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

This study has been completed.
Sponsor:
Collaborators:
National Cancer Institute (NCI)
Eastern Cooperative Oncology Group
Information provided by (Responsible Party):
Gary Morrow, University of Rochester NCORP Research Base
ClinicalTrials.gov Identifier:
NCT00002850
First received: November 1, 1999
Last updated: October 13, 2015
Last verified: October 2015
  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
Drug: ciprofloxacin
Drug: ofloxacin
Drug: 160 mg trimethoprim and 800 mg sulfamethoxazole
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel 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: First three months of chemotherapy ] [ Designated as safety issue: No ]
    This study evaluated the impact of prophylactic antibiotics on the incidence of serious bacterial infections (SBIs) during the first 2 months of treatment in patients with newly diagnosed multiple myeloma. Patients with multiple myeloma receiving initial chemotherapy were randomized on a 1:1:1 basis to daily ciprofloxacin, trimethoprim-sulfamethoxazole, or observation and evaluated for SBI for the first 2 months of treatment.


Enrollment: 212
Study Start Date: March 1997
Study Completion Date: January 2012
Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Ciprofloxacin or ofloxacin

Quinolone:

Ciprofloxacin 500 mg every 12 hours or Ofloxacin400 mg every 12 hours.

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.
Other Name: Cipro
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.
Other Name: Floxin
Experimental: TMP-SMX
TMP-SMX: 160 mg trimethoprim and 800 mg sulfamethoxazole every 12 hours
Drug: 160 mg trimethoprim and 800 mg sulfamethoxazole
Begin oral TMP-SMX 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..
Other Names:
  • TMP-SMX
  • Septra
  • Bactrim
No Intervention: No prophylaxis
The patient will receive no prophylactic antibiotics.

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.
  • Arm III: The patient will receive no prophylaxis.

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 212 patients (71 per treatment arm) will be accrued for this study.

  Eligibility

Ages Eligible for Study:   18 Years to 120 Years   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion:

  • Patient must have a diagnosis of multiple myeloma confirmed by the presence of:
  • Bone marrow plasmacytosis with >10% abnormal plasma cells or multiple biopsy-proven plasmacytomas, and at least one of the criteria below must be documented:

    1. Myeloma protein in the serum
    2. Myeloma protein in the urine (free monoclonal light chain)
    3. Radiologic evidence of osteolytic lesions (generalized osteoporosis qualifies only if the bone marrow aspirate contains >20% plasma cells)
  • Patients must have no active infection during the prior seven days and be off all antibiotics for the prior seven days.
  • Patients cannot have received radiotherapy during the preceding ten days.
  • Primary therapy for multiple myeloma must start within three days after entry to this study. For purposes of eligibility for this study, myelosuppressive chemotherapy or high-dose dexamethasone based regimens are acceptable as primary therapy. The high-dose dexamethasone regimen must include, at a minimum, dexamethasone 40 mg per day days 1-4, 9-12, 17-20 for the first cycle and 40 mg per day on days 1-4 of the second cycle.
  • Patients who are to receive dexamethasone alone or dexamethasone with thalidomide are among those eligible for this protocol.
  • Patients must have a serum creatinine <5.0 mg/dl and not require dialysis at the time of study entry. If patients require dialysis after enrollment, they can continue on the protocol using the adjusted medication guidelines
  • Written informed consent must be obtained prior to entry.

Exclusion:

- Patients with smoldering myeloma, history of hypersensitivity to fluoroquinolones or trimethoprim, bone marrow transplant or autologous stem cell rescue planned during the first two months of treatment, patients taking theophylline, or patients previously treated with chemotherapy or high-dose dexamethasone

  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
National Cancer Institute (NCI)
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

Responsible Party: Gary Morrow, Director, UR NCORP Research BAase, University of Rochester NCORP Research Base
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
Results First Received: July 10, 2014
Last Updated: October 13, 2015
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:
Infection
Communicable Diseases
Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Anti-Bacterial Agents
Ciprofloxacin
Ofloxacin
Levofloxacin
Trimethoprim, Sulfamethoxazole Drug Combination
Antibiotics, Antitubercular
Trimethoprim
Sulfamethoxazole
Anti-Infective Agents
Antitubercular Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on July 21, 2016