Daratumumab in Combination With Lenalidomide and Dexamethasone in Relapsed and Relapsed-refractory Multiple Myeloma

Status: Recruiting
Phase: Phase 1/Phase 2
Diagnosis: Multiple Myeloma
NCT ID: NCT01615029 (View complete trial on ClinicalTrials.gov)
DFCI Protocol ID: 13-440

 

The purpose of this study is to establish the safety profile of daratumumab when given in combination with Lenalidomide and dexamethasone in subjects with relapsed or relapsed and refractory Multiple Myeloma (MM).

 

Conducting Institutions:
Dana-Farber Cancer Institute, Brigham and Women's Hospital

Overall PI:
Jacob Laubach, MD, Dana-Farber Cancer Institute

Site-responsible Investigators:

Contacts:
Dana-Farber Cancer Institute: Heidi DiPietro, RN, 617-632-2570, hdipietro@partners.org
Dana-Farber Cancer Institute: Kristen Cummings, RN, 617-632-2570, kcummings2@partners.org

Eligibility Criteria

Inclusion Criteria: - (Part 1) Have MM after receiving a minimum of 2 and a maximum of 4 prior lines of therapy and be eligible for treatment with Len/Dex. - (Part 2) Have relapsed MM after receiving a minimum of 1 and a maximum of 3 prior lines of therapy, and be eligible for treatment with Len/Dex. - Be older than or be 18 years of age. - ECOG performance status (0-2). - Following receipt of verbal and written information about the study, the patient must provide signed informed consent before any study related activity is carried out. Exclusion Criteria: - Have previously received an allogenic stem cell transplant. - Have received autologous stem cell transplant within 12 weeks before the first infusion. - Have received chemotherapy or any experimental drug or therapy within 3 weeks before the first infusion. - Have received bortezomib, lenalidomide, or thalidomide within 2 weeks before the first infusion. - Have multiple myeloma that is refractory to lenalidomide, defined as not having a minimum clinical response of MR for at least 2 months during the last treatment with lenalidomide).
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