Prevention of Treatment Induced Neuropathy in Multiple Myeloma
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|