A Phase I/II Study of Amrubicin in Combination With Lenalidomide and Weekly Dexamethasone in Relapsed/Refractory Multiple Myeloma
We hope to learn if amrubicin is safe and useful for patients with multiple myeloma that requires additional treatment.
Stanford is not currently accepting new patients for this trial. You may want to check clinicaltrials.gov to see if other locations are recruiting.
- drug : Amrubicin
- drug : Aspirin
- drug : Dexamethasone
- drug : Lenalidomide
Phase: Phase 1/Phase 2
Ages Eligible For Study:
- The patient has relapsed or refractory multiple myeloma that has progressed following at least one (1) prior therapy. - The patient has measurable disease defined as one of the following: serum M-protein >=1 g/dL urine M-protein >=200 mg/24 hours - Must have received at least one (1) prior line of systemic treatment that may have included lenalidomide and/or an anthracycline. - No cytotoxic chemotherapy within 4 weeks prior to first dose of amrubicin. NOTE: this interval may be reduced to 14 days for thalidomide, lenalidomide, bortezomib or corticosteroids, provided other entry criteria are met. - Age >= 18 at the time of consent. - The patient has a life expectancy of more than >= months. - No known central nervous system involvement by myeloma. - ECOG performance status 0-1 at study registration during phase I. Once safety is confirmed, ECOG performance status 0-2 at study registration during phase II. - No poorly controlled intercurrent illness. - Platelets >100 x 10^9/L, Hemoglobin > 8.0g/dL and ANC >1.5 x 10^9/L - AST and ALT <= x upper limit of normal (ULN), total bilirubin <= 1.5 x ULN - Calculated creatinine clearance >= 50 ml/min by Cockcroft-Gault formula. - Left ventricular ejection fraction (LVEF) >=50% by Echocardiogram (ECHO) or multiple gate acquisition scan (MUGA) - All study participants must be registered into the mandatory RevAssist program, and be willing and able to comply with the Requirements of RevAssist. - Disease free of prior malignancies for >= 5 years with exception of currently treated basal cell, squamous cell carcinoma of the skin, or carcinoma "insitu" of the cervix or breast. - Females of childbearing potential (FCBP) must have a negative serum or urine pregnancy test with a sensitivity of at least 50 mIU/mL within 10 - 14 days and again within 24 hours prior to prescribing lenalidomide for Cycle 1 (prescriptions must be filled within 7 days) and must either commit to continued abstinence from heterosexual intercourse or begin TWO acceptable methods of birth control, one highly effective method and one additional effective method AT THE SAME TIME, at least 28 days before she starts taking lenalidomide. FCBP must also agree to ongoing pregnancy testing. Men must agree to use a latex condom during sexual contact with a FCBP even if they have had a successful vasectomy. See Appendix: Risks of Fetal Exposure, Pregnancy Testing Guidelines and Acceptable Birth Control Methods. - Ability to understand and the willingness to sign a written informed consent document. - Able to adhere to the study visit schedule and other protocol requirements. - Able to take aspirin (81 or >=25 mg) daily as prophylactic anticoagulation Patients intolerant to ASA may use warfarin or low molecular weight heparin (LMWH). Patients with previous thromboembolic event on lenalidomide or thalidomide may be started on warfarin or LMWH. Patients already taking warfarin or LMWH do not require additional aspirin.