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Active Not Recruiting
NCT04497961
A Study of Health-Related Quality of Life in People With Multiple Myeloma Receiving Daratumumab or Lenalidomide
Conditions: Multiple Myeloma
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: PHASE2
Enrollment: 95
Sponsor: Memorial Sloan Kettering Cancer Center
Location: Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities) Basking Ridge New Jersey
Summary
The purpose of this study is to compare maintenance therapy approaches in people with newly diagnosed multiple myeloma (MM) that has responded well to a first round of treatment. The researchers will compare giving the usual maintenance therapy (lenalidomide) with giving daratumumab as maintenance therapy, and they will look at which drug gives participants a better health-related quality of life during treatment. The researchers will measure participants' quality of life using various questionnaires. This study will help researchers find out whether this different approach of giving daratumumab as maintenance therapy is better, the same as, or worse than the usual approach.
Eligibility Criteria
Inclusion Criteria:
* Patients with plasma cell myeloma treated with combination therapy with or without ASCT, who at the time of study enrollment have documented evidence of very good partial response (VGPR) or better according to International Myeloma Workshop Consensus Panel.
* Enrollment within 6 months from completion of initial combination therapy (with or without ASCT). Enrollment within 7 months will be permitted if we are unable to start the patient on study within 6 months of end of combination therapy or date of transplant due to medical or logistic reasons.
* Age ≥18 years.
* ECOG performance status ≤ 2 (see Appendix A).
* Subjects who have had ASCT may enroll following minimum 100-day washout per standard guidelines
* Patient must have adequate hematologic, renal, and hepatic function as defined by:
* Absolute neutrophil count ≥ 1.0K /μL (growth factor support is permissible)
* Platelets ≥ 50K/μL (transfusions are permissible)
* Hemoglobin ≥ 8 g/dL (transfusions are permissible)
* Creatinine clearance (CrCl) of greater than or equal to 40 mL/min. using the CKD-EPI formula (see Appendix C). If the CrCl based on the CKD-EPI formula is \
Source: ClinicalTrials.gov (NCT04497961). StuddyBuddy aggregates publicly available trial information.