CompletedPhase 2

Prevention of Treatment Induced Neuropathy in Multiple Myeloma

United States79 participantsStarted 2011-01-25

Plain-language summary

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.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. 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
✓. Age greater than or equal to 18 years
✓. Able to render informed consent and to follow protocol requirements
✓. 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
✓. 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

✕. Hypersensitivity to tetracyclines
✕. Poorly controlled or advanced diabetes mellitus (hemoglobin A1c \>/= 8 %)
✕. Women who are pregnant or nursing
✕. Patients with peripheral neuropathy of \>/= grade 2 by CTCAE v4.0.
✕. 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
✕. 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
✕. Have current signs or symptoms of severe, progressive or uncontrolled renal, hepatic, gastrointestinal, endocrine, pulmonary, cardiac, neurologic, or cerebral disease
✕. Inability to use interactive voice recognition software due to physical limitations (e.g. hearing impairment)

What they're measuring

The Difference Between Touch Detection Thresholds From the Sensorimotor Evaluation at Baseline and After 10 Weeks of Induction Therapy.

Timeframe: baseline and week 10

Trial details

NCT IDNCT01283997

SponsorM.D. Anderson Cancer Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-08-22

Results submitted2023-07-11

View on ClinicalTrials.gov More Myeloma trials