Phase 2
Completed N=152
Study of Bortezomib and Dexamethasone With or Without Elotuzumab to Treat Relapsed or Refractory Multiple Myeloma
Source: ClinicalTrials.gov NCT01478048 ↗Enrolled (actual)
152
Serious AEs
46.7%
Results posted
Jan 2016
Primary outcomePrimary: Median Investigator-Assessed Progression-free Survival (PFS) Time (Months) From Randomization to Date of First Tumor Progression or Death Due to Any Cause - Randomized Participants — 9.7; 6.9 Months — p=0.0923
Summary
The purpose of the study is to determine whether the addition of Elotuzumab to Bortezomib/ Dexamethasone will prolong the time before myeloma worsens [progression free survival (PFS)].
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Median Investigator-Assessed Progression-free Survival (PFS) Time (Months) From Randomization to Date of First Tumor Progression or Death Due to Any Cause - Randomized Participants |
9.7; 6.9 | 0.0923 |
| PRIMARY Number of Investigator-Assessed Progression-free Survival Events From Randomization to Date of First Tumor Progression or Death Due to Any Cause - All Randomized Participants |
52; 59 | — |
| PRIMARY 1 Year Progression-Free Survival Rate - Randomized Participants |
0.39; 0.33 | — |
| SECONDARY Median Progression-free Survival Time (Months) From Randomization to Date of First Tumor Progression or Death Due to Any Cause, in Randomized Participants With at Least One FcγRIIIa V Allele |
9.9; 8.1 | — |
| SECONDARY Investigator-Assessed Objective Response Rate (ORR) - All Randomized Participants |
64.9; 62.7 | — |
| SECONDARY Investigator-Assessed Objective Response Rate in Randomized Participants With at Least One FcγRIIIa V Allele |
60.0; 61.1 | — |
Eligibility Criteria
For additional information, please contact the BMS oncology clinical trial information service at 855-216-0126 or email [email protected]. Please visit www.BMSStudyConnect.com for more information on clinical trial participation.
Inclusion Criteria
- Documented progression from most recent line of therapy
- Measurable disease
- 1 to 3 prior lines of therapy
- Subjects may be proteasome inhibitor naive or have received prior proteasome inhibitor therapy provided all the following criteria are met:
- The subject did not discontinue any proteasome inhibitor due to intolerance or grade ≥ 3 toxicity
- The subject is not refractory to any proteasome inhibitor, defined as progression during treatment or within 60 days after the last dose
- The subject previously achieved a partial response (PR) or better to previous proteasome inhibitor (PI)
Exclusion Criteria
- Monoclonal gammopathy of undetermined significance (MGUS), smoldering myeloma, or Waldenstrom's macroglobulinemia
- Active plasma cell leukemia
- Known Human immunodeficiency virus (HIV) infection or active hepatitis A, B, or C
Data sourced from ClinicalTrials.gov (NCT01478048). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.