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

Alternate Title

Randomized Study of Co-Trimoxazole Versus Ciprofloxacin or Ofloxacin Versus No Prophylaxis for the Prevention of Early Infection in Patients With Multiple Myeloma

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
No phase specified	Supportive care	Closed	18 and over	NCI	URCC-U10994 NCI-C95-0001, URCC-URRSRB-6993, NCI-P96-0073, ECOG-U1099, NCT00002850

Trial Description

Purpose:

Giving antibiotics may be effective in preventing or controlling early infection in patients with multiple myeloma and may improve their response to chemotherapy.

This randomized clinical trial is studying antibiotics to see how well they work compared to no antibiotics in preventing early infection in patients with multiple myeloma.

Eligibility:

Eligibility criteria include the following:

• At least 18 years old
• Not planning to have bone marrow transplantation or stem cell transplantation within the first 2 months of chemotherapy
• At least 10 days since radiation therapy
• At least 7 days since antibiotics
• 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 be randomly assigned to one of three groups. Patients in group one will receive co-trimoxaxzole by mouth twice a day for 2 months followed by observation for 2 months. Patients in group two will receive either ciprofloxacin or ofloxacin by mouth twice a day for 2 months, followed by observation for 1 month. Patients in group three will be observed for 3 months. All patients will be evaluated at 6 months, 1 year, and 2 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

University of Rochester Cancer Center CCOP Research Base

Jane T. Hickok, MD, MPH, Protocol chair		Ph: 585-275-5513
Gary Morrow, PhD, MS, Protocol co-chair		Ph: 585-275-5513

Eastern Cooperative Oncology Group

Martin Oken, MD, Protocol chair		Ph: 320-693-4574
Claire Pomeroy, MD, Protocol co-chair		Ph: 916-734-3578 Email: claire.pomeroy@ucdmc.ucdavis.edu

Registry Information
Official Title		Oral Antibiotic Prophylaxis of Early Infection in Multiple Myeloma
Trial Start Date		1997-03-28
Trial Completion Date		2008-12-31 (estimated)
Registered in ClinicalTrials.gov		NCT00002850
Date Submitted to PDQ		1996-09-18
Information Last Verified		2008-01-16
NCI Grant/Contract Number		CA037420

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