Short Course Daratumumab in Patients With Multiple Myeloma (NCT03490344) | Clinical Trial Compass
CompletedPhase 2
Short Course Daratumumab in Patients With Multiple Myeloma
United States10 participantsStarted 2018-05-03
Plain-language summary
The purpose of this study is to test the safety of short course Daratumumab in combination with lenalidomide and to find out what effects, if any, short course Daratumumab in combination with lenalidomide has on people and their risk of multiple myeloma. The study is also designed to test the amount of remaining myeloma cells in your body after treatment with daratumumab which is known as minimal residual disease (MRD).
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* Patients with a diagnosis of Multiple Myeloma who have achieved a VGPR or better (based on best response) after induction with or without consolidation therapy/ HDT ASCT
* MRD positive at screening by flow cytometry
* Additionally, patients who were previously MRD negative after induction therapy with/without consolidative HDT/ASCT and have turned MRD positive (by flow cytometry) based on bone marrow done at screening and do not have any evidence of progressive disease are eligible
* Patients must be on standard of care lenalidomide maintenance therapy for at least 6 months at the time of study enrollment
* Patient can be receiving bisphosphonate therapy per the treating oncologist's discretion
* Creatinine clearance ≥45 ml/min using the Cockcroft-Gault method, MDRD, or CKD-EPI formula. If the calculated CrCl based on Cockcroft-Gault method, MDRD, or CKD-EPI is \<45 mL/min, patient will have a 24 hr urine collection to measure CrCl.
* Age ≥18 years
* Eastern Cooperative Oncology Group (ECOG) performance status 0-2
* Male or female patient who accepts and is able to use recognized effective contraception (oral contraceptives, IUCD, barrier method of contraception in conjunction with spermicidal jelly) throughout the study when relevant.
* Absolute neutrophil count (ANC) ≥1.0 x 10\^9/L, hemoglobin ≥8 g/dL, and platelet count ≥75 x 10\^9/L. No transfusion or growth factor support for one week prior to labs.
* Adequate hepatic function, with bilirubin \< 1.…
What they're measuring
1
Number of Participants With MRD Negativity by the Completion of 6 Months of Daratumumab Therapy