Prevention of Treatment Induced Neuropathy in Multiple Myeloma - Full Text View

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:

Genetics Home Reference related topics: multiple myeloma

MedlinePlus related topics: Multiple Myeloma

Drug Information available for: Minocycline Minocycline hydrochloride

Genetic and Rare Diseases Information Center resources: Multiple Myeloma

U.S. FDA Resources

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 2017 (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: Dynacin Minocin Minocin PAC Myrac Solodyn

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Eligibility


Ages Eligible for Study:	18 Years and older (Adult, Senior)
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01283997

Locations


United States, Texas
University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030

Sponsors and Collaborators

M.D. Anderson Cancer Center

National Cancer Institute (NCI)

Investigators


Principal Investigator:	Sheeba K. Thomas, MD	M.D. Anderson Cancer Center

More Information

Additional Information:

University of Texas MD Anderson Cancer Center Website This link exits the ClinicalTrials.gov site


Responsible Party:	M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:	NCT01283997 History of Changes
Other Study ID Numbers:	2006-0022 NCI-2011-00247 1P01CA124787-01
Study First Received:	January 25, 2011
Last Updated:	December 1, 2015
Health Authority:	United States: Food and Drug Administration United States: Federal Government

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

ClinicalTrials.gov processed this record on September 27, 2016