Trial Outcomes & Findings for Rituxan/BEAM vs Bexxar/BEAM in Autologous Hematopoietic Stem Cell Transplant for Non-Hodgkin's Lymphoma (BMTCTN0401) (NCT NCT00329030)

Last Updated: 2021-11-01

Results Overview

Patients are considered a failure for this endpoint if they die, relapse/progress, or receive anti-lymphoma therapy, other than post-transplant consolidative localized radiation (maximum 3 sites) to sites of prior bulk disease pre-transplant (\> 3cm). The time to this event is the time from randomization until death, relapse/progression, receipt of anti-lymphoma therapy, or last follow up, whichever comes first.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

224 participants

Primary outcome timeframe

1 and 2 years

Results posted on

2021-11-01

Participant Flow

Participant milestones

Participant milestones
Measure	B-BEAM Patients received Bexxar/BEAM with the dosimetric dose of 5 mCi Bexxar on Day -19 and the therapeutic dose calculated to administer 75 cGy total body dose (TBD) on Day -12. Patients will then receive carmustine (BCNU) 300 mg/m2 Day -6, Etoposide 100 mg/m2 BID Days -5 to -2, Cytarabine 100 mg/m2 BID Days -5 to -2, and Melphalan 140 mg/m2 Day -1 followed by ASCT	R-BEAM Patients received Rituxan/BEAM, with Rituxan 375 mg/m2 IV Days -19 and -12, BCNU 300 mg/m2 Day -6, Etoposide 100 mg/m2 BID Days -5 to -2, Cytarabine 100 mg/m2 BID Days -5 to -2, and Melphalan 140 mg/m2 Day -1 followed by ASCT
Overall Study STARTED	111	113
Overall Study COMPLETED	103	107
Overall Study NOT COMPLETED	8	6

Reasons for withdrawal

Reasons for withdrawal
Measure	B-BEAM Patients received Bexxar/BEAM with the dosimetric dose of 5 mCi Bexxar on Day -19 and the therapeutic dose calculated to administer 75 cGy total body dose (TBD) on Day -12. Patients will then receive carmustine (BCNU) 300 mg/m2 Day -6, Etoposide 100 mg/m2 BID Days -5 to -2, Cytarabine 100 mg/m2 BID Days -5 to -2, and Melphalan 140 mg/m2 Day -1 followed by ASCT	R-BEAM Patients received Rituxan/BEAM, with Rituxan 375 mg/m2 IV Days -19 and -12, BCNU 300 mg/m2 Day -6, Etoposide 100 mg/m2 BID Days -5 to -2, Cytarabine 100 mg/m2 BID Days -5 to -2, and Melphalan 140 mg/m2 Day -1 followed by ASCT
Overall Study Withdrawal by Subject	1	3
Overall Study Progressive Disease	6	2
Overall Study Ineligible Pathology	1	1

