Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Trial Contact Information
Registry Information

Alternate Title

Antibiotic Therapy in Preventing Early Infection in Patients With Multiple Myeloma Who Are Receiving Chemotherapy

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

Objectives

1. Evaluate whether oral antibiotic prophylaxis with co-trimoxazole (TMP-SMX) versus ciprofloxacin (CPFX) or ofloxacin versus no prophylaxis will significantly reduce rates of serious bacterial infections during the first 3 months of chemotherapy in patients with multiple myeloma.
2. Determine whether antibiotic prophylaxis with TMP-SMX or CPFX (or ofloxacin) is associated with an increased incidence of nonbacterial infection or an increased rate of infection from organisms resistant to prophylactic antibiotics.
3. Evaluate whether oral antibiotic prophylaxis with CPFX or ofloxacin is as effective as TMP-SMX without the associated toxic effects.
4. Evaluate whether protection against early infection in multiple myeloma patients can improve their response to initial chemotherapy.

Entry Criteria

Disease Characteristics:

• Diagnosis of multiple myeloma (MM) based on one of the following:
  • Bone marrow plasmacytosis with at least 10% abnormal plasma cells
  • Multiple biopsy-proven plasmacytomas



• At least 1 of the following required:
  • Myeloma protein in serum
  • Myeloma protein in urine, i.e., free monoclonal light chain
  • Radiologic evidence of osteolytic lesions
    • Generalized osteoporosis qualifies only if bone marrow aspirate contains at least 20% plasma cells



• No smoldering myeloma



• Planning to initiate 1 of the following regimens as primary therapy for MM within 3 days of study entry:
  • Myelosuppressive chemotherapy
  • High-dose dexamethasone
  • Dexamethasone and thalidomide

Prior/Concurrent Therapy:

Biologic therapy:

• See Disease Characteristics
• No bone marrow transplant or autologous stem cell rescue planned within first 2 months of myeloma chemotherapy
• No concurrent prophylactic filgrastim (G-CSF) during the first 2 months of study participation
• No concurrent intravenous immunoglobulins

Chemotherapy:

• See Disease Characteristics
• No prior chemotherapy (except mithramycin)

Endocrine therapy:

• See Disease Characteristics
• Prior corticosteroids allowed
• No prior high-dose dexamethasone

Radiotherapy:

• At least 10 days since prior radiotherapy
• No radiotherapy planned for near future

Surgery:

• Not specified

Other:

• At least 7 days since prior antibiotics
• No concurrent theophylline
• No concurrent sucralfate or oral antacids if receive ciprofloxacin or ofloxacin

Patient Characteristics:

Age:

• 18 and over

Performance status:

• Not specified

Hematopoietic:

• Not specified

Hepatic:

• Not specified

Renal:

• Creatinine less than 5.0 mg/dL
• No requirement for dialysis at study entry
  • If required after entry, patients continue study with adjusted medication guidelines

Other:

• Not pregnant
• No history of hypersensitivity to fluoroquinolones or trimethoprim
• At least 7 days since prior active infection

Expected Enrollment

A total of 210 patients (70 per treatment arm) will be accrued for this study.

Outline

This is a randomized, multicenter study. Patients are stratified by participating center. Patients are randomized to 1 of 3 treatment arms.

• Arm I: Patients receive co-trimoxazole every 12 hours for 2 months followed by observation for 2 months.



• Arm II: Patients receive oral ciprofloxacin or ofloxacin every 12 hours for 2 months followed by observation for 1 month.



• Arm III: Patients receive no prophylactic antibiotics and are observed for 3 months.

Patients continue their randomly assigned treatment throughout any infection in addition to any treatment needed for infection. Patients also remain on their randomly assigned treatment if chemotherapy is discontinued, changed, or delayed during the 3 month study.

Patients are followed at 6 months, 1 year, and 2 years.

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