Trial Outcomes & Findings for Study of Bortezomib,Lenalidomide,Dexamethasone & Elotuzumab in Newly Diagnosed MM (NCT NCT02375555)
NCT ID: NCT02375555
Last Updated: 2024-10-01
Results Overview
Disease response was defined as the proportion of patients who achieved a response of partial response or better using International Myeloma Working Group (IMWG) response criteria. Partial Response (PR) defined as 50% reduction of serum M-protein and reduction in 24h urinary M-protein by ≥90% or to \<200mg/24h; Very Good Partial Response (VGPR) defined as serum and urine M-protein detectable by immunofixation but not on electrophoresis or ≥90% reduction in serum M-protein plus urine M-protein level \<100mg/24h; Complete Response (CR) defined as negative immunofixation on serum and urine and, disappearance of any soft tissue plasmacytomas and, \<5% plasma cells in BM; Stringent Complete Response (sCR) defined as normal FLC ratio and absence of clonal cells in BM by immunohistochemistry or 2-4 color flow cytometry. The Clopper and Pearson method was used to estimate the 95% CIs for the response rate at Week 12.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
40 participants
Primary outcome timeframe
Participants were followed up to 12 weeks.
Results posted on
2024-10-01
Participant Flow
Participants were enrolled from May 2015 to April 2016.
Participant milestones
| Measure |
Elotuzumab, Lenalidomide, Bortezomib, and Dexamethasone
Participants will receive therapy with the combination of lenalidomide, bortezomib, and dexamethasone and elotuzumab (E-RVD). Induction cycles (1 to 8) are 21-day cycles.
* Elotuzumab will be administered by intravenous (IV) infusion
* Bortezomib as a subcutaneous injection
* Lenalidomide single daily oral dose
* Dexamethasone as oral tablets and IV infusion
* Stem cell mobilization will be performed for all subjects at the end of Cycle 4.
Subjects who attain at least a partial response (PR) may elect to stop E-RVD at the end of Induction Cycle 4 and proceed to autologous SCT. Subjects who do not proceed to SCT may receive 8 cycles of induction therapy.
\- The maintenance schedule (28 days) will start after 8 cycles of induction regimen for subjects not proceeding with SCT, or after recovery from SCT for subjects proceeding with it.
Maintenance therapy with E-RVD will be administered to all patients, with the specific maintenance regimen determined by risk category.
Lenalidomide
Elotuzumab
Bortezomib
Dexamethasone
Stem Cell Mobilization
|
|---|---|
|
Induction Period
STARTED
|
40
|
|
Induction Period
Induction Therapy Cycles 1-4
|
34
|
|
Induction Period
Induction Therapy Cycles 5-8
|
12
|
|
Induction Period
Autologous Stem Cell Transplant
|
19
|
|
Induction Period
COMPLETED
|
29
|
|
Induction Period
NOT COMPLETED
|
11
|
|
Maintenance Period
STARTED
|
29
|
|
Maintenance Period
COMPLETED
|
0
|
|
Maintenance Period
NOT COMPLETED
|
29
|
Reasons for withdrawal
| Measure |
Elotuzumab, Lenalidomide, Bortezomib, and Dexamethasone
Participants will receive therapy with the combination of lenalidomide, bortezomib, and dexamethasone and elotuzumab (E-RVD). Induction cycles (1 to 8) are 21-day cycles.
* Elotuzumab will be administered by intravenous (IV) infusion
* Bortezomib as a subcutaneous injection
* Lenalidomide single daily oral dose
* Dexamethasone as oral tablets and IV infusion
* Stem cell mobilization will be performed for all subjects at the end of Cycle 4.
Subjects who attain at least a partial response (PR) may elect to stop E-RVD at the end of Induction Cycle 4 and proceed to autologous SCT. Subjects who do not proceed to SCT may receive 8 cycles of induction therapy.
\- The maintenance schedule (28 days) will start after 8 cycles of induction regimen for subjects not proceeding with SCT, or after recovery from SCT for subjects proceeding with it.
Maintenance therapy with E-RVD will be administered to all patients, with the specific maintenance regimen determined by risk category.
Lenalidomide
Elotuzumab
Bortezomib
Dexamethasone
Stem Cell Mobilization
|
|---|---|
|
Induction Period
Adverse Event
|
7
|
|
Induction Period
Withdrawal by Subject
|
2
|
|
Induction Period
Other
|
1
|
|
Induction Period
Didn't meet criteria for maintenance therapy
|
1
|
|
Maintenance Period
Adverse Event
|
2
|
|
Maintenance Period
Withdrawal by Subject
|
4
|
|
Maintenance Period
Death
|
1
|
|
Maintenance Period
Disease Progression
|
5
|
|
Maintenance Period
Patient Non-compliance
|
1
|
|
Maintenance Period
Still on maintenance
|
16
|
Baseline Characteristics
Study of Bortezomib,Lenalidomide,Dexamethasone & Elotuzumab in Newly Diagnosed MM
Baseline characteristics by cohort
| Measure |
Elotuzumab, Lenalidomide, Bortezomib, and Dexamethasone
n=40 Participants
Participants will receive therapy with the combination of lenalidomide, bortezomib, and dexamethasone and elotuzumab (E-RVD). Induction cycles (1 to 8) are 21-day cycles.
