incidence of treatment-emergent Serious Adverse Events (SAEs) and non-serious adverse events (AEs).
General disorders Temperature intolerance	1.9% 1/52 • Number of events 1 • weekly for 8 weeks, then every 2 weeks till the start of mobilization for Induction treatment and 70-120 days post-ASCT, every 2 weeks during 16 weeks of Consolidation treatment, and monthly for 24 months of Maintenance treatment up to 30 days after last dose of study drugs. Assessments will be made through analysis of the reported incidence of treatment-emergent Serious Adverse Events (SAEs) and non-serious adverse events (AEs).
General disorders Unevaluable event	1.9% 1/52 • Number of events 1 • weekly for 8 weeks, then every 2 weeks till the start of mobilization for Induction treatment and 70-120 days post-ASCT, every 2 weeks during 16 weeks of Consolidation treatment, and monthly for 24 months of Maintenance treatment up to 30 days after last dose of study drugs. Assessments will be made through analysis of the reported incidence of treatment-emergent Serious Adverse Events (SAEs) and non-serious adverse events (AEs).
Immune system disorders Hypogammaglobulinaemia	1.9% 1/52 • Number of events 1 • weekly for 8 weeks, then every 2 weeks till the start of mobilization for Induction treatment and 70-120 days post-ASCT, every 2 weeks during 16 weeks of Consolidation treatment, and monthly for 24 months of Maintenance treatment up to 30 days after last dose of study drugs. Assessments will be made through analysis of the reported incidence of treatment-emergent Serious Adverse Events (SAEs) and non-serious adverse events (AEs).
Immune system disorders Seasonal allergy	7.7% 4/52 • Number of events 4 • weekly for 8 weeks, then every 2 weeks till the start of mobilization for Induction treatment and 70-120 days post-ASCT, every 2 weeks during 16 weeks of Consolidation treatment, and monthly for 24 months of Maintenance treatment up to 30 days after last dose of study drugs. Assessments will be made through analysis of the reported incidence of treatment-emergent Serious Adverse Events (SAEs) and non-serious adverse events (AEs).
Infections and infestations Bronchitis	7.7% 4/52 • Number of events 4 • weekly for 8 weeks, then every 2 weeks till the start of mobilization for Induction treatment and 70-120 days post-ASCT, every 2 weeks during 16 weeks of Consolidation treatment, and monthly for 24 months of Maintenance treatment up to 30 days after last dose of study drugs. Assessments will be made through analysis of the reported incidence of treatment-emergent Serious Adverse Events (SAEs) and non-serious adverse events (AEs).
Infections and infestations Candida infection	1.9% 1/52 • Number of events 1 • weekly for 8 weeks, then every 2 weeks till the start of mobilization for Induction treatment and 70-120 days post-ASCT, every 2 weeks during 16 weeks of Consolidation treatment, and monthly for 24 months of Maintenance treatment up to 30 days after last dose of study drugs. Assessments will be made through analysis of the reported incidence of treatment-emergent Serious Adverse Events (SAEs) and non-serious adverse events (AEs).
Infections and infestations Conjunctivitis	1.9% 1/52 • Number of events 1 • weekly for 8 weeks, then every 2 weeks till the start of mobilization for Induction treatment and 70-120 days post-ASCT, every 2 weeks during 16 weeks of Consolidation treatment, and monthly for 24 months of Maintenance treatment up to 30 days after last dose of study drugs. Assessments will be made through analysis of the reported incidence of treatment-emergent Serious Adverse Events (SAEs) and non-serious adverse events (AEs).
Infections and infestations Folliculitis	1.9% 1/52 • Number of events 1 • weekly for 8 weeks, then every 2 weeks till the start of mobilization for Induction treatment and 70-120 days post-ASCT, every 2 weeks during 16 weeks of Consolidation treatment, and monthly for 24 months of Maintenance treatment up to 30 days after last dose of study drugs. Assessments will be made through analysis of the reported incidence of treatment-emergent Serious Adverse Events (SAEs) and non-serious adverse events (AEs).
Infections and infestations Fungal infection	5.8% 3/52 • Number of events 3 • weekly for 8 weeks, then every 2 weeks till the start of mobilization for Induction treatment and 70-120 days post-ASCT, every 2 weeks during 16 weeks of Consolidation treatment, and monthly for 24 months of Maintenance treatment up to 30 days after last dose of study drugs. Assessments will be made through analysis of the reported incidence of treatment-emergent Serious Adverse Events (SAEs) and non-serious adverse events (AEs).
Infections and infestations Gastroenteritis	1.9% 1/52 • Number of events 1 • weekly for 8 weeks, then every 2 weeks till the start of mobilization for Induction treatment and 70-120 days post-ASCT, every 2 weeks during 16 weeks of Consolidation treatment, and monthly for 24 months of Maintenance treatment up to 30 days after last dose of study drugs. Assessments will be made through analysis of the reported incidence of treatment-emergent Serious Adverse Events (SAEs) and non-serious adverse events (AEs).
Infections and infestations Gastrointestinal viral infection	1.9% 1/52 • Number of events 1 • weekly for 8 weeks, then every 2 weeks till the start of mobilization for Induction treatment and 70-120 days post-ASCT, every 2 weeks during 16 weeks of Consolidation treatment, and monthly for 24 months of Maintenance treatment up to 30 days after last dose of study drugs. Assessments will be made through analysis of the reported incidence of treatment-emergent Serious Adverse Events (SAEs) and non-serious adverse events (AEs).
Infections and infestations Gingivitis	3.8% 2/52 • Number of events 2 • weekly for 8 weeks, then every 2 weeks till the start of mobilization for Induction treatment and 70-120 days post-ASCT, every 2 weeks during 16 weeks of Consolidation treatment, and monthly for 24 months of Maintenance treatment up to 30 days after last dose of study drugs. Assessments will be made through analysis of the reported incidence of treatment-emergent Serious Adverse Events (SAEs) and non-serious adverse events (AEs).
Infections and infestations Herpes zoster	1.9% 1/52 • Number of events 1 • weekly for 8 weeks, then every 2 weeks till the start of mobilization for Induction treatment and 70-120 days post-ASCT, every 2 weeks during 16 weeks of Consolidation treatment, and monthly for 24 months of Maintenance treatment up to 30 days after last dose of study drugs. Assessments will be made through analysis of the reported incidence of treatment-emergent Serious Adverse Events (SAEs) and non-serious adverse events (AEs).
Infections and infestations Hordeolum	1.9% 1/52 • Number of events 1 • weekly for 8 weeks, then every 2 weeks till the start of mobilization for Induction treatment and 70-120 days post-ASCT, every 2 weeks during 16 weeks of Consolidation treatment, and monthly for 24 months of Maintenance treatment up to 30 days after last dose of study drugs. Assessments will be made through analysis of the reported incidence of treatment-emergent Serious Adverse Events (SAEs) and non-serious adverse events (AEs).
Infections and infestations Infection	1.9% 1/52 • Number of events 1 • weekly for 8 weeks, then every 2 weeks till the start of mobilization for Induction treatment and 70-120 days post-ASCT, every 2 weeks during 16 weeks of Consolidation treatment, and monthly for 24 months of Maintenance treatment up to 30 days after last dose of study drugs. Assessments will be made through analysis of the reported incidence of treatment-emergent Serious Adverse Events (SAEs) and non-serious adverse events (AEs).
Infections and infestations Influenza	9.6% 5/52 • Number of events 5 • weekly for 8 weeks, then every 2 weeks till the start of mobilization for Induction treatment and 70-120 days post-ASCT, every 2 weeks during 16 weeks of Consolidation treatment, and monthly for 24 months of Maintenance treatment up to 30 days after last dose of study drugs. Assessments will be made through analysis of the reported incidence of treatment-emergent Serious Adverse Events (SAEs) and non-serious adverse events (AEs).
Infections and infestations Nasopharyngitis	3.8% 2/52 • Number of events 2 • weekly for 8 weeks, then every 2 weeks till the start of mobilization for Induction treatment and 70-120 days post-ASCT, every 2 weeks during 16 weeks of Consolidation treatment, and monthly for 24 months of Maintenance treatment up to 30 days after last dose of study drugs. Assessments will be made through analysis of the reported incidence of treatment-emergent Serious Adverse Events (SAEs) and non-serious adverse events (AEs).
Infections and infestations Oral herpes	1.9% 1/52 • Number of events 1 • weekly for 8 weeks, then every 2 weeks till the start of mobilization for Induction treatment and 70-120 days post-ASCT, every 2 weeks during 16 weeks of Consolidation treatment, and monthly for 24 months of Maintenance treatment up to 30 days after last dose of study drugs. Assessments will be made through analysis of the reported incidence of treatment-emergent Serious Adverse Events (SAEs) and non-serious adverse events (AEs).
Infections and infestations Parainfluenzae virus infection	1.9% 1/52 • Number of events 1 • weekly for 8 weeks, then every 2 weeks till the start of mobilization for Induction treatment and 70-120 days post-ASCT, every 2 weeks during 16 weeks of Consolidation treatment, and monthly for 24 months of Maintenance treatment up to 30 days after last dose of study drugs. Assessments will be made through analysis of the reported incidence of treatment-emergent Serious Adverse Events (SAEs) and non-serious adverse events (AEs).
Infections and infestations Pneumonia	15.4% 8/52 • Number of events 9 • weekly for 8 weeks, then every 2 weeks till the start of mobilization for Induction treatment and 70-120 days post-ASCT, every 2 weeks during 16 weeks of Consolidation treatment, and monthly for 24 months of Maintenance treatment up to 30 days after last dose of study drugs. Assessments will be made through analysis of the reported incidence of treatment-emergent Serious Adverse Events (SAEs) and non-serious adverse events (AEs).
Infections and infestations Rhinitis	5.8% 3/52 • Number of events 4 • weekly for 8 weeks, then every 2 weeks till the start of mobilization for Induction treatment and 70-120 days post-ASCT, every 2 weeks during 16 weeks of Consolidation treatment, and monthly for 24 months of Maintenance treatment up to 30 days after last dose of study drugs. Assessments will be made through analysis of the reported incidence of treatment-emergent Serious Adverse Events (SAEs) and non-serious adverse events (AEs).
Infections and infestations Rhinovirus infection	3.8% 2/52 • Number of events 2 • weekly for 8 weeks, then every 2 weeks till the start of mobilization for Induction treatment and 70-120 days post-ASCT, every 2 weeks during 16 weeks of Consolidation treatment, and monthly for 24 months of Maintenance treatment up to 30 days after last dose of study drugs. Assessments will be made through analysis of the reported incidence of treatment-emergent Serious Adverse Events (SAEs) and non-serious adverse events (AEs).
Infections and infestations Sinusitis	7.7% 4/52 • Number of events 6 • weekly for 8 weeks, then every 2 weeks till the start of mobilization for Induction treatment and 70-120 days post-ASCT, every 2 weeks during 16 weeks of Consolidation treatment, and monthly for 24 months of Maintenance treatment up to 30 days after last dose of study drugs. Assessments will be made through analysis of the reported incidence of treatment-emergent Serious Adverse Events (SAEs) and non-serious adverse events (AEs).
Infections and infestations Skin infection	1.9% 1/52 • Number of events 1 • weekly for 8 weeks, then every 2 weeks till the start of mobilization for Induction treatment and 70-120 days post-ASCT, every 2 weeks during 16 weeks of Consolidation treatment, and monthly for 24 months of Maintenance treatment up to 30 days after last dose of study drugs. Assessments will be made through analysis of the reported incidence of treatment-emergent Serious Adverse Events (SAEs) and non-serious adverse events (AEs).
Infections and infestations Upper respiratory tract infection	19.2% 10/52 • Number of events 12 • weekly for 8 weeks, then every 2 weeks till the start of mobilization for Induction treatment and 70-120 days post-ASCT, every 2 weeks during 16 weeks of Consolidation treatment, and monthly for 24 months of Maintenance treatment up to 30 days after last dose of study drugs. Assessments will be made through analysis of the reported incidence of treatment-emergent Serious Adverse Events (SAEs) and non-serious adverse events (AEs).
