Prevention of Treatment Induced Neuropathy in Multiple Myeloma
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ClinicalTrials.gov Identifier: NCT01283997 |
Recruitment Status :
Active, not recruiting
First Posted : January 26, 2011
Last Update Posted : June 30, 2022
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Condition or disease | Intervention/treatment | Phase |
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Myeloma | Other: Placebo Drug: Minocycline | Phase 2 |

Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 79 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 25, 2011 |
Estimated Primary Completion Date : | April 30, 2023 |
Estimated Study Completion Date : | April 30, 2023 |

Arm | Intervention/treatment |
---|---|
Placebo Comparator: Placebo Group
1 dose on first day of induction therapy, then every 12 hours for 10 weeks.
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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.
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Drug: Minocycline
200 mg by mouth for 1 dose, then 100 mg by mouth every 12 hours for 10 weeks.
Other Names:
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- 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.

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

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 |
Responsible Party: | M.D. Anderson Cancer Center |
ClinicalTrials.gov Identifier: | NCT01283997 |
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: | June 30, 2022 |
Last Verified: | June 2022 |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Multiple Myeloma Neuropathy Peripheral Nerve Function Touch Detection Threshold Nerve Damage Thalidomide Bortezomib |
Velcade Minocycline Dynacin Minocin Minocin PAC Myrac Solodyn |
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 |