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NCT00186238 Clinical Trial

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

Multiple Myeloma Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00186238
Other study ID # BMT27
Secondary ID 73217BMT27
Status Completed
Phase Phase 2
First received September 13, 2005
Last updated September 10, 2010
Start date September 1994
Est. completion date April 2010

Study information
Verified date September 2010
Source Stanford University
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility
Status Completed
Enrollment 300
Est. completion date April 2010
Est. primary completion date September 2006
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 75 Years
Eligibility Inclusion Criteria:- received cytoreduction prior to transplant

- adequate organ function

Exclusion Criteria:- previous transplant

- smoldering MM or benign monoclonal gammopathy

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Procedure:
• high dose chemotherapy then autologous hematopoietic cell transplant

Locations
Country Name City State
United States Stanford University School of Medicine Stanford California

Sponsors (1)
Lead Sponsor Collaborator
Stanford University

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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) Yes
See also
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Active, not recruiting NCT03989414 - A Study to Determine the Recommended Dose and Regimen and to Evaluate the Safety and Preliminary Efficacy of CC-92480 in Combination With Standard Treatments in Participants With Relapsed or Refractory Multiple Myeloma (RRMM) and Newly Diagnosed Multiple Myeloma (NDMM) Phase 1/Phase 2
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Completed NCT02546167 - CART-BCMA Cells for Multiple Myeloma Phase 1