Infections and infestations Urinary tract infection	3.8% 2/52 • Number of events 2 • weekly for 8 weeks, then every 2 weeks till the start of mobilization for Induction treatment and 70-120 days post-ASCT, every 2 weeks during 16 weeks of Consolidation treatment, and monthly for 24 months of Maintenance treatment up to 30 days after last dose of study drugs. Assessments will be made through analysis of the reported incidence of treatment-emergent Serious Adverse Events (SAEs) and non-serious adverse events (AEs).
Infections and infestations Viral upper respiratory tract infection	1.9% 1/52 • Number of events 1 • weekly for 8 weeks, then every 2 weeks till the start of mobilization for Induction treatment and 70-120 days post-ASCT, every 2 weeks during 16 weeks of Consolidation treatment, and monthly for 24 months of Maintenance treatment up to 30 days after last dose of study drugs. Assessments will be made through analysis of the reported incidence of treatment-emergent Serious Adverse Events (SAEs) and non-serious adverse events (AEs).
Infections and infestations Vulvovaginal mycotic infection	1.9% 1/52 • Number of events 1 • weekly for 8 weeks, then every 2 weeks till the start of mobilization for Induction treatment and 70-120 days post-ASCT, every 2 weeks during 16 weeks of Consolidation treatment, and monthly for 24 months of Maintenance treatment up to 30 days after last dose of study drugs. Assessments will be made through analysis of the reported incidence of treatment-emergent Serious Adverse Events (SAEs) and non-serious adverse events (AEs).
Injury, poisoning and procedural complications Arthropod bite	1.9% 1/52 • Number of events 1 • weekly for 8 weeks, then every 2 weeks till the start of mobilization for Induction treatment and 70-120 days post-ASCT, every 2 weeks during 16 weeks of Consolidation treatment, and monthly for 24 months of Maintenance treatment up to 30 days after last dose of study drugs. Assessments will be made through analysis of the reported incidence of treatment-emergent Serious Adverse Events (SAEs) and non-serious adverse events (AEs).
Injury, poisoning and procedural complications Contusion	3.8% 2/52 • Number of events 2 • weekly for 8 weeks, then every 2 weeks till the start of mobilization for Induction treatment and 70-120 days post-ASCT, every 2 weeks during 16 weeks of Consolidation treatment, and monthly for 24 months of Maintenance treatment up to 30 days after last dose of study drugs. Assessments will be made through analysis of the reported incidence of treatment-emergent Serious Adverse Events (SAEs) and non-serious adverse events (AEs).
Injury, poisoning and procedural complications Fall	5.8% 3/52 • Number of events 3 • weekly for 8 weeks, then every 2 weeks till the start of mobilization for Induction treatment and 70-120 days post-ASCT, every 2 weeks during 16 weeks of Consolidation treatment, and monthly for 24 months of Maintenance treatment up to 30 days after last dose of study drugs. Assessments will be made through analysis of the reported incidence of treatment-emergent Serious Adverse Events (SAEs) and non-serious adverse events (AEs).
Injury, poisoning and procedural complications Infusion related reaction	5.8% 3/52 • Number of events 4 • weekly for 8 weeks, then every 2 weeks till the start of mobilization for Induction treatment and 70-120 days post-ASCT, every 2 weeks during 16 weeks of Consolidation treatment, and monthly for 24 months of Maintenance treatment up to 30 days after last dose of study drugs. Assessments will be made through analysis of the reported incidence of treatment-emergent Serious Adverse Events (SAEs) and non-serious adverse events (AEs).
Injury, poisoning and procedural complications Lumbar vertebral fracture	1.9% 1/52 • Number of events 1 • weekly for 8 weeks, then every 2 weeks till the start of mobilization for Induction treatment and 70-120 days post-ASCT, every 2 weeks during 16 weeks of Consolidation treatment, and monthly for 24 months of Maintenance treatment up to 30 days after last dose of study drugs. Assessments will be made through analysis of the reported incidence of treatment-emergent Serious Adverse Events (SAEs) and non-serious adverse events (AEs).
Injury, poisoning and procedural complications Post procedural erythema	1.9% 1/52 • Number of events 1 • weekly for 8 weeks, then every 2 weeks till the start of mobilization for Induction treatment and 70-120 days post-ASCT, every 2 weeks during 16 weeks of Consolidation treatment, and monthly for 24 months of Maintenance treatment up to 30 days after last dose of study drugs. Assessments will be made through analysis of the reported incidence of treatment-emergent Serious Adverse Events (SAEs) and non-serious adverse events (AEs).
Injury, poisoning and procedural complications Post procedural haemorrhage	1.9% 1/52 • Number of events 1 • weekly for 8 weeks, then every 2 weeks till the start of mobilization for Induction treatment and 70-120 days post-ASCT, every 2 weeks during 16 weeks of Consolidation treatment, and monthly for 24 months of Maintenance treatment up to 30 days after last dose of study drugs. Assessments will be made through analysis of the reported incidence of treatment-emergent Serious Adverse Events (SAEs) and non-serious adverse events (AEs).
Injury, poisoning and procedural complications Procedural pain	1.9% 1/52 • Number of events 1 • weekly for 8 weeks, then every 2 weeks till the start of mobilization for Induction treatment and 70-120 days post-ASCT, every 2 weeks during 16 weeks of Consolidation treatment, and monthly for 24 months of Maintenance treatment up to 30 days after last dose of study drugs. Assessments will be made through analysis of the reported incidence of treatment-emergent Serious Adverse Events (SAEs) and non-serious adverse events (AEs).
Injury, poisoning and procedural complications Skin abrasion	1.9% 1/52 • Number of events 1 • weekly for 8 weeks, then every 2 weeks till the start of mobilization for Induction treatment and 70-120 days post-ASCT, every 2 weeks during 16 weeks of Consolidation treatment, and monthly for 24 months of Maintenance treatment up to 30 days after last dose of study drugs. Assessments will be made through analysis of the reported incidence of treatment-emergent Serious Adverse Events (SAEs) and non-serious adverse events (AEs).
Investigations Alanine aminotransferase increased	5.8% 3/52 • Number of events 4 • weekly for 8 weeks, then every 2 weeks till the start of mobilization for Induction treatment and 70-120 days post-ASCT, every 2 weeks during 16 weeks of Consolidation treatment, and monthly for 24 months of Maintenance treatment up to 30 days after last dose of study drugs. Assessments will be made through analysis of the reported incidence of treatment-emergent Serious Adverse Events (SAEs) and non-serious adverse events (AEs).
Investigations Aspartate aminotransferase increased	3.8% 2/52 • Number of events 2 • weekly for 8 weeks, then every 2 weeks till the start of mobilization for Induction treatment and 70-120 days post-ASCT, every 2 weeks during 16 weeks of Consolidation treatment, and monthly for 24 months of Maintenance treatment up to 30 days after last dose of study drugs. Assessments will be made through analysis of the reported incidence of treatment-emergent Serious Adverse Events (SAEs) and non-serious adverse events (AEs).
Investigations Blood alkaline phosphatase increased	3.8% 2/52 • Number of events 8 • weekly for 8 weeks, then every 2 weeks till the start of mobilization for Induction treatment and 70-120 days post-ASCT, every 2 weeks during 16 weeks of Consolidation treatment, and monthly for 24 months of Maintenance treatment up to 30 days after last dose of study drugs. Assessments will be made through analysis of the reported incidence of treatment-emergent Serious Adverse Events (SAEs) and non-serious adverse events (AEs).
Investigations Blood bilirubin increased	1.9% 1/52 • Number of events 2 • weekly for 8 weeks, then every 2 weeks till the start of mobilization for Induction treatment and 70-120 days post-ASCT, every 2 weeks during 16 weeks of Consolidation treatment, and monthly for 24 months of Maintenance treatment up to 30 days after last dose of study drugs. Assessments will be made through analysis of the reported incidence of treatment-emergent Serious Adverse Events (SAEs) and non-serious adverse events (AEs).
Investigations Blood creatinine increased	5.8% 3/52 • Number of events 3 • weekly for 8 weeks, then every 2 weeks till the start of mobilization for Induction treatment and 70-120 days post-ASCT, every 2 weeks during 16 weeks of Consolidation treatment, and monthly for 24 months of Maintenance treatment up to 30 days after last dose of study drugs. Assessments will be made through analysis of the reported incidence of treatment-emergent Serious Adverse Events (SAEs) and non-serious adverse events (AEs).
Investigations Blood glucose increased	1.9% 1/52 • Number of events 2 • weekly for 8 weeks, then every 2 weeks till the start of mobilization for Induction treatment and 70-120 days post-ASCT, every 2 weeks during 16 weeks of Consolidation treatment, and monthly for 24 months of Maintenance treatment up to 30 days after last dose of study drugs. Assessments will be made through analysis of the reported incidence of treatment-emergent Serious Adverse Events (SAEs) and non-serious adverse events (AEs).
Investigations Blood immunoglobulin G decreased	1.9% 1/52 • Number of events 1 • weekly for 8 weeks, then every 2 weeks till the start of mobilization for Induction treatment and 70-120 days post-ASCT, every 2 weeks during 16 weeks of Consolidation treatment, and monthly for 24 months of Maintenance treatment up to 30 days after last dose of study drugs. Assessments will be made through analysis of the reported incidence of treatment-emergent Serious Adverse Events (SAEs) and non-serious adverse events (AEs).
Investigations Blood magnesium decreased	1.9% 1/52 • Number of events 1 • weekly for 8 weeks, then every 2 weeks till the start of mobilization for Induction treatment and 70-120 days post-ASCT, every 2 weeks during 16 weeks of Consolidation treatment, and monthly for 24 months of Maintenance treatment up to 30 days after last dose of study drugs. Assessments will be made through analysis of the reported incidence of treatment-emergent Serious Adverse Events (SAEs) and non-serious adverse events (AEs).
Investigations Blood phosphorus decreased	3.8% 2/52 • Number of events 2 • weekly for 8 weeks, then every 2 weeks till the start of mobilization for Induction treatment and 70-120 days post-ASCT, every 2 weeks during 16 weeks of Consolidation treatment, and monthly for 24 months of Maintenance treatment up to 30 days after last dose of study drugs. Assessments will be made through analysis of the reported incidence of treatment-emergent Serious Adverse Events (SAEs) and non-serious adverse events (AEs).
Investigations Blood potassium decreased	1.9% 1/52 • Number of events 1 • weekly for 8 weeks, then every 2 weeks till the start of mobilization for Induction treatment and 70-120 days post-ASCT, every 2 weeks during 16 weeks of Consolidation treatment, and monthly for 24 months of Maintenance treatment up to 30 days after last dose of study drugs. Assessments will be made through analysis of the reported incidence of treatment-emergent Serious Adverse Events (SAEs) and non-serious adverse events (AEs).
Investigations Blood potassium increased	1.9% 1/52 • Number of events 1 • weekly for 8 weeks, then every 2 weeks till the start of mobilization for Induction treatment and 70-120 days post-ASCT, every 2 weeks during 16 weeks of Consolidation treatment, and monthly for 24 months of Maintenance treatment up to 30 days after last dose of study drugs. Assessments will be made through analysis of the reported incidence of treatment-emergent Serious Adverse Events (SAEs) and non-serious adverse events (AEs).
Investigations Body temperature increased	3.8% 2/52 • Number of events 2 • weekly for 8 weeks, then every 2 weeks till the start of mobilization for Induction treatment and 70-120 days post-ASCT, every 2 weeks during 16 weeks of Consolidation treatment, and monthly for 24 months of Maintenance treatment up to 30 days after last dose of study drugs. Assessments will be made through analysis of the reported incidence of treatment-emergent Serious Adverse Events (SAEs) and non-serious adverse events (AEs).
