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Antibiotic Therapy in Preventing Early Infection in Patients With Multiple Myeloma Who Are Receiving Chemotherapy
This study is ongoing, but not recruiting participants.
First Received: November 1, 1999   Last Updated: May 9, 2009   History of Changes
Sponsors and Collaborators: University of Rochester
National Cancer Institute (NCI)
Eastern Cooperative Oncology Group
Information provided by: National Cancer Institute (NCI)
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
Infection
Multiple Myeloma and Plasma Cell Neoplasm
Drug: ciprofloxacin
Drug: ofloxacin
Drug: trimethoprim-sulfamethoxazole

Study Type: Interventional
Study Design: Supportive Care, Randomized, Active Control
Official Title: Oral Antibiotic Prophylaxis of Early Infection in Multiple Myeloma

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Estimated Enrollment: 210
Study Start Date: March 1997
Estimated Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
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 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.

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

Additional Information:
No publications provided

Study ID Numbers: CDR0000065093, URCC-U10994, NCI-C95-0001, URCC-URRSRB-6993, NCI-P96-0073, ECOG-U1099
Study First Received: November 1, 1999
Last Updated: May 9, 2009
ClinicalTrials.gov Identifier: NCT00002850     History of Changes
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
stage I multiple myeloma
stage II multiple myeloma
stage III multiple myeloma
infection

Study placed in the following topic categories:
Trimethoprim
Immunoproliferative Disorders
Sulfamethoxazole
Blood Protein Disorders
Hematologic Diseases
Blood Coagulation Disorders
Ofloxacin
Vascular Diseases
Folate
Anti-Infective Agents, Urinary
Trimethoprim-Sulfamethoxazole Combination
Paraproteinemias
Folinic Acid
Folic Acid Antagonists
Hemostatic Disorders
Vitamin B9
Multiple Myeloma
Folic Acid
Antimalarials
Ciprofloxacin
Anti-Bacterial Agents
Hemorrhagic Disorders
Lymphoproliferative Disorders
Neoplasms, Plasma Cell

Additional relevant MeSH terms:
Communicable Diseases
Anti-Infective Agents
Antiprotozoal Agents
Trimethoprim
Molecular Mechanisms of Pharmacological Action
Blood Protein Disorders
Paraproteinemias
Trimethoprim-Sulfamethoxazole Combination
Renal Agents
Hemostatic Disorders
Infection
Antimalarials
Anti-Bacterial Agents
Ciprofloxacin
Antiparasitic Agents
Hemorrhagic Disorders
Therapeutic Uses
Cardiovascular Diseases
Nucleic Acid Synthesis Inhibitors
Neoplasms by Histologic Type
Immunoproliferative Disorders
Immune System Diseases
Sulfamethoxazole
Hematologic Diseases
Vascular Diseases
Anti-Infective Agents, Urinary
Enzyme Inhibitors
Folic Acid Antagonists
Pharmacologic Actions
Multiple Myeloma

ClinicalTrials.gov processed this record on July 02, 2009