NCT01706666

Bortezomib Based Consolidation in Multiple Myeloma Patients Completing Stem Cell Transplant

A Phase II Randomized Study of Three Subcutaneous Bortezomib-based Consolidation Treatments for Patients Completing Induction Therapy and Stem Cell Transplantation for Newly Diagnosed Multiple Myeloma

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 3 (actual)
• Sponsor: Mayo Clinic · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This randomized phase II trial studies how well giving bortezomib with or without combination chemotherapy works as consolidation therapy in patients with newly diagnosed multiple myeloma who have completed stem cell transplant. Bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as cyclophosphamide, dexamethasone, and lenalidomide, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. It is not yet known whether giving bortezomib is more effective with or without combination chemotherapy in the post transplant setting.

Detailed description

PRIMARY OBJECTIVES: I. To compare the stringent complete response (sCR) rate after 12 cycles among arms. SECONDARY OBJECTIVES: I. To compare progression-free and overall survival among arms. II. To describe the adverse event profile of each arm. TERTIARY OBJECTIVES: I. To compare sCR after 6 cycles and 24 cycles and quality of life among arms. OUTLINE: Patients are randomized to 1 of 3 treatment arms. ARM A: Patients receive bortezomib subcutaneously (SC) on days 1 and 15 of courses 1-12 and day 1 of courses 13-24. ARM B: Patients receive bortezomib SC as in Arm A, cyclophosphamide orally (PO) on days 1 and 15 of courses 1-12 and day 1 of courses 13-24, and dexamethasone PO on days 1 and 15 of courses 1-12 and day 1 of courses 13-24. ARM C: Patients receive bortezomib SC as in Arm A and lenalidomide PO once daily (QD) on days 1-28. In all arms, treatment continues every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up every 6 months for 3 years.

Conditions

• Stage I Multiple Myeloma
• Stage II Multiple Myeloma
• Stage III Multiple Myeloma

Interventions

Type	Name	Description
DRUG	bortezomib	Given SC
DRUG	cyclophosphamide	Given PO
DRUG	lenalidomide	Given PO
OTHER	laboratory biomarker analysis	Correlative studies
DRUG	dexamethasone	Given PO
PROCEDURE	quality-of-life assessment	Ancillary studies

Timeline

• Start date: 2012-12-07
• Primary completion: 2014-07-10
• Completion: 2016-05-17
• First posted: 2012-10-15
• Last updated: 2018-09-17
• Results posted: 2016-06-03

Locations

4 sites across 1 country: United States