Bortezomib or High-Dose Dexamethasone for Relapsed Multiple Myeloma
- Study type
- Clinical trial
- Study name
- APEX
- Design
- Randomised comparative trial (bortezomib versus high-dose dexamethasone); patients in the dexamethasone group could cross over to bortezomib in a companion study after disease progression
- Sample size
- 669 patients
- Source
- N Engl J Med · 2005
In plain words
In this large study, people with multiple myeloma that had come back were treated either with the drug bortezomib or with high-dose dexamethasone. Patients in the bortezomib group responded to treatment more often, went longer before the disease got worse and survived better. On the other hand, severe (grade 3 or 4) side effects were slightly more common in the bortezomib group. Decisions about treatment should always be made with your own doctor.
Key results
Treatment arms and regimens
Bortezomib IV bolus at a dose of 1.3 mg/m² body surface area on days 1, 4, 8 and 11 for eight 3-week cycles, then on days 1, 8, 15 and 22 for three 5-week cycles.
Oral dexamethasone 40 mg on days 1 to 4, 9 to 12 and 17 to 20 for four 5-week cycles, then on days 1 to 4 for five 4-week cycles. Patients in this group were allowed to cross over to bortezomib in a companion study after disease progression.
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 relapsed multiple myeloma who had received one to three prior treatments.
Endpoints
Primary endpoint: time to disease progression. Results reported in the abstract also included response rate, one-year survival, overall survival and grade 3 or 4 adverse events.
Safety and side effects
Grade 3 or 4 adverse events were reported in 75% of patients in the bortezomib group and 60% of patients in the dexamethasone group.
Clinical significance and place in guidelines
This trial showed that in relapsed multiple myeloma after one to three prior treatments, bortezomib is superior to high-dose dexamethasone in terms of response, time to progression and survival. The current place of this regimen in clinical guidelines and its regulatory status should be checked in up-to-date sources, as the abstract does not address them.
Limitations
Patients in the dexamethasone group were allowed to cross over to bortezomib after disease progression. This may affect the interpretation of the overall survival results. Other limitations should be checked in the full text of the paper. Grade 3 or 4 adverse events were also more frequent in the bortezomib group.
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.