Intervention for Symptom Burden During Maintenance Therapy for Multiple Myeloma
Myeloma
About this trial
This is an interventional treatment trial for Myeloma focused on measuring Myeloma, Multiple Myeloma, MM, Symptom Burden, Symptom reduction, Maintenance therapy with lenalidomide, Minocycline, Dynacin, Minocin, Minocin PAC, Myrac, Solodyn, Placebo, Sugar pill, MD Anderson Symptom Inventory, MDASI, Questionnaires, Surveys
Eligibility Criteria
Inclusion Criteria:
- Patients with pathologically diagnosed who have received induction chemotherapy, with or without AuSCT, and who have qualified to receive lenalidomide-based maintenance therapy for their MM.
- Patients > or = 18 years old.
- Patients able to render informed consent and to follow protocol requirements.
- Patients who speak English (due to patient-reported outcome language options, we are only accruing English-speaking patients to the protocol).
- Patients with normal renal function according to MD Anderson testing standards and no prior renal disease [screening cut off for serum creatinine < 1.5 times the upper limit of normal].
- Patients with normal hepatic function according to MD Anderson testing standards and no prior liver disease [screening results for total bilirubin must be < 1.5 times the upper limit of normal; screening results for alkaline phosphatase (ALP) and alanine aminotransferase (ALT) must be < 2 times the upper limit of normal; if available, screening results for aspartate aminotransferase (AST) must be < 2 times the upper limit of normal].
Exclusion Criteria:
- Patients who are taking minocycline for other conditions, as determined by the treating physician
- Patients with hypersensitivity to tetracyclines
- Women who are pregnant or nursing; pregnancy will be confirmed by urine test
- Patients who are enrolled in other clinical trials that have symptom management as primary outcome
- Patients who are not able to use telephone-based interactive voice response software due to physical limitations (e.g., impaired hearing)
- Patients taking any tetracycline in the last 15 days
- Patients on Vitamin K antagonist warfarin
Sites / Locations
- University of Texas MD Anderson Cancer Center
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
Minocycline
Placebo
Minocycline 200 mg by mouth for the first dose, then 100 mg by mouth every 12 hours for three months beginning at initiation of Lenalidomide maintenance chemotherapy for MM. Completion of MD Anderson Symptom Inventory (MDASI) questionnaires at baseline, weekly during Lenalidomide therapy, and at end of treatment visit.
Placebo 200 mg by mouth for the first day of Lenalidomide maintenance therapy for MM, then 100 mg doses every 12 hours for three months (three cycles of maintenance chemotherapy). Completion of MD Anderson Symptom Inventory (MDASI) questionnaires at baseline, weekly during Lenalidomide therapy, and at end of treatment visit.