Baseline Characteristics

Rituxan/BEAM vs Bexxar/BEAM in Autologous Hematopoietic Stem Cell Transplant for Non-Hodgkin's Lymphoma (BMTCTN0401)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	B-BEAM n=111 Participants Bexxar/BEAM	R-BEAM n=113 Participants Rituxan/BEAM	Total n=224 Participants Total of all reporting groups
Age, Continuous	55.1 years STANDARD_DEVIATION 13.5 • n=5 Participants	56.8 years STANDARD_DEVIATION 12.5 • n=7 Participants	56.0 years STANDARD_DEVIATION 13.0 • n=5 Participants
Sex: Female, Male Female	43 Participants n=5 Participants	39 Participants n=7 Participants	82 Participants n=5 Participants
Sex: Female, Male Male	68 Participants n=5 Participants	74 Participants n=7 Participants	142 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants n=5 Participants	9 Participants n=7 Participants	11 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	99 Participants n=5 Participants	101 Participants n=7 Participants	200 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	10 Participants n=5 Participants	3 Participants n=7 Participants	13 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) Asian	2 Participants n=5 Participants	3 Participants n=7 Participants	5 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	4 Participants n=5 Participants	3 Participants n=7 Participants	7 Participants n=5 Participants
Race (NIH/OMB) White	99 Participants n=5 Participants	103 Participants n=7 Participants	202 Participants n=5 Participants
Race (NIH/OMB) More than one race	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	4 Participants n=5 Participants	2 Participants n=7 Participants	6 Participants n=5 Participants
Primary Disease Stage Primary Induction Failure	21 participants n=5 Participants	15 participants n=7 Participants	36 participants n=5 Participants
Primary Disease Stage First Relapse	35 participants n=5 Participants	46 participants n=7 Participants	81 participants n=5 Participants
Primary Disease Stage Second Complete Remission	55 participants n=5 Participants	52 participants n=7 Participants	107 participants n=5 Participants
Karnofsky Performance-status Score 100%	29 participants n=5 Participants	26 participants n=7 Participants	55 participants n=5 Participants
Karnofsky Performance-status Score 90%	67 participants n=5 Participants	63 participants n=7 Participants	130 participants n=5 Participants
Karnofsky Performance-status Score 80%	12 participants n=5 Participants	19 participants n=7 Participants	31 participants n=5 Participants
Karnofsky Performance-status Score 70%	3 participants n=5 Participants	5 participants n=7 Participants	8 participants n=5 Participants
Disease Status at Transplantation First Partial Response	21 participants n=5 Participants	15 participants n=7 Participants	36 participants n=5 Participants
Disease Status at Transplantation First Relapse	35 participants n=5 Participants	45 participants n=7 Participants	80 participants n=5 Participants
Disease Status at Transplantation Second Complete Remission	55 participants n=5 Participants	53 participants n=7 Participants	108 participants n=5 Participants
Number of Prior Therapies 1	2 participants n=5 Participants	7 participants n=7 Participants	9 participants n=5 Participants
Number of Prior Therapies 2	93 participants n=5 Participants	83 participants n=7 Participants	176 participants n=5 Participants
Number of Prior Therapies 3	16 participants n=5 Participants	23 participants n=7 Participants	39 participants n=5 Participants

PRIMARY outcome

Timeframe: 1 and 2 years

Outcome measures

Outcome measures
Measure	B-BEAM n=103 Participants Bexxar/BEAM	R-BEAM n=107 Participants Rituxan/BEAM
Progression-free Survival (PFS) 1 year	53.2 percentage of participants Interval 43.5 to 61.9	56.6 percentage of participants Interval 46.8 to 65.2
Progression-free Survival (PFS) 2 years	48.6 percentage of participants Interval 39.0 to 57.5	49.0 percentage of participants Interval 39.3 to 58.0

SECONDARY outcome

Timeframe: 1 and 2 years

The event is death from any cause. The time to this event is the time from randomization to death or last follow-up. Surviving patients are censored at the time of last observation

Outcome measures

Outcome measures
Measure	B-BEAM n=103 Participants Bexxar/BEAM	R-BEAM n=107 Participants Rituxan/BEAM
Overall Survival 1 year	68.5 percentage of participants Interval 58.9 to 76.2	73.7 percentage of participants Interval 64.4 to 80.9
Overall Survival 2 years	60.1 percentage of participants Interval 50.3 to 68.6	66.3 percentage of participants Interval 56.6 to 74.3

SECONDARY outcome

Timeframe: 1 and 2 years

The time to this event is measured from randomization. Deaths without relapse/progression are considered as a competing risk. Surviving patients with no history of relapse/progression are censored at time of last follow-up.

