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

Alternate Title

Phase I/II Study of Autologous Stem Cell Transplantation after Chemotherapy and Immunotherapy Followed by Thalidomide in Patients With High-Risk or Refractory Multiple Myeloma

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II, Phase I	Biomarker/Laboratory analysis, Treatment	Active	18 to 80	NCI	MSGCC-0610-GCC 0610 GCC, UPCC-0610-GCC, NCT00499577

Trial Description

Purpose:

Vaccines made from peptides may help the body build an effective immune response to kill tumor cells. Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Thalidomide may stop the growth of cancer cells by stopping blood flow to the cancer. A stem cell transplant using stem cells from the patient may be able to replace immune cells that were destroyed by chemotherapy used to kill cancer cells. Giving an infusion of the donor’s T cells after the transplant may help destroy any remaining cancer cells.

This phase I/II trial is studying the side effects of stem cell transplant given together with chemotherapy and biological therapy and to see how well it works in treating patients with high-risk or refractory multiple myeloma.

Eligibility:

Eligibility criteria include the following:

• 18-80 years old
• Measurable disease
• No myelodysplasia
• At least 2 weeks since steroid therapy or chemotherapy
• No more than four previous courses of treatment for myeloma
• 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 vaccine therapy and injections of GM-CSF. About 10 days later, T-cells will be collected and treated in the laboratory.

Patients will then receive dexamethasone and thalidomide once a day for 4 days. They will also receive 4-day continuous infusions of cisplatin, doxorubicin, cyclophosphamide, and etoposide. Beginning the day after finishing chemotherapy, patients will receive an injection of G-CSF once a day.

Patients will then receive an infusion of high-dose melphalan on day 1 and an infusion of stem cells on day 2. Beginning on day 7, they will receive injections of G-CSF.

Patients will receive an infusion of treated T-cells on day 4. They will receive vaccine therapy and GM-CSF 3, 7, and 14 weeks after transplant.

Six months after transplant, patients will receive low-dose thalidomide for as long as benefit is shown.

Patients will undergo blood sample collection periodically for laboratory studies.

After finishing treatment, patients will be evaluated periodically.

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

Greenebaum Cancer Center at University of Maryland Medical Center

Aaron Rapoport, MD, Principal investigator		Ph: 410-328-1230; 800-888-8823 Email: arapoport@umm.edu

U.S.A.
Maryland
	Baltimore
	Greenebaum Cancer Center at University of Maryland Medical Center
		Clinical Trials Office - Greenebaum Cancer Center at University of Maryladn Medical Center	Ph:  800-888-8823
Pennsylvania
	Philadelphia
	Abramson Cancer Center of the University of Pennsylvania
		Clinical Trials Office - Abramson Cancer Center of the University of Pennsylvania	Ph:  800-474-9892

Registry Information
Official Title		Phase I/II Combination Immunotherapy After ASCT for Advanced Myeloma to Study HTERT Vaccination Followed by Adoptive Transfer of Vaccine-Primed Autologous T Cells
Trial Start Date		2006-12-26
Trial Completion Date		2009-06-26 (estimated)
Registered in ClinicalTrials.gov		NCT00499577
Date Submitted to PDQ		2007-05-30
Information Last Verified		2008-11-30
NCI Grant/Contract Number		CA130293