High Dose Sequential Therapy and Autologous Stem Cell Rescue for Multiple Myeloma

Phase 2

Completed

• Conditions: Multiple Myeloma

• Registration Number: NCT00186238
• Lead Sponsor: Stanford University

Brief Summary

To assess the role of autologous hematopoietic cell rescue in the treatment of multiple myeloma.

Detailed Description

To assess the toxicity and efficacy of sequentially administered high dose cyclophosphamide and VP-16 followed by total body irradiation or BCNU and high dose mephalan and autologous stem cell rescue in the treatment of multiple myeloma.

Study Timeline

• Study Start: 1994-09
• Study First Submitted: 2005-09-13
• Study First Submitted QC: 2005-09-13
• Study First Posted: 2005-09-16
• Primary Completion: 2006-09
• Study Completion: 2010-04
• Status Verified: 2010-09
• Last Update Submitted: 2010-09-10
• Last Update Posted: 2010-09-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

• received cytoreduction prior to transplant

• adequate organ function

Exclusion Criteria

• previous transplant

• smoldering MM or benign monoclonal gammopathy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Toxicity and efficacy of sequentially administered high dose chemotherapy and autologous hematopoietic cell transplantation	Patients will have a daily CBC with platelet count, and chemistries until engraftment, then as indicated clinically. Chest x-rays will be done weekly until engraftment, then as indicated clinically. Patients will be restaged for abnormal proteins (SPIE)

Trial Locations

Locations (1)

Stanford University School of Medicine; 🇺🇸 Stanford, California, United States