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Alternate Title
Basic Trial Information
Trial Description
     Purpose
     Eligibility
     Treatment/Intervention
Trial Contact Information
Related Information
Registry Information

Alternate Title

Phase II Study of Autologous Peripheral Blood Stem Cell (PBSC) Transplantation Followed By Non-Myeloablative Allogeneic PBSC Transplantation in Patients With Multiple Myeloma

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II	Treatment	Closed	Under 65	NCI	CALGB-100001 NCT00028600

Trial Description

Purpose:

Peripheral blood stem cell transplant using stem cells from the patient or a donor may be able to replace immune cells that were destroyed by chemotherapy used to kill tumor cells. The donated stem cells may also help destroy any remaining cancer cells (graft-versus-tumor effect).

This phase II trial is studying how well autologous peripheral stem cell transplant followed by donor peripheral stem cell transplant works in treating patients with multiple myeloma.

Eligibility:

Eligibility criteria include the following:

• Younger than 65 years old
• Must have an identical match brother or sister stem cell donor
• Must be enrolled in clinical trial CLB-8461
• At least 4 weeks since chemotherapy, radiation therapy, or surgery
• For more information about the eligibility criteria for this trial, refer to the Health Professional version.

Final eligibility for a clinical trial is determined by the health professionals conducting the trial.

Treatment/Intervention:

Patients will receive an infusion of cyclophosphamide and injections of filgrastim followed by stem cell collection. After 2-4 weeks, patients will receive an infusion of melphalan followed 2 days later by reinfusion of the stem cells. Beginning on day 5, they will receive injections of filgrastim once a day until blood counts return to normal. Two to 4 months after transplant, patients will receive another chemotherapy regimen followed by donor peripheral stem cell transplant and filgrastim. They will also receive treatment for prevention of graft-versus-host disease. Some patients will receive infusions of donor white blood cells every 8 weeks for up to three treatments.

Patients will be evaluated every 3 months for 3 years, every 6 months for 5 years, and once a year for 15 years.

Important:

For more details about this trial, refer to the Health Professional version of the trial summary.

If you are interested in participating in a clinical trial, contact your doctor for a referral or call a trial contact person listed below. You may see the same contact person listed at more than one site, however, if you call the number listed you can ask to speak to the study coordinator or person involved with the specific trial you are interested in. If you have questions about cancer or clinical trials, call the Cancer Information Service at 1-800-4-CANCER (1-800-422-6237). General information about clinical trials, including risks, benefits, and costs, can be found on NCI's Web site.

Trial Contact Information

Trial Lead Organizations

Cancer and Leukemia Group B

Kenneth Anderson, MD, Protocol chair		Ph: 617-632-2144; 866-790-4500 Email: kenneth_anderson@dfci.harvard.edu

Related Information

PDQ® clinical trial CALGB-8461

Registry Information
Official Title		Autologous Followed By Non-Myeloablative Allogeneic Transplant For Multiple Myeloma
Trial Start Date		2001-11-15
Registered in ClinicalTrials.gov		NCT00028600
Date Submitted to PDQ		2001-10-22
Information Last Verified		2008-03-18
NCI Grant/Contract Number		CA31946

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