A Study of Health-Related Quality of Life in People With Multiple Myeloma Receiving Daratumumab or Lenalidomide
- Conditions
- Multiple Myeloma
- Registration Number
- NCT04497961
- Lead Sponsor
- Memorial Sloan Kettering Cancer Center
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 100
Inclusion Criteria:<br><br> - Patients with plasma cell myeloma treated with combination therapy with or without<br> ASCT, who at the time of study enrollment have documented evidence of very good<br> partial response (VGPR) or better according to International Myeloma Workshop<br> Consensus Panel.<br><br> - Enrollment within 6 months from completion of initial combination therapy (with or<br> without ASCT). Enrollment within 7 months will be permitted if we are unable to<br> start the patient on study within 6 months of end of combination therapy or date of<br> transplant due to medical or logistic reasons.<br><br> - Age =18 years.<br><br> - ECOG performance status = 2 (see Appendix A).<br><br> - Subjects who have had ASCT may enroll following minimum 100-day washout per standard<br> guidelines<br><br> - Patient must have adequate hematologic, renal, and hepatic function as defined by:<br><br> - Absolute neutrophil count = 1.0K /µL (growth factor support is permissible)<br><br> - Platelets = 50K/µL (transfusions are permissible)<br><br> - Hemoglobin = 8 g/dL (transfusions are permissible)<br><br> - Creatinine clearance (CrCl) of greater than or equal to 40 mL/min. using the<br> CKD-EPI formula (see Appendix C). If the CrCl based on the CKD-EPI formula is<br> <40 mL/min, the patient will have a 24 hr urine collection to measure CrCl. The<br> measured CrCl must also be = 40 ml/min.<br><br> - Total bilirubin = 2 mg/dL (exception: documented Gilbert's syndrome), AST<br> (SGOT) and ALT (SGPT) = 3 x ULN<br><br> - Patients must be able to take daily prophylactic anticoagulation medication, such<br> as: aspirin (81 or 325 mg) warfarin, low molecular weight heparin, or other<br> medications as clinically indicated.<br><br> - Patients must be able to take prophylactic antiviral medication such as acyclovir or<br> valacyclovir<br><br> - Patient must understand and voluntarily sign an informed consent form, with the<br> understanding that the patient may withdraw consent at any time without prejudice to<br> future medical care.<br><br>Additional inclusion criteria for patients randomized to arm A:<br><br> - Study participants must be registered into the mandatory Revlimid REMS® program and<br> be willing and able to comply with the requirements of the REMS® program.<br><br> - Women of childbearing potential should be advised to avoid becoming pregnant and<br> must adhere to the scheduled pregnancy testing as required in the Revlimid REMS®<br> program. They must be agreeable to use acceptable methods of birth control<br> throughout the study and for at least 4 weeks after stopping lenalidomide.<br> Recommendation is for 2 effective contraceptive methods during the study and for at<br> least 4 weeks after the last dose. Adequate forms of contraception are<br> double-barrier methods (condoms with spermicidal jelly or foam and diaphragm with<br> spermicidal jelly or foam), oral, depo provera, or injectable contraceptives,<br> intrauterine devices, and tubal ligation.<br><br> - A female of childbearing potential is a sexually mature female who: 1) has not<br> undergone a hysterectomy (the surgical removal of the uterus) or bilateral<br> oophorectomy (the surgical removal of both ovaries) or 2) has not been naturally<br> postmenopausal (amenorrhea following cancer therapy does not rule out childbearing<br> potential) for at least 24 consecutive months (i.e., has had menses at any time<br> during the preceding 24 consecutive months).<br><br> - Females of childbearing potential who have not previously taken Lenalidomide must<br> have a negative serum or urine pregnancy test with a sensitivity of at least 50<br> mIU/mL within 10 - 14 days and again within 24 hours prior to prescribing<br> lenalidomide for Cycle 1 (prescriptions must be filled within 7 days as required by<br> Revlimid REMS®).<br><br> - Females of childbearing potential must adhere to the scheduled pregnancy testing as<br> required in the Revlimid REMS® program.<br><br> - Men must agree to use a latex condom during sexual contact with a female of<br> childbearing potential even if they have had a successful vasectomy. See Appendix B:<br> Lenalidomide Risks of Fetal Exposure, Pregnancy Testing Guidelines and Acceptable<br> Birth Control Methods.<br><br>Additional inclusion criteria for patients randomized to arm B:<br><br> - Females of reproductive potential must agree to use an effective method of birth<br> control during treatment and for at least 3 months after cessation of daratumumab.<br><br> - Males who are sexually active with a female of reproductive potential must agree to<br> use an effective method of birth control during treatment and for at least 3 months<br> after cessation of daratumumab.<br><br> - Subjects agree to not donate eggs/sperm for 3 months following cessation of<br> daratumumab.<br><br>Additional inclusion criteria for patients interested in the nutrition intervention<br>(declining the sub-study will not preclude patients from enrollment into primary study):<br><br> - Interest in trying a plant-based diet and plant-based recipes<br><br>Exclusion Criteria:<br><br> - Patients with progressive or refractory plasma cell myeloma, as defined by<br> International Myeloma Workshop Consensus Panel criteria.<br><br> - History of disease refractory to lenalidomide or daratumumab, as defined by the IMWG<br> as failure to achieve minimal response or development of progressive disease while<br> on therapy.<br><br> - Multiple myeloma patients who have received prior anti myeloma therapy for<br> smoldering myeloma<br><br> - Patients who are receiving any other investigational agents with the intent to treat<br> myeloma. Permitted concurrent therapies include:<br><br> - Bisphosphonates/RANK ligand inhibitors (denosumab)<br><br> - Plasma cell leukemia<br><br> - Pregnant or breastfeeding females. Because there is a potential risk for adverse<br> events to nursing infants secondary to treatment of the mother with lenalidomide,<br> lactating females must agree not to breastfeed while taking lenalidomide.<br><br> - Risk for adverse events to nursing infants secondary to treatment of the mother with<br> daratumumab is unknown, as such lactating females must agree not to breastfeed while<br> on daratumumab.<br><br> - Patient has known chronic obstructive pulmonary disease (COPD) with a forced<br> expiratory volume in 1 second (FEV1) <50% of predicted normal. Note that FEV1<br> testing is required for subjects suspected of having COPD and subjects must be<br> excluded if FEV1 <50% of predicted normal).<br><br> - Patient has known moderate or severe persistent asthma, within the last 2 years, or<br> currently has uncontrolled asthma of any classification (refer to Appendix D).<br> (Subjects who currently have controlled intermittent asthma or controlled mild<br> persistent asthma are allowed to participate in the study.)<br><br> - Uncontrolled hypertension or diabetes that is not being managed by a physician. Once<br> care for diabetes or hypertension is established, patient is eligible for the study.<br><br> - Seropositive for hepatitis B (defined by a positive test for hepatitis B surface<br> antigen [HBsAg]). Subjects with resolved infection (ie, subjects who are HBsAg<br> negative but positive for antibodies to hepatitis B core antigen [anti-HBc] and/or<br> antibodies to hepatitis B surface antigen [anti-HBs]) must be screened using<br> real-time polymerase chain reaction (PCR) measurement of hepatitis
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Difference in the global health status
- Secondary Outcome Measures
Name Time Method difference in overall survival and progression-free survival