Outcome measures

Outcome measures
Measure	B-BEAM n=103 Participants Bexxar/BEAM	R-BEAM n=107 Participants Rituxan/BEAM
Incidence of Relapse/Progression 1 year	39.6 percentage of participants Interval 30.4 to 48.8	40.7 percentage of participants Interval 31.5 to 49.9
Incidence of Relapse/Progression 2 years	44.2 percentage of participants Interval 34.8 to 53.6	47.4 percentage of participants Interval 38.0 to 56.8

SECONDARY outcome

Timeframe: Day 100 and 2 years

Outcome measures

Outcome measures
Measure	B-BEAM n=103 Participants Bexxar/BEAM	R-BEAM n=107 Participants Rituxan/BEAM
Complete Response (CR) and Partial Response (PR) Proportion Day 100	69.9 percentage of participants Interval 60.1 to 78.6	71.0 percentage of participants Interval 61.5 to 79.4
Complete Response (CR) and Partial Response (PR) Proportion 2 years	48.5 percentage of participants Interval 38.6 to 58.6	43.9 percentage of participants Interval 34.3 to 53.9

SECONDARY outcome

Timeframe: 100 and 180 days

Outcome measures

Outcome measures
Measure	B-BEAM n=103 Participants Bexxar/BEAM	R-BEAM n=107 Participants Rituxan/BEAM
Platelet Recovery to 20,000 Cells/μL Day 100	83.5 percentage of participants Interval 76.2 to 90.8	82.2 percentage of participants Interval 74.8 to 89.6
Platelet Recovery to 20,000 Cells/μL Day 180	84.5 percentage of participants Interval 77.4 to 91.6	83.2 percentage of participants Interval 75.9 to 90.5

SECONDARY outcome

Timeframe: 100 days, 1 year

Hematologic function will be defined as ANC \> 1,500 neutrophils/μL, hemoglobin \> 10 g/dL without transfusion support, and platelet count \> 100,000/μL without transfusion support.

Outcome measures

Outcome measures
Measure	B-BEAM n=103 Participants Bexxar/BEAM	R-BEAM n=107 Participants Rituxan/BEAM
Hematologic Function Day 100	34.8 percentage of participants Interval 25.2 to 45.4	38.5 percentage of participants Interval 28.8 to 49.0
Hematologic Function 1 year	64.0 percentage of participants Interval 52.1 to 74.8	58.9 percentage of participants Interval 46.8 to 70.3

SECONDARY outcome

Timeframe: 1 year

Population: 67 patients treated with B-BEAM incurred a total of 139 infections. 60 patients treated with R-BEAM incurred a total of 121 infections.

Outcome measures

Outcome measures
Measure	B-BEAM n=103 Participants Bexxar/BEAM	R-BEAM n=107 Participants Rituxan/BEAM
Incidence of Infection 1 Infection	38 participants	35 participants
Incidence of Infection 2 Infections	14 participants	11 participants
Incidence of Infection 3 Infections	5 participants	7 participants
Incidence of Infection 4 Infections	3 participants	4 participants
Incidence of Infection 5 Infections	1 participants	0 participants
Incidence of Infection 6-10 Infections	6 participants	2 participants
Incidence of Infection >10 Infections	0 participants	1 participants

SECONDARY outcome

Timeframe: Day 21

Mucositis severity will be scored per the modified Oral Mucositis Assessment Scale (OMAS) scoring system on a scale of 0 - 4, where 0 equals normal mucosa and 4 equals severe mucosa.

Outcome measures

Outcome measures
Measure	B-BEAM n=103 Participants Bexxar/BEAM	R-BEAM n=107 Participants Rituxan/BEAM
Mucositis Severity	0.72 scores on a scale Interval 0.0 to 2.0	0.31 scores on a scale Interval 0.0 to 1.75

SECONDARY outcome

Timeframe: 1 year

Tests to be performed on peripheral blood include CD2, CD3, CD4, CD8, CD19, CD3+/CD25+, CD45 RA/RO, CD56+/CD3-.

