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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 Hydroxychloroquine and Bortezomib in Patients With Relapsed or Refractory Multiple Myeloma

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II, Phase I	Biomarker/Laboratory analysis, Treatment	Active	18 and over	NCI	UPCC-01407 UPCC 01407, UPCC-IRB-806149, NCT00568880

Trial Description

Purpose:

Drugs used in chemotherapy, such as hydroxychloroquine, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving hydroxychloroquine together with bortezomib may kill more cancer cells.

This phase I/II trial is studying the side effects and best dose of hydroxychloroquine when given together with bortezomib and to see how well it works in treating patients with relapsed or refractory multiple myeloma.

Eligibility:

Eligibility criteria include the following:

• At least 18 years old
• Cancer came back or did not respond after previous treatment
• No CNS disease
• At least 2 weeks since thalidomide or lenalidomide
• 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 hydroxychloroquine by mouth every other day for 2 weeks. They will then receive hydroxychloroquine by mouth up to three times a day or every other day and an infusion of bortezomib twice a week for 2 weeks. Treatment with hydroxychloroquine given together with bortezomib may repeat every 3 weeks for at least two courses.

Patients will undergo blood and bone marrow 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

Abramson Cancer Center of the University of Pennsylvania

Dan Vogl, MD, Protocol chair		Ph: 215-662-7910

U.S.A.
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		A Phase I/II Trial of Hydroxychloroquine added to Bortezomib for Relapsed/Refractory Myeloma
Trial Start Date		2007-11-08
Trial Completion Date		2009-11-08 (estimated)
Registered in ClinicalTrials.gov		NCT00568880
Date Submitted to PDQ		2007-11-12
Information Last Verified		2009-07-05
NCI Grant/Contract Number		CA16520

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