A Study to Determine the Recommended Dose and Regimen and to Evaluate the Safety and Preliminary Efficacy of CC-92480 in Combination With Standard Treatments in Participants With Relapsed or Refractory Multiple Myeloma (RRMM) and Newly Diagnosed Multiple Myeloma (NDMM)
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| ClinicalTrials.gov Identifier: NCT03989414 |
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Recruitment Status :
Recruiting
First Posted : June 18, 2019
Last Update Posted : March 29, 2023
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Sponsor:
Celgene
Information provided by (Responsible Party):
Celgene
- Study Details
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Brief Summary:
The purpose of this study is to evaluate the safety and preliminary efficacy of CC-92480 in combination with standard treatments.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Multiple Myeloma | Drug: CC-92480 Drug: Bortezomib Drug: Dexamethasone Drug: Daratumumab Drug: Carfilzomib Drug: Elotuzumab Drug: Isatuximab | Phase 1 Phase 2 |
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 424 participants |
| Allocation: | Non-Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | A Phase 1/2, Multicenter, Open-label, Study to Determine the Recommended Dose and Regimen, and Evaluate the Safety and Preliminary Efficacy of CC-92480 in Combination With Standard Treatments in Subjects With Relapsed or Refractory Multiple Myeloma (RRMM) and Newly Diagnosed Multiple Myeloma (NDMM) |
| Actual Study Start Date : | September 30, 2019 |
| Estimated Primary Completion Date : | January 31, 2025 |
| Estimated Study Completion Date : | July 31, 2026 |
Resource links provided by the National Library of Medicine
MedlinePlus Genetics related topics:
Multiple myeloma
MedlinePlus related topics:
Multiple Myeloma
| Arm | Intervention/treatment |
|---|---|
| Experimental: Cohort A: CC-92480 with bortezomib and dexamethasone |
Drug: CC-92480
Specified dose on specified days
Other Names:
Drug: Bortezomib Specified dose on specified days Drug: Dexamethasone Specified dose on specified days |
| Experimental: Cohort C: CC-92480 with carfilzomib and dexamethasone |
Drug: CC-92480
Specified dose on specified days
Other Names:
Drug: Dexamethasone Specified dose on specified days Drug: Carfilzomib Specified dose on specified days |
| Experimental: Cohort H: CC-92480 with elotuzumab and dexamethasone |
Drug: CC-92480
Specified dose on specified days
Other Names:
Drug: Dexamethasone Specified dose on specified days Drug: Elotuzumab Specified dose on specified days |
| Experimental: Cohort I: CC-92480 with isatuximab and dexamethasone |
Drug: CC-92480
Specified dose on specified days
Other Names:
Drug: Dexamethasone Specified dose on specified days Drug: Isatuximab Specified dose on specified days |
| Experimental: Cohort D: CC-92480 with bortezomib and dexamethasone |
Drug: CC-92480
Specified dose on specified days
Other Names:
Drug: Bortezomib Specified dose on specified days Drug: Dexamethasone Specified dose on specified days |
| Experimental: Cohort F: CC-92480 with carfilzomib and dexamethasone |
Drug: CC-92480
Specified dose on specified days
Other Names:
Drug: Dexamethasone Specified dose on specified days Drug: Carfilzomib Specified dose on specified days |
| Experimental: Cohort J: CC-92480 with elotuzumab and dexamethasone |
Drug: CC-92480
Specified dose on specified days
Other Names:
Drug: Dexamethasone Specified dose on specified days Drug: Elotuzumab Specified dose on specified days |
| Experimental: Cohort K: CC-92480 with isatuximab and dexamethasone |
Drug: CC-92480
Specified dose on specified days
Other Names:
Drug: Dexamethasone Specified dose on specified days Drug: Isatuximab Specified dose on specified days |
| Experimental: Cohort G: CC-92480 with bortezomib and dexamethasone |
Drug: CC-92480
Specified dose on specified days
Other Names:
Drug: Bortezomib Specified dose on specified days Drug: Dexamethasone Specified dose on specified days |
| Experimental: Subcohort B1: CC-92480 with daratumumab and dexamethasone |
Drug: CC-92480
Specified dose on specified days
Other Names:
Drug: Dexamethasone Specified dose on specified days Drug: Daratumumab Specified dose on specified days |
| Experimental: Subcohort B2: CC-92480 with daratumumab and dexamethasone |
Drug: CC-92480
Specified dose on specified days
Other Names:
Drug: Dexamethasone Specified dose on specified days Drug: Daratumumab Specified dose on specified days |
