Prevention of Treatment Induced Neuropathy in Multiple Myeloma
A Phase II Study of Minocycline vs. Placebo to Prevent Treatment Induced Neuropathy in Multiple Myeloma
3 other identifiers
interventional
79
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Jan 2011
Longer than P75 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 25, 2011
CompletedStudy Start
First participant enrolled
January 25, 2011
CompletedFirst Posted
Study publicly available on registry
January 26, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 22, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
August 22, 2022
CompletedResults Posted
Study results publicly available
June 13, 2024
CompletedJune 13, 2024
June 1, 2024
11.6 years
January 25, 2011
July 11, 2023
June 12, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The Difference Between Touch Detection Thresholds From the Sensorimotor Evaluation at Baseline and After 10 Weeks of Induction Therapy.
Touch detection thresholds are determined using the up/down method with calibrated von Frey monofilaments, Starting with a 0.5mN force, the von Frey monofilament is applied for approximately 1 sec. If the subject fails to detect the stimulus, then the next higher force von Frey monofilament is applied. When the subject detects the presence of the stimulus, the next lower von Frey is administered. The up/down test sequence continues until the same force filament is detected for three additional applications. The force of that filament is then assigned as the touch threshold
baseline and week 10
Secondary Outcomes (1)
Change in the Mean Value of Patient-reported MD Anderson Symptom Inventory for Multiple Myeloma (MDASI-MM) Numbness Scores From Baseline to Week 10 Post Treatment.
baseline and week 10
Study Arms (2)
Placebo Group
PLACEBO COMPARATOR1 dose on first day of induction therapy, then every 12 hours for 10 weeks.
Minocycline Group
EXPERIMENTAL200 mg orally for 1 dose, then 100 mg orally every 12 hours for 10 weeks.
Interventions
One pill by mouth on Day 1. Staring on Day 2, 2 times a day (every 12 hours) by mouth for 10 weeks.
200 mg by mouth for 1 dose, then 100 mg by mouth every 12 hours for 10 weeks.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- M.D. Anderson Cancer Centerlead
- National Cancer Institute (NCI)collaborator
Study Sites (1)
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Sheeba Thomas,Professor, Lymphoma-Myeloma
- Organization
- UT MD Anderson Cancer Center
Study Officials
- PRINCIPAL INVESTIGATOR
Sheeba K. Thomas, MD
M.D. Anderson Cancer Center
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 25, 2011
First Posted
January 26, 2011
Study Start
January 25, 2011
Primary Completion
August 22, 2022
Study Completion
August 22, 2022
Last Updated
June 13, 2024
Results First Posted
June 13, 2024
Record last verified: 2024-06