Randomized Phase III Study of Dexamethasone With or Without Genasense (Bcl-2 Antisense Oligonucleotide) in Patients With Relapsed or Refractory Multiple Myeloma
OBJECTIVES:
- Compare the time to disease progression in patients with relapsed or refractory
multiple myeloma treated with dexamethasone with or without oblimersen.
- Compare the duration of response and objective response rate in patients treated with
these regimens.
- Compare the proportion of patients without disease progression after 6 months and the
proportion of patients who have not discontinued treatment after 6 months in these two
patient groups.
- Compare the safety of these regimens in these patients.
- Compare survival of patients treated with these regimens.
OUTLINE: This is a randomized, open-label, multicenter study. Patients are stratified
according to response to prior therapy (relapsed vs refractory), prior autologous stem cell
transplantation (yes vs no), and number of prior therapy regimens (1-2 vs 3-6). Patients are
randomized to 1 of 2 treatment arms.
Arm I
- Induction: Patients receive oblimersen (G3139) IV continuously on days 1-7 and 15-21
and oral dexamethasone daily on days 4-7, 11-14, and 18-21.
- Maintenance: One week after completion of induction therapy, patients with stable or
responsive disease receive G3139 IV continuously on days 1-7 and oral dexamethasone
daily on days 4-7. Courses repeat every 3 weeks for a maximum of 1 year in the absence
of disease progression or unacceptable toxicity.
Arm II
- Induction: Patients receive oral dexamethasone daily for 4 days on weeks 1-3.
- Maintenance: One week after completion of induction therapy, patients with stable or
responsive disease receive oral dexamethasone daily for 4 days. Courses repeat every 3
weeks for a maximum of 1 year in the absence of disease progression or unacceptable
toxicity.
Patients are followed every 2 months for 2 years.
PROJECTED ACCRUAL: A total of 200 patients (100 per treatment arm) will be accrued for this
study.
Interventional
Allocation: Randomized, Masking: Open Label, Primary Purpose: Treatment
Stanley R. Frankel, MD
Study Chair
Genta Incorporated
United States: Federal Government
CDR0000068722
NCT00017602
December 2000
Name | Location |
---|---|
Genta Incorporated | Berkeley Heights, New Jersey 07922 |