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)

NCT03989414 | Active Not Recruiting Phase 1 DMC FDA Drug

• 3 other identifiers: CC-92480-MM-002U1111-1233-56192023-505219-19
• Study Type: interventional
• Target: 424
• Locations: 9 countries
• Sites: 49

Brief Summary

The purpose of this study is to evaluate the safety and preliminary efficacy of CC-92480 in combination with standard treatments.

Conditions

Multiple Myeloma

Keywords

Relapsed or Refractory Multiple Myeloma; Newly Diagnosed Multiple Myeloma; Multiple Myeloma; CC-92480

Outcome Measures

Primary Outcomes (4)

• Recommended Dose

  Up to approximately 3 years

• Recommended regimen as measured by dose-limiting toxicities

  Up to approximately 3 years

• Number of participants with Adverse Events (AEs)

  From first participant first visit until 28 days after the last subject discontinues study treatment, up to 5 years

• Overall response rate (ORR)

  Up to approximately 5 years

Secondary Outcomes (4)

• Time-to-response (TTR)

  Up to approximately 5 years

• Duration of response (DOR)

  Up to approximately 5 years

• Complete Response (CR) rate

  Up to approximately 5 years

• Very good partial response (VGPR) rate - Cohorts D and E

  Up to approximately 5 years

Study Arms (15)

