Study of Combination PS-341 and Thalidomide in Multiple Myeloma
Multiple Myeloma
About this trial
This is an interventional treatment trial for Multiple Myeloma focused on measuring Multiple Myeloma, Thalidomide, Velcade, PS-341, Refractory, Bortezomid
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
Sites / Locations
- University of Arkansas for Medical Sciences/MIRT
Arms of the Study
Arm 1
Arm 2
Active Comparator
Active Comparator
1
2