A Randomized Trial Comparing Z-Dex With VAD as Induction Therapy for Patients With Multiple Myeloma

Trial Information

A Randomized Trial Comparing Z-Dex With VAD as Induction Therapy for Patients With Multiple Myeloma

OBJECTIVES:

- Compare the partial and complete response rates in patients with multiple myeloma
treated with induction therapy comprising idarubicin and dexamethasone vs vincristine,
doxorubicin, and dexamethasone.

- Compare the disease progression, time to achieve maximal response, and duration of
response in patients treated with these 2 regimens.

- Compare the quality of life of patients treated with these 2 regimens.

OUTLINE: This is a randomized, multicenter study. Patients are randomized to 1 of 2
treatment arms.

- Arm I: Patients receive oral idarubicin and oral dexamethasone daily on days 1-4.
Treatment continues every 3 weeks for 4 courses in the absence of disease progression
or unacceptable toxicity. Patients also receive oral dexamethasone daily on days 8-11
during course 1 only.

- Arm II: Patients receive oral dexamethasone daily, doxorubicin IV continuously, and
vincristine IV continuously on days 1-4. Courses repeat as in arm I. Patients receive
additional dexamethasone as in arm I.

Patients without a maximal response after completion of course 4 may receive up to 2
additional courses.

Quality of life is assessed at baseline and then prior to each study course.

Patients are followed for survival.

PROJECTED ACCRUAL: A total of 200 patients (100 per arm) will be accrued for this study
within 2 years.