Investigations Breath sounds abnormal	1.9% 1/52 • Number of events 1 • weekly for 8 weeks, then every 2 weeks till the start of mobilization for Induction treatment and 70-120 days post-ASCT, every 2 weeks during 16 weeks of Consolidation treatment, and monthly for 24 months of Maintenance treatment up to 30 days after last dose of study drugs. Assessments will be made through analysis of the reported incidence of treatment-emergent Serious Adverse Events (SAEs) and non-serious adverse events (AEs).
Investigations Hepatic enzyme increased	1.9% 1/52 • Number of events 1 • weekly for 8 weeks, then every 2 weeks till the start of mobilization for Induction treatment and 70-120 days post-ASCT, every 2 weeks during 16 weeks of Consolidation treatment, and monthly for 24 months of Maintenance treatment up to 30 days after last dose of study drugs. Assessments will be made through analysis of the reported incidence of treatment-emergent Serious Adverse Events (SAEs) and non-serious adverse events (AEs).
Investigations Immunoglobulins decreased	1.9% 1/52 • Number of events 1 • weekly for 8 weeks, then every 2 weeks till the start of mobilization for Induction treatment and 70-120 days post-ASCT, every 2 weeks during 16 weeks of Consolidation treatment, and monthly for 24 months of Maintenance treatment up to 30 days after last dose of study drugs. Assessments will be made through analysis of the reported incidence of treatment-emergent Serious Adverse Events (SAEs) and non-serious adverse events (AEs).
Investigations Neutrophil count decreased	5.8% 3/52 • Number of events 6 • weekly for 8 weeks, then every 2 weeks till the start of mobilization for Induction treatment and 70-120 days post-ASCT, every 2 weeks during 16 weeks of Consolidation treatment, and monthly for 24 months of Maintenance treatment up to 30 days after last dose of study drugs. Assessments will be made through analysis of the reported incidence of treatment-emergent Serious Adverse Events (SAEs) and non-serious adverse events (AEs).
Investigations Platelet count decreased	3.8% 2/52 • Number of events 2 • weekly for 8 weeks, then every 2 weeks till the start of mobilization for Induction treatment and 70-120 days post-ASCT, every 2 weeks during 16 weeks of Consolidation treatment, and monthly for 24 months of Maintenance treatment up to 30 days after last dose of study drugs. Assessments will be made through analysis of the reported incidence of treatment-emergent Serious Adverse Events (SAEs) and non-serious adverse events (AEs).
Investigations Weight decreased	7.7% 4/52 • Number of events 6 • weekly for 8 weeks, then every 2 weeks till the start of mobilization for Induction treatment and 70-120 days post-ASCT, every 2 weeks during 16 weeks of Consolidation treatment, and monthly for 24 months of Maintenance treatment up to 30 days after last dose of study drugs. Assessments will be made through analysis of the reported incidence of treatment-emergent Serious Adverse Events (SAEs) and non-serious adverse events (AEs).
Investigations Weight increased	1.9% 1/52 • Number of events 1 • weekly for 8 weeks, then every 2 weeks till the start of mobilization for Induction treatment and 70-120 days post-ASCT, every 2 weeks during 16 weeks of Consolidation treatment, and monthly for 24 months of Maintenance treatment up to 30 days after last dose of study drugs. Assessments will be made through analysis of the reported incidence of treatment-emergent Serious Adverse Events (SAEs) and non-serious adverse events (AEs).
Investigations White blood cell count decreased	5.8% 3/52 • Number of events 3 • weekly for 8 weeks, then every 2 weeks till the start of mobilization for Induction treatment and 70-120 days post-ASCT, every 2 weeks during 16 weeks of Consolidation treatment, and monthly for 24 months of Maintenance treatment up to 30 days after last dose of study drugs. Assessments will be made through analysis of the reported incidence of treatment-emergent Serious Adverse Events (SAEs) and non-serious adverse events (AEs).
Metabolism and nutrition disorders Decreased appetite	32.7% 17/52 • Number of events 19 • weekly for 8 weeks, then every 2 weeks till the start of mobilization for Induction treatment and 70-120 days post-ASCT, every 2 weeks during 16 weeks of Consolidation treatment, and monthly for 24 months of Maintenance treatment up to 30 days after last dose of study drugs. Assessments will be made through analysis of the reported incidence of treatment-emergent Serious Adverse Events (SAEs) and non-serious adverse events (AEs).
Metabolism and nutrition disorders Dehydration	7.7% 4/52 • Number of events 5 • weekly for 8 weeks, then every 2 weeks till the start of mobilization for Induction treatment and 70-120 days post-ASCT, every 2 weeks during 16 weeks of Consolidation treatment, and monthly for 24 months of Maintenance treatment up to 30 days after last dose of study drugs. Assessments will be made through analysis of the reported incidence of treatment-emergent Serious Adverse Events (SAEs) and non-serious adverse events (AEs).
Metabolism and nutrition disorders Hypercalcaemia	3.8% 2/52 • Number of events 4 • weekly for 8 weeks, then every 2 weeks till the start of mobilization for Induction treatment and 70-120 days post-ASCT, every 2 weeks during 16 weeks of Consolidation treatment, and monthly for 24 months of Maintenance treatment up to 30 days after last dose of study drugs. Assessments will be made through analysis of the reported incidence of treatment-emergent Serious Adverse Events (SAEs) and non-serious adverse events (AEs).
Metabolism and nutrition disorders Hyperglycaemia	11.5% 6/52 • Number of events 11 • weekly for 8 weeks, then every 2 weeks till the start of mobilization for Induction treatment and 70-120 days post-ASCT, every 2 weeks during 16 weeks of Consolidation treatment, and monthly for 24 months of Maintenance treatment up to 30 days after last dose of study drugs. Assessments will be made through analysis of the reported incidence of treatment-emergent Serious Adverse Events (SAEs) and non-serious adverse events (AEs).
Metabolism and nutrition disorders Hyperlipidaemia	1.9% 1/52 • Number of events 1 • weekly for 8 weeks, then every 2 weeks till the start of mobilization for Induction treatment and 70-120 days post-ASCT, every 2 weeks during 16 weeks of Consolidation treatment, and monthly for 24 months of Maintenance treatment up to 30 days after last dose of study drugs. Assessments will be made through analysis of the reported incidence of treatment-emergent Serious Adverse Events (SAEs) and non-serious adverse events (AEs).
Metabolism and nutrition disorders Hypocalcaemia	3.8% 2/52 • Number of events 5 • weekly for 8 weeks, then every 2 weeks till the start of mobilization for Induction treatment and 70-120 days post-ASCT, every 2 weeks during 16 weeks of Consolidation treatment, and monthly for 24 months of Maintenance treatment up to 30 days after last dose of study drugs. Assessments will be made through analysis of the reported incidence of treatment-emergent Serious Adverse Events (SAEs) and non-serious adverse events (AEs).
Metabolism and nutrition disorders Hypokalaemia	9.6% 5/52 • Number of events 6 • weekly for 8 weeks, then every 2 weeks till the start of mobilization for Induction treatment and 70-120 days post-ASCT, every 2 weeks during 16 weeks of Consolidation treatment, and monthly for 24 months of Maintenance treatment up to 30 days after last dose of study drugs. Assessments will be made through analysis of the reported incidence of treatment-emergent Serious Adverse Events (SAEs) and non-serious adverse events (AEs).
Metabolism and nutrition disorders Hypomagnesaemia	3.8% 2/52 • Number of events 2 • weekly for 8 weeks, then every 2 weeks till the start of mobilization for Induction treatment and 70-120 days post-ASCT, every 2 weeks during 16 weeks of Consolidation treatment, and monthly for 24 months of Maintenance treatment up to 30 days after last dose of study drugs. Assessments will be made through analysis of the reported incidence of treatment-emergent Serious Adverse Events (SAEs) and non-serious adverse events (AEs).
Metabolism and nutrition disorders Hyponatraemia	9.6% 5/52 • Number of events 9 • weekly for 8 weeks, then every 2 weeks till the start of mobilization for Induction treatment and 70-120 days post-ASCT, every 2 weeks during 16 weeks of Consolidation treatment, and monthly for 24 months of Maintenance treatment up to 30 days after last dose of study drugs. Assessments will be made through analysis of the reported incidence of treatment-emergent Serious Adverse Events (SAEs) and non-serious adverse events (AEs).
Metabolism and nutrition disorders Hypophosphataemia	9.6% 5/52 • Number of events 8 • weekly for 8 weeks, then every 2 weeks till the start of mobilization for Induction treatment and 70-120 days post-ASCT, every 2 weeks during 16 weeks of Consolidation treatment, and monthly for 24 months of Maintenance treatment up to 30 days after last dose of study drugs. Assessments will be made through analysis of the reported incidence of treatment-emergent Serious Adverse Events (SAEs) and non-serious adverse events (AEs).
Metabolism and nutrition disorders Metabolic acidosis	1.9% 1/52 • Number of events 1 • weekly for 8 weeks, then every 2 weeks till the start of mobilization for Induction treatment and 70-120 days post-ASCT, every 2 weeks during 16 weeks of Consolidation treatment, and monthly for 24 months of Maintenance treatment up to 30 days after last dose of study drugs. Assessments will be made through analysis of the reported incidence of treatment-emergent Serious Adverse Events (SAEs) and non-serious adverse events (AEs).
Metabolism and nutrition disorders Tumour lysis syndrome	1.9% 1/52 • Number of events 1 • weekly for 8 weeks, then every 2 weeks till the start of mobilization for Induction treatment and 70-120 days post-ASCT, every 2 weeks during 16 weeks of Consolidation treatment, and monthly for 24 months of Maintenance treatment up to 30 days after last dose of study drugs. Assessments will be made through analysis of the reported incidence of treatment-emergent Serious Adverse Events (SAEs) and non-serious adverse events (AEs).
Metabolism and nutrition disorders Vitamin D deficiency	1.9% 1/52 • Number of events 1 • weekly for 8 weeks, then every 2 weeks till the start of mobilization for Induction treatment and 70-120 days post-ASCT, every 2 weeks during 16 weeks of Consolidation treatment, and monthly for 24 months of Maintenance treatment up to 30 days after last dose of study drugs. Assessments will be made through analysis of the reported incidence of treatment-emergent Serious Adverse Events (SAEs) and non-serious adverse events (AEs).
Musculoskeletal and connective tissue disorders Arthralgia	23.1% 12/52 • Number of events 19 • weekly for 8 weeks, then every 2 weeks till the start of mobilization for Induction treatment and 70-120 days post-ASCT, every 2 weeks during 16 weeks of Consolidation treatment, and monthly for 24 months of Maintenance treatment up to 30 days after last dose of study drugs. Assessments will be made through analysis of the reported incidence of treatment-emergent Serious Adverse Events (SAEs) and non-serious adverse events (AEs).
Musculoskeletal and connective tissue disorders Arthropathy	1.9% 1/52 • Number of events 1 • weekly for 8 weeks, then every 2 weeks till the start of mobilization for Induction treatment and 70-120 days post-ASCT, every 2 weeks during 16 weeks of Consolidation treatment, and monthly for 24 months of Maintenance treatment up to 30 days after last dose of study drugs. Assessments will be made through analysis of the reported incidence of treatment-emergent Serious Adverse Events (SAEs) and non-serious adverse events (AEs).
Musculoskeletal and connective tissue disorders Back pain	25.0% 13/52 • Number of events 17 • weekly for 8 weeks, then every 2 weeks till the start of mobilization for Induction treatment and 70-120 days post-ASCT, every 2 weeks during 16 weeks of Consolidation treatment, and monthly for 24 months of Maintenance treatment up to 30 days after last dose of study drugs. Assessments will be made through analysis of the reported incidence of treatment-emergent Serious Adverse Events (SAEs) and non-serious adverse events (AEs).
