Finding studies
Finding studies
Take this into the appointment.
Saves the questions and what to expect into your notes, next to the visit they belong to.
Lead
National Cancer Institute (NCI)
PRIMARY OBJECTIVES: I. To compare response rate, time to response, duration of response, toxicity, and survival in the two regimens (vincristine sulfate, carmustine, melphalan, cyclophosphamide, prednisone \[VBMCP\] vs. VBMCP alternating with high-dose cyclophosphamide and then with recombinant interferon alfa-2b \[r alpha2b-IFN\]) in patients with previously untreated multiple myeloma. II. To determine the value of the ancillary laboratory studies to predict response and survival. OUTLINE: INDUCTION PHASE: Patients receive VBMCP comprising vincristine sulfate intravenously (IV) on day 1, carmustine IV on day 1, melphalan orally (PO) on days 1-4, cyclophosphamide IV on day 1, and prednisone PO on days 1-7. Treatment repeats every 35 days for 2 courses in the absence of disease progression or unacceptable toxicity. CONSOLIDATION PHASE: Patients are randomized to 1 of 2 treatment arms. ARM A: Patients receive VBMCP as in the induction phase. Courses repeat every 35 days in the absence of disease progression or unacceptable toxicity. ARM B: Patients receive vincristine sulfate, carmustine, and melphalan as in the induction phase, high-dose cyclophosphamide IV on days 1-4 and prednisone PO on days 1-4 during courses 3 and 5. Patients receive VBMCP as in the induction phase during even numbered courses. Patients receive recombinant interferon alfa-2b subcutaneously (SC) on days 1, 3, 5, 8, 10, 12, 15, 17, 19, and 22 during odd courses beginning course 7. Treatment repeats every 35 days for courses 3-5, every 21 days for even courses beginning course 6, and every 22 days for odd courses beginning course 7 in the absence of disease progression or unacceptable toxicity. In both arms, treatment continues for up to 2 years. After completion of study treatment, patients are followed up for 1 year.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
