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 · tracked via the Priya Life Science Canada tracker

Sponsor

Celgene

Phase

Phase 1/2

Started

2019-09-30

Last updated

2024-11-29

Condition(s) studied

Multiple Myeloma

Investigational drug(s) / intervention(s)

CC-92480 →Bortezomib →Dexamethasone →Daratumumab →Carfilzomib →Elotuzumab →Isatuximab →Carfilzomib →

CC-92480: Specified dose on specified days

Bortezomib: Specified dose on specified days

Dexamethasone: Specified dose on specified days

Daratumumab: Specified dose on specified days

Carfilzomib: Specified dose on specified days

Elotuzumab: Specified dose on specified days

Isatuximab: Specified dose on specified days

Carfilzomib: Specified dose on specified days

Study summary

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

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

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

Primary outcome measure(s)

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

Trial sites (49)

Facility	City	Region
Local Institution - 119	Denver	Colorado
Local Institution - 104	Tampa	Florida
Local Institution - 108	Atlanta	Georgia
Local Institution - 112	Chicago	Illinois
Local Institution - 107	Chicago	Illinois
Local Institution - 117	Boston	Massachusetts
Local Institution - 101	Boston	Massachusetts
Local Institution - 118	Boston	Massachusetts
Local Institution - 113	Detroit	Michigan
Local Institution - 106	Rochester	Minnesota
Hackensack University Medical Center	Hackensack	New Jersey
Local Institution - 110	Winston-Salem	North Carolina
Local Institution - 115	Columbus	Ohio
Local Institution - 114	Nashville	Tennessee
Local Institution - 116	Houston	Texas
Swedish Cancer Institute	Seattle	Washington
Local Institution - 201	Calgary	Alberta
Local Institution - 205	Edmonton	Alberta
Local Institution - 204	Halifax	Nova Scotia
Local Institution - 203	Toronto	Ontario
Local Institution - 202	Montreal	Quebec
Local Institution - 802	Brno	Czechia
Local Institution - 801	Ostrava-Poruba	Czechia
Local Institution - 803	Prague	Czechia
Local Institution - 902	Odense	Denmark
Local Institution - 903	Vejle	Denmark
Local Institution - 703	Lille	France
Local Institution - 705	Marseille	France
Local Institution - 704	Nantes	France
Local Institution - 701	Toulouse	France
Local Institution - 702	Tours	France
Local Institution - 604	Freiburg im Breisgau	Germany
Local Institution - 605	Hamburg	Germany
Local Institution - 601	Heidelberg	Germany
Local Institution - 602	München	Germany
Local Institution - 603	Würzburg	Germany
Local Institution - 301	Athens	Greece
Local Institution - 404	Brescia	Italy
Local Institution - 401	Milan	Italy
Local Institution - 403	Reggio Emilia	Italy

+ 9 more sites — see the full list on the official registry below.

On this site

📄 Darzalex (daratumumab) drug profile →

More Celgene trials in Canada

A Study to Evaluate the Efficacy and Safety of Golcadomide in Combination With Rituximab in Participants With Newly Diagnosed Advanced Stage Follicular Lymphoma Active, not recruiting

A Study to Evaluate Mezigdomide, Bortezomib and Dexamethasone (MEZIVd) Versus Pomalidomide, Bortezomib and Dexamethasone (PVd) in Participants With Relapsed or Refractory Multiple Myeloma (RRMM) Recruiting

A Study to Compare the Efficacy and Safety of Luspatercept (ACE-536) Versus Epoetin Alfa for the Treatment of Anemia Due to IPSS-R Very Low, Low, or Intermediate Risk Myelodysplastic Syndromes (MDS) Participants Who Require Red Blood Cell Transfusions and Are ESA Naïve Active, not recruiting

A Study to Determine the Recommended Dose and Schedule, and Evaluate the Safety and Preliminary Efficacy of Mezigdomide in Combination With Elranatamab in Participants With Relapsed and/or Refractory Multiple Myeloma Recruiting

A Study to Determine Dose, Safety, Tolerability and Efficacy of CC-220 Monotherapy, and in Combination With Other Treatments in Subjects With Multiple Myeloma Active, not recruiting

Other trials for the same condition

A Study Evaluating the Safety, Pharmacokinetics, and Activity of Cevostamab in Participants With Relapsed or Refractory Multiple Myeloma Recruiting

Fixed Duration vs Continuous Anti-CD38 Antibody Therapy Among Transplant Ineligible Older Adults With Newly-Diagnosed Multiple Myeloma Recruiting

A Study Comparing Anitocabtagene Autoleucel to Standard of Care Therapy in Participants With Relapsed/ Refractory Multiple Myeloma Active, not recruiting

A Study of Bortezomib, Lenalidomide and Dexamethasone (VRd) Followed by Cilta-cel, a CAR-T Therapy Directed Against BCMA Versus VRd Followed by Lenalidomide and Dexamethasone (Rd) Therapy in Participants With Newly Diagnosed Multiple Myeloma for Whom ASCT is Not Planned as Initial Therapy Active, not recruiting

A Study of Combination Therapy With Venetoclax, Daratumumab and Dexamethasone (With and Without Bortezomib) in Participants With Relapsed or Refractory Multiple Myeloma Active, not recruiting

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT03989414 on ClinicalTrials.gov ↗ ← All trials in Canada