Musculoskeletal and connective tissue disorders Bone pain	7.7% 4/52 • Number of events 5 • weekly for 8 weeks, then every 2 weeks till the start of mobilization for Induction treatment and 70-120 days post-ASCT, every 2 weeks during 16 weeks of Consolidation treatment, and monthly for 24 months of Maintenance treatment up to 30 days after last dose of study drugs. Assessments will be made through analysis of the reported incidence of treatment-emergent Serious Adverse Events (SAEs) and non-serious adverse events (AEs).
Musculoskeletal and connective tissue disorders Flank pain	1.9% 1/52 • Number of events 1 • weekly for 8 weeks, then every 2 weeks till the start of mobilization for Induction treatment and 70-120 days post-ASCT, every 2 weeks during 16 weeks of Consolidation treatment, and monthly for 24 months of Maintenance treatment up to 30 days after last dose of study drugs. Assessments will be made through analysis of the reported incidence of treatment-emergent Serious Adverse Events (SAEs) and non-serious adverse events (AEs).
Musculoskeletal and connective tissue disorders Joint stiffness	3.8% 2/52 • Number of events 2 • weekly for 8 weeks, then every 2 weeks till the start of mobilization for Induction treatment and 70-120 days post-ASCT, every 2 weeks during 16 weeks of Consolidation treatment, and monthly for 24 months of Maintenance treatment up to 30 days after last dose of study drugs. Assessments will be made through analysis of the reported incidence of treatment-emergent Serious Adverse Events (SAEs) and non-serious adverse events (AEs).
Musculoskeletal and connective tissue disorders Joint swelling	1.9% 1/52 • Number of events 1 • weekly for 8 weeks, then every 2 weeks till the start of mobilization for Induction treatment and 70-120 days post-ASCT, every 2 weeks during 16 weeks of Consolidation treatment, and monthly for 24 months of Maintenance treatment up to 30 days after last dose of study drugs. Assessments will be made through analysis of the reported incidence of treatment-emergent Serious Adverse Events (SAEs) and non-serious adverse events (AEs).
Musculoskeletal and connective tissue disorders Lumbar spinal stenosis	1.9% 1/52 • Number of events 1 • weekly for 8 weeks, then every 2 weeks till the start of mobilization for Induction treatment and 70-120 days post-ASCT, every 2 weeks during 16 weeks of Consolidation treatment, and monthly for 24 months of Maintenance treatment up to 30 days after last dose of study drugs. Assessments will be made through analysis of the reported incidence of treatment-emergent Serious Adverse Events (SAEs) and non-serious adverse events (AEs).
Musculoskeletal and connective tissue disorders Muscle spasms	32.7% 17/52 • Number of events 23 • weekly for 8 weeks, then every 2 weeks till the start of mobilization for Induction treatment and 70-120 days post-ASCT, every 2 weeks during 16 weeks of Consolidation treatment, and monthly for 24 months of Maintenance treatment up to 30 days after last dose of study drugs. Assessments will be made through analysis of the reported incidence of treatment-emergent Serious Adverse Events (SAEs) and non-serious adverse events (AEs).
Musculoskeletal and connective tissue disorders Muscle tightness	1.9% 1/52 • Number of events 1 • weekly for 8 weeks, then every 2 weeks till the start of mobilization for Induction treatment and 70-120 days post-ASCT, every 2 weeks during 16 weeks of Consolidation treatment, and monthly for 24 months of Maintenance treatment up to 30 days after last dose of study drugs. Assessments will be made through analysis of the reported incidence of treatment-emergent Serious Adverse Events (SAEs) and non-serious adverse events (AEs).
Musculoskeletal and connective tissue disorders Muscular weakness	3.8% 2/52 • Number of events 3 • weekly for 8 weeks, then every 2 weeks till the start of mobilization for Induction treatment and 70-120 days post-ASCT, every 2 weeks during 16 weeks of Consolidation treatment, and monthly for 24 months of Maintenance treatment up to 30 days after last dose of study drugs. Assessments will be made through analysis of the reported incidence of treatment-emergent Serious Adverse Events (SAEs) and non-serious adverse events (AEs).
Musculoskeletal and connective tissue disorders Musculoskeletal chest pain	3.8% 2/52 • Number of events 2 • weekly for 8 weeks, then every 2 weeks till the start of mobilization for Induction treatment and 70-120 days post-ASCT, every 2 weeks during 16 weeks of Consolidation treatment, and monthly for 24 months of Maintenance treatment up to 30 days after last dose of study drugs. Assessments will be made through analysis of the reported incidence of treatment-emergent Serious Adverse Events (SAEs) and non-serious adverse events (AEs).
Musculoskeletal and connective tissue disorders Musculoskeletal discomfort	1.9% 1/52 • Number of events 1 • weekly for 8 weeks, then every 2 weeks till the start of mobilization for Induction treatment and 70-120 days post-ASCT, every 2 weeks during 16 weeks of Consolidation treatment, and monthly for 24 months of Maintenance treatment up to 30 days after last dose of study drugs. Assessments will be made through analysis of the reported incidence of treatment-emergent Serious Adverse Events (SAEs) and non-serious adverse events (AEs).
Musculoskeletal and connective tissue disorders Musculoskeletal pain	3.8% 2/52 • Number of events 2 • weekly for 8 weeks, then every 2 weeks till the start of mobilization for Induction treatment and 70-120 days post-ASCT, every 2 weeks during 16 weeks of Consolidation treatment, and monthly for 24 months of Maintenance treatment up to 30 days after last dose of study drugs. Assessments will be made through analysis of the reported incidence of treatment-emergent Serious Adverse Events (SAEs) and non-serious adverse events (AEs).
Musculoskeletal and connective tissue disorders Myalgia	11.5% 6/52 • Number of events 7 • weekly for 8 weeks, then every 2 weeks till the start of mobilization for Induction treatment and 70-120 days post-ASCT, every 2 weeks during 16 weeks of Consolidation treatment, and monthly for 24 months of Maintenance treatment up to 30 days after last dose of study drugs. Assessments will be made through analysis of the reported incidence of treatment-emergent Serious Adverse Events (SAEs) and non-serious adverse events (AEs).
Musculoskeletal and connective tissue disorders Neck pain	5.8% 3/52 • Number of events 3 • weekly for 8 weeks, then every 2 weeks till the start of mobilization for Induction treatment and 70-120 days post-ASCT, every 2 weeks during 16 weeks of Consolidation treatment, and monthly for 24 months of Maintenance treatment up to 30 days after last dose of study drugs. Assessments will be made through analysis of the reported incidence of treatment-emergent Serious Adverse Events (SAEs) and non-serious adverse events (AEs).
Musculoskeletal and connective tissue disorders Pain in extremity	15.4% 8/52 • Number of events 9 • weekly for 8 weeks, then every 2 weeks till the start of mobilization for Induction treatment and 70-120 days post-ASCT, every 2 weeks during 16 weeks of Consolidation treatment, and monthly for 24 months of Maintenance treatment up to 30 days after last dose of study drugs. Assessments will be made through analysis of the reported incidence of treatment-emergent Serious Adverse Events (SAEs) and non-serious adverse events (AEs).
Musculoskeletal and connective tissue disorders Pain in jaw	1.9% 1/52 • Number of events 1 • weekly for 8 weeks, then every 2 weeks till the start of mobilization for Induction treatment and 70-120 days post-ASCT, every 2 weeks during 16 weeks of Consolidation treatment, and monthly for 24 months of Maintenance treatment up to 30 days after last dose of study drugs. Assessments will be made through analysis of the reported incidence of treatment-emergent Serious Adverse Events (SAEs) and non-serious adverse events (AEs).
Musculoskeletal and connective tissue disorders Temporomandibular joint syndrome	1.9% 1/52 • Number of events 1 • weekly for 8 weeks, then every 2 weeks till the start of mobilization for Induction treatment and 70-120 days post-ASCT, every 2 weeks during 16 weeks of Consolidation treatment, and monthly for 24 months of Maintenance treatment up to 30 days after last dose of study drugs. Assessments will be made through analysis of the reported incidence of treatment-emergent Serious Adverse Events (SAEs) and non-serious adverse events (AEs).
Nervous system disorders Balance disorder	3.8% 2/52 • Number of events 2 • weekly for 8 weeks, then every 2 weeks till the start of mobilization for Induction treatment and 70-120 days post-ASCT, every 2 weeks during 16 weeks of Consolidation treatment, and monthly for 24 months of Maintenance treatment up to 30 days after last dose of study drugs. Assessments will be made through analysis of the reported incidence of treatment-emergent Serious Adverse Events (SAEs) and non-serious adverse events (AEs).
Nervous system disorders Disturbance in attention	5.8% 3/52 • Number of events 3 • weekly for 8 weeks, then every 2 weeks till the start of mobilization for Induction treatment and 70-120 days post-ASCT, every 2 weeks during 16 weeks of Consolidation treatment, and monthly for 24 months of Maintenance treatment up to 30 days after last dose of study drugs. Assessments will be made through analysis of the reported incidence of treatment-emergent Serious Adverse Events (SAEs) and non-serious adverse events (AEs).
Nervous system disorders Dizziness	11.5% 6/52 • Number of events 7 • weekly for 8 weeks, then every 2 weeks till the start of mobilization for Induction treatment and 70-120 days post-ASCT, every 2 weeks during 16 weeks of Consolidation treatment, and monthly for 24 months of Maintenance treatment up to 30 days after last dose of study drugs. Assessments will be made through analysis of the reported incidence of treatment-emergent Serious Adverse Events (SAEs) and non-serious adverse events (AEs).
Nervous system disorders Dizziness postural	5.8% 3/52 • Number of events 3 • weekly for 8 weeks, then every 2 weeks till the start of mobilization for Induction treatment and 70-120 days post-ASCT, every 2 weeks during 16 weeks of Consolidation treatment, and monthly for 24 months of Maintenance treatment up to 30 days after last dose of study drugs. Assessments will be made through analysis of the reported incidence of treatment-emergent Serious Adverse Events (SAEs) and non-serious adverse events (AEs).
Nervous system disorders Dysgeusia	5.8% 3/52 • Number of events 3 • weekly for 8 weeks, then every 2 weeks till the start of mobilization for Induction treatment and 70-120 days post-ASCT, every 2 weeks during 16 weeks of Consolidation treatment, and monthly for 24 months of Maintenance treatment up to 30 days after last dose of study drugs. Assessments will be made through analysis of the reported incidence of treatment-emergent Serious Adverse Events (SAEs) and non-serious adverse events (AEs).
Nervous system disorders Dysgraphia	1.9% 1/52 • Number of events 1 • weekly for 8 weeks, then every 2 weeks till the start of mobilization for Induction treatment and 70-120 days post-ASCT, every 2 weeks during 16 weeks of Consolidation treatment, and monthly for 24 months of Maintenance treatment up to 30 days after last dose of study drugs. Assessments will be made through analysis of the reported incidence of treatment-emergent Serious Adverse Events (SAEs) and non-serious adverse events (AEs).
Nervous system disorders Head discomfort	1.9% 1/52 • Number of events 1 • weekly for 8 weeks, then every 2 weeks till the start of mobilization for Induction treatment and 70-120 days post-ASCT, every 2 weeks during 16 weeks of Consolidation treatment, and monthly for 24 months of Maintenance treatment up to 30 days after last dose of study drugs. Assessments will be made through analysis of the reported incidence of treatment-emergent Serious Adverse Events (SAEs) and non-serious adverse events (AEs).
Nervous system disorders Headache	21.2% 11/52 • Number of events 15 • weekly for 8 weeks, then every 2 weeks till the start of mobilization for Induction treatment and 70-120 days post-ASCT, every 2 weeks during 16 weeks of Consolidation treatment, and monthly for 24 months of Maintenance treatment up to 30 days after last dose of study drugs. Assessments will be made through analysis of the reported incidence of treatment-emergent Serious Adverse Events (SAEs) and non-serious adverse events (AEs).
