RECRUITINGPhase 1 / Phase 2INTERVENTIONAL
A Study to Evaluate Safety, Drug Levels and Effectiveness of CC-92480 (BMS-986348) in Combination With Other Treatments in Participants With Relapsed or Refractory Multiple Myeloma
An Exploratory Phase 1b/2a Multicenter, Open-Label, Novel-Novel Combination Study to Assess the Safety, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy of CC-92480 (BMS-986348) in Novel Therapeutic Combinations in Participants With Relapsed or Refractory Multiple Myeloma
About This Trial
The purpose of this study is to assess the safety, tolerability and preliminary effectiveness of CC-92480 (BMS-986348) in novel therapeutic combinations for the treatment of Relapsed or Refractory Multiple Myeloma (RRMM).
Who May Be Eligible (Plain English)
Who May Qualify:
- Relapsed or refractory multiple myeloma (MM) and must:
1. Have documented disease progression during or after their last myeloma therapy.
2. For Part 1 Dose Finding: Be refractory to, intolerant to, or not a candidate for available, established therapies known to provide clinical benefit in MM; For Part 2 Dose Expansion: Be refractory to or have relapsed after the protocol specified number of prior lines of therapy that include an immunomodulatory drug (IMiD), a proteasome inhibitor, an anti-CD38 mAb, and a T-cell redirecting therapy (TRT, eg, a CAR-T or T-cell engaging bispecific treatment) unless the participant is not a candidate for TRT.
- Must have measurable disease.
- Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 or 1.
- Agree to follow the CC-92480 Pregnancy Prevention Plan (PPP).
Who Should NOT Join This Trial:
- Known active or history of central nervous system (CNS) involvement of MM
- Plasma cell leukemia; Waldenstrom's macroglobulinemia; polyneuropathy, organomegaly, endocrinopathy, M-protein, and skin changes (POEMS) syndrome; or clinically significant light-chain amyloidosis.
- Impaired cardiac function or clinically significant cardiac disease
- Previous SARS-CoV-2 infection within 14 days for asymptomatic or mild symptomatic infections or 28 days for severe/critical illness prior to Cycle 1 Day 1 (C1D1)
- For Part 1: received prior therapy with CC-92480
- For Part 2: received prior therapy with CC-92480, tazemetostat, BMS-986158, or trametinib
- Previously received allogeneic stem-cell transplant at any time or received autologous stem-cell transplant within 12 weeks of initiating study treatment
- Received any of the following within 14 days prior to initiating study treatment:
1. Plasmapheresis
2. Major surgery
3. Radiation therapy other than local therapy for myeloma associated bone lesions
4. Use of any systemic anti-myeloma drug therapy
...See full criteria on ClinicalTrials.gov
Always talk to your doctor about whether this trial is right for you.
Original Eligibility Criteria
View original clinical language
Inclusion Criteria:
* Relapsed or refractory multiple myeloma (MM) and must:
1. Have documented disease progression during or after their last myeloma therapy.
2. For Part 1 Dose Finding: Be refractory to, intolerant to, or not a candidate for available, established therapies known to provide clinical benefit in MM; For Part 2 Dose Expansion: Be refractory to or have relapsed after the protocol specified number of prior lines of therapy that include an immunomodulatory drug (IMiD), a proteasome inhibitor, an anti-CD38 mAb, and a T-cell redirecting therapy (TRT, eg, a CAR-T or T-cell engaging bispecific treatment) unless the participant is not a candidate for TRT.
* Must have measurable disease.
* Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 or 1.
* Agree to follow the CC-92480 Pregnancy Prevention Plan (PPP).
Exclusion Criteria:
* Known active or history of central nervous system (CNS) involvement of MM
* Plasma cell leukemia; Waldenstrom's macroglobulinemia; polyneuropathy, organomegaly, endocrinopathy, M-protein, and skin changes (POEMS) syndrome; or clinically significant light-chain amyloidosis.
* Impaired cardiac function or clinically significant cardiac disease
* Previous SARS-CoV-2 infection within 14 days for asymptomatic or mild symptomatic infections or 28 days for severe/critical illness prior to Cycle 1 Day 1 (C1D1)
* For Part 1: received prior therapy with CC-92480
* For Part 2: received prior therapy with CC-92480, tazemetostat, BMS-986158, or trametinib
* Previously received allogeneic stem-cell transplant at any time or received autologous stem-cell transplant within 12 weeks of initiating study treatment
* Received any of the following within 14 days prior to initiating study treatment:
1. Plasmapheresis
2. Major surgery
3. Radiation therapy other than local therapy for myeloma associated bone lesions
4. Use of any systemic anti-myeloma drug therapy
* Used any investigational agents within 28 days or 5 half-lives (whichever is shorter) prior to initiating study treatment
* COVID-19 vaccine within 14 days prior to C1D1
Other protocol-defined inclusion/exclusion criteria apply
Treatments Being Tested
DRUG
CC-92480
Specified dose on specified days
DRUG
Tazemetostat
Specified dose on specified days
DRUG
BMS-986158
Specified dose on specified days
DRUG
Trametinib
Specified dose on specified days
DRUG
Dexamethasone
Specified dose on specified days
Locations (17)
UAB Comprehensive Cancer Center
Birmingham, Alabama, United States
Johns Hopkins Medicine - The Sidney Kimmel Comprehensive Cancer Center
Baltimore, Maryland, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, United States
John Theurer Cancer Center at Hackensack UMC
Hackensack, New Jersey, United States
Memorial Sloan Kettering Cancer Center
New York, New York, United States
Alberta Health Services AHS - Foothills Medical Centre FMC
Calgary, Alberta, Canada
University of Alberta - Cross Cancer Institute
Edmonton, Alberta, Canada
University Health Network UHN - Princess Margaret Hospital PMH
Toronto, Ontario, Canada
Oslo University Hospital
Oslo, Outside US and Canada, Norway
ICO - Hospital Germans Trias i Pujol
Barcelona, Spain
Hospital Universitario 12 de Octubre
Madrid, Spain
Hospital Universitario Marques de Valdecilla
Santander, Spain
The Christie NHS Foundation Trust
Manchester, Greater Manchester, United Kingdom
Local Institution - 0001
Leicester, Leicestershire, United Kingdom
Local Institution - 0014
Liverpool, Merseyside, United Kingdom
Churchill Hospital
Oxford, Oxfordshire, United Kingdom
NIHR UCLH Clinical Research Facility
London, United Kingdom