Intervention for Symptom Burden During Maintenance Therapy for Multiple Myeloma

• Status: Completed
• Trial end date: 2020-09-18
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: M.D. Anderson Cancer Center
• Collaborator: National Cancer Institute (NCI)
• Treatments: Lenalidomide; Minocycline; Thalidomide

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