Clinical trial · Interventional
Prevention of Treatment Induced Neuropathy in Multiple Myeloma
A Phase II Study of Minocycline vs. Placebo to Prevent Treatment Induced Neuropathy in Multiple Myeloma
NCT01283997CI-TRIAL-00077949completedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Myeloma | Multiple Myeloma | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Minocycline | Drug | — | UNRESOLVED |
| Placebo | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- PLACEBO_COMPARATOR
- label
- Placebo Group
- description
- 1 dose on first day of induction therapy, then every 12 hours for 10 weeks.
- interventionNames
- Other: Placebo
- type
- EXPERIMENTAL
- label
- Minocycline Group
- description
- 200 mg orally for 1 dose, then 100 mg orally every 12 hours for 10 weeks.
- interventionNames
- Drug: Minocycline
Primary outcomes (1)
- measure
- The Difference Between Touch Detection Thresholds From the Sensorimotor Evaluation at Baseline and After 10 Weeks of Induction Therapy.
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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)
References
Publications (0)
Data not yet available
No reference posted for this study.