Multiple Myeloma Clinical Trial
Official title:
Clinical Protocol Bortezomib Consolidation in Patients With Myeloma Following Treatment With High-dose Melphalan and Autologous Stem Cell Support. A Randomised NMSG Trial (15/05)
Multiple myeloma is a malignant incurable hematological disease where survival has been significantly improved by high-dose melphalan with autologous stem cell support (ASCT) in younger patients. However, the disease will eventually relapse and new treatment is demanded. Bortezomib is a newly approved drug for treating relapsing multiple myeloma. It has a different biological effect and response even in patients refractory to conventional chemotherapy. The purpose of the study is in a randomized design to investigate if addition of bortezomib by 20 injections during a 4 months period starting 3 month after ASCT can prolong the time to progression compared to patients receiving no consolidation or maintenance therapy.
Rationale:
ASCT prolongs EFS and OS for myeloma patients < 65 years of age. During the period from ASCT
to progression most myeloma patients experience few symptoms and have a good quality of
life11. A further prolongation of EFS would be a big step forward in myeloma treatment.
Bortezomib is a new promising agent, which has shown clear anti-myeloma effect in heavily
pre-treated patients. After ASCT the tumour cell burden is low and it is the hypothesis of
this clinical trial that the unique mechanism of action of bortezomib may reduce the number
of tumour cells even further and by doing so prolong EFS.
Primary objective:
* Evaluate the effect on EFS (an event is defined as either progression or death of any
cause without preceding progression) of consolidation treatment with bortezomib after ASCT
compared to no consolidation
Secondary objectives:
- Overall survival from ASCT
- Overall survival from start of relapse treatment
- Time to need for relapse treatment
- Response rate in patients not in CR following ASCT
- Toxicity from consolidation treatment
- Quality of life
- Cost utility
- Planned subgroup analysis: comparison of primary and secondary endpoint in patients
receiving one vs. two high dose treatments
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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