ClinicalTrials.gov
ClinicalTrials.gov Menu

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
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease Intervention/treatment Phase
Myeloma Other: Placebo Drug: Minocycline Phase 2

  Show Detailed Description

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 142 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Multiple Myeloma

Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
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


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. 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.


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. 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
  2. Age greater than or equal to 18 years
  3. Able to render informed consent and to follow protocol requirements
  4. 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
  5. 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:

  1. Hypersensitivity to tetracyclines
  2. Poorly controlled or advanced diabetes mellitus (hemoglobin A1c >/= 8 %)
  3. Women who are pregnant or nursing
  4. Patients with peripheral neuropathy of >/= grade 2 by CTCAE v4.0.
  5. 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
  6. 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
  7. Have current signs or symptoms of severe, progressive or uncontrolled renal, hepatic, gastrointestinal, endocrine, pulmonary, cardiac, neurologic, or cerebral disease
  8. Inability to use interactive voice recognition software due to physical limitations (e.g. hearing impairment)
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

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


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
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations 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 ( Registry Identifier: NCI CTRP )
1P01CA124787-01 ( U.S. NIH Grant/Contract )
First Posted: January 26, 2011    Key Record Dates
Last Update Posted: January 10, 2018
Last Verified: January 2018

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

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