Bortezomib and High-dose Melphalan at Myeloma Relapse

• Status: Unknown status
• Trial end date: 2010-09-01
• Target enrollment: 0
• Participant gender: All

Summary

The prognosis after retreating with high-dose melphalan with stem cell support after first relapse after high-dose treatment is dependent on the time to first relapse. Bortezomib can increase chemosensitivity of e.g. melphalan. The trial aims at determining the toxicity of adding bortezomib to high-dose melphalan with stem cell support and evaluating whether the time to a second relapse can be prolonged.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

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

Criteria

Inclusion Criteria:

• First relapse after ASCT

• Symptomatic myeloma

• More than 2,0 x 10^6 CD34+ stem cells / kg bodyweight in the freezer for stem cell support

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

• Age > 18 years

Exclusion Criteria:

• Allogeneic transplantation scheduled as a part of the treatment

• Expected survival of less than one month.

• Performance status (WHO) > 3

• Neuropathy > Grade 3 (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 melphalan, dexamethasone, 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