Nervous system disorders Hyperaesthesia	1.9% 1/52 • Number of events 1 • weekly for 8 weeks, then every 2 weeks till the start of mobilization for Induction treatment and 70-120 days post-ASCT, every 2 weeks during 16 weeks of Consolidation treatment, and monthly for 24 months of Maintenance treatment up to 30 days after last dose of study drugs. Assessments will be made through analysis of the reported incidence of treatment-emergent Serious Adverse Events (SAEs) and non-serious adverse events (AEs).
Nervous system disorders Hypoaesthesia	7.7% 4/52 • Number of events 4 • weekly for 8 weeks, then every 2 weeks till the start of mobilization for Induction treatment and 70-120 days post-ASCT, every 2 weeks during 16 weeks of Consolidation treatment, and monthly for 24 months of Maintenance treatment up to 30 days after last dose of study drugs. Assessments will be made through analysis of the reported incidence of treatment-emergent Serious Adverse Events (SAEs) and non-serious adverse events (AEs).
Nervous system disorders Hypogeusia	1.9% 1/52 • Number of events 1 • weekly for 8 weeks, then every 2 weeks till the start of mobilization for Induction treatment and 70-120 days post-ASCT, every 2 weeks during 16 weeks of Consolidation treatment, and monthly for 24 months of Maintenance treatment up to 30 days after last dose of study drugs. Assessments will be made through analysis of the reported incidence of treatment-emergent Serious Adverse Events (SAEs) and non-serious adverse events (AEs).
Nervous system disorders Mental impairment	1.9% 1/52 • Number of events 1 • weekly for 8 weeks, then every 2 weeks till the start of mobilization for Induction treatment and 70-120 days post-ASCT, every 2 weeks during 16 weeks of Consolidation treatment, and monthly for 24 months of Maintenance treatment up to 30 days after last dose of study drugs. Assessments will be made through analysis of the reported incidence of treatment-emergent Serious Adverse Events (SAEs) and non-serious adverse events (AEs).
Nervous system disorders Migraine	1.9% 1/52 • Number of events 1 • weekly for 8 weeks, then every 2 weeks till the start of mobilization for Induction treatment and 70-120 days post-ASCT, every 2 weeks during 16 weeks of Consolidation treatment, and monthly for 24 months of Maintenance treatment up to 30 days after last dose of study drugs. Assessments will be made through analysis of the reported incidence of treatment-emergent Serious Adverse Events (SAEs) and non-serious adverse events (AEs).
Nervous system disorders Neuropathy peripheral	25.0% 13/52 • Number of events 21 • weekly for 8 weeks, then every 2 weeks till the start of mobilization for Induction treatment and 70-120 days post-ASCT, every 2 weeks during 16 weeks of Consolidation treatment, and monthly for 24 months of Maintenance treatment up to 30 days after last dose of study drugs. Assessments will be made through analysis of the reported incidence of treatment-emergent Serious Adverse Events (SAEs) and non-serious adverse events (AEs).
Nervous system disorders Paraesthesia	9.6% 5/52 • Number of events 5 • weekly for 8 weeks, then every 2 weeks till the start of mobilization for Induction treatment and 70-120 days post-ASCT, every 2 weeks during 16 weeks of Consolidation treatment, and monthly for 24 months of Maintenance treatment up to 30 days after last dose of study drugs. Assessments will be made through analysis of the reported incidence of treatment-emergent Serious Adverse Events (SAEs) and non-serious adverse events (AEs).
Nervous system disorders Peripheral sensory neuropathy	7.7% 4/52 • Number of events 4 • weekly for 8 weeks, then every 2 weeks till the start of mobilization for Induction treatment and 70-120 days post-ASCT, every 2 weeks during 16 weeks of Consolidation treatment, and monthly for 24 months of Maintenance treatment up to 30 days after last dose of study drugs. Assessments will be made through analysis of the reported incidence of treatment-emergent Serious Adverse Events (SAEs) and non-serious adverse events (AEs).
Nervous system disorders Restless legs syndrome	1.9% 1/52 • Number of events 2 • weekly for 8 weeks, then every 2 weeks till the start of mobilization for Induction treatment and 70-120 days post-ASCT, every 2 weeks during 16 weeks of Consolidation treatment, and monthly for 24 months of Maintenance treatment up to 30 days after last dose of study drugs. Assessments will be made through analysis of the reported incidence of treatment-emergent Serious Adverse Events (SAEs) and non-serious adverse events (AEs).
Nervous system disorders Sensory disturbance	1.9% 1/52 • Number of events 1 • weekly for 8 weeks, then every 2 weeks till the start of mobilization for Induction treatment and 70-120 days post-ASCT, every 2 weeks during 16 weeks of Consolidation treatment, and monthly for 24 months of Maintenance treatment up to 30 days after last dose of study drugs. Assessments will be made through analysis of the reported incidence of treatment-emergent Serious Adverse Events (SAEs) and non-serious adverse events (AEs).
Nervous system disorders Syncope	7.7% 4/52 • Number of events 5 • weekly for 8 weeks, then every 2 weeks till the start of mobilization for Induction treatment and 70-120 days post-ASCT, every 2 weeks during 16 weeks of Consolidation treatment, and monthly for 24 months of Maintenance treatment up to 30 days after last dose of study drugs. Assessments will be made through analysis of the reported incidence of treatment-emergent Serious Adverse Events (SAEs) and non-serious adverse events (AEs).
Nervous system disorders Taste disorder	5.8% 3/52 • Number of events 4 • weekly for 8 weeks, then every 2 weeks till the start of mobilization for Induction treatment and 70-120 days post-ASCT, every 2 weeks during 16 weeks of Consolidation treatment, and monthly for 24 months of Maintenance treatment up to 30 days after last dose of study drugs. Assessments will be made through analysis of the reported incidence of treatment-emergent Serious Adverse Events (SAEs) and non-serious adverse events (AEs).
Nervous system disorders Tremor	7.7% 4/52 • Number of events 5 • weekly for 8 weeks, then every 2 weeks till the start of mobilization for Induction treatment and 70-120 days post-ASCT, every 2 weeks during 16 weeks of Consolidation treatment, and monthly for 24 months of Maintenance treatment up to 30 days after last dose of study drugs. Assessments will be made through analysis of the reported incidence of treatment-emergent Serious Adverse Events (SAEs) and non-serious adverse events (AEs).
Psychiatric disorders Affect lability	1.9% 1/52 • Number of events 1 • weekly for 8 weeks, then every 2 weeks till the start of mobilization for Induction treatment and 70-120 days post-ASCT, every 2 weeks during 16 weeks of Consolidation treatment, and monthly for 24 months of Maintenance treatment up to 30 days after last dose of study drugs. Assessments will be made through analysis of the reported incidence of treatment-emergent Serious Adverse Events (SAEs) and non-serious adverse events (AEs).
Psychiatric disorders Agitation	3.8% 2/52 • Number of events 2 • weekly for 8 weeks, then every 2 weeks till the start of mobilization for Induction treatment and 70-120 days post-ASCT, every 2 weeks during 16 weeks of Consolidation treatment, and monthly for 24 months of Maintenance treatment up to 30 days after last dose of study drugs. Assessments will be made through analysis of the reported incidence of treatment-emergent Serious Adverse Events (SAEs) and non-serious adverse events (AEs).
Psychiatric disorders Anxiety	15.4% 8/52 • Number of events 8 • weekly for 8 weeks, then every 2 weeks till the start of mobilization for Induction treatment and 70-120 days post-ASCT, every 2 weeks during 16 weeks of Consolidation treatment, and monthly for 24 months of Maintenance treatment up to 30 days after last dose of study drugs. Assessments will be made through analysis of the reported incidence of treatment-emergent Serious Adverse Events (SAEs) and non-serious adverse events (AEs).
Psychiatric disorders Confusional state	3.8% 2/52 • Number of events 2 • weekly for 8 weeks, then every 2 weeks till the start of mobilization for Induction treatment and 70-120 days post-ASCT, every 2 weeks during 16 weeks of Consolidation treatment, and monthly for 24 months of Maintenance treatment up to 30 days after last dose of study drugs. Assessments will be made through analysis of the reported incidence of treatment-emergent Serious Adverse Events (SAEs) and non-serious adverse events (AEs).
Psychiatric disorders Depression	11.5% 6/52 • Number of events 7 • weekly for 8 weeks, then every 2 weeks till the start of mobilization for Induction treatment and 70-120 days post-ASCT, every 2 weeks during 16 weeks of Consolidation treatment, and monthly for 24 months of Maintenance treatment up to 30 days after last dose of study drugs. Assessments will be made through analysis of the reported incidence of treatment-emergent Serious Adverse Events (SAEs) and non-serious adverse events (AEs).
Psychiatric disorders Disorientation	1.9% 1/52 • Number of events 1 • weekly for 8 weeks, then every 2 weeks till the start of mobilization for Induction treatment and 70-120 days post-ASCT, every 2 weeks during 16 weeks of Consolidation treatment, and monthly for 24 months of Maintenance treatment up to 30 days after last dose of study drugs. Assessments will be made through analysis of the reported incidence of treatment-emergent Serious Adverse Events (SAEs) and non-serious adverse events (AEs).
Psychiatric disorders Hallucination, visual	1.9% 1/52 • Number of events 1 • weekly for 8 weeks, then every 2 weeks till the start of mobilization for Induction treatment and 70-120 days post-ASCT, every 2 weeks during 16 weeks of Consolidation treatment, and monthly for 24 months of Maintenance treatment up to 30 days after last dose of study drugs. Assessments will be made through analysis of the reported incidence of treatment-emergent Serious Adverse Events (SAEs) and non-serious adverse events (AEs).
Psychiatric disorders Insomnia	30.8% 16/52 • Number of events 18 • weekly for 8 weeks, then every 2 weeks till the start of mobilization for Induction treatment and 70-120 days post-ASCT, every 2 weeks during 16 weeks of Consolidation treatment, and monthly for 24 months of Maintenance treatment up to 30 days after last dose of study drugs. Assessments will be made through analysis of the reported incidence of treatment-emergent Serious Adverse Events (SAEs) and non-serious adverse events (AEs).
Psychiatric disorders Irritability	3.8% 2/52 • Number of events 2 • weekly for 8 weeks, then every 2 weeks till the start of mobilization for Induction treatment and 70-120 days post-ASCT, every 2 weeks during 16 weeks of Consolidation treatment, and monthly for 24 months of Maintenance treatment up to 30 days after last dose of study drugs. Assessments will be made through analysis of the reported incidence of treatment-emergent Serious Adverse Events (SAEs) and non-serious adverse events (AEs).
Psychiatric disorders Libido decreased	1.9% 1/52 • Number of events 1 • weekly for 8 weeks, then every 2 weeks till the start of mobilization for Induction treatment and 70-120 days post-ASCT, every 2 weeks during 16 weeks of Consolidation treatment, and monthly for 24 months of Maintenance treatment up to 30 days after last dose of study drugs. Assessments will be made through analysis of the reported incidence of treatment-emergent Serious Adverse Events (SAEs) and non-serious adverse events (AEs).
Psychiatric disorders Mental status changes	1.9% 1/52 • Number of events 1 • weekly for 8 weeks, then every 2 weeks till the start of mobilization for Induction treatment and 70-120 days post-ASCT, every 2 weeks during 16 weeks of Consolidation treatment, and monthly for 24 months of Maintenance treatment up to 30 days after last dose of study drugs. Assessments will be made through analysis of the reported incidence of treatment-emergent Serious Adverse Events (SAEs) and non-serious adverse events (AEs).
Psychiatric disorders Mood altered	1.9% 1/52 • Number of events 1 • weekly for 8 weeks, then every 2 weeks till the start of mobilization for Induction treatment and 70-120 days post-ASCT, every 2 weeks during 16 weeks of Consolidation treatment, and monthly for 24 months of Maintenance treatment up to 30 days after last dose of study drugs. Assessments will be made through analysis of the reported incidence of treatment-emergent Serious Adverse Events (SAEs) and non-serious adverse events (AEs).
