A Study of Elotuzumab in Combination With Pomalidomide and Low Dose Dexamethasone and Elotuzumab in Combination With Nivolumab in Patients With Multiple Myeloma Relapsed or Refractory to Prior Treatment With Lenalidomide.
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| ClinicalTrials.gov Identifier: NCT02612779 |
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Recruitment Status :
Completed
First Posted : November 24, 2015
Results First Posted : August 6, 2020
Last Update Posted : July 2, 2021
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Multiple Myeloma | Drug: Elotuzumab Drug: Pomalidomide Drug: Dexamethasone Drug: Nivolumab | Phase 2 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 74 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | A Phase 2, Multiple Cohort Study of Elotuzumab in Combination With Pomalidomide and Low-Dose Dexamethasone (EPd), and in Combination With Nivolumab (EN), in Patients With Multiple Myeloma Relapsed or Refractory to Prior Treatment With Lenalidomide. |
| Actual Study Start Date : | February 9, 2016 |
| Actual Primary Completion Date : | July 29, 2019 |
| Actual Study Completion Date : | June 12, 2020 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: Elotuzumab + Pomalidamide + Low Dose Dexamethasone (EPd)
patients will receive treatment with elotuzumab in combination with pomalidomide and low-dose dexamethasone. Patients are eligible to receive Nivolumab at progression.
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Drug: Elotuzumab Drug: Pomalidomide Drug: Dexamethasone Drug: Nivolumab |
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Experimental: Elotuzumab + Nivolumab (EN)
Patients will receive treatment with a combination of elotuzumab and nivolumab
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Drug: Elotuzumab Drug: Nivolumab |
- Progression Free Survival (PFS) [ Time Frame: From first dose to study completion date (up to approximately 50 months) ]
PFS is defined as the time from first dosing date to the date of the first documented progression or death due to any cause, whichever occurs first.
Progression is determined per International Myeloma Working Group (IMWG) uniform criteria.
Participants who die without a reported prior progression were considered to have progressed on the date of their death.
Participants who did not progress or die were censored on the date of their last evaluable assessment. Participants who did not have any on study efficacy assessments and did not die were censored on the first dosing date.
Participants who switched to subsequent therapy prior to documented progression were censored on the date of the last evaluable assessment prior to the initiation of the new therapy.
- Objective Response Rate (ORR) [ Time Frame: From first dose to study completion date (up to approximately 50 months) ]ORR is defined as the percent of participants with best overall response of partial response (PR) or better. Response is determined per IMWG uniform criteria.
- Objective Response Rate (ORR) [ Time Frame: From first dose to study completion date (up to approximately 50 months) ]ORR is defined as the percent of participants with best overall response of partial response (PR) or better. Response is determined per IMWG uniform criteria.
- Progression Free Survival (PFS) [ Time Frame: From first dose to study completion date (up to approximately 50 months) ]
PFS is defined as the time from first dosing date to the date of the first documented progression or death due to any cause, whichever occurs first.
Progression is determined per International Myeloma Working Group (IMWG) uniform criteria.
Participants who die without a reported prior progression were considered to have progressed on the date of their death.
Participants who did not progress or die were censored on the date of their last evaluable assessment. Participants who did not have any on study efficacy assessments and did not die were censored on the first dosing date.
Participants who switched to subsequent therapy prior to documented progression were censored on the date of the last evaluable assessment prior to the initiation of the new therapy.
- Overall Survival (OS) [ Time Frame: From first dose to study completion date (up to approximately 50 months) ]OS is defined as the time from first dosing date to the date of death from any cause.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com
Inclusion Criteria:
- All subjects must have documented disease progression per IMWG criteria during or after their last anti-myeloma therapy.
- ECOG Performance Status less than or equal to 2
- Subject Re-enrollment: This study permits the re-enrollment of a subject that has discontinued the study as a pre-treatment failure (ie, has not been treated). If re-enrolled, the subject must be re-consented.
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EPd Cohort:
- must have received at least 1 but no greater than 2 prior lines of therapy (note: induction and stem cell transplants with or without maintenance therapy is considered 1 line of therapy)
- Subjects must have received prior treatment with a lenalidomide-containing regimen for at least 2 consecutive cycles (full therapeutic dose) and must have been deemed as relapsed, refractory, or intolerant. Refractory is defined as progressing on-treatment or within 60 days of the last dose.
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EN Cohort:
- Subjects must have received at least 3 prior lines of therapy including a proteasome inhibitor (PI) and an immunomodulatory (IMID) agent OR were double-refractory to both an IMID and a PI. Refractory is defined as progressing on-treatment or within 60 days of the last dose.
Exclusion Criteria:
- Subjects with solitary bone or extramedullary plasmacytoma as the only evidence of plasma cells dyscrasia
- Subjects with monoclonal gammopathy of undetermined significance (MGUS), smoldering multiple myeloma (SMM), primary amyloidosis, Waldenstrom's macroglobulinemia, or POEMS syndrome (plasma cell dyscrasia with poly neuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes)
- Subjects with Central Nervous System involvement with multiple myeloma
Other protocol defined inclusion/exclusion criteria could apply.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02612779
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| Study Director: | Bristol Myers Squibb | Bristol-Myers Squibb |
Documents provided by Bristol-Myers Squibb:
| Responsible Party: | Bristol-Myers Squibb |
| ClinicalTrials.gov Identifier: | NCT02612779 |
| Other Study ID Numbers: |
CA204-142 |
| First Posted: | November 24, 2015 Key Record Dates |
| Results First Posted: | August 6, 2020 |
| Last Update Posted: | July 2, 2021 |
| Last Verified: | June 2021 |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |
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Multiple Myeloma Neoplasms, Plasma Cell Neoplasms by Histologic Type Neoplasms Hemostatic Disorders Vascular Diseases Cardiovascular Diseases Paraproteinemias Blood Protein Disorders Hematologic Diseases Hemorrhagic Disorders Lymphoproliferative Disorders Immunoproliferative Disorders Immune System Diseases Dexamethasone |
Nivolumab Pomalidomide Elotuzumab Anti-Inflammatory Agents Antiemetics Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs Gastrointestinal Agents Glucocorticoids Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Antineoplastic Agents, Hormonal Antineoplastic Agents Antineoplastic Agents, Immunological |