EUCTR2010-022445-20-ES
Active, not recruiting
Phase 1
A Phase 3, Randomized, Open Label Trial ofLenalidomide/dexamethasone With or Without Elotuzumab in Subjectswith Previously Untreated Multiple Myeloma.
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Bristol-Myers Squibb International Corporation
- Enrollment
- 748
- Status
- Active, not recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\) Signed Written Informed Consent
- •a) Subject is, in the investigator's opinion, willing and able to comply
- •with the protocol requirements.
- •b) Subject has given voluntary written informed consent before
- •performance of any study\-related procedure not part of normal medical
- •care, with the understanding that consent may be withdrawn by the
- •subject at any time without prejudice to their future medical care.
- •2\) Target Population
- •a) Age \>or\= 18 years or legal age of consent per local regulations.
- •b) ECOG performance status c) Life\-expectancy \> 3 months.
Exclusion Criteria
- •1\) Target Disease Exceptions
- •a) Subjects with non\-secretory or oligo\-secretory or serum free lightchain only myeloma.
- •b) Smoldering MM, defined as asymptomatic MM with absence of lytic bone lesions.
- •c) Monoclonal Gammopathy of Undetermined Significance (MGUS) defined by all of the following: serum M protein \< 3 g/dL, absence of lytic bone lesions, anemia, hypercalcemia and renal insufficiency related to monoclonal protein and (if determined) proportion of plasma cells in the bone marrow of 10% or less.
- •d) Diagnosis of Waldenstrom's disease or other conditions in which IgM M protein is present in the absence of a clonal plasma cell infiltration with lytic bone lesions.
- •e) Plasma cell leukemia.
- •2\) Medical History and Concurrent Diseases
- •a) Known or suspected cardiac amyloidosis; POEMS syndrome (plasma cell dyscrasia with polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes).
- •b) Significant cardiac disease as determined by the investigator including:
- •i) Known or suspected cardiac amyloidosis;
Outcomes
Primary Outcomes
Not specified
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