* Elotuzumab will be administered by intravenous (IV) infusion
* Bortezomib as a subcutaneous injection
* Lenalidomide single daily oral dose
* Dexamethasone as oral tablets and IV infusion
* Stem cell mobilization will be performed for all subjects at the end of Cycle 4.
Subjects may elect to stop E-RVD at the end of Cycle 4 and proceed to autologous SCT. Subjects who do not proceed to SCT may receive 8 cycles of induction therapy.
The maintenance schedule (28 days) will start after 8 cycles of induction regimen for subjects not proceeding with SCT, or after recovery from SCT for subjects proceeding with it.
Maintenance therapy with E-RVD will be administered to all patients, with the specific maintenance regimen determined by risk category.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
24 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
16 Participants
n=5 Participants
|
|
Age, Continuous
|
61 years
STANDARD_DEVIATION 8.6 • n=5 Participants
|
|
Sex: Female, Male
Female
|
17 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
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
6 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
28 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
5 Participants
n=5 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) Performance Status
Grade 0
|
26 Participants
n=5 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) Performance Status
Grade 1
|
13 Participants
n=5 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) Performance Status
Grade 2
|
1 Participants
n=5 Participants
|
|
International Staging System (ISS) Multiple Myeloma Stage
Stage I
|
24 Participants
n=5 Participants
|
|
International Staging System (ISS) Multiple Myeloma Stage
Stage II
|
10 Participants
n=5 Participants
|
|
International Staging System (ISS) Multiple Myeloma Stage
Stage III
|
6 Participants
n=5 Participants
|
|
Cytogenetic risk classification
High
|
6 Participants
n=5 Participants
|
|
Cytogenetic risk classification
Standard
|
19 Participants
n=5 Participants
|
|
Cytogenetic risk classification
Missing
|
15 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Participants were followed up to 12 weeks.Population: The analysis dataset is comprised of 34 efficacy-evaluable participants, where it was defined as participants who were dosed, had a post-baseline scan and also had at least 4-cycles of induction.
Disease response was defined as the proportion of patients who achieved a response of partial response or better using International Myeloma Working Group (IMWG) response criteria. Partial Response (PR) defined as 50% reduction of serum M-protein and reduction in 24h urinary M-protein by ≥90% or to \<200mg/24h; Very Good Partial Response (VGPR) defined as serum and urine M-protein detectable by immunofixation but not on electrophoresis or ≥90% reduction in serum M-protein plus urine M-protein level \<100mg/24h; Complete Response (CR) defined as negative immunofixation on serum and urine and, disappearance of any soft tissue plasmacytomas and, \<5% plasma cells in BM; Stringent Complete Response (sCR) defined as normal FLC ratio and absence of clonal cells in BM by immunohistochemistry or 2-4 color flow cytometry. The Clopper and Pearson method was used to estimate the 95% CIs for the response rate at Week 12.
Outcome measures
| Measure |
Elotuzumab, Lenalidomide, Bortezomib, and Dexamethasone
n=34 Participants
Participants will receive therapy with the combination of lenalidomide, bortezomib, and dexamethasone and elotuzumab (E-RVD). Induction cycles (1 to 8) are 21-day cycles.
* Elotuzumab will be administered by intravenous (IV) infusion
* Bortezomib as a subcutaneous injection
* Lenalidomide single daily oral dose
* Dexamethasone as oral tablets and IV infusion
* Stem cell mobilization will be performed for all subjects at the end of Cycle 4.
Subjects may elect to stop E-RVD at the end of Cycle 4 and proceed to autologous SCT. Subjects who do not proceed to SCT may receive 8 cycles of induction therapy.
The maintenance schedule (28 days) will start after 8 cycles of induction regimen for subjects not proceeding with SCT, or after recovery from SCT for subjects proceeding with it.
Maintenance therapy with E-RVD will be administered to all patients, with the specific maintenance regimen determined by risk category.
|
|---|---|
|
4 Cycle Response Rate
|
0.971 proportion of participants
Interval 0.847 to 0.999
|
SECONDARY outcome
Timeframe: The most distant time of stem cell mobilization from time of registration is 21.4 weeks with a median of 15.14 weeks.Population: The analysis population is comprised of participants who underwent stem cell mobilization after completing 4 cycles of induction therapy.
