Multiple Myeloma Clinical Trial

Study of CC-93269, a BCMA x CD3 T Cell Engaging Antibody, in Participants With Relapsed and Refractory Multiple Myeloma

Summary

Study CC-93269-MM-001 is an open-label, Phase 1, dose escalation (Part A and C) and expansion (Parts B and D), first-in-human clinical study of CC-93269 in subjects with relapsed and refractory multiple myeloma.

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Full Description

The dose escalation parts (Part A with CC-93269 administered intravenous (IV) and Part C subcutaneous (SC)) of the study will evaluate the safety and tolerability of escalating doses of CC-93269, administered IV or SC, to determine the maximum tolerated dose (MTD) and non-tolerated dose (NTD) of CC-93269. The expansion parts (Part B and D) will further evaluate the safety and efficacy of CC-93269 administered IV or SC at or below the MTD in selected expansion cohorts of up to approximately 20 evaluable subjects each in order to determine the Recommended Phase 2 dose (RP2D).One or more dosing regimens may be selected for cohort expansion. All treatments will be administered in 28-day cycles for up to 2 years or extended up to 5 years for subjects maintaining clinical benefit at the discretion of the Safety Review Committee, until confirmed disease progression, unacceptable toxicity, or subject/investigator decision to withdraw.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

History of multiple myeloma with relapsed and refractory disease
Eastern Cooperative Oncology Group Performance Status of 0 or 1
Must have measurable disease as determined by the central laboratory

Exclusion Criteria:

Symptomatic central nervous system involvement of multiple myeloma
Prior autologous stem cell transplant ≤ 3 months prior
Prior allogeneic stem cell transplant with either standard or reduced intensity conditioning ≤ 12 months prior
History of concurrent second cancers requiring active, ongoing systemic treatment

Other protocol-defined inclusion/exclusion criteria apply

Study is for people with:

Multiple Myeloma

Phase:

Phase 1

Estimated Enrollment:

220

Study ID:

NCT03486067

Recruitment Status:

Active, not recruiting

Sponsor:

Celgene

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There are 28 Locations for this study

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University of Alabama at Birmingham
Birmingham Alabama, 35294, United States
University Of California San Francisco Medical Center
San Francisco California, 94142, United States
Yale Cancer Center
New Haven Connecticut, 06510, United States
Winship Cancer Institute of Emory University
Atlanta Georgia, 30322, United States
Massachusetts General Hospital
Boston Massachusetts, 02114, United States
Beth Israel Deaconess Medical Center
Boston Massachusetts, 02215, United States
Henry Ford Medical Center - New Center One
Detroit Michigan, 48202, United States
Icahn School of Medicine at Mount Sinai Mount Sinai West
New York New York, 10019, United States
Swedish Cancer Institute
Seattle Washington, 98104, United States
Local Institution - 305
Erlangen , 91054, Germany
Local Institution - 303
Hamburg , 20246, Germany
Local Institution - 302
Heidelberg , 69120, Germany
Local Institution - 304
Tuebingen , 72076, Germany
Local Institution - 402
Bergamo , 24127, Italy
Local Institution - 403
Meldola , 47014, Italy
Local Institution - 401
Milan , 20089, Italy
Local Institution - 206
Barcelona , 08916, Spain
Local Institution - 208
Barcelona , 8035, Spain
Local Institution - 205
Madrid , 28007, Spain
Local Institution - 201
Pamplona , 31008, Spain
Local Institution - 203
Salamanca , 37007, Spain
Local Institution - 204
Santander , 39008, Spain
Local Institution - 207
Valencia , 46009, Spain
Local Institution - 202
Valencia , 46017, Spain
Local Institution - 504
Gothenborg , 413 4, Sweden
Local Institution - 502
Lund , SE-22, Sweden
Local Institution - 501
Stockholm , 141 8, Sweden
Local Institution - 505
Uppsala , 75158, Sweden

How clear is this clinincal trial information?

Study is for people with:

Multiple Myeloma

Phase:

Phase 1

Estimated Enrollment:

220

Study ID:

NCT03486067

Recruitment Status:

Active, not recruiting

Sponsor:


Celgene

How clear is this clinincal trial information?

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