Outcome measures

Outcome measures
Measure	B-BEAM n=103 Participants Bexxar/BEAM	R-BEAM n=107 Participants Rituxan/BEAM
Immune Reconstitution CD2 (cells/uL)	1006.0 cells/uL Standard Deviation 767.6	1024.9 cells/uL Standard Deviation 1074.7
Immune Reconstitution CD3 (cells/uL)	921.8 cells/uL Standard Deviation 694.8	990.3 cells/uL Standard Deviation 1056.1
Immune Reconstitution CD4 (cells/uL)	342.8 cells/uL Standard Deviation 223.9	286.1 cells/uL Standard Deviation 213.3
Immune Reconstitution CD8 (cells/uL)	558.5 cells/uL Standard Deviation 517.9	697.7 cells/uL Standard Deviation 901.1
Immune Reconstitution CD19 (cells/uL)	143.4 cells/uL Standard Deviation 140.5	140.8 cells/uL Standard Deviation 203.0
Immune Reconstitution CD3+/CD25+ (cells/uL)	112.2 cells/uL Standard Deviation 92.8	118.0 cells/uL Standard Deviation 127.7
Immune Reconstitution CD45RA (cells/uL)	469.3 cells/uL Standard Deviation 404.4	579.8 cells/uL Standard Deviation 620.5
Immune Reconstitution CD45RO (cells/uL)	476.2 cells/uL Standard Deviation 337.4	727.8 cells/uL Standard Deviation 798.8
Immune Reconstitution CD56+/CD3- (cells/uL)	125.1 cells/uL Standard Deviation 94.6	130.5 cells/uL Standard Deviation 135.7

SECONDARY outcome

Timeframe: 1 year

Tests to be performed on peripheral blood for quantitative immunoglobulins include IgM, IgG and IgA.

Outcome measures

Outcome measures
Measure	B-BEAM n=103 Participants Bexxar/BEAM	R-BEAM n=107 Participants Rituxan/BEAM
Immune Reconstitution of Quantitative Immunoglobulins IgA (mg/dL)	68.5 mg/dL Standard Deviation 42.6	85.0 mg/dL Standard Deviation 71.8
Immune Reconstitution of Quantitative Immunoglobulins IgG (mg/dL)	619.6 mg/dL Standard Deviation 289.2	643.8 mg/dL Standard Deviation 395.3
Immune Reconstitution of Quantitative Immunoglobulins IgM (mg/dL)	51.0 mg/dL Standard Deviation 36.0	79.0 mg/dL Standard Deviation 154.4

SECONDARY outcome

Timeframe: 1 and 2 years

TRM is defined as death occurring in a patient from causes other than relapse or progression

Outcome measures

Outcome measures
Measure	B-BEAM n=103 Participants Bexxar/BEAM	R-BEAM n=107 Participants Rituxan/BEAM
Treatment-related Mortality (TRM) 1 year	5.9 percentage of participants Interval 1.2 to 10.6	2.9 percentage of participants Interval 0.0 to 6.0
Treatment-related Mortality (TRM) 2 years	5.9 percentage of participants Interval 1.2 to 10.6	3.9 percentage of participants Interval 0.2 to 7.6

SECONDARY outcome

Timeframe: Day 28 and Day 60

Time to neutrophil recovery will be the first of two consecutive days of \> 500 neutrophils/μL following the expected nadir.

Outcome measures

Outcome measures
Measure	B-BEAM n=103 Participants Bexxar/BEAM	R-BEAM n=107 Participants Rituxan/BEAM
Neutrophil Recovery Day 28	96.1 percentage of participants Interval 92.2 to 100.0	93.5 percentage of participants Interval 88.6 to 98.4
Neutrophil Recovery Day 60	96.1 percentage of participants Interval 92.2 to 100.0	95.3 percentage of participants Interval 91.2 to 99.4

Adverse Events

B-BEAM

Serious events: 11 serious events

Other events: 0 other events

Deaths: 0 deaths

R-BEAM

Serious events: 6 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Adverse event data not reported