Successful SC Mob defined as the proportion of participants with the ability to collect a total of at least 2\*10\^6 CD34+ cells/kg.
Outcome measures
| Measure |
Elotuzumab, Lenalidomide, Bortezomib, and Dexamethasone
n=31 Participants
Participants will receive therapy with the combination of lenalidomide, bortezomib, and dexamethasone and elotuzumab (E-RVD). Induction cycles (1 to 8) are 21-day cycles.
* Elotuzumab will be administered by intravenous (IV) infusion
* Bortezomib as a subcutaneous injection
* Lenalidomide single daily oral dose
* Dexamethasone as oral tablets and IV infusion
* Stem cell mobilization will be performed for all subjects at the end of Cycle 4.
Subjects may elect to stop E-RVD at the end of Cycle 4 and proceed to autologous SCT. Subjects who do not proceed to SCT may receive 8 cycles of induction therapy.
The maintenance schedule (28 days) will start after 8 cycles of induction regimen for subjects not proceeding with SCT, or after recovery from SCT for subjects proceeding with it.
Maintenance therapy with E-RVD will be administered to all patients, with the specific maintenance regimen determined by risk category.
|
|---|---|
|
Successful Stem Cell Mobilization (SC Mob) Rate
|
0.968 proportion of participants
Interval 0.833 to 0.999
|
SECONDARY outcome
Timeframe: Participants were followed up to 12 weeks.Population: The analysis dataset is comprised of participants who were dosed (parallel with the safety population).
The 4 cycle ever DM rate is the proportion of participants who started therapy and required dose modification of any study drug during the first four cycles of E-RVD.
Outcome measures
| Measure |
Elotuzumab, Lenalidomide, Bortezomib, and Dexamethasone
n=40 Participants
Participants will receive therapy with the combination of lenalidomide, bortezomib, and dexamethasone and elotuzumab (E-RVD). Induction cycles (1 to 8) are 21-day cycles.
* Elotuzumab will be administered by intravenous (IV) infusion
* Bortezomib as a subcutaneous injection
* Lenalidomide single daily oral dose
* Dexamethasone as oral tablets and IV infusion
* Stem cell mobilization will be performed for all subjects at the end of Cycle 4.
Subjects may elect to stop E-RVD at the end of Cycle 4 and proceed to autologous SCT. Subjects who do not proceed to SCT may receive 8 cycles of induction therapy.
The maintenance schedule (28 days) will start after 8 cycles of induction regimen for subjects not proceeding with SCT, or after recovery from SCT for subjects proceeding with it.
Maintenance therapy with E-RVD will be administered to all patients, with the specific maintenance regimen determined by risk category.
|
|---|---|
|
4 Cycle Ever Dose Modification (DM) Rate
|
.40 proportion of participants
Interval 0.25 to 0.57
|
SECONDARY outcome
Timeframe: The adverse event observation period defined as the time on treatment (+30d) is 278 weeks.Population: All participants in the safety population.
Grade 3 and 4 TEA rate was defined as the proportion of participants who experienced a grade 3 or 4 adverse event of any attribution based on NCI Common Toxicity Criteria for Adverse Events Version 4 (CTCAEv4) on treatment.
Outcome measures
| Measure |
Elotuzumab, Lenalidomide, Bortezomib, and Dexamethasone
n=40 Participants
Participants will receive therapy with the combination of lenalidomide, bortezomib, and dexamethasone and elotuzumab (E-RVD). Induction cycles (1 to 8) are 21-day cycles.
* Elotuzumab will be administered by intravenous (IV) infusion
* Bortezomib as a subcutaneous injection
* Lenalidomide single daily oral dose
* Dexamethasone as oral tablets and IV infusion
* Stem cell mobilization will be performed for all subjects at the end of Cycle 4.
Subjects may elect to stop E-RVD at the end of Cycle 4 and proceed to autologous SCT. Subjects who do not proceed to SCT may receive 8 cycles of induction therapy.
The maintenance schedule (28 days) will start after 8 cycles of induction regimen for subjects not proceeding with SCT, or after recovery from SCT for subjects proceeding with it.
Maintenance therapy with E-RVD will be administered to all patients, with the specific maintenance regimen determined by risk category.
|
|---|---|
|
Grade 3 and 4 Treatment-Emergent Adverse Event (TEAE) Rate
|
0.70 proportion of participants
Interval 0.53 to 0.83
|
SECONDARY outcome
Timeframe: Participants were followed up to 273.6 weeks.Population: Best responses to E-RVD in the safety population, defined as participants with Multiple Myeloma who received one or more dose of elotuzumab. Out of the 40 participants included in the safety population, one participant did not receive or more dose of elotuzumab, and was not included in the best response analysis population.
