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.

View Full Description

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:

Recruiting

Sponsor:

Celgene

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There are 33 Locations for this study

See Locations Near You

University of Alabama at Birmingham
Birmingham Alabama, 35294, United States More Info
Luciano Costa, Site 105
Contact
205-934-9695
University Of California San Francisco Medical Center
San Francisco California, 94142, United States More Info
Sandy Wong, Site 103
Contact
415-353-8363
Yale Cancer Center
New Haven Connecticut, 06510, United States More Info
Noffar Bar, Site 107
Contact
000-000-0000
Winship Cancer Institute of Emory University
Atlanta Georgia, 30322, United States More Info
Craig Hofmeister, Site 106
Contact
404-778-8580
Massachusetts General Hospital
Boston Massachusetts, 02114, United States More Info
Andrew Yee, Site 109
Contact
617-632-2104
Beth Israel Deaconess Medical Center
Boston Massachusetts, 02215, United States More Info
Jacalyn Rosenblatt, Site 111
Contact
617-667-9920
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 More Info
Swathi Namburi, Site 101
Contact
Local Institution - 305
Erlangen , 91054, Germany More Info
Site 305
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Local Institution - 303
Hamburg , 20246, Germany More Info
Site 303
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Local Institution - 302
Heidelberg , 69120, Germany More Info
Site 302
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Local Institution - 0506
Munich , 81829, Germany
Local Institution - 0507
Munich , 81829, Germany
Local Institution - 306
München , 81675, Germany More Info
Site 306
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Local Institution - 304
Tuebingen , 72076, Germany More Info
Site 304
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Local Institution - 402
Bergamo , 24127, Italy More Info
Site 402
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Local Institution - 403
Meldola , 47014, Italy More Info
Site 403
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Local Institution - 401
Milan , 20089, Italy More Info
Site 401
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Local Institution - 602
Nagoya-shi Aichi, 46786, Japan More Info
Site 602
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Local Institution - 603
Shibuya-ku Tokyo, 15089, Japan More Info
Site 603
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Local Institution - 601
Kyoto , 602-8, Japan More Info
Site 601
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Local Institution - 206
Barcelona , 08916, Spain More Info
Site 206
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Local Institution - 208
Barcelona , 8035, Spain More Info
Site 208
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Local Institution - 205
Madrid , 28007, Spain More Info
Site 205
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Local Institution - 201
Pamplona , 31008, Spain More Info
Site 201
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Local Institution - 203
Salamanca , 37007, Spain More Info
Site 203
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Local Institution - 204
Santander , 39008, Spain More Info
Site 204
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Local Institution - 207
Valencia , 46009, Spain More Info
Site 207
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Local Institution - 202
Valencia , 46017, Spain More Info
Site 202
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Local Institution - 504
Gothenborg , 413 4, Sweden More Info
Site 504
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Local Institution - 502
Lund , SE-22, Sweden More Info
Site 502
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Local Institution - 501
Stockholm , 141 8, Sweden More Info
Site 501
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Local Institution - 505
Uppsala , 75158, Sweden More Info
Site 505
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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:

Recruiting

Sponsor:


Celgene

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