Cohort A: CC-92480 with bortezomib and dexamethasone

EXPERIMENTAL

Drug: CC-92480; Drug: Bortezomib; Drug: Dexamethasone

Cohort C: CC-92480 with carfilzomib and dexamethasone

EXPERIMENTAL

Drug: CC-92480; Drug: Dexamethasone; Drug: Carfilzomib

Cohort H: CC-92480 with elotuzumab and dexamethasone

EXPERIMENTAL

Drug: CC-92480; Drug: Dexamethasone; Drug: Elotuzumab

Cohort I: CC-92480 with isatuximab and dexamethasone

EXPERIMENTAL

Drug: CC-92480; Drug: Dexamethasone; Drug: Isatuximab

Cohort D: CC-92480 with bortezomib and dexamethasone

EXPERIMENTAL

Drug: CC-92480; Drug: Bortezomib; Drug: Dexamethasone

Cohort F: CC-92480 with carfilzomib and dexamethasone

EXPERIMENTAL

Drug: CC-92480; Drug: Dexamethasone; Drug: Carfilzomib

Cohort J: CC-92480 with elotuzumab and dexamethasone

EXPERIMENTAL

Drug: CC-92480; Drug: Dexamethasone; Drug: Elotuzumab

Cohort K: CC-92480 with isatuximab and dexamethasone

EXPERIMENTAL

Drug: CC-92480; Drug: Dexamethasone; Drug: Isatuximab

Cohort G: CC-92480 with bortezomib and dexamethasone

EXPERIMENTAL

Drug: CC-92480; Drug: Bortezomib; Drug: Dexamethasone

Subcohort B1: CC-92480 with daratumumab and dexamethasone

EXPERIMENTAL

Drug: CC-92480; Drug: Dexamethasone; Drug: Daratumumab

Subcohort B2: CC-92480 with daratumumab and dexamethasone

EXPERIMENTAL

Drug: CC-92480; Drug: Dexamethasone; Drug: Daratumumab

Subcohort B3: CC-92480 with daratumumab and dexamethasone

EXPERIMENTAL

Drug: CC-92480; Drug: Dexamethasone; Drug: Daratumumab

Subcohort E1: CC-92480 with daratumumab and dexamethasone

EXPERIMENTAL

Drug: CC-92480; Drug: Dexamethasone; Drug: Daratumumab

Subcohort E2: CC-92480 with daratumumab and dexamethasone

EXPERIMENTAL

Drug: CC-92480; Drug: Dexamethasone; Drug: Daratumumab

Subcohort E3: CC-92480 with daratumumab and dexamethasone

EXPERIMENTAL

Drug: CC-92480; Drug: Dexamethasone; Drug: Daratumumab

Interventions

CC-92480 DRUG

Specified dose on specified days

Also known as: BMS-986348, mezigdomide

Cohort A: CC-92480 with bortezomib and dexamethasone; Cohort C: CC-92480 with carfilzomib and dexamethasone; Cohort D: CC-92480 with bortezomib and dexamethasone; Cohort F: CC-92480 with carfilzomib and dexamethasone; Cohort G: CC-92480 with bortezomib and dexamethasone; Cohort H: CC-92480 with elotuzumab and dexamethasone; Cohort I: CC-92480 with isatuximab and dexamethasone; Cohort J: CC-92480 with elotuzumab and dexamethasone; Cohort K: CC-92480 with isatuximab and dexamethasone; Subcohort B1: CC-92480 with daratumumab and dexamethasone; Subcohort B2: CC-92480 with daratumumab and dexamethasone; Subcohort B3: CC-92480 with daratumumab and dexamethasone; Subcohort E1: CC-92480 with daratumumab and dexamethasone; Subcohort E2: CC-92480 with daratumumab and dexamethasone; Subcohort E3: CC-92480 with daratumumab and dexamethasone

Bortezomib DRUG

Specified dose on specified days

Cohort A: CC-92480 with bortezomib and dexamethasone; Cohort D: CC-92480 with bortezomib and dexamethasone; Cohort G: CC-92480 with bortezomib and dexamethasone

Dexamethasone DRUG

Specified dose on specified days

Cohort A: CC-92480 with bortezomib and dexamethasone; Cohort C: CC-92480 with carfilzomib and dexamethasone; Cohort D: CC-92480 with bortezomib and dexamethasone; Cohort F: CC-92480 with carfilzomib and dexamethasone; Cohort G: CC-92480 with bortezomib and dexamethasone; Cohort H: CC-92480 with elotuzumab and dexamethasone; Cohort I: CC-92480 with isatuximab and dexamethasone; Cohort J: CC-92480 with elotuzumab and dexamethasone; Cohort K: CC-92480 with isatuximab and dexamethasone; Subcohort B1: CC-92480 with daratumumab and dexamethasone; Subcohort B2: CC-92480 with daratumumab and dexamethasone; Subcohort B3: CC-92480 with daratumumab and dexamethasone; Subcohort E1: CC-92480 with daratumumab and dexamethasone; Subcohort E2: CC-92480 with daratumumab and dexamethasone; Subcohort E3: CC-92480 with daratumumab and dexamethasone

Daratumumab DRUG

Specified dose on specified days

Subcohort B1: CC-92480 with daratumumab and dexamethasone; Subcohort B2: CC-92480 with daratumumab and dexamethasone; Subcohort B3: CC-92480 with daratumumab and dexamethasone; Subcohort E1: CC-92480 with daratumumab and dexamethasone; Subcohort E2: CC-92480 with daratumumab and dexamethasone; Subcohort E3: CC-92480 with daratumumab and dexamethasone

Carfilzomib DRUG

Specified dose on specified days

Cohort C: CC-92480 with carfilzomib and dexamethasone

Elotuzumab DRUG

Specified dose on specified days

Cohort H: CC-92480 with elotuzumab and dexamethasone; Cohort J: CC-92480 with elotuzumab and dexamethasone

Isatuximab DRUG

Specified dose on specified days

Cohort I: CC-92480 with isatuximab and dexamethasone; Cohort K: CC-92480 with isatuximab and dexamethasone

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1 or 2
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Celgene: lead

Study Sites (49)

