Myeloma
Randomized Phase 3B Study of Three Treatment Regimens in SUbjects with Previously Untreated Multiple Myeloma Who are not Considered Candidates for High-Dose Chemotherapy and Autologous Stem Cell Transplantation: VELCADE (Bortezomib), Thalidomide, and Dexamethasone (VTD), Versus VELCADE and Dexamethasone (VD) Versus VELCADE, Melphalan, and Prednisone (VMP)
Eligibility Criteria (per Protocol dated 03/18/08):
- Subject must not be a candidate for high-dose chemotherapy and stem cell transplantation (HDT/SCT) due to age, presence of important comorbid condition(s) likely to have a negative impact on tolerability of HDT-SCT, or subject preference.
- Karnofsky Performance Status (KPS) score of at least 50%.
- Subject must have measurable disease requiring systemic therapy.
- Subject not eligible is there is diagnosis of smoldering multiple myeloma or MGUS.
- Subject not eligible if there is diagnosis of Waldentrom’s disease, or other conditions in which IgM M-protein is present in the absence of a clonal plasma cell infiltration or lytic bone lesions.
- Subject not eligible if previously or currently treated with any systemic therapy for multiple myeloma. Prior treatment of hypercalcemia or spinal cord compression with corticosteroids or radiation therapy, respectively, does not disqualify the subject (the dose of corticosteroids should not exceed the equivalent of 160 mg of dexamethasone in a 2-week period).
- Not eligible if there has been major surgery within 30 days before randomization.
- Not eligible if there has been myocardial infarction within 6 months prior to enrollment or New York Hospital Association (NYHA) Class III or IV heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia or significant conduction system abnormalities in the opinion of the investigator. Prior to study entry, any abnormality on electrocardiogram (ECG) must be determined and documented by the investigator to be not clinicallly relevant to the subject’s participation in the study.
- Not eligible if there has been prior malignancy, except for adequately treated basal cell skin cancer, in situ cervical cancer, in situ breast cancer, in situ prostate cancer, or other cancer for which the subject has been disease-free for at least 3 years.
- Other criteria, as determined by the protocol.
For information about this study, please contact Robin Stewart, RN, PhD, CCRC at (863) 904-1877.