Return to List

Study Summary
No. 2006-0022:.......Myeloma......Sheeba K. Thomas......Lymphoma/Myeloma
.
Study Summary Title
Study Summary
Number:		2006-0022
Study Title:A Phase II study of Minocycline vs. Placebo to Prevent Treatment Induced Neuropathy in Multiple Myeloma
.
Physician New Patient Referral
Name:Sheeba K. ThomasPatients Call:800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)
Dept:Lymphoma/MyelomaReferring MD
Call:		800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)
Phone:713-792-2860
Contact us about clinical trials
.
General Information
Disease Group:MyelomaSupported By:N/A
Phase of Study:Phase IIReturn
Visit:		Before each cycle of therapy, approximately every 3-4 weeks.
Treatment
Agents:		MinocyclineHome Care:N/A
Treatment Loc:Only at MDACC
Estimated
Length of Stay
in Houston:		N/A
Description/
Intervention:		The goal of this clinical research study is to see if MinocinŽ (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.
.
Study Objectives / Outcomes
Primary Objectives

1. To compare the safety of minocycline vs. placebo in patients receiving induction therapy for multiple myeloma with a regimen containing thalidomide, and/or bortezomib

2. To compare the effect of minocycline vs. placebo on peripheral nerve function, as determined by a change in touch detection threshold, among patients receiving induction therapy of previously untreated multiple myeloma with a regimen containing thalidomide, and/or bortezomib.

Secondary Objectives

1. To evaluate the effect of minocycline vs. placebo on patients' neuropathic symptoms during induction therapy of previously untreated multiple myeloma with a regimen containing thalidomide and/or bortezomib.

2. To evaluate the effect of minocycline vs. placebo on serum cytokine levels in patients receiving induction therapy of previously untreated multiple myeloma with a regimen containing thalidomide and/or bortezomib.

3. To evaluate the effect of minocycline vs. placebo on neurocognitive function in patients receiving induction therapy of previously untreated multiple myeloma with a regimen containing thalidomide and/or bortezomib.

4. To evaluate the effect of minocycline vs. placebo on daytime somnolence in patients receiving induction therapy of previously untreated multiple myeloma with a regimen containing thalidomide and/or bortezomib.
.
Study Status Information
Study Activation / Registration Date:
IRB Review and Approval Date:01/25/2011
Study Type:Phase Ii Or Phase I/Ii
Recruitment Status:Open
Projected Accrual:N/A
.
Enrollment Eligibility
If you do not meet the enrollment eligibility, there may be other treatment options for you. Please Contact the Referral Office for more information.
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 munimum 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 mehtod 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)
.
Links
Registration Number: NCT01283997
Study Information on Clinical Trials Registry (clinicaltrials.gov)
Other Links:
.
Results

Return to Clinical Trials at M.D. Anderson Cancer Center