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 |
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.
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.
We found this trial at
8
sites
1721 East 19th Ave., Suite #200 & #300
Denver, Colorado 80218
Denver, Colorado 80218
720-754-4800
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