A Study of CC-95266 in Participants With Relapsed and/or Refractory Multiple Myeloma

Study Purpose

The purpose of this study is to evaluate the safety and preliminary efficacy of CC-95266 in participants with relapsed and/or refractory multiple myeloma (R/R MM).

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

  • - Age ≥ 18 years.
  • - Participant has a diagnosis of multiple myeloma (MM) with relapsed and/or refractory disease.
Participants must have documented progressive disease on or within 12 months of completing treatment with the last anti-myeloma treatment regimen, except for participants with cellular therapy (eg, Chimeric antigen receptor (CAR) T-cell therapy) as their last treatment, who may enroll beyond 12 months.
  • - Participants must have received at least 3 prior anti-myeloma treatment regimens (note: induction with or without hematopoietic stem cell transplant (HSCT) and with or without maintenance therapy is considered one regimen), including: - Autologous stem cell transplant.
  • - A regimen that included an immunomodulatory agent (eg, thalidomide, lenalidomide, pomalidomide) and a proteasome inhibitor (eg, bortezomib, carfilzomib, ixazomib), either alone or combination.
  • - Anti-CD38 (eg, daratumumab), either alone or combination.
  • - Measurable disease.
  • - Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
  • - Adequate organ function.

Exclusion Criteria:

  • - Known active or history of central nervous system (CNS) involvement of MM.
  • - Active or history of plasma cell leukemia, Waldenstrom's macroglobulinemia, POEMS (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, skin changes) syndrome, or clinically significant amyloidosis.
  • - Active autoimmune disease requiring immunosuppressive therapy.
  • - History or presence of clinically significant CNS pathology such as seizure disorder, aphasia, stroke, severe brain injuries, dementia, Parkinson's disease, cerebellar disease, or psychosis.
Other protocol-defined inclusion/exclusion criteria apply

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT04674813
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 1
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Juno Therapeutics, a Subsidiary of Celgene
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Bristol-Myers Squibb
Principal Investigator Affiliation Bristol-Myers Squibb
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Multiple Myeloma
Study Website: View Trial Website
Arms & Interventions

Arms

Experimental: Administration of CC-95266

Interventions

Drug: - CC-95266

Specified dose on specified days

Drug: - Fludarabine

Specified dose on specified days

Drug: - Cyclophosphamide

Specified dose on specified days

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

University of Alabama Birmingham, Birmingham, Alabama

Status

Recruiting

Address

University of Alabama Birmingham

Birmingham, Alabama, 10016

University of Alabama Birmingham, Birmingham, Alabama

Status

Recruiting

Address

University of Alabama Birmingham

Birmingham, Alabama, 10016

Site Contact

Susan Bal, Site 005

Clinical.Trials@bms.com

205-934-1908

City of Hope, Duarte, California

Status

Recruiting

Address

City of Hope

Duarte, California, 91010-301

City Of Hope, Duarte, California

Status

Recruiting

Address

City Of Hope

Duarte, California, 91010-301

Site Contact

Myo Htut, Site 009

Clinical.Trials@bms.com

626-256-4673

San Francisco, California

Status

Not yet recruiting

Address

University of California, San Francisco Comprehensive Cancer Center

San Francisco, California, 94143

San Francisco, California

Status

Not yet recruiting

Address

University of California, San Francisco Comprehensive Cancer Center

San Francisco, California, 94143

Site Contact

Nina Shah, Site 012

Clinical.Trials@bms.com

713-792-2121

Colorado Blood Cancer Institute, Denver, Colorado

Status

Recruiting

Address

Colorado Blood Cancer Institute

Denver, Colorado, 80218

Colorado Blood Cancer Institute, Denver, Colorado

Status

Recruiting

Address

Colorado Blood Cancer Institute

Denver, Colorado, 80218

Site Contact

Tara Gregory, Site 002

Clinical.Trials@bms.com

720-754-4800

Baltimore, Maryland

Status

Recruiting

Address

University of Maryland - Greenebaum Comprehensive Cancer Center

Baltimore, Maryland, 21201

Baltimore, Maryland

Status

Recruiting

Address

University of Maryland - Greenebaum Comprehensive Cancer Center

Baltimore, Maryland, 21201

Site Contact

Mehmet Kocoglu, Site 008

Clinical.Trials@bms.com

203-824-3507

Dana Farber Cancer Institute, Boston, Massachusetts

Status

Recruiting

Address

Dana Farber Cancer Institute

Boston, Massachusetts, 02115

Dana Farber Cancer Institute, Boston, Massachusetts

Status

Recruiting

Address

Dana Farber Cancer Institute

Boston, Massachusetts, 02115

Site Contact

Omar Nadeem, Site 010

Clinical.Trials@bms.com

617-831-7333

Mount Sinai Medical Center, New York, New York

Status

Not yet recruiting

Address

Mount Sinai Medical Center

New York, New York, 10029

Mount Sinai Medical Center, New York, New York

Status

Recruiting

Address

Mount Sinai Medical Center

New York, New York, 10029

Site Contact

Adriana Rossi, Site 011

Clinical.Trials@bms.com

646-962-6500

Nashville, Tennessee

Status

Recruiting

Address

Sarah Cannon Research Institute Center for Blood Cancers

Nashville, Tennessee, 37203

Nashville, Tennessee

Status

Recruiting

Address

Sarah Cannon Research Institute Center for Blood Cancers

Nashville, Tennessee, 37203

Site Contact

Jesus Berdeja, Site 001

Clinical.Trials@bms.com

615-329-0570

Dallas, Texas

Status

Recruiting

Address

Southwestern Medical Center- Harold C Simmons Comprehensive Cancer Center

Dallas, Texas, 75390

Dallas, Texas

Status

Recruiting

Address

Southwestern Medical Center- Harold C Simmons Comprehensive Cancer Center

Dallas, Texas, 75390

Site Contact

Larry Anderson, Site 006

Clinical.Trials@bms.com

214-648-5906

Swedish Cancer Institute, Seattle, Washington

Status

Not yet recruiting

Address

Swedish Cancer Institute

Seattle, Washington, 98104

Swedish Cancer Institute, Seattle, Washington

Status

Recruiting

Address

Swedish Cancer Institute

Seattle, Washington, 98104

Site Contact

Daniel Egan, Site 003

Clinical.Trials@bms.com

617-699-2437