NCT00002653

Combination Chemotherapy With or Without Cyclophosphamide and Prednisone in Treating Older Patients With Multiple Myeloma

VIIITH MYELOMATOSIS TRIAL: A RANDOMISED TRIAL OF TREATMENT FOR INDUCING FIRST PLATEAU PHASE ABCM VS 3 COURSES OF ABCM FOLLOWED BY ORAL WEEKLY CYCLOPHOSPHAMIDE

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,000 (estimated)
• Sponsor: Medical Research Council · Other Government
• Sex: All
• Age: 65 Years – 74 Years
• Healthy volunteers: Not accepted

Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. It is not yet known which combination chemotherapy regimen is most effective in treating older patients with multiple myeloma. PURPOSE: Randomized phase III trial to compare the effectiveness of combination chemotherapy with or without cyclophosphamide and prednisone in treating older patients with multiple myeloma.

Detailed description

OBJECTIVES: * Compare the efficacy of doxorubicin, carmustine, cyclophosphamide, and melphalan (ABCM) with or without oral cyclophosphamide and prednisone as induction for the first plateau phase in elderly patients with previously untreated multiple myeloma. OUTLINE: This is a randomized, multicenter study. Patients are stratified according to center. Patients receive doxorubicin IV followed immediately by carmustine IV over 1-2 hours on day 1 and oral melphalan (L-PAM) and oral cyclophosphamide (CTX) on days 22-25 (ABCM). Treatment continues every 6 weeks for 3 courses in the absence of disease progression or unacceptable toxicity. Patients whose blood counts recover within 6 weeks after beginning L-PAM and CTX during course 3 are randomized to 1 of 2 treatment arms. Patients whose blood counts fail to recover within 6 weeks after beginning L-PAM and CTX during course 3 are assigned to arm II. * Arm I: Patients continue ABCM for a maximum of 12 courses in the absence of a plateau phase after completion of at least 4 courses, disease progression, or unacceptable toxicity. * Arm II: Patients receive oral cyclophosphamide once weekly and oral prednisone every other day. Treatment continues every 6 weeks in the absence of a plateau phase after completion of 3 courses of ABCM plus a minimum of 8 weeks on arm II or less than 3 courses of ABCM plus 6 months on arm II, disease progression, or unacceptable toxicity. Patients on both arms with bone pain or failure to respond to chemotherapy may undergo minimal radiotherapy. Patients achieving plateau phase may enter the MRC trial of interferon alfa-2b. Patients are followed every 3 months. PROJECTED ACCRUAL: A total of 1,000 patients will be accrued for this study within approximately 5 years.

Conditions

• Multiple Myeloma and Plasma Cell Neoplasm

Interventions

Type	Name	Description
DRUG	carmustine
DRUG	cyclophosphamide
DRUG	doxorubicin hydrochloride
DRUG	melphalan
DRUG	prednisone
RADIATION	radiation therapy

Timeline

• Start date: 1993-09-01
• First posted: 2003-04-10
• Last updated: 2013-12-19

Locations

1 site across 1 country: United Kingdom