Best responses to E-RVD was assessed using International Myeloma Working Group (IMWG) response criteria: Partial Response (PR) defined as 50% reduction of serum M-protein and reduction in 24h urinary M-protein by ≥90% or to \<200mg/24h; Very Good Partial Response (VGPR) defined as serum and urine M-protein detectable by immunofixation but not on electrophoresis or ≥90% reduction in serum M-protein plus urine M-protein level \<100mg/24h; Complete Response (CR) defined as negative immunofixation on serum and urine and, disappearance of any soft tissue plasmacytomas and, \<5% plasma cells in BM; Stringent Complete Response (sCR) defined as normal FLC ratio and absence of clonal cells in BM by immunohistochemistry or 2-4 color flow cytometry.
Outcome measures
| Measure |
Elotuzumab, Lenalidomide, Bortezomib, and Dexamethasone
n=39 Participants
Participants will receive therapy with the combination of lenalidomide, bortezomib, and dexamethasone and elotuzumab (E-RVD). Induction cycles (1 to 8) are 21-day cycles.
* Elotuzumab will be administered by intravenous (IV) infusion
* Bortezomib as a subcutaneous injection
* Lenalidomide single daily oral dose
* Dexamethasone as oral tablets and IV infusion
* Stem cell mobilization will be performed for all subjects at the end of Cycle 4.
Subjects may elect to stop E-RVD at the end of Cycle 4 and proceed to autologous SCT. Subjects who do not proceed to SCT may receive 8 cycles of induction therapy.
The maintenance schedule (28 days) will start after 8 cycles of induction regimen for subjects not proceeding with SCT, or after recovery from SCT for subjects proceeding with it.
Maintenance therapy with E-RVD will be administered to all patients, with the specific maintenance regimen determined by risk category.
|
|---|---|
|
Best Responses to E-RVD.
Sustained complete response (sCR)
|
9 Participants
|
|
Best Responses to E-RVD.
Complete response (CR)
|
8 Participants
|
|
Best Responses to E-RVD.
Very good partial response (VGPR)
|
16 Participants
|
|
Best Responses to E-RVD.
Partial response (PR)
|
5 Participants
|
|
Best Responses to E-RVD.
Minimal response (MR)
|
1 Participants
|
SECONDARY outcome
Timeframe: Participants were followed up to 24 weeks.Population: Safety population comprised of 40 patients, of which 19 received ASCT and 12 completed 8 full induction cycles.
ORR was defined as the proportion of patients who achieved a disease response of partial response (PR) or better using IMWG response criteria. PR defined as 50% reduction of serum M-protein and reduction in 24h urinary M-protein by ≥90% or to \<200mg/24h; Very Good Partial Response (VGPR) defined as serum and urine M-protein detectable by immunofixation but not on electrophoresis or ≥90% reduction in serum M-protein plus urine M-protein level \<100mg/24h; Complete Response (CR) defined as negative immunofixation on serum and urine and, disappearance of any soft tissue plasmacytomas and, \<5% plasma cells in BM; Stringent Complete Response (sCR) defined as normal FLC ratio and absence of clonal cells in BM by immunohistochemistry or 2-4 color flow cytometry.
Outcome measures
| Measure |
Elotuzumab, Lenalidomide, Bortezomib, and Dexamethasone
n=40 Participants
Participants will receive therapy with the combination of lenalidomide, bortezomib, and dexamethasone and elotuzumab (E-RVD). Induction cycles (1 to 8) are 21-day cycles.
* Elotuzumab will be administered by intravenous (IV) infusion
* Bortezomib as a subcutaneous injection
* Lenalidomide single daily oral dose
* Dexamethasone as oral tablets and IV infusion
* Stem cell mobilization will be performed for all subjects at the end of Cycle 4.
Subjects may elect to stop E-RVD at the end of Cycle 4 and proceed to autologous SCT. Subjects who do not proceed to SCT may receive 8 cycles of induction therapy.
The maintenance schedule (28 days) will start after 8 cycles of induction regimen for subjects not proceeding with SCT, or after recovery from SCT for subjects proceeding with it.
Maintenance therapy with E-RVD will be administered to all patients, with the specific maintenance regimen determined by risk category.
|
|---|---|
|
Objective Response Rate (ORR) at End of 8 Cycles of Induction Therapy.
|
0.950 proportion of participants
Interval 0.831 to 0.994
|
SECONDARY outcome
Timeframe: Participants were followed up to 92 days.Population: This analysis population was restricted to the subjects whose best response was PR or better.
Time to response is defined as the time from the first dose of study drug to the first documentation of response partial response (PR) or better. Disease response was assessed using International Myeloma Working Group (IMWG) response criteria: Partial Response (PR) defined as 50% reduction of serum M-protein and reduction in 24h urinary M-protein by ≥90% or to \<200mg/24h; Very Good Partial Response (VGPR) defined as serum and urine M-protein detectable by immunofixation but not on electrophoresis or ≥90% reduction in serum M-protein plus urine M-protein level \<100mg/24h; Complete Response (CR) defined as negative immunofixation on serum and urine and, disappearance of any soft tissue plasmacytomas and, \<5% plasma cells in BM; Stringent Complete Response (sCR) defined as normal FLC ratio and absence of clonal cells in BM by immunohistochemistry or 2-4 color flow cytometry.