Psychiatric disorders Mood swings	1.9% 1/52 • Number of events 1 • weekly for 8 weeks, then every 2 weeks till the start of mobilization for Induction treatment and 70-120 days post-ASCT, every 2 weeks during 16 weeks of Consolidation treatment, and monthly for 24 months of Maintenance treatment up to 30 days after last dose of study drugs. Assessments will be made through analysis of the reported incidence of treatment-emergent Serious Adverse Events (SAEs) and non-serious adverse events (AEs).
Psychiatric disorders Nightmare	1.9% 1/52 • Number of events 1 • weekly for 8 weeks, then every 2 weeks till the start of mobilization for Induction treatment and 70-120 days post-ASCT, every 2 weeks during 16 weeks of Consolidation treatment, and monthly for 24 months of Maintenance treatment up to 30 days after last dose of study drugs. Assessments will be made through analysis of the reported incidence of treatment-emergent Serious Adverse Events (SAEs) and non-serious adverse events (AEs).
Psychiatric disorders Sleep disorder	1.9% 1/52 • Number of events 2 • weekly for 8 weeks, then every 2 weeks till the start of mobilization for Induction treatment and 70-120 days post-ASCT, every 2 weeks during 16 weeks of Consolidation treatment, and monthly for 24 months of Maintenance treatment up to 30 days after last dose of study drugs. Assessments will be made through analysis of the reported incidence of treatment-emergent Serious Adverse Events (SAEs) and non-serious adverse events (AEs).
Renal and urinary disorders Dysuria	1.9% 1/52 • Number of events 1 • weekly for 8 weeks, then every 2 weeks till the start of mobilization for Induction treatment and 70-120 days post-ASCT, every 2 weeks during 16 weeks of Consolidation treatment, and monthly for 24 months of Maintenance treatment up to 30 days after last dose of study drugs. Assessments will be made through analysis of the reported incidence of treatment-emergent Serious Adverse Events (SAEs) and non-serious adverse events (AEs).
Renal and urinary disorders Haematuria	1.9% 1/52 • Number of events 1 • weekly for 8 weeks, then every 2 weeks till the start of mobilization for Induction treatment and 70-120 days post-ASCT, every 2 weeks during 16 weeks of Consolidation treatment, and monthly for 24 months of Maintenance treatment up to 30 days after last dose of study drugs. Assessments will be made through analysis of the reported incidence of treatment-emergent Serious Adverse Events (SAEs) and non-serious adverse events (AEs).
Renal and urinary disorders Nephrolithiasis	1.9% 1/52 • Number of events 1 • weekly for 8 weeks, then every 2 weeks till the start of mobilization for Induction treatment and 70-120 days post-ASCT, every 2 weeks during 16 weeks of Consolidation treatment, and monthly for 24 months of Maintenance treatment up to 30 days after last dose of study drugs. Assessments will be made through analysis of the reported incidence of treatment-emergent Serious Adverse Events (SAEs) and non-serious adverse events (AEs).
Renal and urinary disorders Nocturia	1.9% 1/52 • Number of events 1 • weekly for 8 weeks, then every 2 weeks till the start of mobilization for Induction treatment and 70-120 days post-ASCT, every 2 weeks during 16 weeks of Consolidation treatment, and monthly for 24 months of Maintenance treatment up to 30 days after last dose of study drugs. Assessments will be made through analysis of the reported incidence of treatment-emergent Serious Adverse Events (SAEs) and non-serious adverse events (AEs).
Renal and urinary disorders Pollakiuria	3.8% 2/52 • Number of events 2 • weekly for 8 weeks, then every 2 weeks till the start of mobilization for Induction treatment and 70-120 days post-ASCT, every 2 weeks during 16 weeks of Consolidation treatment, and monthly for 24 months of Maintenance treatment up to 30 days after last dose of study drugs. Assessments will be made through analysis of the reported incidence of treatment-emergent Serious Adverse Events (SAEs) and non-serious adverse events (AEs).
Renal and urinary disorders Urinary tract pain	1.9% 1/52 • Number of events 1 • weekly for 8 weeks, then every 2 weeks till the start of mobilization for Induction treatment and 70-120 days post-ASCT, every 2 weeks during 16 weeks of Consolidation treatment, and monthly for 24 months of Maintenance treatment up to 30 days after last dose of study drugs. Assessments will be made through analysis of the reported incidence of treatment-emergent Serious Adverse Events (SAEs) and non-serious adverse events (AEs).
Renal and urinary disorders Urine flow decreased	1.9% 1/52 • Number of events 1 • weekly for 8 weeks, then every 2 weeks till the start of mobilization for Induction treatment and 70-120 days post-ASCT, every 2 weeks during 16 weeks of Consolidation treatment, and monthly for 24 months of Maintenance treatment up to 30 days after last dose of study drugs. Assessments will be made through analysis of the reported incidence of treatment-emergent Serious Adverse Events (SAEs) and non-serious adverse events (AEs).
Reproductive system and breast disorders Dyspareunia	1.9% 1/52 • Number of events 1 • weekly for 8 weeks, then every 2 weeks till the start of mobilization for Induction treatment and 70-120 days post-ASCT, every 2 weeks during 16 weeks of Consolidation treatment, and monthly for 24 months of Maintenance treatment up to 30 days after last dose of study drugs. Assessments will be made through analysis of the reported incidence of treatment-emergent Serious Adverse Events (SAEs) and non-serious adverse events (AEs).
Reproductive system and breast disorders Erectile dysfunction	1.9% 1/52 • Number of events 1 • weekly for 8 weeks, then every 2 weeks till the start of mobilization for Induction treatment and 70-120 days post-ASCT, every 2 weeks during 16 weeks of Consolidation treatment, and monthly for 24 months of Maintenance treatment up to 30 days after last dose of study drugs. Assessments will be made through analysis of the reported incidence of treatment-emergent Serious Adverse Events (SAEs) and non-serious adverse events (AEs).
Reproductive system and breast disorders Pelvic pain	1.9% 1/52 • Number of events 1 • weekly for 8 weeks, then every 2 weeks till the start of mobilization for Induction treatment and 70-120 days post-ASCT, every 2 weeks during 16 weeks of Consolidation treatment, and monthly for 24 months of Maintenance treatment up to 30 days after last dose of study drugs. Assessments will be made through analysis of the reported incidence of treatment-emergent Serious Adverse Events (SAEs) and non-serious adverse events (AEs).
Reproductive system and breast disorders Perineal pain	1.9% 1/52 • Number of events 1 • weekly for 8 weeks, then every 2 weeks till the start of mobilization for Induction treatment and 70-120 days post-ASCT, every 2 weeks during 16 weeks of Consolidation treatment, and monthly for 24 months of Maintenance treatment up to 30 days after last dose of study drugs. Assessments will be made through analysis of the reported incidence of treatment-emergent Serious Adverse Events (SAEs) and non-serious adverse events (AEs).
Reproductive system and breast disorders Prostatic obstruction	1.9% 1/52 • Number of events 1 • weekly for 8 weeks, then every 2 weeks till the start of mobilization for Induction treatment and 70-120 days post-ASCT, every 2 weeks during 16 weeks of Consolidation treatment, and monthly for 24 months of Maintenance treatment up to 30 days after last dose of study drugs. Assessments will be made through analysis of the reported incidence of treatment-emergent Serious Adverse Events (SAEs) and non-serious adverse events (AEs).
Reproductive system and breast disorders Vaginal haemorrhage	1.9% 1/52 • Number of events 1 • weekly for 8 weeks, then every 2 weeks till the start of mobilization for Induction treatment and 70-120 days post-ASCT, every 2 weeks during 16 weeks of Consolidation treatment, and monthly for 24 months of Maintenance treatment up to 30 days after last dose of study drugs. Assessments will be made through analysis of the reported incidence of treatment-emergent Serious Adverse Events (SAEs) and non-serious adverse events (AEs).
Reproductive system and breast disorders Vulvovaginal dryness	1.9% 1/52 • Number of events 1 • weekly for 8 weeks, then every 2 weeks till the start of mobilization for Induction treatment and 70-120 days post-ASCT, every 2 weeks during 16 weeks of Consolidation treatment, and monthly for 24 months of Maintenance treatment up to 30 days after last dose of study drugs. Assessments will be made through analysis of the reported incidence of treatment-emergent Serious Adverse Events (SAEs) and non-serious adverse events (AEs).
Reproductive system and breast disorders Vulvovaginal inflammation	1.9% 1/52 • Number of events 1 • weekly for 8 weeks, then every 2 weeks till the start of mobilization for Induction treatment and 70-120 days post-ASCT, every 2 weeks during 16 weeks of Consolidation treatment, and monthly for 24 months of Maintenance treatment up to 30 days after last dose of study drugs. Assessments will be made through analysis of the reported incidence of treatment-emergent Serious Adverse Events (SAEs) and non-serious adverse events (AEs).
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disease	3.8% 2/52 • Number of events 2 • weekly for 8 weeks, then every 2 weeks till the start of mobilization for Induction treatment and 70-120 days post-ASCT, every 2 weeks during 16 weeks of Consolidation treatment, and monthly for 24 months of Maintenance treatment up to 30 days after last dose of study drugs. Assessments will be made through analysis of the reported incidence of treatment-emergent Serious Adverse Events (SAEs) and non-serious adverse events (AEs).
Respiratory, thoracic and mediastinal disorders Cough	30.8% 16/52 • Number of events 21 • weekly for 8 weeks, then every 2 weeks till the start of mobilization for Induction treatment and 70-120 days post-ASCT, every 2 weeks during 16 weeks of Consolidation treatment, and monthly for 24 months of Maintenance treatment up to 30 days after last dose of study drugs. Assessments will be made through analysis of the reported incidence of treatment-emergent Serious Adverse Events (SAEs) and non-serious adverse events (AEs).
Respiratory, thoracic and mediastinal disorders Dysphonia	5.8% 3/52 • Number of events 4 • weekly for 8 weeks, then every 2 weeks till the start of mobilization for Induction treatment and 70-120 days post-ASCT, every 2 weeks during 16 weeks of Consolidation treatment, and monthly for 24 months of Maintenance treatment up to 30 days after last dose of study drugs. Assessments will be made through analysis of the reported incidence of treatment-emergent Serious Adverse Events (SAEs) and non-serious adverse events (AEs).
Respiratory, thoracic and mediastinal disorders Dyspnoea	17.3% 9/52 • Number of events 15 • weekly for 8 weeks, then every 2 weeks till the start of mobilization for Induction treatment and 70-120 days post-ASCT, every 2 weeks during 16 weeks of Consolidation treatment, and monthly for 24 months of Maintenance treatment up to 30 days after last dose of study drugs. Assessments will be made through analysis of the reported incidence of treatment-emergent Serious Adverse Events (SAEs) and non-serious adverse events (AEs).
Respiratory, thoracic and mediastinal disorders Dyspnoea exertional	3.8% 2/52 • Number of events 2 • weekly for 8 weeks, then every 2 weeks till the start of mobilization for Induction treatment and 70-120 days post-ASCT, every 2 weeks during 16 weeks of Consolidation treatment, and monthly for 24 months of Maintenance treatment up to 30 days after last dose of study drugs. Assessments will be made through analysis of the reported incidence of treatment-emergent Serious Adverse Events (SAEs) and non-serious adverse events (AEs).
Respiratory, thoracic and mediastinal disorders Emphysema	1.9% 1/52 • Number of events 1 • weekly for 8 weeks, then every 2 weeks till the start of mobilization for Induction treatment and 70-120 days post-ASCT, every 2 weeks during 16 weeks of Consolidation treatment, and monthly for 24 months of Maintenance treatment up to 30 days after last dose of study drugs. Assessments will be made through analysis of the reported incidence of treatment-emergent Serious Adverse Events (SAEs) and non-serious adverse events (AEs).
