Multiple Myeloma Clinical Trial

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

Summary

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.

View Eligibility Criteria

Eligibility 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

Study is for people with:

Multiple Myeloma

Phase:

Phase 1

Estimated Enrollment:

160

Study ID:

NCT04036461

Recruitment Status:

Recruiting

Sponsor:

Celgene

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There are 27 Locations for this study

See Locations Near You

University of California San Diego Moores Cancer Center
La Jolla California, 92093, United States
University Of California San Diego Moores Cancer Center
La Jolla California, 92093, United States More Info
Caitlin Costello, Site 107
Contact
858-822-5380
Florida Cancer Specialists
Sarasota Florida, 34232, United States
Roswell Park Cancer Institute
Buffalo New York, 14263, United States
Mount Sinai Hospital
New York New York, 10029, United States
Mount Sinai Hospital
New York New York, 10029, United States More Info
Larysa Sanchez, Site 106
Contact
Oregon Health & Science University
Portland Oregon, 97239, United States
UT Southwestern Medical Center
Dallas Texas, 75390, United States
UT Southwestern Medical Center
Dallas Texas, 75390, United States More Info
Larry Anderson, Site 104
Contact
214-648-5906
Swedish Cancer Institute
Seattle Washington, 98104, United States
Tom Baker Cancer Center
Calgary Alberta, T2N 4, Canada
Local Institution - 202
Toronto Ontario, M5G 2, Canada More Info
Site 202
Contact
Princess Margaret Cancer Centre
Toronto Ontario, M5G 2, Canada
Hopital Maisonneuve Rosemont dba CIUSSS de lEst de lIle de Montreal
Montreal Quebec, H1T 2, Canada
Local Institution - 201
Montreal Quebec, H1T 2, Canada More Info
Site 201
Contact
Institut Paoli Calmettes
Marseille Cedex 9 , 13273, France
CHU Montpellier - Hôpital Saint Eloi
Montpellier CEDEX 5 , 34295, France
CHU Nantes Hotel Dieu
Nantes , 44093, France
Hopital Saint Antoine
Paris , 75571, France
Centre Hospitalier Lyon Sud
Pierre Bénite , 69495, France
Institut Claudiu Regaud, IUCT-Oncopole
Toulouse , 31059, France
ASST-Ospedale di Bergamo
Bergamo , 24127, Italy
University of Bologna
Bologna , 40138, Italy
Azienda Ospedaliero - Universitaria "Policlinico - Vittorio Emanuele" - Ospedale Vittorio Emanuele
Catania , 95124, Italy
Local Institution - 503
Catania , 95124, Italy
Istituto Nazionale dei Tumori | Fondazione IRCCS
Milan , 20133, Italy
Local Institution - 504
Milan , 20133, Italy
Local Institution - 406
Badalona , 08916, Spain More Info
Site 406
Contact
Clinic Barcelona Hospital Universitari
Barcelona , 08036, Spain
Hospital Universitario 12 de Octubre
Madrid , 28041, Spain
Local Institution - 401
Madrid , 28041, Spain More Info
Site 401
Contact
Local Institution - 407
Malaga , 29011, Spain More Info
Site 407
Contact
Complejo Asistencial Universitario de Salamanca - H. Clinico
Salamanca , 37007, Spain
Local Institution - 402
Salamanca , 37007, Spain More Info
Site 402
Contact
HUV Rocio
Sevillla , 41013, Spain
Hospital Universitari i Politecnic La Fe de Valencia
Valencia , 46026, Spain
Local Institution - 403
Valencia , 46026, Spain More Info
Site 403
Contact

How clear is this clinincal trial information?

Study is for people with:

Multiple Myeloma

Phase:

Phase 1

Estimated Enrollment:

160

Study ID:

NCT04036461

Recruitment Status:

Recruiting

Sponsor:


Celgene

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