Intervention for Symptom Burden During Maintenance Therapy for Multiple Myeloma
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT01793051 |
Recruitment Status :
Completed
First Posted : February 15, 2013
Results First Posted : November 24, 2021
Last Update Posted : November 24, 2021
|
- Study Details
- Tabular View
- Study Results
- Disclaimer
- How to Read a Study Record
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.
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Myeloma | Drug: Minocycline Other: Placebo Behavioral: Questionnaires | Phase 2 |

Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 88 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double (Participant, Investigator) |
Primary Purpose: | Treatment |
Official Title: | A Phase II Randomized Study of the Efficacy of Minocycline vs. Placebo to Reduce Symptom Burden During Maintenance Therapy for Multiple Myeloma |
Actual Study Start Date : | March 22, 2013 |
Actual Primary Completion Date : | September 18, 2020 |
Actual Study Completion Date : | September 18, 2020 |

Arm | Intervention/treatment |
---|---|
Experimental: Minocycline
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. |
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 Names:
Behavioral: Questionnaires Completion of MD Anderson Symptom Inventory (MDASI) questionnaires at baseline, weekly during Lenalidomide therapy, and at end of treatment visit.
Other Names:
|
Placebo Comparator: Placebo
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. |
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).
Other Name: Sugar pill Behavioral: Questionnaires Completion of MD Anderson Symptom Inventory (MDASI) questionnaires at baseline, weekly during Lenalidomide therapy, and at end of treatment visit.
Other Names:
|
- Symptom Reduction [ Time Frame: Baseline to 3 months (three cycles with assessments made at beginning of each) ]Minocycline tested for its ability to reduce the value of a patient's 3 month (± two days) area under the curve (AUC) for the mean of 5 symptoms: fatigue, pain, muscle weakness, numbness, and bone aches. The AUC is calculated using a trapezoidal approximation, derived by multiplying half of the base with the sum of the two heights. The two heights correspond to the two mean symptom scores computed at each of these assessments. The AUC is measured in units of mean MDASI score in days. The area for the subsequent trapezoid can be calculated in the same way. Given a baseline, weekly assessment schedule over a three month period and end of trial assessment, there will be a total of 14 trapezoids. The AUC is the sum of the area of the 14 trapezoids. Each of the trapezoid has a maximum value of 70 (0.5*7 days*(10+10)). Hence, the AUC will have a minimum score of 0 and a maximum score of 980. Higher AUC values indicate worse outcomes.

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01793051
United States, Texas | |
University of Texas MD Anderson Cancer Center | |
Houston, Texas, United States, 77030 |
Principal Investigator: | Robert Orlowski, MD, PHD | M.D. Anderson Cancer Center |
Documents provided by M.D. Anderson Cancer Center:
Responsible Party: | M.D. Anderson Cancer Center |
ClinicalTrials.gov Identifier: | NCT01793051 |
Other Study ID Numbers: |
2012-0413 P01CA124787 ( U.S. NIH Grant/Contract ) NCI-2013-00700 ( Registry Identifier: NCI CTRP ) |
First Posted: | February 15, 2013 Key Record Dates |
Results First Posted: | November 24, 2021 |
Last Update Posted: | November 24, 2021 |
Last Verified: | November 2021 |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
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 |
Multiple Myeloma Neoplasms, Plasma Cell Neoplasms by Histologic Type Neoplasms Hemostatic Disorders Vascular Diseases Cardiovascular Diseases Paraproteinemias Blood Protein Disorders |
Hematologic Diseases Hemorrhagic Disorders Lymphoproliferative Disorders Immunoproliferative Disorders Immune System Diseases Minocycline Anti-Bacterial Agents Anti-Infective Agents |