A Study of Health-Related Quality of Life in People With Multiple Myeloma Receiving Daratumumab o… (NCT04497961) | Clinical Trial Compass
Active — Not RecruitingPhase 2
A Study of Health-Related Quality of Life in People With Multiple Myeloma Receiving Daratumumab or Lenalidomide
United States95 participantsStarted 2020-08-28
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 \<40 mL/min, the patient will have a 24 hr urine collection to measure CrCl. The measured CrCl must also be ≥ 40 ml/min.
* Total bilirubin ≤ 2 mg/dL (exception: documented Gilbert's syndrome), AST (SGOT) and ALT (SGPT) ≤ 3 x ULN
* Patients must be able to take daily prophylactic anticoagulation medication, such as: aspirin…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.