Respiratory, thoracic and mediastinal disorders Epistaxis	3.8% 2/52 • Number of events 2 • weekly for 8 weeks, then every 2 weeks till the start of mobilization for Induction treatment and 70-120 days post-ASCT, every 2 weeks during 16 weeks of Consolidation treatment, and monthly for 24 months of Maintenance treatment up to 30 days after last dose of study drugs. Assessments will be made through analysis of the reported incidence of treatment-emergent Serious Adverse Events (SAEs) and non-serious adverse events (AEs).
Respiratory, thoracic and mediastinal disorders Haemoptysis	1.9% 1/52 • Number of events 1 • weekly for 8 weeks, then every 2 weeks till the start of mobilization for Induction treatment and 70-120 days post-ASCT, every 2 weeks during 16 weeks of Consolidation treatment, and monthly for 24 months of Maintenance treatment up to 30 days after last dose of study drugs. Assessments will be made through analysis of the reported incidence of treatment-emergent Serious Adverse Events (SAEs) and non-serious adverse events (AEs).
Respiratory, thoracic and mediastinal disorders Hypoxia	1.9% 1/52 • Number of events 1 • weekly for 8 weeks, then every 2 weeks till the start of mobilization for Induction treatment and 70-120 days post-ASCT, every 2 weeks during 16 weeks of Consolidation treatment, and monthly for 24 months of Maintenance treatment up to 30 days after last dose of study drugs. Assessments will be made through analysis of the reported incidence of treatment-emergent Serious Adverse Events (SAEs) and non-serious adverse events (AEs).
Respiratory, thoracic and mediastinal disorders Lower respiratory tract congestion	1.9% 1/52 • Number of events 1 • weekly for 8 weeks, then every 2 weeks till the start of mobilization for Induction treatment and 70-120 days post-ASCT, every 2 weeks during 16 weeks of Consolidation treatment, and monthly for 24 months of Maintenance treatment up to 30 days after last dose of study drugs. Assessments will be made through analysis of the reported incidence of treatment-emergent Serious Adverse Events (SAEs) and non-serious adverse events (AEs).
Respiratory, thoracic and mediastinal disorders Nasal congestion	5.8% 3/52 • Number of events 3 • weekly for 8 weeks, then every 2 weeks till the start of mobilization for Induction treatment and 70-120 days post-ASCT, every 2 weeks during 16 weeks of Consolidation treatment, and monthly for 24 months of Maintenance treatment up to 30 days after last dose of study drugs. Assessments will be made through analysis of the reported incidence of treatment-emergent Serious Adverse Events (SAEs) and non-serious adverse events (AEs).
Respiratory, thoracic and mediastinal disorders Oropharyngeal discomfort	1.9% 1/52 • Number of events 2 • weekly for 8 weeks, then every 2 weeks till the start of mobilization for Induction treatment and 70-120 days post-ASCT, every 2 weeks during 16 weeks of Consolidation treatment, and monthly for 24 months of Maintenance treatment up to 30 days after last dose of study drugs. Assessments will be made through analysis of the reported incidence of treatment-emergent Serious Adverse Events (SAEs) and non-serious adverse events (AEs).
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	15.4% 8/52 • Number of events 8 • weekly for 8 weeks, then every 2 weeks till the start of mobilization for Induction treatment and 70-120 days post-ASCT, every 2 weeks during 16 weeks of Consolidation treatment, and monthly for 24 months of Maintenance treatment up to 30 days after last dose of study drugs. Assessments will be made through analysis of the reported incidence of treatment-emergent Serious Adverse Events (SAEs) and non-serious adverse events (AEs).
Respiratory, thoracic and mediastinal disorders Paranasal sinus hypersecretion	1.9% 1/52 • Number of events 1 • weekly for 8 weeks, then every 2 weeks till the start of mobilization for Induction treatment and 70-120 days post-ASCT, every 2 weeks during 16 weeks of Consolidation treatment, and monthly for 24 months of Maintenance treatment up to 30 days after last dose of study drugs. Assessments will be made through analysis of the reported incidence of treatment-emergent Serious Adverse Events (SAEs) and non-serious adverse events (AEs).
Respiratory, thoracic and mediastinal disorders Productive cough	7.7% 4/52 • Number of events 4 • weekly for 8 weeks, then every 2 weeks till the start of mobilization for Induction treatment and 70-120 days post-ASCT, every 2 weeks during 16 weeks of Consolidation treatment, and monthly for 24 months of Maintenance treatment up to 30 days after last dose of study drugs. Assessments will be made through analysis of the reported incidence of treatment-emergent Serious Adverse Events (SAEs) and non-serious adverse events (AEs).
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	3.8% 2/52 • Number of events 2 • weekly for 8 weeks, then every 2 weeks till the start of mobilization for Induction treatment and 70-120 days post-ASCT, every 2 weeks during 16 weeks of Consolidation treatment, and monthly for 24 months of Maintenance treatment up to 30 days after last dose of study drugs. Assessments will be made through analysis of the reported incidence of treatment-emergent Serious Adverse Events (SAEs) and non-serious adverse events (AEs).
Respiratory, thoracic and mediastinal disorders Rhinitis allergic	3.8% 2/52 • Number of events 2 • weekly for 8 weeks, then every 2 weeks till the start of mobilization for Induction treatment and 70-120 days post-ASCT, every 2 weeks during 16 weeks of Consolidation treatment, and monthly for 24 months of Maintenance treatment up to 30 days after last dose of study drugs. Assessments will be made through analysis of the reported incidence of treatment-emergent Serious Adverse Events (SAEs) and non-serious adverse events (AEs).
Respiratory, thoracic and mediastinal disorders Rhinorrhoea	1.9% 1/52 • Number of events 1 • weekly for 8 weeks, then every 2 weeks till the start of mobilization for Induction treatment and 70-120 days post-ASCT, every 2 weeks during 16 weeks of Consolidation treatment, and monthly for 24 months of Maintenance treatment up to 30 days after last dose of study drugs. Assessments will be made through analysis of the reported incidence of treatment-emergent Serious Adverse Events (SAEs) and non-serious adverse events (AEs).
Respiratory, thoracic and mediastinal disorders Sinus congestion	9.6% 5/52 • Number of events 6 • weekly for 8 weeks, then every 2 weeks till the start of mobilization for Induction treatment and 70-120 days post-ASCT, every 2 weeks during 16 weeks of Consolidation treatment, and monthly for 24 months of Maintenance treatment up to 30 days after last dose of study drugs. Assessments will be made through analysis of the reported incidence of treatment-emergent Serious Adverse Events (SAEs) and non-serious adverse events (AEs).
Respiratory, thoracic and mediastinal disorders Sleep apnoea syndrome	1.9% 1/52 • Number of events 1 • weekly for 8 weeks, then every 2 weeks till the start of mobilization for Induction treatment and 70-120 days post-ASCT, every 2 weeks during 16 weeks of Consolidation treatment, and monthly for 24 months of Maintenance treatment up to 30 days after last dose of study drugs. Assessments will be made through analysis of the reported incidence of treatment-emergent Serious Adverse Events (SAEs) and non-serious adverse events (AEs).
Respiratory, thoracic and mediastinal disorders Sneezing	1.9% 1/52 • Number of events 1 • weekly for 8 weeks, then every 2 weeks till the start of mobilization for Induction treatment and 70-120 days post-ASCT, every 2 weeks during 16 weeks of Consolidation treatment, and monthly for 24 months of Maintenance treatment up to 30 days after last dose of study drugs. Assessments will be made through analysis of the reported incidence of treatment-emergent Serious Adverse Events (SAEs) and non-serious adverse events (AEs).
Respiratory, thoracic and mediastinal disorders Upper-airway cough syndrome	3.8% 2/52 • Number of events 2 • weekly for 8 weeks, then every 2 weeks till the start of mobilization for Induction treatment and 70-120 days post-ASCT, every 2 weeks during 16 weeks of Consolidation treatment, and monthly for 24 months of Maintenance treatment up to 30 days after last dose of study drugs. Assessments will be made through analysis of the reported incidence of treatment-emergent Serious Adverse Events (SAEs) and non-serious adverse events (AEs).
Respiratory, thoracic and mediastinal disorders Wheezing	11.5% 6/52 • Number of events 6 • weekly for 8 weeks, then every 2 weeks till the start of mobilization for Induction treatment and 70-120 days post-ASCT, every 2 weeks during 16 weeks of Consolidation treatment, and monthly for 24 months of Maintenance treatment up to 30 days after last dose of study drugs. Assessments will be made through analysis of the reported incidence of treatment-emergent Serious Adverse Events (SAEs) and non-serious adverse events (AEs).
Skin and subcutaneous tissue disorders Acne	1.9% 1/52 • Number of events 1 • weekly for 8 weeks, then every 2 weeks till the start of mobilization for Induction treatment and 70-120 days post-ASCT, every 2 weeks during 16 weeks of Consolidation treatment, and monthly for 24 months of Maintenance treatment up to 30 days after last dose of study drugs. Assessments will be made through analysis of the reported incidence of treatment-emergent Serious Adverse Events (SAEs) and non-serious adverse events (AEs).
Skin and subcutaneous tissue disorders Alopecia	3.8% 2/52 • Number of events 2 • weekly for 8 weeks, then every 2 weeks till the start of mobilization for Induction treatment and 70-120 days post-ASCT, every 2 weeks during 16 weeks of Consolidation treatment, and monthly for 24 months of Maintenance treatment up to 30 days after last dose of study drugs. Assessments will be made through analysis of the reported incidence of treatment-emergent Serious Adverse Events (SAEs) and non-serious adverse events (AEs).
Skin and subcutaneous tissue disorders Blister	1.9% 1/52 • Number of events 1 • weekly for 8 weeks, then every 2 weeks till the start of mobilization for Induction treatment and 70-120 days post-ASCT, every 2 weeks during 16 weeks of Consolidation treatment, and monthly for 24 months of Maintenance treatment up to 30 days after last dose of study drugs. Assessments will be made through analysis of the reported incidence of treatment-emergent Serious Adverse Events (SAEs) and non-serious adverse events (AEs).
Skin and subcutaneous tissue disorders Decubitus ulcer	1.9% 1/52 • Number of events 1 • weekly for 8 weeks, then every 2 weeks till the start of mobilization for Induction treatment and 70-120 days post-ASCT, every 2 weeks during 16 weeks of Consolidation treatment, and monthly for 24 months of Maintenance treatment up to 30 days after last dose of study drugs. Assessments will be made through analysis of the reported incidence of treatment-emergent Serious Adverse Events (SAEs) and non-serious adverse events (AEs).
Skin and subcutaneous tissue disorders Dry skin	1.9% 1/52 • Number of events 1 • weekly for 8 weeks, then every 2 weeks till the start of mobilization for Induction treatment and 70-120 days post-ASCT, every 2 weeks during 16 weeks of Consolidation treatment, and monthly for 24 months of Maintenance treatment up to 30 days after last dose of study drugs. Assessments will be made through analysis of the reported incidence of treatment-emergent Serious Adverse Events (SAEs) and non-serious adverse events (AEs).
Skin and subcutaneous tissue disorders Erythema	3.8% 2/52 • Number of events 2 • weekly for 8 weeks, then every 2 weeks till the start of mobilization for Induction treatment and 70-120 days post-ASCT, every 2 weeks during 16 weeks of Consolidation treatment, and monthly for 24 months of Maintenance treatment up to 30 days after last dose of study drugs. Assessments will be made through analysis of the reported incidence of treatment-emergent Serious Adverse Events (SAEs) and non-serious adverse events (AEs).
Skin and subcutaneous tissue disorders Erythema multiforme	1.9% 1/52 • Number of events 1 • weekly for 8 weeks, then every 2 weeks till the start of mobilization for Induction treatment and 70-120 days post-ASCT, every 2 weeks during 16 weeks of Consolidation treatment, and monthly for 24 months of Maintenance treatment up to 30 days after last dose of study drugs. Assessments will be made through analysis of the reported incidence of treatment-emergent Serious Adverse Events (SAEs) and non-serious adverse events (AEs).
