Prevention of Treatment Induced Neuropathy in Multiple Myeloma
|ClinicalTrials.gov Identifier: NCT01283997|
Recruitment Status : Active, not recruiting
First Posted : January 26, 2011
Last Update Posted : January 10, 2018
|Condition or disease||Intervention/treatment||Phase|
|Myeloma||Other: Placebo Drug: Minocycline||Phase 2|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||142 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Official Title:||A Phase II Study of Minocycline vs. Placebo to Prevent Treatment Induced Neuropathy in Multiple Myeloma|
|Actual Study Start Date :||January 2011|
|Estimated Primary Completion Date :||January 2020|
|Estimated Study Completion Date :||January 2020|
U.S. FDA Resources
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.
- Difference Between Touch Detection Thresholds From the Sensorimotor Evaluation at Baseline and After 10 weeks of Induction Therapy [ Time Frame: 10 weeks ]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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01283997
|United States, Texas|
|University of Texas MD Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Sheeba K. Thomas, MD||M.D. Anderson Cancer Center|