Intervention for Symptom Burden During Maintenance Therapy for Multiple Myeloma
Condition: Myeloma
MeSH terms: Multiple Myeloma; Neoplasms, Plasma Cell
Intervention: Minocycline; Placebo; Questionnaires
Intervention description: 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 therapy for MM.; 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.
Intervention MeSH terms: Minocycline
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 88.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: 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

Summary:

      The goal of this clinical research study is to learn if minocycline can help reduce the
      symptoms reported by patients with MM who receive therapy with lenalidomide.

      Minocycline is an antibiotic and has been shown to interrupt pro-inflammatory cytokine
      production, which may help to reduce multiple symptoms.
    

Eligibility criteria:

        Inclusion Criteria:

          1. 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.

          2. Patients > or = 18 years old.

          3. Patients able to render informed consent and to follow protocol requirements.

          4. Patients who speak English (due to patient-reported outcome language options, we are
             only accruing English-speaking patients to the protocol).

          5. 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].

          6. 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:

          1. Patients who are taking minocycline for other conditions, as determined by the
             treating physician

          2. Patients with hypersensitivity to tetracyclines

          3. Women who are pregnant or nursing; pregnancy will be confirmed by urine test

          4. Patients who are enrolled in other clinical trials that have symptom management as
             primary outcome

          5. Patients who are not able to use telephone-based interactive voice response software
             due to physical limitations (e.g., impaired hearing)

          6. Patients taking any tetracycline in the last 15 days

          7. Patients on Vitamin K antagonist warfarin