Conditions: MULTIPLE MYELOMA
Keywords: PLASMACYTOMA
Allocation: NON_RANDOMIZED | Intervention model: SINGLE_GROUP
Enrollment: 11
Healthy volunteers: yes

Brief summary:
To evaluate changes in coagulation (blood clotting) factors and platelet function in multiple myeloma participants undergoing VELCADE treatment for the first time.

Detailed description:
Cardiovascular complications during the treatment of patients with multiple myeloma are not uncommon, (10%) and the frequency clearly increases with the use of regimens containing thalidomide in combination with glucocorticosteroids or chemotherapy especially adriamycin. Even with prophylactic anticoagulation, DVT still occurs in 10% of such patients. The use of full anticoagulation raises considerable concern of bleeding especially during the post chemotherapy thrombocytopenic period. We observed no thromboembolic episodes when Velcade was added to thalidomide and adriamycin containing chemotherapy.

Therefore, we would like to investigate this protective antithrombotic effect of VELCADE in a malignancy associated with a hypercoagulable state in a group of 10 patients with Relapsed/Refractory Multiple Myeloma.

Arms:
arm 1: Treatment on this study will last 2 cycles. Each cycle consists of 3 weeks, or 21 days. After you have gone off study, you will be followed every three months for approximately 2 years.

Each cycle will consist of 3 weeks (21 days) according to the schedule below.

DRUG ROUTE DOSE DAYS Velcade IV 1.3 mg/m2 1,4,8, and 11 This 21-day period will be considered one treatment cycle; Cycle 2 would commence on Day 22 (Cycle 2, Day 1). Patients may continue to receive treatment every 21 days, provided there is no evidence of disease progression or no unacceptable toxicity for a two cycles.

Interventions: intervention 1: Velcade
Intervention descriptions: intervention 1: Except for the two PCR-based genotyping assays, which will be conducted only on baseline samples, tests will be assessed at baseline, 1-3 hours after the first dose of Velcade day 1 and on day 11 of the first cycle of Velcade.

The platelet Aggregation Test will be done only if Platelet count is 100 000.

Protocol document: