A Study of Carfilzomib, Lenalidomide, Dexamethasone and Daratumumab for Patients With Relapsed/Re… (NCT03556332) | Clinical Trial Compass
Active — Not RecruitingPhase 2
A Study of Carfilzomib, Lenalidomide, Dexamethasone and Daratumumab for Patients With Relapsed/Refractory Myeloma With Salvage Autologous Hematopoietic Cell Transplantation
United States41 participantsStarted 2018-07-02
Plain-language summary
The purpose of this study is to test any good and bad effects of giving a combination of study drugs before and after autologous stem cell transplant.
Who can participate
Age range18 Years – 75 Years
SexALL
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Inclusion Criteria:
* Patient must be capable, willing, and able to provide written, informed consent.
* Age ≥ 18-years-old and \<= 75-years-old.
* Histologic confirmation of multiple myeloma by the enrolling institution
* Symptomatic myeloma that has progressed/relapsed after 1 to 3 prior lines of therapy
* Patients who have received \<=1 cycle of therapy after most recent progression/relapse are eligible to enroll on study
* Treatment of hypercalcemia or spinal cord compression or aggressively progressing myeloma with current or prior corticosteroids is permitted
* Bisphosphonates are permitted
* Concurrent or prior treatment with corticosteroids for indications other than multiple myeloma is permitted
* Prior treatment with radiotherapy is permitted
* Patients with measurable disease who received up to one cycle of any therapy within 60 days with a washout period of 4 weeks from last dose (on a trial or outside a trial) are eligible
* Maintenance single agent imid (ie. lenalidomide or pomalidomide) or monoclonal antibody (ie. daratumumab) do not require the 4-week washout period
* More than 2 x 10\^6 autologous CD34+ cells/kg cryopreserved. The graft may not be CD34+ selected or otherwise manipulated to remove tumor or other cells. The graft can be collected at the transplanting institution or by a referring center.
* Planning to receive autologous HCT per institutional standards as part of standard of care. Eligibility for autologous HCT should be based on i…
What they're measuring
1
number of patients with complete remission (CR) rate