Multiple Myeloma Clinical Trial
Official title:
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
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).
| Status | Recruiting |
| Enrollment | 220 |
| Est. completion date | October 12, 2026 |
| Est. primary completion date | October 12, 2026 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | Inclusion Criteria: - Relapsed or refractory multiple myeloma (MM) and must: 1. have documented disease progression during or after their last myeloma therapy 2. be refractory to, intolerant to, or not a candidate for available, established therapies known to provide clinical benefit in MM - 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 |
| Country | Name | City | State |
|---|---|---|---|
| Canada | 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 |
| Norway | Oslo University Hospital | Oslo | |
| Spain | Local Institution - 0011 | Barcelona | |
| Spain | Hospital Universitario 12 de Octubre | Madrid | |
| Spain | Hospital Universitario Marques de Valdecilla | Santander | |
| United Kingdom | Local Institution - 0001 | Leicester | Leicestershire |
| United Kingdom | Local Institution - 0014 | Liverpool | Merseyside |
| United Kingdom | NIHR UCLH Clinical Research Facility | London | |
| United Kingdom | The Christie NHS Foundation Trust | Manchester | Greater Manchester |
| United Kingdom | Churchill Hospital | Oxford | Oxfordshire |
| United States | Johns Hopkins Medicine - The Sidney Kimmel Comprehensive Cancer Center | Baltimore | Maryland |
| United States | UAB Comprehensive Cancer Center | Birmingham | Alabama |
| 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 |
| Lead Sponsor | Collaborator |
|---|---|
| Bristol-Myers Squibb |
United States, Canada, Norway, Spain, United Kingdom,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Number of participants with adverse events (AEs) | From first participant first visit until 28 days after the last participant discontinues study treatment, up to approximately 4 years | ||
| Primary | Establish recommended Phase 2 dose (RP2D) | Up to approximately 2 years | ||
| Primary | Establish dosing schedule of each combination for Part 2 Dose Expansion | Up to approximately 2 years | ||
| Secondary | Overall response rate (ORR) | Up to approximately 4 years | ||
| Secondary | Very good partial response rate (VGPRR) | Up to approximately 4 years | ||
| Secondary | Complete response rate (CRR) | Up to approximately 4 years | ||
| Secondary | Time-to-response (TTR) | Up to approximately 4 years | ||
| Secondary | Duration of response (DOR) | Up to approximately 4 years | ||
| Secondary | Progression-free survival (PFS) | Up to approximately 4 years | ||
| Secondary | Maximum observed plasma concentration (Cmax) | Up to approximately 28 days | ||
| Secondary | Time to maximum plasma concentration (Tmax) | Up to approximately 28 days | ||
| Secondary | Area under the concentration-time curve (AUC) | Up to approximately 28 days |
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT05027594 -
Ph I Study in Adult Patients With Relapsed or Refractory Multiple Myeloma
|
Phase 1 | |
| Completed |
NCT02412878 -
Once-weekly Versus Twice-weekly Carfilzomib in Combination With Dexamethasone in Adults With Relapsed and Refractory Multiple Myeloma
|
Phase 3 | |
| Completed |
NCT01947140 -
Pralatrexate + Romidepsin in Relapsed/Refractory Lymphoid Malignancies
|
Phase 1/Phase 2 | |
| Recruiting |
NCT05971056 -
Providing Cancer Care Closer to Home for Patients With Multiple Myeloma
|
N/A | |
| Recruiting |
NCT05243797 -
Phase 3 Study of Teclistamab in Combination With Lenalidomide and Teclistamab Alone Versus Lenalidomide Alone in Participants With Newly Diagnosed Multiple Myeloma as Maintenance Therapy Following Autologous Stem Cell Transplantation
|
Phase 3 | |
| Active, not recruiting |
NCT04555551 -
MCARH109 Chimeric Antigen Receptor (CAR) Modified T Cells for the Treatment of Multiple Myeloma
|
Phase 1 | |
| Recruiting |
NCT05618041 -
The Safety and Efficay Investigation of CAR-T Cell Therapy for Patients With Hematological Malignancies
|
N/A | |
| Active, not recruiting |
NCT03844048 -
An Extension Study of Venetoclax for Subjects Who Have Completed a Prior Venetoclax Clinical Trial
|
Phase 3 | |
| Recruiting |
NCT03412877 -
Administration of Autologous T-Cells Genetically Engineered to Express T-Cell Receptors Reactive Against Neoantigens in People With Metastatic Cancer
|
Phase 2 | |
| Completed |
NCT02916979 -
Myeloid-Derived Suppressor Cells and Checkpoint Immune Regulators' Expression in Allogeneic SCT Using FluBuATG
|
Phase 1 | |
| Recruiting |
NCT03570983 -
A Trial Comparing Single Agent Melphalan to Carmustine, Etoposide, Cytarabine, and Melphalan (BEAM) as a Preparative Regimen for Patients With Multiple Myeloma Undergoing High Dose Therapy Followed by Autologous Stem Cell Reinfusion
|
Phase 2 | |
| Completed |
NCT03665155 -
First-in- Human Imaging of Multiple Myeloma Using 89Zr-DFO-daratumumab, a CD38-targeting Monoclonal Antibody
|
Phase 1/Phase 2 | |
| Terminated |
NCT03399448 -
NY-ESO-1-redirected CRISPR (TCRendo and PD1) Edited T Cells (NYCE T Cells)
|
Phase 1 | |
| Completed |
NCT02812706 -
Isatuximab Single Agent Study in Japanese Relapsed AND Refractory Multiple Myeloma Patients
|
Phase 1/Phase 2 | |
| Active, not recruiting |
NCT05024045 -
Study of Oral LOXO-338 in Patients With Advanced Blood Cancers
|
Phase 1 | |
| Active, not recruiting |
NCT03792763 -
Denosumab for High Risk SMM and SLiM CRAB Positive, Early Myeloma Patients
|
Phase 2 | |
| Active, not recruiting |
NCT03989414 -
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)
|
Phase 1/Phase 2 | |
| Withdrawn |
NCT03608501 -
A Study of Ixazomib, Thalidomide and Dexamethasone in Newly Diagnosed and Treatment-naive Multiple Myeloma (MM) Participants Non-eligible for Autologous Stem-cell Transplantation
|
Phase 2 | |
| Recruiting |
NCT04537442 -
Clinical Study to Evaluate the Safety and Efficacy of IM21 CAR-T Cells in the Treatment of Elderly Patients With Relapsed or Refractory Multiple Myeloma
|
Phase 1 | |
| Completed |
NCT02546167 -
CART-BCMA Cells for Multiple Myeloma
|
Phase 1 |