A Study of CC-99712, a BCMA Antibody-Drug Conjugate, in Participants With Relapsed and Refractory Multiple Myeloma

Study Purpose

Study CC-99712-MM-001 is an open-label, Phase 1, dose escalation (Part A) and expansion (Part B), First-in-Human (FIH) clinical study of CC-99712 in monotherapy or combination with BMS-986405 in participants with relapsed and refractory multiple myeloma (MM). The dose escalation part (Part A) of the study will evaluate the safety and tolerability of escalating doses of CC-99712, administered intravenously (IV) in monotherapy (Arm 1) or combination with BMS-986405 (Arm 2), to determine the maximum tolerated dose (MTD) of CC-99712 guided by a Bayesian logistic regression model (BLRM). A modified accelerated titration design will also be used for Arm 1 and Arm 2. The MTD may be established separately for CC-99712 administered at Q3W and/ or Q4W schedules. The expansion part (Part B) will further evaluate the safety and efficacy of CC-99712 in monotherapy (Arm 1) or combination (Arm 2) administered at or below the MTD in selected expansion cohorts in order to determine the RP2D. One or more doses or dosing regimens may be selected for cohort expansion. All participants will be treated until confirmed disease progression per IMWG criteria, unacceptable toxicity, or participants//Investigator decision to withdraw.

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

Participants must satisfy the following criteria to be enrolled in the study: Inclusion.

  • - Participant is ≥ 18 years of age at the time of signing the ICF.
  • - Participant has a history of multiple myeloma (MM) with relapsed and/or refractory disease.
  • - Participant must have measurable disease.
  • - Participant has an Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 or 1.
Exclusion Criteria.
  • - Participant has symptomatic central nervous system involvement of MM.
  • - Participant had a prior autologous stem cell transplant ≤ 3 months prior to starting CC-99712.
  • - Participant had a prior allogeneic stem cell transplant with either standard or reduced intensity conditioning ≤ 6 months prior to starting CC-99712 or is on systemic immunosuppression for graft-versus host disease.
  • - Subject is a pregnant or lactating female.
  • - Subject has known human immunodeficiency virus (HIV) infection.
  • - Subject has active hepatitis B or C (HBV/HCV) infection.
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.

NCT04036461
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.

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 Canada, France, Italy, Spain, 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: Arm 1 (CC-99712 monotherapy)

CC-99712 will be administered via intravenous (IV) infusion.

Experimental: Arm 2 (CC-99712 and BMS-986405 combination)

CC-99712 will be administered via IV infusion. BMS-986405 will be administered orally.

Interventions

Drug: - CC-99712

CC-99712

Drug: - BMS-986405

BMS-986405

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.

