Status:
TERMINATED
A Study of CC-99712, a BCMA Antibody-Drug Conjugate, in Participants With Relapsed and Refractory Multiple Myeloma
Lead Sponsor:
Celgene
Conditions:
Multiple Myeloma
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief 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 parti...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
August 26 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 19 2024
Estimated Enrollment :
47 Patients enrolled
Trial Details
Trial ID
NCT04036461
Start Date
August 26 2019
End Date
August 19 2024
Last Update
August 30 2024
Active Locations (20)
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1
Local Institution - 107
La Jolla, California, United States, 92093
2
Local Institution - 105
Sarasota, Florida, United States, 34232
3
Local Institution - 103
Buffalo, New York, United States, 14263
4
Local Institution - 106
New York, New York, United States, 10029