Study of Combination PS-341 and Thalidomide in Multiple Myeloma

University of Arkansas

Status and phase

Completed

Phase 1

Conditions

Multiple Myeloma

Treatments

Drug: PS-341

Drug: Dexamethasone

Drug: Thalidomide

Study type

Interventional

Funder types

Other

Identifiers

NCT00083460

UARK 2001-37

Details and patient eligibility

About

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.

Full 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.

Enrollment

86 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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