Status:
COMPLETED
Intervention for Symptom Burden During Maintenance Therapy for Multiple Myeloma
Lead Sponsor:
M.D. Anderson Cancer Center
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Myeloma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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 h...
Detailed Description
Study Groups: If participant agrees to take part in this study, they will be randomly assigned (as in the flip of a coin) to 1 of 2 groups. Group 1 will take a placebo during maintenance therapy. G...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 22 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 18 2020
Estimated Enrollment :
88 Patients enrolled
Trial Details
Trial ID
NCT01793051
Start Date
March 22 2013
End Date
September 18 2020
Last Update
November 24 2021
Active Locations (1)
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1
University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030