Antibiotic Therapy in Preventing Early Infection in Patients With Multiple Myeloma Who Are Receiving Chemotherapy - Full Text View

Sponsor:	University of Rochester
Collaborators:	National Cancer Institute (NCI) Eastern Cooperative Oncology Group
Information provided by:	University of Rochester
ClinicalTrials.gov Identifier:	NCT00002850

Purpose

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

PURPOSE: 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.

Condition	Intervention	Phase
Infection Multiple Myeloma and Plasma Cell Neoplasm	Drug: ciprofloxacin Drug: ofloxacin Drug: trimethoprim-sulfamethoxazole	Phase III

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Factorial Assignment Masking: Open Label Primary Purpose: Supportive Care
Official Title:	Oral Antibiotic Prophylaxis of Early Infection in Multiple Myeloma

Resource links provided by NLM:

Genetics Home Reference related topics: aceruloplasminemia hemophilia

MedlinePlus related topics: Antibiotics Cancer Multiple Myeloma

Drug Information available for: Ofloxacin Ciprofloxacin Ciprofloxacin hydrochloride Ciprofloxacin lactate Levofloxacin Ofloxacin hydrochloride Sulfamethoxazole Trimethoprim Trimethoprim-sulfamethoxazole combination

U.S. FDA Resources

Further study details as provided by University of Rochester:

Primary Outcome Measures:

Proportion of patients experiencing a serious bacterial infection [ Time Frame: during the first three months of chemotherapy ] [ Designated as safety issue: No ]

Enrollment:	210
Study Start Date:	March 1997
Estimated Study Completion Date:	August 2015
Estimated Primary Completion Date:	January 2015 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Ciprofloxacin or ofloxacin	Drug: ciprofloxacin Begin oral ciprofloxacin when they start chemotherapy for multiple myeloma. Assigned treatment consists of ciprofloxacin (Cipro® 500 mg po tablet every 12 hours for two months. The patient will continue to be observed one additional month on study continuing regular myeloma chemotherapy. Drug: ofloxacin Begin oral ofloxacin when they start chemotherapy for multiple myeloma. Assigned treatment consists of ofloxacin (500 mg po tablet every 12 hours for two months. The patient will continue to be observed one additional month on study continuing regular myeloma chemotherapy.
Experimental: TMP-SMX	Drug: trimethoprim-sulfamethoxazole Begin oral Trimethoprim-sulfamethoxazole when they start chemotherapy for multiple myeloma. Assigned treatment consists of TMP-SMX (Septra® or Bactrim®) 1 DS tablet [TMP-SMX DS = 160 mg trimethoprim and 800 mg sulfamethoxazole] every 12 hours for two months..

Arms

Assigned Interventions

Experimental: Ciprofloxacin or ofloxacin

Drug: ciprofloxacin

Begin oral ciprofloxacin when they start chemotherapy for multiple myeloma. Assigned treatment consists of ciprofloxacin (Cipro® 500 mg po tablet every 12 hours for two months. The patient will continue to be observed one additional month on study continuing regular myeloma chemotherapy.

Drug: ofloxacin

Begin oral ofloxacin when they start chemotherapy for multiple myeloma. Assigned treatment consists of ofloxacin (500 mg po tablet every 12 hours for two months. The patient will continue to be observed one additional month on study continuing regular myeloma chemotherapy.

Experimental: TMP-SMX

Drug: trimethoprim-sulfamethoxazole

Begin oral Trimethoprim-sulfamethoxazole when they start chemotherapy for multiple myeloma. Assigned treatment consists of TMP-SMX (Septra® or Bactrim®) 1 DS tablet [TMP-SMX DS = 160 mg trimethoprim and 800 mg sulfamethoxazole] every 12 hours for two months..

Detailed Description:

OBJECTIVES:

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.
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.
Evaluate whether oral antibiotic prophylaxis with CPFX or ofloxacin is as effective as TMP-SMX without the associated toxic effects.
Evaluate whether protection against early infection in multiple myeloma patients can improve their response to initial chemotherapy.

OUTLINE: This is a randomized, multicenter study. Patients are stratified by participating center. Patients are randomized to 1 of 2treatment 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.

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.

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

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

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

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00002850

Show 45 Study Locations

Sponsors and Collaborators

University of Rochester

National Cancer Institute (NCI)

Eastern Cooperative Oncology Group

Investigators

Study Chair:	Jane T. Hickok, MD, MPH	James P. Wilmot Cancer Center
Study Chair:	Gary R. Morrow, PhD, MS	University of Rochester
Study Chair:	Martin M. Oken, MD	CCOP - Metro-Minnesota
Study Chair:	Claire Pomeroy, MD	University of California, Davis

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Martin Oken, MD, Hubert H. Humphrey Cancer Center
ClinicalTrials.gov Identifier:	NCT00002850 History of Changes
Other Study ID Numbers:	CDR0000065093, U10CA037420, URCC-U10994, NCI-C95-0001, URCC-URRSRB-6993, NCI-P96-0073, ECOG-U1099
Study First Received:	November 1, 1999
Last Updated:	August 3, 2011
Health Authority:	United States: Federal Government

Keywords provided by University of Rochester:

stage I multiple myeloma
stage II multiple myeloma
stage III multiple myeloma
infection

Additional relevant MeSH terms:

Neoplasms
Multiple Myeloma
Neoplasms, Plasma Cell
Plasmacytoma
Neoplasms by Histologic Type
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases

Anti-Bacterial Agents
Ofloxacin
Ciprofloxacin
Sulfamethoxazole
Trimethoprim
Trimethoprim-Sulfamethoxazole Combination
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Infective Agents, Urinary
Renal Agents
Antimalarials

ClinicalTrials.gov processed this record on February 09, 2012