Efficacy of Bortezomib Consolidation After High-dose Melphalan With Stem Cell Support in Myeloma Patients

• Status: Completed
• Trial end date: 2010-05-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Nordic Myeloma Study Group
• Collaborator: Janssen-Cilag Ltd.
• Treatments: Bortezomib; Melphalan

Criteria

Inclusion Criteria:

• Symptomatic myeloma diagnosis according to criteria in attachment 3

• ASCT is performed or has been performed in the last five weeks (time limit two weeks for patients randomised at 2nd transplantation) as a part of primary therapy

• Signed informed consent given prior to any study related activities have been performed

Exclusion Criteria:

• Prior exposure to bortezomib

• Allogeneic transplantation scheduled as a part of the primary treatment

• Neuropathy > Grade 2 (neurological symptoms interfering with ADL)

• Non-secreting myeloma

• Other concurrent disease making bortezomib treatment unsuitable

• Positive pregnancy test (only applicable for women with childbearing potential)

• Has known or suspected hypersensitivity or intolerance to boron, mannitol, or heparin, if an indwelling catheter is used

• Uncontrolled or severe cardiovascular disease including myocardial infarction within 6 months of enrolment, New York Heart Association (NYHA) Class III or IV heart failure (Attachment 6, NYHA Classification of Cardiac Disease), uncontrolled angina, clinically significant pericardial disease, or cardiac amyloidosis

• History of hypotension or has decreased blood pressure (sitting systolic blood pressure [SBP] £100 mmHg and/or sitting diastolic blood pressure [DBP] £60 mmHg)

• Serious medical or psychiatric illness likely to interfere with participation in this clinical study

• Have received an experimental drug or used an experimental medical device within 4 weeks prior to inclusion into the study