Velcade Consolidation Bone Study

• Status: Completed
• Trial end date: 2014-04-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to assess the effect of bortezomib on myeloma-related bone disease, analyzing bone mineral density (BMD) in patients with Multiple Myeloma (MMY) who have received high dose chemotherapy and autologous stem cell transplantation for primary treatment of MMY (single- or double-transplant). Eligible patients will be randomized (study treatment assigned by chance like flipping a coin) to either bortezomib or observation alone. Patients in the bortezomib arm will receive treatment of bortezomib for a total of 4 cycles. All subjects will be followed for a total of 24 months after randomization.

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

Details

• Lead Sponsor: Janssen-Cilag International NV
• Treatments: Bortezomib

Criteria

Inclusion Criteria:

• Adult Multiple Myeloma patients in partial response or better after high dose chemotherapy and autologous stem cell transplantation

• Patient fulfills defined laboratory requirements within 14 days before enrolment

• If female, is either postmenopausal for more than 24 consecutive months or surgically sterilized or willing to use an acceptable method of birth control for defined period

• If male, agree to use an acceptable barrier method of contraception and to not donate sperm up to 3 months following treatment

Exclusion Criteria:

• Patient received another antimyeloma or experimental therapy following autologous stem cell transplantation

• Patient has a peripheral neuropathy or neuropathic pain of grade 2 or greater intensity as defined by the NCI common terminology criteria of adverse event (NCI CTCAE) version 3.0

• Patient has an uncontrolled or severe cardiovascular disease within 6 months of enrolment

• Patient has any conditions that would compromise his/her well-being or the completion of the study requirements