An Investigational Immuno-therapy Study of Nivolumab, Pomalidomide and Dexamethasone Combinations in Patients With Multiple Myeloma (CheckMate 602)
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| ClinicalTrials.gov Identifier: NCT02726581 |
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Recruitment Status :
Completed
First Posted : April 1, 2016
Last Update Posted : May 4, 2022
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The purpose of this study is to evaluate the safety and effectiveness of several combination therapies for Multiple Myeloma. Upon entry into the study, patients will be randomized (assigned by chance) to receive either:
Group 1: nivolumab, pomalidomide and dexamethasone OR Group 2: pomalidomide and dexamethasone OR Group 3: nivolumab, elotuzumab, pomalidomide and dexamethasone.
Enrollment is closed for all groups.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Multiple Myeloma | Biological: Nivolumab Biological: Elotuzumab Drug: Pomalidomide Drug: Dexamethasone | Phase 3 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 170 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | An Open-Label, Randomized Phase 3 Trial of Combinations of Nivolumab, Pomalidomide and Dexamethasone in Relapsed and Refractory Multiple Myeloma |
| Actual Study Start Date : | August 10, 2016 |
| Actual Primary Completion Date : | March 9, 2022 |
| Actual Study Completion Date : | March 9, 2022 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: Investigational Arm
Nivolumab, Pomalidomide and Dexamethasone Enrollment is closed for this arm |
Biological: Nivolumab
Specified dose on specified days, IV (intravenous)
Other Name: BMS-936558 Drug: Pomalidomide Specified dose on specified days, PO (by mouth) Drug: Dexamethasone Specified dose on specified days, PO |
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Active Comparator: Control Arm
Pomalidomide and Dexamethasone Enrollment is closed for this arm |
Drug: Pomalidomide
Specified dose on specified days, PO (by mouth) Drug: Dexamethasone Specified dose on specified days, PO |
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Experimental: Exploratory Arm
Nivolumab, Elotuzumab, Pomalidomide and Dexamethasone Enrollment is closed for this arm |
Biological: Nivolumab
Specified dose on specified days, IV (intravenous)
Other Name: BMS-936558 Biological: Elotuzumab Specified dose on specified days, IV
Other Name: BMS-901608 Drug: Pomalidomide Specified dose on specified days, PO (by mouth) Drug: Dexamethasone Specified dose on specified days, PO |
- Progression free survival (PFS) by investigator [ Time Frame: Approximately 47 months from the time of 1st patient randomization ]
- Overall Survival (OS) [ Time Frame: Approximately 47 months from the time of 1st patient randomization ]
- Time to objective response (TTR) by investigator [ Time Frame: Approximately 47 months from the time of 1st patient randomization ]
- Duration of objective response (DOR) by investigator [ Time Frame: Approximately 47 months from the time of 1st patient randomization ]
- Objective response rate (ORR) by investigator [ Time Frame: Approximately 47 months from the time of 1st patient randomization ]
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 |
Inclusion Criteria:
- Refractory or relapsed and refractory multiple myeloma
- Measurable disease
- Have received ≥ 2 lines of prior therapy which must have included an immune modulatory drug (IMiD) and a proteasome inhibitor alone or in combination
Exclusion Criteria:
- Solitary bone or extramedullary plasmacytoma disease only
- Active plasma cell leukemia
Other protocol defined inclusion/exclusion criteria 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): NCT02726581
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| Study Director: | Bristol-Myers Squibb | Bristol-Myers Squibb |
| Responsible Party: | Bristol-Myers Squibb |
| ClinicalTrials.gov Identifier: | NCT02726581 |
| Other Study ID Numbers: |
CA209-602 2015-005699-21 ( EudraCT Number ) |
| First Posted: | April 1, 2016 Key Record Dates |
| Last Update Posted: | May 4, 2022 |
| Last Verified: | April 2022 |
| 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 |