NL-OMON50598CompletedPhase 2
An Open Label, Randomized Phase 2 Trial of Pomalidomide/Dexamethasone With or Without Elotuzumab in relapsed and refractory Multiple Myeloma. - CA204-125: Pomalidomide/Dexamethasone +/- Elotuzumab in Multiple Myeloma
Bristol-Myers Squibb0 sites12 target enrollmentStarted: TBDLast updated:
Conditions
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Enrollment
- 12
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Ages
- 18 to 99 (—)
Inclusion Criteria
- •Subjects who are diagnosed with relapsed and refractory multiple myeloma
- •defined as:
- •(1) * 2 prior lines of therapy which must have included at least 2 consecutive
- •cycles of lenalidomide and a proteosome inhibitor alone or in combination.
- •(2) Documented refractory or relapsed and refractory multiple myeloma
- •(3) Refractory to proteosome inhibitor and lenalidomide, and to their last
- •(4) Relapsed and refractory patients had achieved at least a partial response
- •to previous treatment with proteosome inhibitor or lenalidomide, or both, but
- •progressed within 6 months, and were refractory to their last treatment.
- •(5) Measurable disease at screening
- •(6) Eastern Cooperative Oncology Group (ECOG) performance status * 2
Exclusion Criteria
- •1) Target Disease Exceptions
- •a) Subjects with solitary bone or extramedullary plasmacytoma as the only
- •evidence of plasma cell dyscrasia.
- •b) Subjects with monoclonal gammopathy of undetermined significance, smoldering
- •multiple myeloma (SMM), amyloidosis, POEMS, or Waldenstrom*s macroglobulinemia
- •c) Subjects with active plasma cell leukemia
- •2) Medical History and Concurrent Diseases
- •a) Any uncontrolled or severe cardiovascular or pulmonary disease determined by
- •the investigator
- •b) Active infection that requires parenteral anti-infective treatment > 14 days
- •c) Unable to tolerate thromboembolic prophylaxis while on the study
- •d) Hypersensitivity reaction to prior IMiD (thalidomide or lenalidomide)
- •e) Grade 2 peripheral neuropathy (per NCI CTCAE v3.0)
- •f) Known active hepatitis A, B, or C
- •g) Known HIV infection
- •h) Gastrointestinal disease that may significantly alter the absorption of
- •pomalidomide
- •i) Prior or concurrent malignancy, except for the following:
- •i) Adequately treated basal cell or squamous cell skin cancer.
- •ii) Any cancer (other than in-situ) from which the subject has been disease
- •free for > 3 years prior to study entry.
- •3) Prior Therapy or Surgery
- •a) Prior treatment with pomalidomide.
- •b) Prior participation in an elotuzumab clinical trial
- •c) Use of any anti-myeloma drug therapy, within 14 days of the initiation of
- •study drug treatment or use of any experimental drug therapy or plasmapheresis
- •within 28 days (or 5 half-lives) whichever is longer of the initiation of study
- •drug treatment (includes dexamethasone).
- •d) Treatment with melphalan or monoclonal antibodies within 6 weeks of the
- •first dose of study drug
- •e) Prior autologous stem cell transplant within 12 weeks of the first dose of
- •study drug.
- •f) Prior allogeneic stem cell transplant except subjects who have completed the
- •stem cell transplant > 12 months prior to first dose of study drug, have no
- •history of graft versus host disease, and are not on topical or systemic
- •immunosuppressive therapy
- •g) Treatment with corticosteroids within 3 weeks of the first dose of study
- •drug, except for the equivalent of *10 mg prednisone per day or corticosteroids
- •with minimal to no systemic absorption or for short course (*4 days) of 40 mg
- •dexamethasone or equivalent for emergency use
- •h) Major cardiac surgery within 8 weeks prior to the first dose of study drug;
- •all other major surgery within 4 weeks prior to the first dose of study drug.
Investigators
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