Back to resultsA 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
Primary Purpose
Multiple Myeloma
Status
Recruiting
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
CC-92480
Tazemetostat
BMS-986158
Trametinib
Dexamethasone
Sponsored by
About this trial
This is an interventional treatment trial for Multiple Myeloma focused on measuring BMS-986348, CC-92480, BMS-986158, Dexamethasone, Tazemetostat, Trametinib
Eligibility Criteria
Inclusion Criteria:
Relapsed or refractory multiple myeloma (MM) and must:
- have documented disease progression during or after their last myeloma therapy
- 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:
- Plasmapheresis
- Major surgery
- Radiation therapy other than local therapy for myeloma associated bone lesions
- 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
Sites / Locations
- UAB Comprehensive Cancer CenterRecruiting
- Johns Hopkins Medicine - The Sidney Kimmel Comprehensive Cancer CenterRecruiting
- Dana-Farber Cancer InstituteRecruiting
- John Theurer Cancer Center at Hackensack UMCRecruiting
- Memorial Sloan Kettering Cancer CenterRecruiting
- Local Institution - 0009Recruiting
- Local Institution - 0008Recruiting
- Local Institution - 0004Recruiting
- Local Institution - 0012Recruiting
- Local Institution - 0011Recruiting
- Local Institution - 0005Recruiting
- Local Institution - 0003Recruiting
- Local Institution - 0006Recruiting
- Local Institution - 0017
- Leicester Royal Infirmary
- Local Institution - 0014
- Local Institution - 0016
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm 7
Arm Type
Experimental
Experimental
Experimental
Active Comparator
Experimental
Experimental
Experimental
Arm Label
Part 1 Arm A: Dose Finding
Part 1 Arm B: Dose Finding
Part 1 Arm C: Dose Finding
Part 2 Arm D: Dose Expansion
Part 2 Arm E: Dose Expansion
Part 2 Arm F: Dose Expansion
Part 2 Arm G: Dose Expansion
Arm Description
Outcomes
Primary Outcome Measures
Number of participants with adverse events (AEs)
Establish recommended Phase 2 dose (RP2D)
Establish dosing schedule of each combination for Part 2 Dose Expansion
Secondary Outcome Measures
Overall response rate (ORR)
Very good partial response rate (VGPRR)
Complete response rate (CRR)
Time-to-response (TTR)
Duration of response (DOR)
Progression-free survival (PFS)
Maximum observed plasma concentration (Cmax)
Time to maximum plasma concentration (Tmax)
Area under the concentration-time curve (AUC)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05372354
Brief Title
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
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
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 18, 2022 (Actual)
Primary Completion Date
October 12, 2026 (Anticipated)
Study Completion Date
October 12, 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bristol-Myers Squibb
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Myeloma
Keywords
BMS-986348, CC-92480, BMS-986158, Dexamethasone, Tazemetostat, Trametinib
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
220 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Part 1 Arm A: Dose Finding
Arm Type
Experimental
Arm Title
Part 1 Arm B: Dose Finding
Arm Type
Experimental
Arm Title
Part 1 Arm C: Dose Finding
Arm Type
Experimental
Arm Title
Part 2 Arm D: Dose Expansion
Arm Type
Active Comparator
Arm Title
Part 2 Arm E: Dose Expansion
Arm Type
Experimental
Arm Title
Part 2 Arm F: Dose Expansion
Arm Type
Experimental
Arm Title
Part 2 Arm G: Dose Expansion
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
CC-92480
Other Intervention Name(s)
BMS-986348
Intervention Description
Specified dose on specified days
Intervention Type
Drug
Intervention Name(s)
Tazemetostat
Intervention Description
Specified dose on specified days
Intervention Type
Drug
Intervention Name(s)
BMS-986158
Intervention Description
Specified dose on specified days
Intervention Type
Drug
Intervention Name(s)
Trametinib
Intervention Description
Specified dose on specified days
Intervention Type
Drug
Intervention Name(s)
Dexamethasone
Intervention Description
Specified dose on specified days
Primary Outcome Measure Information:
Title
Number of participants with adverse events (AEs)
Time Frame
From first participant first visit until 28 days after the last participant discontinues study treatment, up to approximately 4 years
Title
Establish recommended Phase 2 dose (RP2D)
Time Frame
Up to approximately 2 years
Title
Establish dosing schedule of each combination for Part 2 Dose Expansion
Time Frame
Up to approximately 2 years
Secondary Outcome Measure Information:
Title
Overall response rate (ORR)
Time Frame
Up to approximately 4 years
Title
Very good partial response rate (VGPRR)
