RECRUITING

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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Conditions

Multiple MyelomaBMS-986348CC-92480BMS-986158DexamethasoneTazemetostatTrametinib

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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).

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

Quick Facts

Study Start:2022-10-18
Study Completion:2026-10-12
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05372354

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Relapsed or refractory multiple myeloma (MM) and must:
  2. 1. have documented disease progression during or after their last myeloma therapy
  3. 2. be refractory to, intolerant to, or not a candidate for available, established therapies known to provide clinical benefit in MM
  4. * Must have measurable disease
  5. * Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 or 1
  6. * Agree to follow the CC-92480 Pregnancy Prevention Plan (PPP)
  1. * Known active or history of central nervous system (CNS) involvement of MM
  2. * Plasma cell leukemia; Waldenstrom's macroglobulinemia; polyneuropathy, organomegaly, endocrinopathy, M-protein, and skin changes (POEMS) syndrome; or clinically significant light-chain amyloidosis.
  3. * Impaired cardiac function or clinically significant cardiac disease
  4. * 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)
  5. * For Part 1: received prior therapy with CC-92480
  6. * For Part 2: received prior therapy with CC-92480, tazemetostat, BMS-986158, or trametinib
  7. * Previously received allogeneic stem-cell transplant at any time or received autologous stem-cell transplant within 12 weeks of initiating study treatment
  8. * Received any of the following within 14 days prior to initiating study treatment:
  9. 1. Plasmapheresis
  10. 2. Major surgery
  11. 3. Radiation therapy other than local therapy for myeloma associated bone lesions
  12. 4. Use of any systemic anti-myeloma drug therapy
  13. * Used any investigational agents within 28 days or 5 half-lives (whichever is shorter) prior to initiating study treatment
  14. * COVID-19 vaccine within 14 days prior to C1D1

Contacts and Locations

Study Contact

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

Principal Investigator

Bristol-Myers Squibb
STUDY_DIRECTOR
Bristol-Myers Squibb

Study Locations (Sites)

UAB Comprehensive Cancer Center
Birmingham, Alabama, 35249
United States
Johns Hopkins Medicine - The Sidney Kimmel Comprehensive Cancer Center
Baltimore, Maryland, 21287
United States
Dana-Farber Cancer Institute
Boston, Massachusetts, 02215
United States
John Theurer Cancer Center at Hackensack UMC
Hackensack, New Jersey, 07601
United States
Memorial Sloan Kettering Cancer Center
New York, New York, 10021
United States

Collaborators and Investigators

Sponsor: Bristol-Myers Squibb

  • Bristol-Myers Squibb, STUDY_DIRECTOR, Bristol-Myers Squibb

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-10-18
Study Completion Date2026-10-12

Study Record Updates

Study Start Date2022-10-18
Study Completion Date2026-10-12

Terms related to this study

Keywords Provided by Researchers

  • BMS-986348
  • CC-92480
  • BMS-986158
  • Dexamethasone
  • Tazemetostat
  • Trametinib

Additional Relevant MeSH Terms

  • Multiple Myeloma