Additional Information

Adam Mendizabal

The EMMES Corporation

Phone: 301-251-1161

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	B-BEAM n=111 participants at risk Bexxar/BEAM	R-BEAM n=113 participants at risk Rituxan/BEAM
Immune system disorders Acute graft versus host disease in liver	0.90% 1/111 • Number of events 1 • Patients will be followed for at least two years post-ASCT. Serious Adverse Events (AE) are defined as events associated with death, life-threatening event, disability, congenital anomaly, required intervention to prevent permanent impairment or damage, hospitalization or other serious adverse event. Only unexpected grades 3-5 adverse events were required to be reported through the AE system per protocol.	0.00% 0/113 • Patients will be followed for at least two years post-ASCT. Serious Adverse Events (AE) are defined as events associated with death, life-threatening event, disability, congenital anomaly, required intervention to prevent permanent impairment or damage, hospitalization or other serious adverse event. Only unexpected grades 3-5 adverse events were required to be reported through the AE system per protocol.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Myelodysplastic syndrome	0.90% 1/111 • Number of events 1 • Patients will be followed for at least two years post-ASCT. Serious Adverse Events (AE) are defined as events associated with death, life-threatening event, disability, congenital anomaly, required intervention to prevent permanent impairment or damage, hospitalization or other serious adverse event. Only unexpected grades 3-5 adverse events were required to be reported through the AE system per protocol.	0.00% 0/113 • Patients will be followed for at least two years post-ASCT. Serious Adverse Events (AE) are defined as events associated with death, life-threatening event, disability, congenital anomaly, required intervention to prevent permanent impairment or damage, hospitalization or other serious adverse event. Only unexpected grades 3-5 adverse events were required to be reported through the AE system per protocol.
Nervous system disorders Syncope	1.8% 2/111 • Number of events 2 • Patients will be followed for at least two years post-ASCT. Serious Adverse Events (AE) are defined as events associated with death, life-threatening event, disability, congenital anomaly, required intervention to prevent permanent impairment or damage, hospitalization or other serious adverse event. Only unexpected grades 3-5 adverse events were required to be reported through the AE system per protocol.	0.00% 0/113 • Patients will be followed for at least two years post-ASCT. Serious Adverse Events (AE) are defined as events associated with death, life-threatening event, disability, congenital anomaly, required intervention to prevent permanent impairment or damage, hospitalization or other serious adverse event. Only unexpected grades 3-5 adverse events were required to be reported through the AE system per protocol.
Cardiac disorders Sinus tachycardia	0.90% 1/111 • Number of events 1 • Patients will be followed for at least two years post-ASCT. Serious Adverse Events (AE) are defined as events associated with death, life-threatening event, disability, congenital anomaly, required intervention to prevent permanent impairment or damage, hospitalization or other serious adverse event. Only unexpected grades 3-5 adverse events were required to be reported through the AE system per protocol.	0.00% 0/113 • Patients will be followed for at least two years post-ASCT. Serious Adverse Events (AE) are defined as events associated with death, life-threatening event, disability, congenital anomaly, required intervention to prevent permanent impairment or damage, hospitalization or other serious adverse event. Only unexpected grades 3-5 adverse events were required to be reported through the AE system per protocol.
Respiratory, thoracic and mediastinal disorders Pneumonitis	0.90% 1/111 • Number of events 1 • Patients will be followed for at least two years post-ASCT. Serious Adverse Events (AE) are defined as events associated with death, life-threatening event, disability, congenital anomaly, required intervention to prevent permanent impairment or damage, hospitalization or other serious adverse event. Only unexpected grades 3-5 adverse events were required to be reported through the AE system per protocol.	0.00% 0/113 • Patients will be followed for at least two years post-ASCT. Serious Adverse Events (AE) are defined as events associated with death, life-threatening event, disability, congenital anomaly, required intervention to prevent permanent impairment or damage, hospitalization or other serious adverse event. Only unexpected grades 3-5 adverse events were required to be reported through the AE system per protocol.
