Prevention of Treatment Induced Neuropathy in Multiple Myeloma
This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
First received: January 25, 2011
Last updated: August 2, 2013
Last verified: August 2013
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.
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
||A Phase II Study of Minocycline vs. Placebo to Prevent Treatment Induced Neuropathy in Multiple Myeloma
Primary Outcome Measures:
| Estimated Enrollment:
| Study Start Date:
| Estimated Primary Completion Date:
||January 2015 (Final data collection date for primary outcome measure)
Placebo Comparator: Placebo Group
1 dose on first day of induction therapy, then every 12 hours for 10 weeks.
One pill by mouth on Day 1. Staring on Day 2, 2 times a day (every 12 hours) by mouth for 10 weeks.
Experimental: Minocycline Group
200 mg orally for 1 dose, then 100 mg orally every 12 hours for 10 weeks.
200 mg by mouth for 1 dose, then 100 mg by mouth every 12 hours for 10 weeks.
- Minocin PAC
|Ages Eligible for Study:
||18 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- 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.
- 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)
Please refer to this study by its ClinicalTrials.gov identifier: NCT01283997
|UT MD Anderson Cancer Center
|Houston, Texas, United States, 77030 |
M.D. Anderson Cancer Center
||Sheeba K. Thomas, MD
||UT MD Anderson Cancer Center
No publications provided
||M.D. Anderson Cancer Center
History of Changes
|Other Study ID Numbers:
|Study First Received:
||January 25, 2011
||August 2, 2013
||United States: Institutional Review Board
Keywords provided by M.D. Anderson Cancer Center:
Peripheral Nerve Function
Touch Detection Threshold
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on December 03, 2013
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Blood Protein Disorders
Immune System Diseases