NCT00432458

Zoledronate With or Without Thalidomide in Treating Patients With Early Stage Multiple Myeloma

A Phase III Randomized Trial of Thalidomide Plus Zoledronic Acid Versus Zoledronic Acid Alone in Patients With Early Stage Multiple Myeloma

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 68 (actual)
• Sponsor: Mayo Clinic · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

RATIONALE: Zoledronate may prevent bone loss and stop the growth of cancer cells in bone. Thalidomide may stop the growth of cancer cells by blocking blood flow to the cancer. It is not yet know whether giving zoledronate together with thalidomide is more effective than zoledronate alone in treating multiple myeloma. PURPOSE: This randomized phase III trial is studying zoledronate and thalidomide see how well they work compared with zoledronate alone in treating patients with early stage multiple myeloma.

Detailed description

OBJECTIVES: Primary * Compare time to progression in patients with early stage multiple myeloma treated with zoledronate with or without thalidomide. Secondary * Compare the response rate, 1-year progression-free survival rate, duration of response, and time to next therapy in patients treated with these regimens. * Assess differences in toxicity of these regimens in these patients. OUTLINE: This is a multicenter, randomized study. Patients are stratified according to the presence of lytic lesions on metastatic bone survey (yes vs no), beta-2 microglobulin level (high vs normal), and bone marrow labeling index (high \[\> 1.0%\] vs low \[≤ 1.0%\]). Patients are randomized to 1 of 2 treatment arms. * Arm I: Patients receive oral thalidomide on days 1-28. Treatment with thalidomide repeats every 28 days in the absence of disease progression or unacceptable toxicity. Patients also receive zoledronate IV over 15 minutes on day 1. Treatment with zoledronate repeats every 84 days for 1 year and once a year thereafter in the absence of disease progression or unacceptable toxicity. * Arm II: Patients receive zoledronate IV over 15 minutes on day 1. Treatment repeats every 84 days for 1 year and once a year thereafter in the absence of disease progression or unacceptable toxicity. Blood samples are collected for research studies at baseline and after courses 3, 6, 9, and 12. Bone marrow aspirates are performed at baseline and after courses 6 and 12. Samples are evaluated for bone marrow angiogenesis; vascular endothelial growth factor (VEGF), VEGF receptor 1 (VEGFR-1), and VEGFR-2 expression; bone marrow angiogenesis-VEGF relationship; bone marrow angiogenesis/apoptosis rate relationship; bone marrow angiogenesis/plasma cell (PC) proliferation rate relationship; VEGF expression/apoptosis rate relationship; and VEGFR expression/PC proliferation rate relationship. After completion of study treatment, patients are followed every 6 months for up to 5 years. PROJECTED ACCRUAL: A total of 120 patients will be accrued for this study.

Conditions

• Multiple Myeloma and Plasma Cell Neoplasm

Interventions

Type	Name	Description
DRUG	Thalidomide	200 mg orally on days 1-28 of 28 day cycle
DRUG	zoledronic acid	4 mg\^2 by IV on day 1 every 84 days for 1 year and once per year thereafter

Timeline

• Start date: 2003-07-01
• Primary completion: 2011-06-01
• Completion: 2012-04-01
• First posted: 2007-02-07
• Last updated: 2012-07-04
• Results posted: 2012-07-04

Locations

4 sites across 1 country: United States