Skin and subcutaneous tissue disorders Hyperhidrosis	3.8% 2/52 • Number of events 2 • weekly for 8 weeks, then every 2 weeks till the start of mobilization for Induction treatment and 70-120 days post-ASCT, every 2 weeks during 16 weeks of Consolidation treatment, and monthly for 24 months of Maintenance treatment up to 30 days after last dose of study drugs. Assessments will be made through analysis of the reported incidence of treatment-emergent Serious Adverse Events (SAEs) and non-serious adverse events (AEs).
Skin and subcutaneous tissue disorders Leukoplakia	1.9% 1/52 • Number of events 1 • weekly for 8 weeks, then every 2 weeks till the start of mobilization for Induction treatment and 70-120 days post-ASCT, every 2 weeks during 16 weeks of Consolidation treatment, and monthly for 24 months of Maintenance treatment up to 30 days after last dose of study drugs. Assessments will be made through analysis of the reported incidence of treatment-emergent Serious Adverse Events (SAEs) and non-serious adverse events (AEs).
Skin and subcutaneous tissue disorders Night sweats	13.5% 7/52 • Number of events 7 • weekly for 8 weeks, then every 2 weeks till the start of mobilization for Induction treatment and 70-120 days post-ASCT, every 2 weeks during 16 weeks of Consolidation treatment, and monthly for 24 months of Maintenance treatment up to 30 days after last dose of study drugs. Assessments will be made through analysis of the reported incidence of treatment-emergent Serious Adverse Events (SAEs) and non-serious adverse events (AEs).
Skin and subcutaneous tissue disorders Onychoclasis	1.9% 1/52 • Number of events 1 • weekly for 8 weeks, then every 2 weeks till the start of mobilization for Induction treatment and 70-120 days post-ASCT, every 2 weeks during 16 weeks of Consolidation treatment, and monthly for 24 months of Maintenance treatment up to 30 days after last dose of study drugs. Assessments will be made through analysis of the reported incidence of treatment-emergent Serious Adverse Events (SAEs) and non-serious adverse events (AEs).
Skin and subcutaneous tissue disorders Pain of skin	1.9% 1/52 • Number of events 1 • weekly for 8 weeks, then every 2 weeks till the start of mobilization for Induction treatment and 70-120 days post-ASCT, every 2 weeks during 16 weeks of Consolidation treatment, and monthly for 24 months of Maintenance treatment up to 30 days after last dose of study drugs. Assessments will be made through analysis of the reported incidence of treatment-emergent Serious Adverse Events (SAEs) and non-serious adverse events (AEs).
Skin and subcutaneous tissue disorders Pruritus	7.7% 4/52 • Number of events 4 • weekly for 8 weeks, then every 2 weeks till the start of mobilization for Induction treatment and 70-120 days post-ASCT, every 2 weeks during 16 weeks of Consolidation treatment, and monthly for 24 months of Maintenance treatment up to 30 days after last dose of study drugs. Assessments will be made through analysis of the reported incidence of treatment-emergent Serious Adverse Events (SAEs) and non-serious adverse events (AEs).
Skin and subcutaneous tissue disorders Rash	23.1% 12/52 • Number of events 17 • weekly for 8 weeks, then every 2 weeks till the start of mobilization for Induction treatment and 70-120 days post-ASCT, every 2 weeks during 16 weeks of Consolidation treatment, and monthly for 24 months of Maintenance treatment up to 30 days after last dose of study drugs. Assessments will be made through analysis of the reported incidence of treatment-emergent Serious Adverse Events (SAEs) and non-serious adverse events (AEs).
Skin and subcutaneous tissue disorders Rash macular	1.9% 1/52 • Number of events 1 • weekly for 8 weeks, then every 2 weeks till the start of mobilization for Induction treatment and 70-120 days post-ASCT, every 2 weeks during 16 weeks of Consolidation treatment, and monthly for 24 months of Maintenance treatment up to 30 days after last dose of study drugs. Assessments will be made through analysis of the reported incidence of treatment-emergent Serious Adverse Events (SAEs) and non-serious adverse events (AEs).
Skin and subcutaneous tissue disorders Rash maculo-papular	5.8% 3/52 • Number of events 4 • weekly for 8 weeks, then every 2 weeks till the start of mobilization for Induction treatment and 70-120 days post-ASCT, every 2 weeks during 16 weeks of Consolidation treatment, and monthly for 24 months of Maintenance treatment up to 30 days after last dose of study drugs. Assessments will be made through analysis of the reported incidence of treatment-emergent Serious Adverse Events (SAEs) and non-serious adverse events (AEs).
Skin and subcutaneous tissue disorders Rash pruritic	1.9% 1/52 • Number of events 1 • weekly for 8 weeks, then every 2 weeks till the start of mobilization for Induction treatment and 70-120 days post-ASCT, every 2 weeks during 16 weeks of Consolidation treatment, and monthly for 24 months of Maintenance treatment up to 30 days after last dose of study drugs. Assessments will be made through analysis of the reported incidence of treatment-emergent Serious Adverse Events (SAEs) and non-serious adverse events (AEs).
Skin and subcutaneous tissue disorders Skin irritation	1.9% 1/52 • Number of events 1 • weekly for 8 weeks, then every 2 weeks till the start of mobilization for Induction treatment and 70-120 days post-ASCT, every 2 weeks during 16 weeks of Consolidation treatment, and monthly for 24 months of Maintenance treatment up to 30 days after last dose of study drugs. Assessments will be made through analysis of the reported incidence of treatment-emergent Serious Adverse Events (SAEs) and non-serious adverse events (AEs).
Skin and subcutaneous tissue disorders Skin lesion	1.9% 1/52 • Number of events 1 • weekly for 8 weeks, then every 2 weeks till the start of mobilization for Induction treatment and 70-120 days post-ASCT, every 2 weeks during 16 weeks of Consolidation treatment, and monthly for 24 months of Maintenance treatment up to 30 days after last dose of study drugs. Assessments will be made through analysis of the reported incidence of treatment-emergent Serious Adverse Events (SAEs) and non-serious adverse events (AEs).
Surgical and medical procedures Cholecystectomy	1.9% 1/52 • Number of events 1 • weekly for 8 weeks, then every 2 weeks till the start of mobilization for Induction treatment and 70-120 days post-ASCT, every 2 weeks during 16 weeks of Consolidation treatment, and monthly for 24 months of Maintenance treatment up to 30 days after last dose of study drugs. Assessments will be made through analysis of the reported incidence of treatment-emergent Serious Adverse Events (SAEs) and non-serious adverse events (AEs).
Surgical and medical procedures Tooth extraction	1.9% 1/52 • Number of events 1 • weekly for 8 weeks, then every 2 weeks till the start of mobilization for Induction treatment and 70-120 days post-ASCT, every 2 weeks during 16 weeks of Consolidation treatment, and monthly for 24 months of Maintenance treatment up to 30 days after last dose of study drugs. Assessments will be made through analysis of the reported incidence of treatment-emergent Serious Adverse Events (SAEs) and non-serious adverse events (AEs).
Vascular disorders Aortic dilatation	1.9% 1/52 • Number of events 1 • weekly for 8 weeks, then every 2 weeks till the start of mobilization for Induction treatment and 70-120 days post-ASCT, every 2 weeks during 16 weeks of Consolidation treatment, and monthly for 24 months of Maintenance treatment up to 30 days after last dose of study drugs. Assessments will be made through analysis of the reported incidence of treatment-emergent Serious Adverse Events (SAEs) and non-serious adverse events (AEs).
Vascular disorders Deep vein thrombosis	5.8% 3/52 • Number of events 3 • weekly for 8 weeks, then every 2 weeks till the start of mobilization for Induction treatment and 70-120 days post-ASCT, every 2 weeks during 16 weeks of Consolidation treatment, and monthly for 24 months of Maintenance treatment up to 30 days after last dose of study drugs. Assessments will be made through analysis of the reported incidence of treatment-emergent Serious Adverse Events (SAEs) and non-serious adverse events (AEs).
Vascular disorders Flushing	1.9% 1/52 • Number of events 1 • weekly for 8 weeks, then every 2 weeks till the start of mobilization for Induction treatment and 70-120 days post-ASCT, every 2 weeks during 16 weeks of Consolidation treatment, and monthly for 24 months of Maintenance treatment up to 30 days after last dose of study drugs. Assessments will be made through analysis of the reported incidence of treatment-emergent Serious Adverse Events (SAEs) and non-serious adverse events (AEs).
Vascular disorders Haematoma	1.9% 1/52 • Number of events 1 • weekly for 8 weeks, then every 2 weeks till the start of mobilization for Induction treatment and 70-120 days post-ASCT, every 2 weeks during 16 weeks of Consolidation treatment, and monthly for 24 months of Maintenance treatment up to 30 days after last dose of study drugs. Assessments will be made through analysis of the reported incidence of treatment-emergent Serious Adverse Events (SAEs) and non-serious adverse events (AEs).
Vascular disorders Hot flush	1.9% 1/52 • Number of events 1 • weekly for 8 weeks, then every 2 weeks till the start of mobilization for Induction treatment and 70-120 days post-ASCT, every 2 weeks during 16 weeks of Consolidation treatment, and monthly for 24 months of Maintenance treatment up to 30 days after last dose of study drugs. Assessments will be made through analysis of the reported incidence of treatment-emergent Serious Adverse Events (SAEs) and non-serious adverse events (AEs).
Vascular disorders Hypertension	5.8% 3/52 • Number of events 4 • weekly for 8 weeks, then every 2 weeks till the start of mobilization for Induction treatment and 70-120 days post-ASCT, every 2 weeks during 16 weeks of Consolidation treatment, and monthly for 24 months of Maintenance treatment up to 30 days after last dose of study drugs. Assessments will be made through analysis of the reported incidence of treatment-emergent Serious Adverse Events (SAEs) and non-serious adverse events (AEs).
Vascular disorders Hypotension	1.9% 1/52 • Number of events 4 • weekly for 8 weeks, then every 2 weeks till the start of mobilization for Induction treatment and 70-120 days post-ASCT, every 2 weeks during 16 weeks of Consolidation treatment, and monthly for 24 months of Maintenance treatment up to 30 days after last dose of study drugs. Assessments will be made through analysis of the reported incidence of treatment-emergent Serious Adverse Events (SAEs) and non-serious adverse events (AEs).
Vascular disorders Pallor	1.9% 1/52 • Number of events 2 • weekly for 8 weeks, then every 2 weeks till the start of mobilization for Induction treatment and 70-120 days post-ASCT, every 2 weeks during 16 weeks of Consolidation treatment, and monthly for 24 months of Maintenance treatment up to 30 days after last dose of study drugs. Assessments will be made through analysis of the reported incidence of treatment-emergent Serious Adverse Events (SAEs) and non-serious adverse events (AEs).
Vascular disorders Phlebitis	1.9% 1/52 • Number of events 1 • weekly for 8 weeks, then every 2 weeks till the start of mobilization for Induction treatment and 70-120 days post-ASCT, every 2 weeks during 16 weeks of Consolidation treatment, and monthly for 24 months of Maintenance treatment up to 30 days after last dose of study drugs. Assessments will be made through analysis of the reported incidence of treatment-emergent Serious Adverse Events (SAEs) and non-serious adverse events (AEs).
Vascular disorders Thrombophlebitis superficial	1.9% 1/52 • Number of events 1 • weekly for 8 weeks, then every 2 weeks till the start of mobilization for Induction treatment and 70-120 days post-ASCT, every 2 weeks during 16 weeks of Consolidation treatment, and monthly for 24 months of Maintenance treatment up to 30 days after last dose of study drugs. Assessments will be made through analysis of the reported incidence of treatment-emergent Serious Adverse Events (SAEs) and non-serious adverse events (AEs).

Additional Information

Sarah Cannon Development Innovations, LLC

Sarah Cannon Development Innovations, LLC

Phone: 844-710-6157

Email: CANN.InnovationsMedical@sarahcannon.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: GT60