Study of Combination PS-341 and Thalidomide in Multiple Myeloma

NCT ID: NCT00083460

Last Updated: 2010-08-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 86 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2001-12-31
• Study Completion Date: 2007-11-30

Brief Summary

The purpose of this study is to assess the toxicity of PS-341 combined with one of four doses of thalidomide in patients with refractory multiple myeloma, and to find the most appropriate doses of PS-341 and thalidomide in the combination.

Detailed Description

Patients will be enrolled in groups of 6-10 patients, each receiving a low dose of PS-341 (1.0 mg/m2) and different dose levels of thalidomide (50, 100, 150, and 200 mg). The first six patients in each group will receive PS-341 alone for the first cycle, and thalidomide will be added on day 22. If the combination is found to be safe in these first 6 patients, the remaining patients in each group will be enrolled. Initially, these patients will receive PS-341 alone and thalidomide will be added subsequently, if deemed safe based on the first 6 patients in each thalidomide dose cohort.

Conditions

Multiple Myeloma

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1

Group Type: ACTIVE_COMPARATOR

PS-341

Intervention Type: DRUG

Arm 1 a dose of 1.0mg/m2. Arm 2 a dose of 1.3mg/m2

Thalidomide

Intervention Type: DRUG

In cohort 1, a dose of 50mg for cycles 2-8. Cohort 2, 100mg for cycles 2-8. Cohort 3, 150mg for cycles 2-8. Cohort 4, 200mg for cycles 2-8.

Dexamethasone

Intervention Type: DRUG

A dose of 20mg for cylces 3-8.

2

Group Type: ACTIVE_COMPARATOR

PS-341

Intervention Type: DRUG

Arm 1 a dose of 1.0mg/m2. Arm 2 a dose of 1.3mg/m2

Thalidomide

Intervention Type: DRUG

In cohort 1, a dose of 50mg for cycles 2-8. Cohort 2, 100mg for cycles 2-8. Cohort 3, 150mg for cycles 2-8. Cohort 4, 200mg for cycles 2-8.

Dexamethasone

Intervention Type: DRUG

A dose of 20mg for cylces 3-8.

Interventions

PS-341

Arm 1 a dose of 1.0mg/m2. Arm 2 a dose of 1.3mg/m2

Intervention Type: DRUG

Thalidomide

In cohort 1, a dose of 50mg for cycles 2-8. Cohort 2, 100mg for cycles 2-8. Cohort 3, 150mg for cycles 2-8. Cohort 4, 200mg for cycles 2-8.

Intervention Type: DRUG

Dexamethasone

A dose of 20mg for cylces 3-8.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• History of histologically documented multiple myeloma with relapsed or resistant disease, defined as previously treated with/without autologous stem cell transplantation and is either relapsing or is resistant after > 1 line of prior therapy for myeloma
• Patients can not be eligible for MTRC phase III protocols of higher priority
• Performance status of greater than or equal to 2 as per SWOG scale
• Patients must have an absolute neutrophil count > 750/mm3, and a platelet count greater than or equal to 25,000/mm3
• No prior malignancy is allowed except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or other cancer for which the patient has been disease free for at least three years. Prior malignancy is acceptable provided there has been no evidence of disease within the three-year interval
• Pregnant or nursing women may not participate. Women of childbearing potential must have a negative pregnancy documented within one week of registration. Women/men of reproductive potential may not participate unless they have agreed to use an effective contraceptive method.
• Male or female adults of at least 18 years of age.
• Signed written informed consent and willingness to meet follow-up schedule and study procedure obligations

Exclusion Criteria

• Chemotherapy or radiotherapy received within the previous 2 weeks
• Prior Treatment of PS-341
• Significant neurotoxicity, defined as grade greater than or equal to 2 neurotoxicity per NCI Common Toxicity Criteria
• POEMS Syndrome
• Non-secretory multiple myeloma
• Active infection requiring antibiotics
• Clinically significant hepatic dysfunction in the absence of liver metastases as noted by bilirubin or AST >3 times the upper normal limit or clinically significant concurrent hepatitis
• New York Hospital Association (NYHA) Class III or Class IV heart failure
• Myocardial infarction within the last 6 months
• Poorly controlled hypertension, diabetes mellitus, or other serious or psychiatric illness that could potentially interfere with the completion of treatment according to this protocol
• Severe renal dysfunction defined as a creatinine clearance < 20 cc/min.
• Absolute neutrophil count < 750/mm3, and a platelet count < 25,000/mm3
• Pregnant or potential for pregnancy
• Breast-feeding

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Arkansas

OTHER

Sponsor Role: lead

Responsible Party

University_Of_Arkansas

Principal Investigators

Barlogie Barthel, M.D. Ph.D

Role: PRINCIPAL_INVESTIGATOR

University of Arkanas for Medical Sciences website

Locations

University of Arkansas for Medical Sciences/MIRT

Little Rock, Arkansas, United States

Countries

United States

Related Links

http://myeloma.uams.edu

Myeloma Institute for Research \& Therapy website

Other Identifiers

UARK 2001-37

Identifier Type: -

Identifier Source: org_study_id