La Jolla, California

Status

Recruiting

Address

University Of California San Diego Moores Cancer Center

La Jolla, California, 92093

Site Contact

Caitlin Costello, Site 107

Clinical.Trials@bms.com

858-822-5380

Florida Cancer Specialists, Sarasota, Florida

Status

Recruiting

Address

Florida Cancer Specialists

Sarasota, Florida, 34232

Site Contact

Manish Patel, Site 105

Clinical.Trials@bms.com

941-377-9993

Roswell Park Cancer Institute, Buffalo, New York

Status

Recruiting

Address

Roswell Park Cancer Institute

Buffalo, New York, 14263

Site Contact

Jens Hillengass, Site 103

Clinical.Trials@bms.com

716-845-8515

Mount Sinai Hospital, New York, New York

Status

Recruiting

Address

Mount Sinai Hospital

New York, New York, 10029

Site Contact

Larysa Sanchez, Site 106

Clinical.Trials@bms.com

855-907-3286

Oregon Health & Science University, Portland, Oregon

Status

Recruiting

Address

Oregon Health & Science University

Portland, Oregon, 97239

Site Contact

Eva Medvedova, Site 101

Clinical.Trials@bms.com

855-907-3286

UT Southwestern Medical Center, Dallas, Texas

Status

Recruiting

Address

UT Southwestern Medical Center

Dallas, Texas, 75390

Site Contact

Larry Anderson, Site 104

Clinical.Trials@bms.com

214-648-5906

Swedish Cancer Institute, Seattle, Washington

Status

Recruiting

Address

Swedish Cancer Institute

Seattle, Washington, 98104

Site Contact

Swathi Namburi, Site 102

Clinical.Trials@bms.com

855-907-3286

International Sites

Local Institution - 202, Toronto, Ontario, Canada

Status

Recruiting

Address

Local Institution - 202

Toronto, Ontario, M5G 2M9

Site Contact

Site 202

Clinical.Trials@bms.com

855-907-3286

Local Institution - 201, Montreal, Quebec, Canada

Status

Active, not recruiting

Address

Local Institution - 201

Montreal, Quebec, H1T 2M4

Institut Paoli Calmettes, Marseille Cedex 9, France

Status

Recruiting

Address

Institut Paoli Calmettes

Marseille Cedex 9, , 13273

Site Contact

Anne-Marie Stoppa, Site 304

Clinical.Trials@bms.com

+33491223847 0 00 0

CHU Montpellier - Hôpital Saint Eloi, Montpellier CEDEX 5, France

Status

Recruiting

Address

CHU Montpellier - Hôpital Saint Eloi

Montpellier CEDEX 5, , 34295

Site Contact

Laure Vincent, Site 301

Clinical.Trials@bms.com

+33467332422

CHU Nantes Hotel Dieu, Nantes, France

Status

Not yet recruiting

Address

CHU Nantes Hotel Dieu

Nantes, , 44093

Site Contact

Philippe Moreau, Site 303

Clinical.Trials@bms.com

33240083271

Hopital Saint Antoine, Paris, France

Status

Recruiting

Address

Hopital Saint Antoine

Paris, , 75571

Site Contact

Mohamad Mothy, Site 302

Clinical.Trials@bms.com

+33240083271 000 00

Centre Hospitalier Lyon Sud, Pierre Bénite, France

Status

Recruiting

Address

Centre Hospitalier Lyon Sud

Pierre Bénite, , 69495

Site Contact

Lionel Karlin, Site 305

Clinical.Trials@bms.com

33478864309

Local Institution - 306, Toulouse, France

Status

Withdrawn

Address

Local Institution - 306

Toulouse, , 31059

Local Institution - 502, Bergamo, Italy

Status

Not yet recruiting

Address

Local Institution - 502

Bergamo, , 24127

Site Contact

Site 502

Clinical.Trials@bms.com

855-907-3286

Local Institution - 501, Bologna, Italy

Status

Recruiting

Address

Local Institution - 501

Bologna, , 40138

Site Contact

Site 501

Clinical.Trials@bms.com

855-907-3286

Local Institution - 503, Catania, Italy

Status

Withdrawn

Address

Local Institution - 503

Catania, , 95124

Local Institution - 504, Milan, Italy

Status

Withdrawn

Address

Local Institution - 504

Milan, , 20133

Local Institution - 406, Badalona, Spain

Status

Active, not recruiting

Address

Local Institution - 406

Badalona, , 08916

Local Institution - 405, Barcelona, Spain

Status

Recruiting

Address

Local Institution - 405

Barcelona, , 08036

Site Contact

Site 405

Clinical.Trials@bms.com

855-907-3286

Local Institution - 401, Madrid, Spain

Status

Recruiting

Address

Local Institution - 401

Madrid, , 28041

Site Contact

Site 401

Clinical.Trials@bms.com

855-907-3286

Local Institution - 407, Malaga, Spain

Status

Active, not recruiting

Address

Local Institution - 407

Malaga, , 29011

Local Institution - 402, Salamanca, Spain

Status

Recruiting

Address

Local Institution - 402

Salamanca, , 37007

Site Contact

Site 402

Clinical.Trials@bms.com

855-907-3286

Local Institution - 404, Sevillla, Spain

Status

Recruiting

Address

Local Institution - 404

Sevillla, , 41013

Site Contact

Site 404

Clinical.Trials@bms.com

855-907-3286

Local Institution - 403, Valencia, Spain

Status

Recruiting

Address

Local Institution - 403

Valencia, , 46026

Site Contact

Site 403

Clinical.Trials@bms.com

855-907-3286