Outcome measures
| Measure |
Elotuzumab, Lenalidomide, Bortezomib, and Dexamethasone
n=38 Participants
Participants will receive therapy with the combination of lenalidomide, bortezomib, and dexamethasone and elotuzumab (E-RVD). Induction cycles (1 to 8) are 21-day cycles.
* Elotuzumab will be administered by intravenous (IV) infusion
* Bortezomib as a subcutaneous injection
* Lenalidomide single daily oral dose
* Dexamethasone as oral tablets and IV infusion
* Stem cell mobilization will be performed for all subjects at the end of Cycle 4.
Subjects may elect to stop E-RVD at the end of Cycle 4 and proceed to autologous SCT. Subjects who do not proceed to SCT may receive 8 cycles of induction therapy.
The maintenance schedule (28 days) will start after 8 cycles of induction regimen for subjects not proceeding with SCT, or after recovery from SCT for subjects proceeding with it.
Maintenance therapy with E-RVD will be administered to all patients, with the specific maintenance regimen determined by risk category.
|
|---|---|
|
Median Time to Response
|
22.0 days
Interval 20.0 to 92.0
|
Adverse Events
Elotuzumab, Lenalidomide, Bortezomib, and Dexamethasone
Serious events: 10 serious events
Other events: 39 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Elotuzumab, Lenalidomide, Bortezomib, and Dexamethasone
n=40 participants at risk
Participants will receive therapy with the combination of lenalidomide, bortezomib, and dexamethasone and elotuzumab (E-RVD). Induction cycles (1 to 8) are 21-day cycles.
* Elotuzumab will be administered by intravenous (IV) infusion
* Bortezomib as a subcutaneous injection
* Lenalidomide single daily oral dose
* Dexamethasone as oral tablets and IV infusion
* Stem cell mobilization will be performed for all subjects at the end of Cycle 4.
Subjects may elect to stop E-RVD at the end of Cycle 4 and proceed to autologous SCT. Subjects who do not proceed to SCT may receive 8 cycles of induction therapy.
The maintenance schedule (28 days) will start after 8 cycles of induction regimen for subjects not proceeding with SCT, or after recovery from SCT for subjects proceeding with it.
Maintenance therapy with E-RVD will be administered to all patients, with the specific maintenance regimen determined by risk category.
|
|---|---|
|
Cardiac disorders
Cardiac arrest
|
2.5%
1/40 • Adverse events were assessed every cycle on treatment, through study completion, an average of 6 years.
|
|
Nervous system disorders
Demyelating polyneuropathy
|
2.5%
1/40 • Adverse events were assessed every cycle on treatment, through study completion, an average of 6 years.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
2.5%
1/40 • Adverse events were assessed every cycle on treatment, through study completion, an average of 6 years.
|
|
Endocrine disorders
Hyperglycemia
|
2.5%
1/40 • Adverse events were assessed every cycle on treatment, through study completion, an average of 6 years.
|
|
General disorders
Hypocalcemia
|
2.5%
1/40 • Adverse events were assessed every cycle on treatment, through study completion, an average of 6 years.
|
|
Psychiatric disorders
Mood change
|
2.5%
1/40 • Adverse events were assessed every cycle on treatment, through study completion, an average of 6 years.
|
|
Vascular disorders
Orthostatic hypotension
|
2.5%
1/40 • Adverse events were assessed every cycle on treatment, through study completion, an average of 6 years.
|
|
Musculoskeletal and connective tissue disorders
Pain in back
|
2.5%
1/40 • Adverse events were assessed every cycle on treatment, through study completion, an average of 6 years.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
2.5%
1/40 • Adverse events were assessed every cycle on treatment, through study completion, an average of 6 years.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary edema
|
2.5%
1/40 • Adverse events were assessed every cycle on treatment, through study completion, an average of 6 years.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
2.5%
1/40 • Adverse events were assessed every cycle on treatment, through study completion, an average of 6 years.
|
|
Blood and lymphatic system disorders
Sepsis
|
2.5%
1/40 • Adverse events were assessed every cycle on treatment, through study completion, an average of 6 years.
|
|
Nervous system disorders
Syncope
|
2.5%
1/40 • Adverse events were assessed every cycle on treatment, through study completion, an average of 6 years.
|
|
Blood and lymphatic system disorders
Thromboembolic event
|
2.5%
1/40 • Adverse events were assessed every cycle on treatment, through study completion, an average of 6 years.
|
Other adverse events
| Measure |
Elotuzumab, Lenalidomide, Bortezomib, and Dexamethasone
n=40 participants at risk
Participants will receive therapy with the combination of lenalidomide, bortezomib, and dexamethasone and elotuzumab (E-RVD). Induction cycles (1 to 8) are 21-day cycles.