Hepatobiliary disorders Cholecystitis	0.90% 1/111 • Number of events 1 • Patients will be followed for at least two years post-ASCT. Serious Adverse Events (AE) are defined as events associated with death, life-threatening event, disability, congenital anomaly, required intervention to prevent permanent impairment or damage, hospitalization or other serious adverse event. Only unexpected grades 3-5 adverse events were required to be reported through the AE system per protocol.	0.00% 0/113 • Patients will be followed for at least two years post-ASCT. Serious Adverse Events (AE) are defined as events associated with death, life-threatening event, disability, congenital anomaly, required intervention to prevent permanent impairment or damage, hospitalization or other serious adverse event. Only unexpected grades 3-5 adverse events were required to be reported through the AE system per protocol.
Surgical and medical procedures Orchidectomy	0.90% 1/111 • Number of events 1 • Patients will be followed for at least two years post-ASCT. Serious Adverse Events (AE) are defined as events associated with death, life-threatening event, disability, congenital anomaly, required intervention to prevent permanent impairment or damage, hospitalization or other serious adverse event. Only unexpected grades 3-5 adverse events were required to be reported through the AE system per protocol.	0.00% 0/113 • Patients will be followed for at least two years post-ASCT. Serious Adverse Events (AE) are defined as events associated with death, life-threatening event, disability, congenital anomaly, required intervention to prevent permanent impairment or damage, hospitalization or other serious adverse event. Only unexpected grades 3-5 adverse events were required to be reported through the AE system per protocol.
Injury, poisoning and procedural complications Engraft failure	0.90% 1/111 • Number of events 1 • Patients will be followed for at least two years post-ASCT. Serious Adverse Events (AE) are defined as events associated with death, life-threatening event, disability, congenital anomaly, required intervention to prevent permanent impairment or damage, hospitalization or other serious adverse event. Only unexpected grades 3-5 adverse events were required to be reported through the AE system per protocol.	0.00% 0/113 • Patients will be followed for at least two years post-ASCT. Serious Adverse Events (AE) are defined as events associated with death, life-threatening event, disability, congenital anomaly, required intervention to prevent permanent impairment or damage, hospitalization or other serious adverse event. Only unexpected grades 3-5 adverse events were required to be reported through the AE system per protocol.
Nervous system disorders Cerebrovascular accident	0.90% 1/111 • Number of events 1 • Patients will be followed for at least two years post-ASCT. Serious Adverse Events (AE) are defined as events associated with death, life-threatening event, disability, congenital anomaly, required intervention to prevent permanent impairment or damage, hospitalization or other serious adverse event. Only unexpected grades 3-5 adverse events were required to be reported through the AE system per protocol.	0.00% 0/113 • Patients will be followed for at least two years post-ASCT. Serious Adverse Events (AE) are defined as events associated with death, life-threatening event, disability, congenital anomaly, required intervention to prevent permanent impairment or damage, hospitalization or other serious adverse event. Only unexpected grades 3-5 adverse events were required to be reported through the AE system per protocol.
Gastrointestinal disorders Eosinophilic oesophagitis	0.90% 1/111 • Number of events 1 • Patients will be followed for at least two years post-ASCT. Serious Adverse Events (AE) are defined as events associated with death, life-threatening event, disability, congenital anomaly, required intervention to prevent permanent impairment or damage, hospitalization or other serious adverse event. Only unexpected grades 3-5 adverse events were required to be reported through the AE system per protocol.	0.00% 0/113 • Patients will be followed for at least two years post-ASCT. Serious Adverse Events (AE) are defined as events associated with death, life-threatening event, disability, congenital anomaly, required intervention to prevent permanent impairment or damage, hospitalization or other serious adverse event. Only unexpected grades 3-5 adverse events were required to be reported through the AE system per protocol.