| Experimental: Subcohort B3: CC-92480 with daratumumab and dexamethasone |
Drug: CC-92480
Specified dose on specified days
Other Names:
Drug: Dexamethasone Specified dose on specified days Drug: Daratumumab Specified dose on specified days |
| Experimental: Subcohort E1: CC-92480 with daratumumab and dexamethasone |
Drug: CC-92480
Specified dose on specified days
Other Names:
Drug: Dexamethasone Specified dose on specified days Drug: Daratumumab Specified dose on specified days |
| Experimental: Subcohort E2: CC-92480 with daratumumab and dexamethasone |
Drug: CC-92480
Specified dose on specified days
Other Names:
Drug: Dexamethasone Specified dose on specified days Drug: Daratumumab Specified dose on specified days |
| Experimental: Subcohort E3: CC-92480 with daratumumab and dexamethasone |
Drug: CC-92480
Specified dose on specified days
Other Names:
Drug: Dexamethasone Specified dose on specified days Drug: Daratumumab Specified dose on specified days |
Primary Outcome Measures :
- Recommended Dose [ Time Frame: Up to approximately 3 years ]
- Recommended regimen as measured by dose-limiting toxicities [ Time Frame: Up to approximately 3 years ]
- Number of participants with Adverse Events (AEs) [ Time Frame: From first participant first visit until 28 days after the last subject discontinues study treatment, up to 5 years ]
- Overall response rate (ORR) [ Time Frame: Up to approximately 5 years ]
Secondary Outcome Measures :
- Time-to-response (TTR) [ Time Frame: Up to approximately 5 years ]
- Duration of response (DOR) [ Time Frame: Up to approximately 5 years ]
- Complete Response (CR) rate [ Time Frame: Up to approximately 5 years ]
- Very good partial response (VGPR) rate - Cohorts D and E [ Time Frame: Up to approximately 5 years ]
Information from the National Library of Medicine
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 |
Criteria
Inclusion Criteria:
• Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1 or 2
For participants in Cohorts A, B, C, D, E, F, H, I, J, and K the following inclusions will also apply:
- Documented diagnosis of multiple myeloma (MM) and measurable disease
- Documented disease progression during or after their last antimyeloma regimen
- Achieved a response (minimal response [MR] or better) to at least 1 prior treatment regimen
Exclusion Criteria:
- Plasma cell leukemia, Waldenstrom's macroglobulinemia, POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes) or clinically significant amyloidosis
- Known central nervous system (CNS) involvement with myeloma
- Received immunosuppressive medication within the last 14 days of initiating study treatment
- Uncontrolled hypertension or uncontrolled diabetes within 14 days prior to enrollment
Other protocol-defined inclusion/exclusion criteria 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): NCT03989414
Contacts
| Contact: BMS Study Connect Contact Center www.BMSStudyConnect.com | 855-907-3286 | Clinical.Trials@bms.com | |
| Contact: First line of the email MUST contain the NCT# and Site #. |
Locations
Show 50 study locations
Sponsors and Collaborators
Celgene
Investigators
| Study Director: | Bristol-Myers Squibb | Bristol-Myers Squibb |
Additional Information:
| Responsible Party: | Celgene |
| ClinicalTrials.gov Identifier: | NCT03989414 |
| Other Study ID Numbers: |
CC-92480-MM-002 U1111-1233-5619 ( Other Identifier: WHO ) 2018-004767-31 ( EudraCT Number ) |
| First Posted: | June 18, 2019 Key Record Dates |
| Last Update Posted: | March 29, 2023 |
| Last Verified: | March 2023 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | Yes |
| Plan Description: | Information relating to our policy on data sharing and the process for requesting data can be found at the following link: https://www.celgene.com/research-development/clinical-trials/clinical-trials-data-sharing/ |
| Supporting Materials: |
Study Protocol Statistical Analysis Plan (SAP) Informed Consent Form (ICF) Clinical Study Report (CSR) Analytic Code |
| Time Frame: | See Plan Description |
| Access Criteria: | See Plan Description |
| URL: | https://www.bms.com/researchers-and-partners/clinical-trials-and-research/disclosure-commitment.html |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |
Keywords provided by Celgene:
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Relapsed or Refractory Multiple Myeloma Newly Diagnosed Multiple Myeloma Multiple Myeloma CC-92480 |
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 |
Bortezomib Daratumumab 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 |