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

Stanford University

Status and phase: Completed; Phase 2

Conditions: Multiple Myeloma

Treatments: Procedure: high dose chemotherapy then autologous hematopoietic cell transplant

Study type: Interventional

Funder types: Other

Identifiers

NCT00186238

NCT00186238

73217

BMT27

Details and patient eligibility

About

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

Full 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.

Enrollment: 300 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:- received cytoreduction prior to transplant

• adequate organ function Exclusion Criteria:- previous transplant
• smoldering MM or benign monoclonal gammopathy

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)