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Acute myeloid leukaemia	0.00% 0/111 • Patients will be followed for at least two years post-ASCT. Serious Adverse Events (AE) are defined as events associated with death, life-threatening event, disability, congenital anomaly, required intervention to prevent permanent impairment or damage, hospitalization or other serious adverse event. Only unexpected grades 3-5 adverse events were required to be reported through the AE system per protocol.	0.88% 1/113 • Number of events 1 • Patients will be followed for at least two years post-ASCT. Serious Adverse Events (AE) are defined as events associated with death, life-threatening event, disability, congenital anomaly, required intervention to prevent permanent impairment or damage, hospitalization or other serious adverse event. Only unexpected grades 3-5 adverse events were required to be reported through the AE system per protocol.
Cardiac disorders Myocardial infarction	0.00% 0/111 • Patients will be followed for at least two years post-ASCT. Serious Adverse Events (AE) are defined as events associated with death, life-threatening event, disability, congenital anomaly, required intervention to prevent permanent impairment or damage, hospitalization or other serious adverse event. Only unexpected grades 3-5 adverse events were required to be reported through the AE system per protocol.	1.8% 2/113 • Number of events 2 • Patients will be followed for at least two years post-ASCT. Serious Adverse Events (AE) are defined as events associated with death, life-threatening event, disability, congenital anomaly, required intervention to prevent permanent impairment or damage, hospitalization or other serious adverse event. Only unexpected grades 3-5 adverse events were required to be reported through the AE system per protocol.
General disorders Death	0.00% 0/111 • Patients will be followed for at least two years post-ASCT. Serious Adverse Events (AE) are defined as events associated with death, life-threatening event, disability, congenital anomaly, required intervention to prevent permanent impairment or damage, hospitalization or other serious adverse event. Only unexpected grades 3-5 adverse events were required to be reported through the AE system per protocol.	0.88% 1/113 • Number of events 1 • Patients will be followed for at least two years post-ASCT. Serious Adverse Events (AE) are defined as events associated with death, life-threatening event, disability, congenital anomaly, required intervention to prevent permanent impairment or damage, hospitalization or other serious adverse event. Only unexpected grades 3-5 adverse events were required to be reported through the AE system per protocol.
Gastrointestinal disorders Gastrointestinal haemorrhage	0.00% 0/111 • Patients will be followed for at least two years post-ASCT. Serious Adverse Events (AE) are defined as events associated with death, life-threatening event, disability, congenital anomaly, required intervention to prevent permanent impairment or damage, hospitalization or other serious adverse event. Only unexpected grades 3-5 adverse events were required to be reported through the AE system per protocol.	0.88% 1/113 • Number of events 1 • Patients will be followed for at least two years post-ASCT. Serious Adverse Events (AE) are defined as events associated with death, life-threatening event, disability, congenital anomaly, required intervention to prevent permanent impairment or damage, hospitalization or other serious adverse event. Only unexpected grades 3-5 adverse events were required to be reported through the AE system per protocol.
Respiratory, thoracic and mediastinal disorders Acute respiratory distress syndrome	0.00% 0/111 • Patients will be followed for at least two years post-ASCT. Serious Adverse Events (AE) are defined as events associated with death, life-threatening event, disability, congenital anomaly, required intervention to prevent permanent impairment or damage, hospitalization or other serious adverse event. Only unexpected grades 3-5 adverse events were required to be reported through the AE system per protocol.	0.88% 1/113 • Number of events 1 • Patients will be followed for at least two years post-ASCT. Serious Adverse Events (AE) are defined as events associated with death, life-threatening event, disability, congenital anomaly, required intervention to prevent permanent impairment or damage, hospitalization or other serious adverse event. Only unexpected grades 3-5 adverse events were required to be reported through the AE system per protocol.