A Phase 3 interventional study of dexamethasone and melphalan in Multiple Myeloma and Plasma Cell Neoplasm, sponsored by NCIC Clinical Trials Group. Completed at 37 sites in 2 countries. Open to participants aged 18 Years to 120 Years. Per ClinicalTrials.gov, last updated 2020-04-02.
Sponsored by NCIC Clinical Trials Group · Phase 3, Interventional, and Treatment
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 patients with multiple myeloma.
PURPOSE: Randomized phase III trial to compare the effectiveness of various combination chemotherapy regimens in treating patients with multiple myeloma.
OBJECTIVES:
OUTLINE: This is a randomized, multicenter study. Patients are stratified by center, stage (I or II vs III), creatinine (less than 2.0 mg/dL vs 2.0 mg/dL or greater), and intention to use prophylactic bisphosphonate (yes vs no).
Induction: Patients are randomized to 1 of 4 treatment arms.
Induction for arms I-IV continues every 4 weeks for 12 courses in the absence of disease progression or unacceptable toxicity. Patients with stable or responding disease after induction proceed to maintenance therapy.
Maintenance:
Quality of life is assessed at baseline, on day 1 of courses 1-3 and then every 3 courses during induction, and then every 3 months during maintenance therapy.
Patients are followed every 6 months.
PROJECTED ACCRUAL: A maximum of 600 patients will be accrued for this study within 6 years.
3,632 studies on the registry are indexed under Multiple Myeloma; 745 are open to participants now.
This study's enrollment of 595 is above the median of 41 across 2,907 interventional studies indexed under Multiple Myeloma.
Browse Multiple Myeloma studies →NCIC Clinical Trials Group is the lead sponsor of 114 studies on the registry; none are open to participants now.
Of its 27 completed or terminated interventional studies of FDA-regulated products, 7 (26%) have results posted.
Counted across the registry records on this site, refreshed daily.
DISEASE CHARACTERISTICS:
Histologically proven previously untreated stage I-III multiple myeloma
Must meet at least 1 of the following conditions:
Detectable serum M-component of IgG, IgA, IgD, or IgE
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
melphalan plus prednisone qd x 4 28 day cycles x 12 cycles; No treatment after stable response.
Drug: melphalan · Drug: prednisone
melphalan plus prednisone qd x 4 28 day cycles x 12 cycles; dexamethasone qd x 4 q 28 days after non-progression
Drug: dexamethasone
40 mg daily for four days given orally and repeated every 28 days should commence on day 29 of the twelfth cycle of induction therapy.
9 mg/m2 daily for 4 days given orally on an empty stomach every 4 weeks
100 mg daily for 4 days given orally on a full stomach with each cycle of melphalan
Overall survival
To compare overall survival between: i) patients receiving melphalan-prednisone and those receiving melphalan-dexamethasone as induction therapy ii) patients maintained by dexamethasone and those on no additional treatment in the subgroup whose disease has not progressed at the time of the 12th induction cycle
Time frame: 9 years
Time to progression
Time frame: 9 years
Response rates
Time frame: 9 years
Toxicity
Time frame: 9 years
Quality of Life
Time frame: 9 years
Plan to share: No
This study is completed, as verified in Mar 2020. You cannot join it, but the record below documents what was studied.
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