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 :
Active, not recruiting
First Posted : November 24, 2015
Last Update Posted : March 18, 2020
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Sponsor:
Bristol-Myers Squibb
Information provided by (Responsible Party):
Bristol-Myers Squibb
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Brief Summary:
Study of elotuzumab in combination with pomalidomide and low dose dexamethasone (EPd Cohort) and elotuzumab in combination with nivolumab (EN Cohort) to assess the safety and efficacy of these combination therapies for treatment of relapsed or refractory MM patients.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Multiple Myeloma | Drug: Elotuzumab Drug: Pomalidomide Drug: Dexamethasone Drug: Nivolumab | Phase 2 |
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 95 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 : | November 24, 2015 |
| Actual Primary Completion Date : | July 29, 2019 |
| Estimated Study Completion Date : | May 29, 2020 |
Resource links provided by the National Library of Medicine
Genetics Home Reference related topics:
Multiple myeloma
MedlinePlus related topics:
Multiple Myeloma
| 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 |
Primary Outcome Measures :
- EPd cohort: Progression Free Survival (PFS) [ Time Frame: Approximately 5 years ]PFS is defined as the time from first dosing date to the date of the first documented progression per IMWG uniform criteria or death due to any cause, whichever occurs first
- EN Cohort: Objective Response Rate (ORR) [ Time Frame: Approximately 5 years ]ORR is defined as proportion of subjects with a best overall response of partial response (PR) or better
Secondary Outcome Measures :
- EPd Cohort: Objective Response Rate (ORR) [ Time Frame: Approximately 5 years ]ORR is defined as proportion of subjects with a best overall response of partial response (PR) or better
- EPd Cohort: Overall Survival Rate (OS) [ Time Frame: Approximately 5 years ]OS is defined as the time from first dosing date to the date of death from any cause. A subject who has not died will be censored at last known date alive
- EN Cohort: Progression Free Survival (PFS) [ Time Frame: Approximately 5 years ]
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
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.
Information from the National Library of Medicine
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
Locations
Show 22 study locations
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
| Study Director: | Bristol Myers Squibb | Bristol-Myers Squibb |
Additional Information:
| Responsible Party: | Bristol-Myers Squibb |
| ClinicalTrials.gov Identifier: | NCT02612779 |
| Other Study ID Numbers: |
CA204-142 |
| First Posted: | November 24, 2015 Key Record Dates |
| Last Update Posted: | March 18, 2020 |
| Last Verified: | March 2020 |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |
Additional relevant MeSH terms:
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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 |