* Elotuzumab will be administered by intravenous (IV) infusion
* Bortezomib as a subcutaneous injection
* Lenalidomide single daily oral dose
* Dexamethasone as oral tablets and IV infusion
* Stem cell mobilization will be performed for all subjects at the end of Cycle 4.
Subjects may elect to stop E-RVD at the end of Cycle 4 and proceed to autologous SCT. Subjects who do not proceed to SCT may receive 8 cycles of induction therapy.
The maintenance schedule (28 days) will start after 8 cycles of induction regimen for subjects not proceeding with SCT, or after recovery from SCT for subjects proceeding with it.
Maintenance therapy with E-RVD will be administered to all patients, with the specific maintenance regimen determined by risk category.
|
|---|---|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
25.0%
10/40 • Adverse events were assessed every cycle on treatment, through study completion, an average of 6 years.
|
|
Blood and lymphatic system disorders
Anemia
|
10.0%
4/40 • Adverse events were assessed every cycle on treatment, through study completion, an average of 6 years.
|
|
General disorders
Fatigue
|
57.5%
23/40 • Adverse events were assessed every cycle on treatment, through study completion, an average of 6 years.
|
|
Gastrointestinal disorders
Constipation
|
45.0%
18/40 • Adverse events were assessed every cycle on treatment, through study completion, an average of 6 years.
|
|
Nervous system disorders
Peripheral neuropathy
|
45.0%
18/40 • Adverse events were assessed every cycle on treatment, through study completion, an average of 6 years.
|
|
Gastrointestinal disorders
Diarrhea
|
30.0%
12/40 • Adverse events were assessed every cycle on treatment, through study completion, an average of 6 years.
|
|
Psychiatric disorders
Insomnia
|
30.0%
12/40 • Adverse events were assessed every cycle on treatment, through study completion, an average of 6 years.
|
|
Musculoskeletal and connective tissue disorders
Pain in back
|
30.0%
12/40 • Adverse events were assessed every cycle on treatment, through study completion, an average of 6 years.
|
|
Investigations
Hypophosphatemia
|
27.5%
11/40 • Adverse events were assessed every cycle on treatment, through study completion, an average of 6 years.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
25.0%
10/40 • Adverse events were assessed every cycle on treatment, through study completion, an average of 6 years.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
22.5%
9/40 • Adverse events were assessed every cycle on treatment, through study completion, an average of 6 years.
|
|
Nervous system disorders
Dizziness
|
22.5%
9/40 • Adverse events were assessed every cycle on treatment, through study completion, an average of 6 years.
|
|
Nervous system disorders
Dysgeusia
|
22.5%
9/40 • Adverse events were assessed every cycle on treatment, through study completion, an average of 6 years.
|
|
Investigations
Hyperglycemia
|
22.5%
9/40 • Adverse events were assessed every cycle on treatment, through study completion, an average of 6 years.
|
|
Gastrointestinal disorders
Nausea
|
20.0%
8/40 • Adverse events were assessed every cycle on treatment, through study completion, an average of 6 years.
|
|
Skin and subcutaneous tissue disorders
Rash
|
20.0%
8/40 • Adverse events were assessed every cycle on treatment, through study completion, an average of 6 years.
|
|
General disorders
Edema limbs
|
17.5%
7/40 • Adverse events were assessed every cycle on treatment, through study completion, an average of 6 years.
|
|
General disorders
Edema peripheral
|
17.5%
7/40 • Adverse events were assessed every cycle on treatment, through study completion, an average of 6 years.
|
|
Investigations
Transaminitis
|
17.5%
7/40 • Adverse events were assessed every cycle on treatment, through study completion, an average of 6 years.
|
|
Eye disorders
Blurred vision
|
15.0%
6/40 • Adverse events were assessed every cycle on treatment, through study completion, an average of 6 years.
|
|
Nervous system disorders
Headache
|
15.0%
6/40 • Adverse events were assessed every cycle on treatment, through study completion, an average of 6 years.
|
|
Musculoskeletal and connective tissue disorders
Cramping in extremities
|
12.5%
5/40 • Adverse events were assessed every cycle on treatment, through study completion, an average of 6 years.
|
|
General disorders
Fever
|
12.5%
5/40 • Adverse events were assessed every cycle on treatment, through study completion, an average of 6 years.
|
|
General disorders
Hypertension
|
12.5%
5/40 • Adverse events were assessed every cycle on treatment, through study completion, an average of 6 years.
|
|
Psychiatric disorders
Mood change
|
12.5%
5/40 • Adverse events were assessed every cycle on treatment, through study completion, an average of 6 years.
|
|
Psychiatric disorders
Anxiety
|
10.0%
4/40 • Adverse events were assessed every cycle on treatment, through study completion, an average of 6 years.
|
|
Gastrointestinal disorders
Dry mouth
|
10.0%
4/40 • Adverse events were assessed every cycle on treatment, through study completion, an average of 6 years.
