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


Phase 2
18 Years
75 Years
Not Enrolling
Both
Multiple Myeloma

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Trial Information

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


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.


Inclusion Criteria:

- received cytoreduction prior to transplant

- adequate organ function

Exclusion Criteria:- previous transplant

- smoldering MM or benign monoclonal gammopathy

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Toxicity and efficacy of sequentially administered high dose chemotherapy and autologous hematopoietic cell transplantation

Outcome Time Frame:

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)

Safety Issue:

Yes

Principal Investigator

Sally Arai

Investigator Role:

Principal Investigator

Investigator Affiliation:

Stanford University

Authority:

United States: Institutional Review Board

Study ID:

BMT27

NCT ID:

NCT00186238

Start Date:

September 1994

Completion Date:

April 2010

Related Keywords:

  • Multiple Myeloma
  • Multiple Myeloma
  • Neoplasms, Plasma Cell

Name

Location
Stanford University School of Medicine Stanford, California  94305-5317