A Study Comparing Daratumumab, Lenalidomide, and Dexamethasone With Lenalidomide and Dexamethasone in Relapsed or Refractory Multiple Myeloma; ODM derived from:


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  1. 5/13/19
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May 13, 2019

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Eligibility Multiple Myeloma NCT02076009

Eligibility Multiple Myeloma NCT02076009

Inclusion Criteria
must have documented multiple myeloma and measurable disease
must have received at least 1 prior line of therapy for multiple myeloma and achieved a response (partial response or better) to at least one prior regimen
must have documented evidence of progressive disease as defined by the international myeloma working group criteria on or after their last regimen
must have an eastern cooperative oncology group performance status score of 0, 1, or 2
Exclusion Criteria
has received any of the following therapies: daratumumab or other anti-cd38 therapies
has received anti-myeloma treatment within 2 weeks or 5 pharmacokinetic half-lives of the treatment
disease shows evidence of refractoriness or intolerance to lenalidomide or if previously treated with a lenalidomide-containing regimen the participant is excluded if he or she discontinued due to any adverse event related to prior lenalidomide treatment
has received autologous stem cell transplantation within 12 weeks before the date of randomization, or previously received an allogenic stem cell transplant (regardless of timing), or planning to undergo a stem cell transplant prior to progression of disease
history of malignancy (other than multiple myeloma) within 5 years before the date of randomization