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CompletedNCT00186238Updated Sep 14, 2010

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

A Phase 2 interventional study of high dose chemotherapy then autologous hematopoietic cell transplant in Multiple Myeloma, sponsored by Stanford University. Completed at 1 site in United States. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2010-09-14.

Sponsored by Stanford University · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
300
Allocation
Non-randomized
Ages
18 Years to 75 Years
Sex
All
01

Study summary

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

Read the 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.

02

Conditions studied

03

In context

Multiple Myeloma

3,632 studies on the registry are indexed under Multiple Myeloma; 745 are open to participants now.

This study's planned enrollment of 300 is above the median of 41 across 2,907 interventional studies indexed under Multiple Myeloma.

Browse Multiple Myeloma studies →

Lead sponsor

Stanford University is the lead sponsor of 2,117 studies on the registry; 425 are open to participants now.

Of its 259 completed or terminated interventional studies of FDA-regulated products, 197 (76%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

Inclusion Criteria:- received cytoreduction prior to transplant

  • adequate organ function Exclusion Criteria:- previous transplant
  • smoldering MM or benign monoclonal gammopathy
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
300 participants (estimated)

Interventions

  • Procedurehigh dose chemotherapy then autologous hematopoietic cell transplant
06

What researchers measure

Primary outcomes

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

    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)

07

Study locations

1 site
  • Stanford University School of Medicine
    Stanford, California 94305, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 14, 2010, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00186238
Lead sponsor
Stanford University
First posted
Sep 16, 2005
Start date
Sep 1994
Primary completion
Sep 2006
Completion
Apr 2010
Last update
Sep 14, 2010

Study contacts

Sally Arai
principal investigator · Stanford University
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2010. You cannot join it, but the record below documents what was studied.

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