MedTrace Logo

Intervention for Symptom Burden During Maintenance Therapy for Multiple Myeloma

NCT01793051 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 88

Last updated 2021-11-24

Study results available
· View outcomes & findings →

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.

Conditions

Interventions

DRUG

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 therapy for MM.

OTHER

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).

BEHAVIORAL

Questionnaires

Completion of MD Anderson Symptom Inventory (MDASI) questionnaires at baseline, weekly during Lenalidomide therapy, and at end of treatment visit.

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • M.D. Anderson Cancer Center

    lead OTHER

Principal Investigators

  • Robert Orlowski, MD, PHD · M.D. Anderson Cancer Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-03-22
Primary Completion
2020-09-18
Completion
2020-09-18
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01793051 on ClinicalTrials.gov