A Study of Elotuzumab in Combination With Pomalidomide and Low Dose Dexamethasone and Elotuzumab in Combination With Nivolumab in Patients With Multiple Myeloma Relapsed or Refractory to Prior Treatment With Lenalidomide.
Status: | Active, not recruiting |
---|---|
Conditions: | Blood Cancer, Hematology, Hematology |
Therapuetic Areas: | Hematology, Oncology |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 2/3/2018 |
Start Date: | December 18, 2015 |
End Date: | January 15, 2020 |
A Phase 2, Multiple Cohort Study of Elotuzumab in Combination With Pomalidomide and Low-Dose Dexamethasone (EPd), and in Combination With Nivolumab (EN), in Patients With Multiple Myeloma Relapsed or Refractory to Prior Treatment With Lenalidomide.
Study of elotuzumab in combination with pomalidomide and low dose dexamethasone (EPd Cohort)
and elotuzumab in combination with nivolumab (EN Cohort) to assess the safety and efficacy of
these combination therapies for treatment of relapsed or refractory MM patients.
and elotuzumab in combination with nivolumab (EN Cohort) to assess the safety and efficacy of
these combination therapies for treatment of relapsed or refractory MM patients.
For more information regarding BMS clinical trial participation, please visit
www.BMSStudyConnect.com
Inclusion Criteria:
1. All subjects must have documented disease progression per IMWG criteria during or
after their last anti-myeloma therapy.
2. ECOG Performance Status less than or equal to 2
3. Subject Re-enrollment: This study permits the re-enrollment of a subject that has
discontinued the study as a pre-treatment failure (ie, has not been treated). If
re-enrolled, the subject must be re-consented.
4. EPd Cohort:
- must have received at least 1 but no greater than 2 prior lines of therapy (note:
induction and stem cell transplants with or without maintenance therapy is
considered 1 line of therapy)
- Subjects must have received prior treatment with a lenalidomide-containing
regimen for at least 2 consecutive cycles (full therapeutic dose) and must have
been deemed as relapsed, refractory, or intolerant. Refractory is defined as
progressing on-treatment or within 60 days of the last dose.
5. EN Cohort:
- Subjects must have received at least 3 prior lines of therapy including a
proteasome inhibitor (PI) and an immunomodulatory (IMID) agent OR were
double-refractory to both an IMID and a PI. Refractory is defined as progressing
on-treatment or within 60 days of the last dose.
Exclusion Criteria:
1. Subjects with solitary bone or extramedullary plasmacytoma as the only evidence of
plasma cells dyscrasia
2. Subjects with monoclonal gammopathy of undetermined significance (MGUS), smoldering
multiple myeloma (SMM), primary amyloidosis, Waldenstrom's macroglobulinemia, or POEMS
syndrome (plasma cell dyscrasia with poly neuropathy, organomegaly, endocrinopathy,
monoclonal protein, and skin changes)
3. Subjects with Central Nervous System involvement with multiple myeloma
Other protocol defined inclusion/exclusion criteria could apply.
We found this trial at
24
sites
Swedish Medical Center Since 1910, Swedish has been the region's hallmark for excellence in health...
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University of Michigan The University of Michigan was founded in 1817 as one of the...
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1721 East 19th Ave., Suite #200 & #300
Denver, Colorado 80218
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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1201 5th Avenue North
Saint Petersburg, Florida 33705
Saint Petersburg, Florida 33705
Phone: 56136641004736
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