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
10.0%
4/40 • Adverse events were assessed every cycle on treatment, through study completion, an average of 6 years.
|
|
General disorders
Hypotension
|
10.0%
4/40 • Adverse events were assessed every cycle on treatment, through study completion, an average of 6 years.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
10.0%
4/40 • Adverse events were assessed every cycle on treatment, through study completion, an average of 6 years.
|
|
Musculoskeletal and connective tissue disorders
Pain in neck
|
10.0%
4/40 • Adverse events were assessed every cycle on treatment, through study completion, an average of 6 years.
|
|
Gastrointestinal disorders
Abdominal pain
|
7.5%
3/40 • Adverse events were assessed every cycle on treatment, through study completion, an average of 6 years.
|
|
General disorders
Congestion
|
7.5%
3/40 • Adverse events were assessed every cycle on treatment, through study completion, an average of 6 years.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
7.5%
3/40 • Adverse events were assessed every cycle on treatment, through study completion, an average of 6 years.
|
|
Skin and subcutaneous tissue disorders
Erythema at injection site
|
7.5%
3/40 • Adverse events were assessed every cycle on treatment, through study completion, an average of 6 years.
|
|
General disorders
Hypokalemia
|
7.5%
3/40 • Adverse events were assessed every cycle on treatment, through study completion, an average of 6 years.
|
|
Blood and lymphatic system disorders
Leukopenia
|
7.5%
3/40 • Adverse events were assessed every cycle on treatment, through study completion, an average of 6 years.
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness
|
7.5%
3/40 • Adverse events were assessed every cycle on treatment, through study completion, an average of 6 years.
|
|
General disorders
Night sweats
|
7.5%
3/40 • Adverse events were assessed every cycle on treatment, through study completion, an average of 6 years.
|
|
General disorders
Orthostatic hypotension
|
7.5%
3/40 • Adverse events were assessed every cycle on treatment, through study completion, an average of 6 years.
|
|
Skin and subcutaneous tissue disorders
Pruritis
|
7.5%
3/40 • Adverse events were assessed every cycle on treatment, through study completion, an average of 6 years.
|
|
Gastrointestinal disorders
Stomach pain
|
7.5%
3/40 • Adverse events were assessed every cycle on treatment, through study completion, an average of 6 years.
|
|
Nervous system disorders
Syncope
|
7.5%
3/40 • Adverse events were assessed every cycle on treatment, through study completion, an average of 6 years.
|
|
Infections and infestations
Thrush
|
7.5%
3/40 • Adverse events were assessed every cycle on treatment, through study completion, an average of 6 years.
|
|
Nervous system disorders
Tremor
|
7.5%
3/40 • Adverse events were assessed every cycle on treatment, through study completion, an average of 6 years.
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory tract infection
|
7.5%
3/40 • Adverse events were assessed every cycle on treatment, through study completion, an average of 6 years.
|
|
Skin and subcutaneous tissue disorders
Bruising
|
5.0%
2/40 • Adverse events were assessed every cycle on treatment, through study completion, an average of 6 years.
|
|
Eye disorders
Cataract
|
5.0%
2/40 • Adverse events were assessed every cycle on treatment, through study completion, an average of 6 years.
|
|
Cardiac disorders
Chest pain
|
5.0%
2/40 • Adverse events were assessed every cycle on treatment, through study completion, an average of 6 years.
|
|
General disorders
Chills
|
5.0%
2/40 • Adverse events were assessed every cycle on treatment, through study completion, an average of 6 years.
|
|
Nervous system disorders
Confusional state
|
5.0%
2/40 • Adverse events were assessed every cycle on treatment, through study completion, an average of 6 years.
|
|
General disorders
Decreased appetite
|
5.0%
2/40 • Adverse events were assessed every cycle on treatment, through study completion, an average of 6 years.
|
|
General disorders
Decreased magnesium
|
5.0%
2/40 • Adverse events were assessed every cycle on treatment, through study completion, an average of 6 years.
|
|
Cardiac disorders
Deep vein thrombosis
|
5.0%
2/40 • Adverse events were assessed every cycle on treatment, through study completion, an average of 6 years.
|
|
General disorders
Dehydration
|
5.0%
2/40 • Adverse events were assessed every cycle on treatment, through study completion, an average of 6 years.
|
|
Psychiatric disorders
Depression
|
5.0%
2/40 • Adverse events were assessed every cycle on treatment, through study completion, an average of 6 years.
