Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

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 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

Show Show detailed description

Layout table for study information
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:
  • Dynacin
  • Minocin
  • Minocin PAC
  • Myrac
  • Solodyn

Behavioral: Questionnaires
Completion of MD Anderson Symptom Inventory (MDASI) questionnaires at baseline, weekly during Lenalidomide therapy, and at end of treatment visit.
Other Names:
  • Surveys
  • MD Anderson Symptom Inventory
  • MDASI

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:
  • Surveys
  • MD Anderson Symptom Inventory
  • MDASI




Primary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

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.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

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


Locations
Layout table for location information
United States, Texas
University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
National Cancer Institute (NCI)
Investigators
Layout table for investigator information
Principal Investigator: Robert Orlowski, MD, PHD M.D. Anderson Cancer Center
  Study Documents (Full-Text)

Documents provided by M.D. Anderson Cancer Center:
Additional Information:
Layout table for additonal information
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

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by M.D. Anderson Cancer Center:
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
Additional relevant MeSH terms:
Layout table for MeSH terms
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