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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)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03989414
Recruitment Status : Recruiting
First Posted : June 18, 2019
Last Update Posted : May 3, 2022
Sponsor:
Information provided by (Responsible Party):
Celgene

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

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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 : February 28, 2025
Estimated Study Completion Date : July 31, 2026

Resource links provided by the National Library of Medicine

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

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

Drug: Dexamethasone
Specified dose on specified days

Drug: Carfilzomib
Specified dose on specified days

Experimental: Cohort H: CC-92480 with elotuzumab and dexamathasone Drug: CC-92480
Specified dose on specified days

Drug: Dexamethasone
Specified dose on specified days

Drug: Elotuzumab
Specified dose on specified days

Experimental: Cohort I: CC-92480 with isatuximab and dexamathasone Drug: CC-92480
Specified dose on specified days

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

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

Drug: Dexamethasone
Specified dose on specified days

Drug: Carfilzomib
Specified dose on specified days

Experimental: Cohort J: CC-92480 with elotuzumab and dexamathasone Drug: CC-92480
Specified dose on specified days

Drug: Dexamethasone
Specified dose on specified days

Drug: Elotuzumab
Specified dose on specified days

Experimental: Cohort K: CC-92480 with isatuximab and dexamathasone Drug: CC-92480
Specified dose on specified days

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

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

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

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

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

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

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

Drug: Dexamethasone
Specified dose on specified days

Drug: Daratumumab
Specified dose on specified days




Primary Outcome Measures :
  1. Recommended Dose [ Time Frame: Up to approximately 3 years ]
  2. Recommended regimen as measured by dose-limiting toxicities [ Time Frame: Up to approximately 3 years ]
  3. 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 ]
  4. Overall response rate (ORR) [ Time Frame: Up to approximately 5 years ]

Secondary Outcome Measures :
  1. Time-to-response (TTR) [ Time Frame: Up to approximately 5 years ]
  2. Duration of response (DOR) [ Time Frame: Up to approximately 5 years ]
  3. Complete Response (CR) rate [ Time Frame: Up to approximately 5 years ]
  4. 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.


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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

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
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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 Show 49 study locations
Sponsors and Collaborators
Celgene
Investigators
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Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
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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: May 3, 2022
Last Verified: April 2022
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.celgene.com/research-development/clinical-trials/clinical-trials-data-sharing/

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Celgene:
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