A Safety, PK and Efficacy Study of CC-92480 in Combination With Dexamethasone in Subjects With Relapsed and Refractory Multiple Myeloma



Status:Recruiting
Conditions:Blood Cancer, Hematology, Hematology
Therapuetic Areas:Hematology, Oncology
Healthy:No
Age Range:18 - Any
Updated:3/16/2019
Start Date:February 6, 2018
End Date:March 1, 2020
Contact:Associate Director Clinical Trial Disclosure
Email:clinicaltrialdisclosure@celgene.com
Phone:1-888-260-1599

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A Phase 1 Multicenter, Open-label Study to Assess the Safety, Pharmacokinetics and Preliminary Efficacy of CC-92480 in Combination With Dexamethasone in Subjects With Relapsed and Refractory Multiple Myeloma

This is an open-label, multi-center, international, Phase 1 study to assess the safety, PK/PD
and preliminary efficacy of CC-92480 in combination with dexamethasone in subjects with RRMM.

All eligible subjects must be refractory to their last line of therapy and have failed, be
intolerant to or are not otherwise candidates for available therapies demonstrated to confer
clinical benefit to subjects with relapsed and refractory multiple myeloma including (at a
minimum), thalidomide, lenalidomide or pomalidomide and a proteasome inhibitor.


Inclusion Criteria:

1. Subject is ≥ 18 years of age and ECOG performance status score of 0, 1 or 2.

2. Subjects must have measurable disease and documented disease progression on or within
60 days from the last dose of their last myeloma therapy and have failed treatment
with, are intolerant to or are not otherwise candidates for available therapies.

3. Subjects must have adequate bone marrow, renal, liver, and cardiac function.

4. Females of childbearing potential (FCBP) and male subjects must agree with the
pregnancy prevention plan.

Exclusion Criteria:

1. Subject has a significant medical condition, laboratory abnormality, or psychiatric
illness that would prevent the subject from participating in the study.

2. Subject has non- or oligosecretory multiple myeloma.

3. Subject is unable or unwilling to undergo protocol required venous thromboembolism
(VTE) prophylaxis.
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Atlanta, Georgia 30322
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450 Brookline Ave
Boston, Massachusetts 2215
617-632-3000
Dana-Farber Cancer Institute Since it’s founding in 1947, Dana-Farber has been committed to providing adults...
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Calgary, Alberta
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1721 East 19th Ave., Suite #200 & #300
Denver, Colorado 80218
720-754-4800
Colorado Blood Cancer Institute When patients come to the Colorado Blood Cancer Institute, the entire...
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Duarte, California 91010
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230 25th Ave N
Nashville, Tennessee 37203
(615) 329-7274
Sarah Cannon Cancer Center People who live with cancer
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Nashville, TN
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1275 York Ave
New York, New York 10021
(212) 639-2000
Memorial Sloan Kettering Cancer Center Memorial Sloan Kettering Cancer Center — the world's oldest and...
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