|
|
Gastrointestinal disorders
Dyspepsia
|
5.0%
2/40 • Adverse events were assessed every cycle on treatment, through study completion, an average of 6 years.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
5.0%
2/40 • Adverse events were assessed every cycle on treatment, through study completion, an average of 6 years.
|
|
General disorders
Flushing
|
5.0%
2/40 • Adverse events were assessed every cycle on treatment, through study completion, an average of 6 years.
|
|
General disorders
Gait disturbance
|
5.0%
2/40 • Adverse events were assessed every cycle on treatment, through study completion, an average of 6 years.
|
|
General disorders
Hiccups
|
5.0%
2/40 • Adverse events were assessed every cycle on treatment, through study completion, an average of 6 years.
|
|
General disorders
Hot flush
|
5.0%
2/40 • Adverse events were assessed every cycle on treatment, through study completion, an average of 6 years.
|
|
General disorders
Hyperuricemia
|
5.0%
2/40 • Adverse events were assessed every cycle on treatment, through study completion, an average of 6 years.
|
|
General disorders
Hypocalcemia
|
5.0%
2/40 • Adverse events were assessed every cycle on treatment, through study completion, an average of 6 years.
|
|
General disorders
Hyponatremia
|
5.0%
2/40 • Adverse events were assessed every cycle on treatment, through study completion, an average of 6 years.
|
|
General disorders
Increased amylase
|
5.0%
2/40 • Adverse events were assessed every cycle on treatment, through study completion, an average of 6 years.
|
|
General disorders
Increased lipase
|
5.0%
2/40 • Adverse events were assessed every cycle on treatment, through study completion, an average of 6 years.
|
|
Respiratory, thoracic and mediastinal disorders
Lower respiratory tract congestion
|
5.0%
2/40 • Adverse events were assessed every cycle on treatment, through study completion, an average of 6 years.
|
|
Blood and lymphatic system disorders
Lymphocyte count decreased
|
5.0%
2/40 • Adverse events were assessed every cycle on treatment, through study completion, an average of 6 years.
|
|
General disorders
Macroglossia
|
5.0%
2/40 • Adverse events were assessed every cycle on treatment, through study completion, an average of 6 years.
|
|
Musculoskeletal and connective tissue disorders
Muscle cramping
|
5.0%
2/40 • Adverse events were assessed every cycle on treatment, through study completion, an average of 6 years.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
5.0%
2/40 • Adverse events were assessed every cycle on treatment, through study completion, an average of 6 years.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
5.0%
2/40 • Adverse events were assessed every cycle on treatment, through study completion, an average of 6 years.
|
|
Nervous system disorders
Neuropathy
|
5.0%
2/40 • Adverse events were assessed every cycle on treatment, through study completion, an average of 6 years.
|
|
General disorders
Edema face
|
5.0%
2/40 • Adverse events were assessed every cycle on treatment, through study completion, an average of 6 years.
|
|
Gastrointestinal disorders
Oropharyngeal pain
|
5.0%
2/40 • Adverse events were assessed every cycle on treatment, through study completion, an average of 6 years.
|
|
Musculoskeletal and connective tissue disorders
Pain in bone
|
5.0%
2/40 • Adverse events were assessed every cycle on treatment, through study completion, an average of 6 years.
|
|
Musculoskeletal and connective tissue disorders
Pain in feet
|
5.0%
2/40 • Adverse events were assessed every cycle on treatment, through study completion, an average of 6 years.
|
|
Musculoskeletal and connective tissue disorders
Pain in hips
|
5.0%
2/40 • Adverse events were assessed every cycle on treatment, through study completion, an average of 6 years.
|
|
Musculoskeletal and connective tissue disorders
Pain in legs
|
5.0%
2/40 • Adverse events were assessed every cycle on treatment, through study completion, an average of 6 years.
|
|
Musculoskeletal and connective tissue disorders
Pain in ribs
|
5.0%
2/40 • Adverse events were assessed every cycle on treatment, through study completion, an average of 6 years.
|
|
Musculoskeletal and connective tissue disorders
Pain in shoulders
|
5.0%
2/40 • Adverse events were assessed every cycle on treatment, through study completion, an average of 6 years.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
5.0%
2/40 • Adverse events were assessed every cycle on treatment, through study completion, an average of 6 years.
|
|
Respiratory, thoracic and mediastinal disorders
Post nasal drip
|
5.0%
2/40 • Adverse events were assessed every cycle on treatment, through study completion, an average of 6 years.
|
|
Nervous system disorders
Sciatica
|
5.0%
2/40 • Adverse events were assessed every cycle on treatment, through study completion, an average of 6 years.
|
|
Cardiac disorders
Tachycardia
|
5.0%
2/40 • Adverse events were assessed every cycle on treatment, through study completion, an average of 6 years.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place