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| ID | Type | Description | Link |
|---|---|---|---|
| 2023-509384-25 | Other Identifier | EU CTR | |
| U1111-1269-5704 | Registry Identifier | WHO |
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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part 1 Arm A: Dose Finding | Experimental |
| |
| Part 1 Arm B: Dose Finding | Experimental |
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| Part 1 Arm C: Dose Finding | Experimental |
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| Part 2 Arm D: Dose Expansion | Active Comparator |
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| Part 2 Arm E: Dose Expansion | Experimental |
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| Part 2 Arm G: Dose Expansion | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CC-92480 | Drug | Specified dose on specified days |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | |
| Number of participants with Serious AEs | Up to approximately 4 years | |
| Number of participants with AEs meeting protocol-defined DLT criteria | Up to approximately 4 years | |
| Number of participants with AEs leading to discontinuation | Up to approximately 4 years | |
| Number of deaths | Up to approximately 4 years | |
| Establish recommended Phase 2 dose (RP2D) | Up to approximately 2 years | |
| Establish dosing schedule of each combination for Part 2 Dose Expansion | Up to approximately 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Overall response rate (ORR) | Up to approximately 4 years | |
| Very good partial response rate (VGPRR) | Up to approximately 4 years | |
| Complete response rate (CRR) |
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Inclusion Criteria:
Relapsed or refractory multiple myeloma (MM) and must:
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:
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
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| BMS Study Connect Contact Center www.BMSStudyConnect.com | Contact | 855-907-3286 | Clinical.Trials@bms.com | |
| First line of email MUST contain NCT # and Site #. | Contact |
| Name | Affiliation | Role |
|---|---|---|
| Bristol-Myers Squibb | Bristol-Myers Squibb | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UAB Comprehensive Cancer Center | Recruiting | Birmingham | Alabama | 35249 | United States |
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| Label | URL |
|---|---|
| BMS Clinical Trial Information | View source |
| BMS Clinical Trial Patient Recruiting | View source |
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| Tazemetostat | Drug | Specified dose on specified days |
|
| BMS-986158 | Drug | Specified dose on specified days |
|
| Trametinib | Drug | Specified dose on specified days |
|
| Dexamethasone | Drug | Specified dose on specified days |
|
| Up to approximately 4 years |
| Time-to-response (TTR) | Up to approximately 4 years |
| Duration of response (DOR) | Up to approximately 4 years |
| Progression-free survival (PFS) | Up to approximately 4 years |
| Maximum observed plasma concentration (Cmax) | Up to approximately 28 days |
| Time to maximum plasma concentration (Tmax) | Up to approximately 28 days |
| Area under the concentration-time curve (AUC) | Up to approximately 28 days |
| Terminal Half-Life (T-Half) | Up to approximately 28 days |
| Apparent total body clearance (CLT/F) | Up to approximately 28 days |
| Apparent volume of distribution (Vz/F) | Up to approximately 28 days |
| Johns Hopkins Medicine - The Sidney Kimmel Comprehensive Cancer Center | Recruiting | Baltimore | Maryland | 21287 | United States |
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| Dana-Farber Cancer Institute | Recruiting | Boston | Massachusetts | 02215 | United States |
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| John Theurer Cancer Center at Hackensack UMC | Recruiting | Hackensack | New Jersey | 07601 | United States |
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| Memorial Sloan Kettering Cancer Center | Recruiting | New York | New York | 10021 | United States |
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| Alberta Health Services AHS - Foothills Medical Centre FMC | Recruiting | Calgary | Alberta | T2N 5G2 | Canada |
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| University of Alberta - Cross Cancer Institute | Recruiting | Edmonton | Alberta | T6G 1Z2 | Canada |
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| University Health Network UHN - Princess Margaret Hospital PMH | Recruiting | Toronto | Ontario | M5G 2M9 | Canada |
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| Oslo University Hospital | Recruiting | Oslo | Outside US and Canada | 0450 | Norway |
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| ICO - Hospital Germans Trias i Pujol | Recruiting | Barcelona | 08026 | Spain |
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| Hospital Universitario 12 de Octubre | Recruiting | Madrid | 28041 | Spain |
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| Hospital Universitario Marques de Valdecilla | Recruiting | Santander | 39008 | Spain |
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| The Christie NHS Foundation Trust | Recruiting | Manchester | Greater Manchester | M20 4BX | United Kingdom |
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| Local Institution - 0001 | Withdrawn | Leicester | Leicestershire | LE1 5WW | United Kingdom |
| Local Institution - 0014 | Withdrawn | Liverpool | Merseyside | L7 8YA | United Kingdom |
| Churchill Hospital | Recruiting | Oxford | Oxfordshire | OX3 7LE | United Kingdom |
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| NIHR UCLH Clinical Research Facility | Recruiting | London | W1T 7HA | United Kingdom |
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| ID | Term |
|---|---|
| D009101 | Multiple Myeloma |
| ID | Term |
|---|---|
| D054219 | Neoplasms, Plasma Cell |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D020141 | Hemostatic Disorders |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010265 | Paraproteinemias |
| D001796 | Blood Protein Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D006474 | Hemorrhagic Disorders |
| D008232 | Lymphoproliferative Disorders |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| C000593333 | tazemetostat |
| C560077 | trametinib |
| D003907 | Dexamethasone |
| ID | Term |
|---|---|
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |
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