Local Institution - 119

Denver, Colorado, 80218, United States

Location

Local Institution - 104

Tampa, Florida, 33612, United States

Location

Local Institution - 108

Atlanta, Georgia, 30322, United States

Location

Local Institution - 112

Chicago, Illinois, 60611, United States

Location

Local Institution - 107

Chicago, Illinois, 60637, United States

Location

Local Institution - 117

Boston, Massachusetts, 02114, United States

Location

Local Institution - 101

Boston, Massachusetts, 02115, United States

Location

Local Institution - 118

Boston, Massachusetts, 02215, United States

Location

Local Institution - 113

Detroit, Michigan, 48201, United States

Location

Local Institution - 106

Rochester, Minnesota, 55905, United States

Location

Hackensack University Medical Center

Hackensack, New Jersey, 07601, United States

Location

Local Institution - 110

Winston-Salem, North Carolina, 27157, United States

Location

Local Institution - 115

Columbus, Ohio, 43210, United States

Location

Local Institution - 114

Nashville, Tennessee, 37203, United States

Location

Local Institution - 116

Houston, Texas, 77030, United States

Location

Swedish Cancer Institute

Seattle, Washington, 98104, United States

Location

Local Institution - 201

Calgary, Alberta, T2N 4N2, Canada

Location

Local Institution - 205

Edmonton, Alberta, T6G 2G3, Canada

Location

Local Institution - 204

Halifax, Nova Scotia, B3H 1V7, Canada

Location

Local Institution - 203

Toronto, Ontario, M5G 2M9, Canada

Location

Local Institution - 202

Montreal, Quebec, H1T 2M4, Canada

Location

Local Institution - 802

Brno, 625 00, Czechia

Location

Local Institution - 801

Ostrava-Poruba, 708 52, Czechia

Location

Local Institution - 803

Prague, 128 08, Czechia

Location

Local Institution - 902

Odense, 5000, Denmark

Location

Local Institution - 903

Vejle, 7100, Denmark

Location

Local Institution - 703

Lille, 59037, France

Location

Local Institution - 705

Marseille, 13273, France

Location

Local Institution - 704

Nantes, 44093, France

Location

Local Institution - 701

Toulouse, 31059, France

Location

Local Institution - 702

Tours, 37044, France

Location

Local Institution - 604

Freiburg im Breisgau, 79106, Germany

Location

Local Institution - 605

Hamburg, 20246, Germany

Location

Local Institution - 601

Heidelberg, 69120, Germany

Location

Local Institution - 602

München, 81675, Germany

Location

Local Institution - 603

Würzburg, 97080, Germany

Location

Local Institution - 301

Athens, 115 28, Greece

Location

Local Institution - 404

Brescia, 25123, Italy

Location

Local Institution - 401

Milan, 20133, Italy

Location

Local Institution - 403

Reggio Emilia, 42100, Italy

Location

Local Institution - 402

Torino, 10126, Italy

Location

Local Institution - 504

Badalona, 08916, Spain

Location

Local Institution - 508

Madrid, 28022, Spain

Location

Local Institution - 501

Madrid, 28041, Spain

Location

Local Institution - 506

Málaga, 29010, Spain

Location

Local Institution - 505

Pamplona, 31008, Spain

Location

Local Institution - 502

Salamanca, 37007, Spain

Location

Local Institution - 503

Santander, 39008, Spain

Location

Local Institution - 507

Valencia, 46026, Spain

Location

Related Links

• BMS Clinical Trial Information
• BMS Clinical Trial Patient Recruiting

MeSH Terms

Conditions

Multiple Myeloma; Recurrence

Interventions

Bortezomib; Dexamethasone; daratumumab; carfilzomib; elotuzumab; isatuximab

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Boronic Acids; Acids, Noncarboxylic; Acids; Inorganic Chemicals; Boron Compounds; Organic Chemicals; Pyrazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 14, 2019
• First Posted: June 18, 2019
• Study Start: September 30, 2019
• Primary Completion (Estimated): November 30, 2026
• Study Completion (Estimated): November 30, 2026
• Last Updated: November 29, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: See Plan Description
• Access Criteria: See Plan Description

Locations

DE (5); ES (8); IT (4); GR (1); FR (5); US (16); CZ (3); DK (2); CA (5)