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A Phase II Study of Minocycline vs. Placebo to Prevent Treatment Induced Neuropathy in Multiple Myeloma

This study is currently Recruiting

July 2011 By M.D. Anderson Cancer Center

First Recieved on January 25, 2011

Last Updated on July 29, 2011

Sponsor: M.D. Anderson Cancer Center
Collaborators:
Information provided by: M.D. Anderson Cancer Center
Identifier: NCT01283997

Purpose

The goal of this clinical research study is to see if Minocin? (minocycline) can help to control nerve damage that causes numbness and tingling in the hands and feet (neuropathy) in patients receiving thalidomide and/or bortezomib.

Study Type: Interventional
Study Design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Eligibility

Ages Eligible for Study:18 Years
Genders Eligible for Study:Both
Accepts Healthy Volunteers:No
Criteria

Inclusion Criteria: 1. Newly diagnosed English speaking patients with symptomatic multiple myeloma who have received 1 or fewer treatment cycles of thalidomide or bortezomib, and who will receive thalidomide and/or twice-weekly schedule bortezomib as part of induction therapy for their multiple myeloma 2. Age greater than or equal to 18 years 3. Able to render informed consent and to follow protocol requirements 4. Women must be postmenopausal (no menstrual period for a minimum of 1 year) or if they are of childbearing potential they must agree to use adequate birth control measures (e.g. abstinence, oral contraceptives, intrauterine device, barrier method with spermicide, implantable or injectable contraceptives or surgical sterilization during the study 5. Men must agree to use adequate birth control measures (e.g. abstinence, oral contraceptives, intrauterine device, barrier method with spermicide, implantable or injectable contraceptives or surgical sterilization) during the study. Exclusion Criteria: 1. Hypersensitivity to tetracyclines 2. Poorly controlled or advanced diabetes mellitus (hemoglobin A1c >/= 8 %) 3. Women who are pregnant or nursing 4. Patients with peripheral neuropathy of >/= grade 2 by CTCAE v4.0. 5. Have a history of alcohol or substance abuse within the preceding 6 months that, in the opinion of the investigator, may increase the risks associated with study participation or study agent administration, or may interfere with interpretation of results 6. Currently have any known malignancy other than multiple myeloma, or have a history of malignancy within the previous 5 years, with the exception of basal cell or squamous cell carcinoma of the skin that has been fully excised with no evidence of recurrence 7. Have current signs or symptoms of severe, progressive or uncontrolled renal, hepatic, gastrointestinal, endocrine, pulmonary, cardiac, neurologic, or cerebral disease 8. Inability to use interactive voice recognition software due to physical limitations (e.g. hearing impairment)

Investigators

  • Investigator: Sheeba K. Thomas, MD - Principal Investigator - UT MD Anderson Cancer Center

Locations

  • UT MD Anderson Cancer Center

    Houston, Texas 77030 United States

Conditions related to this trial:

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