Prevention of Treatment Induced Neuropathy in Multiple Myeloma
This study is currently recruiting participants.
Verified September 2012 by M.D. Anderson Cancer Center
Sponsor:
M.D. Anderson Cancer Center
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT01283997
First received: January 25, 2011
Last updated: September 13, 2012
Last verified: September 2012
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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.
| Condition | Intervention | Phase |
|---|---|---|
|
Myeloma |
Other: Placebo Drug: Minocycline |
Phase 2 |
| 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 |
| Official Title: | A Phase II Study of Minocycline vs. Placebo to Prevent Treatment Induced Neuropathy in Multiple Myeloma |
Resource links provided by NLM:
Further study details as provided by M.D. Anderson Cancer Center:
Primary Outcome Measures:
- Difference Between Touch Detection Thresholds From the Sensorimotor Evaluation at Baseline and After 10 weeks of Induction Therapy [ Time Frame: 10 weeks ] [ Designated as safety issue: No ]Touch detection testing prior to each cycle of multiple myeloma therapy +/- 3 business days until week 10 where measurements summarized by descriptive statistics at each time point for both treatment groups.
| Estimated Enrollment: | 142 |
| Study Start Date: | January 2011 |
| Estimated Primary Completion Date: | January 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Placebo Comparator: Placebo Group
1 dose on first day of induction therapy, then every 12 hours for 10 weeks.
|
Other: Placebo
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.
|
Drug: Minocycline
200 mg by mouth for 1 dose, then 100 mg by mouth every 12 hours for 10 weeks.
Other Names:
|
Show Detailed Description Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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)
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01283997
Contacts
| Contact: Sheeba K. Thomas, MD | 713-792-2860 |
Locations
| United States, Texas | |
| UT MD Anderson Cancer Center | Recruiting |
| Houston, Texas, United States, 77030 | |
| Principal Investigator: Sheeba K. Thomas, MD | |
Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
| Principal Investigator: | Sheeba K. Thomas, MD | UT MD Anderson Cancer Center |
More Information
Additional Information:
No publications provided
| Responsible Party: | M.D. Anderson Cancer Center |
| ClinicalTrials.gov Identifier: | NCT01283997 History of Changes |
| Other Study ID Numbers: | 2006-0022 |
| Study First Received: | January 25, 2011 |
| Last Updated: | September 13, 2012 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by M.D. Anderson Cancer Center:
|
Multiple Myeloma Neuropathy Peripheral Nerve Function Touch Detection Threshold Nerve Damage Thalidomide Bortezomib |
Velcade Minocycline Dynacin Minocin Minocin PAC Myrac Solodyn |
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 Minocycline Anti-Bacterial Agents Anti-Infective Agents Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on September 26, 2012
