Bortezomib plus Melphalan and Prednisone for Initial Treatment of Multiple Myeloma
- Study type
- Clinical trial
- Study name
- VISTA
- Phase
- Phase 3
- Design
- Randomised phase 3 trial comparing melphalan and prednisone with or without bortezomib
- Sample size
- 682 patients
- Source
- N Engl J Med · 2008
- Trial registration
- NCT00111319
In plain words
In this study, patients with multiple myeloma who could not have high-dose treatment had the drug bortezomib added to the standard treatment (melphalan and prednisone). Adding this drug slowed the growth of the disease, improved the response to treatment and helped patients live longer. Severe (grade 3) side effects were slightly more common, but deaths caused by treatment did not increase.
Key results
Treatment arms and regimens
Nine 6-week cycles of melphalan at 9 mg/m² of body surface area and prednisone at 60 mg/m² on days 1 to 4, plus bortezomib at 1.3 mg/m² on days 1, 4, 8, 11, 22, 25, 29 and 32 in cycles 1 to 4 and on days 1, 8, 22 and 29 in cycles 5 to 9.
Nine 6-week cycles of melphalan at 9 mg/m² and prednisone at 60 mg/m² on days 1 to 4, alone.
Source of the regimen details: Abstract of the paper
Doses are given for the information of specialists, as in this study’s protocol, and are not a prescription. Every drug must be prescribed by the treating physician for the individual patient.
Study population
Patients with newly diagnosed, previously untreated multiple myeloma who were ineligible for high-dose therapy.
Endpoints
Primary endpoint: time to progression. Response rate, duration of response and overall survival were also reported.
Safety and side effects
Adverse events were consistent with the known toxicity profiles of bortezomib and melphalan-prednisone. Grade 3 events were more frequent in the bortezomib group (53% versus 44%; P=0.02), but there was no significant difference in grade 4 events (28% and 27%) or treatment-related deaths (1% and 2%).
Clinical significance and place in guidelines
Based on the abstract, adding bortezomib to melphalan-prednisone in myeloma patients unsuitable for high-dose therapy was superior to the standard treatment of the time. The current status of this regimen in clinical guidelines and drug approvals should be checked separately.
Limitations
The abstract gives no further information on limitations. The comparison was only with melphalan-prednisone, and further details (such as neurological adverse events and long-term follow-up) are in the full text.
This summary was prepared by the editorial team from the published paper; the original paper is the final reference. Read the original abstract on PubMed.