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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00186238

Enrollment

300

Registered

2005-09-16

Start date

1994-09-30

Completion date

2010-04-30

Last updated

2010-09-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Multiple Myeloma

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.

Interventions

PROCEDUREhigh dose chemotherapy then autologous hematopoietic cell transplant

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

Inclusion criteria

- received cytoreduction prior to transplant * adequate organ function

Exclusion criteria

- previous transplant * smoldering MM or benign monoclonal gammopathy

Design outcomes

Primary

Measure	Time frame
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)

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026