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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Eastern Cooperative Oncology Group
Information provided by (Responsible Party):
Gary Morrow, University of Rochester
ClinicalTrials.gov Identifier:
NCT00002850
First received: November 1, 1999
Last updated: January 31, 2014
Last verified: January 2014
  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 3

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:


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..

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

  Show 45 Study Locations
Sponsors and Collaborators
Gary Morrow
Eastern Cooperative Oncology Group
Investigators
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:
No publications provided

Responsible Party: Gary Morrow, Director, URCC CCOP Research Base, University of Rochester
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: January 31, 2014
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
Antibiotics, Antitubercular
Ciprofloxacin
Sulfamethoxazole
Trimethoprim
Trimethoprim-Sulfamethoxazole Combination
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antitubercular Agents
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Infective Agents, Urinary

ClinicalTrials.gov processed this record on July 22, 2014