Time Frame
Up to approximately 4 years
Title
Complete response rate (CRR)
Time Frame
Up to approximately 4 years
Title
Time-to-response (TTR)
Time Frame
Up to approximately 4 years
Title
Duration of response (DOR)
Time Frame
Up to approximately 4 years
Title
Progression-free survival (PFS)
Time Frame
Up to approximately 4 years
Title
Maximum observed plasma concentration (Cmax)
Time Frame
Up to approximately 28 days
Title
Time to maximum plasma concentration (Tmax)
Time Frame
Up to approximately 28 days
Title
Area under the concentration-time curve (AUC)
Time Frame
Up to approximately 28 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Relapsed or refractory multiple myeloma (MM) and must:
have documented disease progression during or after their last myeloma therapy
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:
Plasmapheresis
Major surgery
Radiation therapy other than local therapy for myeloma associated bone lesions
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
BMS Study Connect Contact Center www.BMSStudyConnect.com
Phone
855-907-3286
Email
Clinical.Trials@bms.com
First Name & Middle Initial & Last Name or Official Title & Degree
First line of email MUST contain NCT # and Site #.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bristol-Myers Squibb
Organizational Affiliation
Bristol-Myers Squibb
Official's Role
Study Director
Facility Information:
Facility Name
UAB Comprehensive Cancer Center
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35249
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Luciano Costa, Site 0002
Phone
205-934-9695
Facility Name
Johns Hopkins Medicine - The Sidney Kimmel Comprehensive Cancer Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Syed Abbas Ali, Site 0015
Phone
410-955-4967
Facility Name
Dana-Farber Cancer Institute
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Monique Hartley-Brown, Site 0010
Phone
857-299-5736
Facility Name
John Theurer Cancer Center at Hackensack UMC
City
Hackensack
State/Province
New Jersey
ZIP/Postal Code
07601
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
David Siegel, Site 0013
Phone
551-996-8704
Facility Name
Memorial Sloan Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Saad Usmani, Site 0007
Phone
980-442-2000
Facility Name
Local Institution - 0009
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2N 4N2
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0009
Facility Name
Local Institution - 0008
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 1Z2
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0008
Facility Name
Local Institution - 0004
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2M9
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0004
Facility Name
Local Institution - 0012
City
Oslo
State/Province
Outside US And Canada
ZIP/Postal Code
0450
Country
Norway
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0012
Facility Name
Local Institution - 0011
City
Barcelona
ZIP/Postal Code
08026
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0011
Facility Name
Local Institution - 0005
City
Madrid
ZIP/Postal Code
28041
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0005
Facility Name
Local Institution - 0003
City
Santander
ZIP/Postal Code
39008
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0003
Facility Name
Local Institution - 0006
City
London
State/Province
Greater London
ZIP/Postal Code
W1T 7HA
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0006
Facility Name
Local Institution - 0017
City
Manchester
State/Province
Greater Manchester
ZIP/Postal Code
M20 4BX
Country
United Kingdom
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0017
Facility Name
Leicester Royal Infirmary
City
Leicester
State/Province
Leicestershire
ZIP/Postal Code
LE1 5WW
Country
United Kingdom
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mamta Garg, Site0001
Phone
+441162586037
Facility Name
Local Institution - 0014
City
Liverpool
State/Province
Merseyside
ZIP/Postal Code
L7 8YA
Country
United Kingdom
Individual Site Status
Withdrawn
Facility Name
Local Institution - 0016
City
Oxford
State/Province
Oxfordshire
ZIP/Postal Code
OX3 7LE
Country
United Kingdom
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0016
12. IPD Sharing Statement
Links:
URL
https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html
Description
BMS Clinical Trial Information
URL
https://www.bmsstudyconnect.com/s/US/English/USenHome
Description
BMS Clinical Trial Patient Recruiting
URL
https://www.fda.gov/Safety/MedWatch/SafetyInformation/default.htm
Description
FDA Safety Alerts and Recalls
Learn more about this trial
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
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