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Intervention for Symptom Burden During Maintenance Therapy for Multiple Myeloma

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01793051
First Posted: February 15, 2013
Last Update Posted: July 21, 2017
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.
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
  Purpose

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 Intervention Phase
Myeloma Drug: Minocycline Other: Placebo Behavioral: Questionnaires Phase 2

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:
  • 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 three-month (± two days) area under the curve (AUC) for five symptoms: fatigue, pain, muscle weakness, numbness, and bone aches, either in combination or individually. AUC is based on the average of five most-severe symptoms (pain, fatigue, bone aches, numbness, muscle weakness) reported by multiple myeloma (MM) patients in previous studies.


Estimated Enrollment: 88
Actual Study Start Date: March 2013
Estimated Study Completion Date: March 2019
Estimated Primary Completion Date: March 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Show Detailed Description

  Eligibility

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.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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
  Contacts and Locations
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
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
Principal Investigator: Robert Orlowski, MD, PHD M.D. Anderson Cancer Center
  More Information

Additional Information:
Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT01793051     History of Changes
Other Study ID Numbers: 2012-0413
P01CA124787 ( U.S. NIH Grant/Contract )
NCI-2013-00700 ( Registry Identifier: NCI CTRP )
First Submitted: February 13, 2013
First Posted: February 15, 2013
Last Update Posted: July 21, 2017
Last Verified: July 2017

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:
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
Lenalidomide
Thalidomide
Minocycline
Immunologic Factors
Physiological Effects of Drugs
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors
Antineoplastic Agents
Immunosuppressive Agents
Leprostatic Agents
Anti-Bacterial Agents
Anti-Infective Agents