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

NCT ID: NCT00002850

Last Updated: 2015-11-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 212 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 1997-03-31
• Study Completion Date: 2012-01-31

Brief Summary

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.

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.

Conditions

Infection; Multiple Myeloma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Ciprofloxacin or ofloxacin

Quinolone:

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

Group Type: EXPERIMENTAL

ciprofloxacin

Intervention Type: DRUG

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.

ofloxacin

Intervention Type: DRUG

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.

TMP-SMX

TMP-SMX: 160 mg trimethoprim and 800 mg sulfamethoxazole every 12 hours

Group Type: EXPERIMENTAL

160 mg trimethoprim and 800 mg sulfamethoxazole

Intervention Type: DRUG

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..

No prophylaxis

The patient will receive no prophylactic antibiotics.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: 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.

Intervention Type: 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..

Intervention Type: DRUG

Other Intervention Names

Cipro; Floxin; TMP-SMX; Septra; Bactrim

Eligibility Criteria

Inclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 120 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Eastern Cooperative Oncology Group

NETWORK

Sponsor Role: collaborator

Gary Morrow

OTHER

Sponsor Role: lead

Responsible Party

Gary Morrow

Director, UR NCORP Research BAase

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Gary R. Morrow, PhD, MS

Role: STUDY_CHAIR

University of Rochester

Martin M. Oken, MD

Role: STUDY_CHAIR

CCOP - Metro-Minnesota

Claire Pomeroy, MD

Role: STUDY_CHAIR

University of California, Davis

Locations

MBCCOP - Gulf Coast

Mobile, Alabama, United States

Mobile Infirmary Medical Center

Mobile, Alabama, United States

Cedar Rapids Oncology Associates

Cedar Rapids, Iowa, United States

McCreery Cancer Center at Ottumwa Regional

Ottumwa, Iowa, United States

Siouxland Hematology-Oncology Associates, LLP

Sioux City, Iowa, United States

Mercy Medical Center - Sioux City

Sioux City, Iowa, United States

St. Luke's Regional Medical Center

Sioux City, Iowa, United States

CCOP - Wichita

Wichita, Kansas, United States

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States

Green Bay Oncology, Limited - Escanaba

Escanaba, Michigan, United States

Dickinson County Healthcare System

Iron Mountain, Michigan, United States

CCOP - Kalamazoo

Kalamazoo, Michigan, United States

Mayo Clinic Cancer Center

Rochester, Minnesota, United States

CCOP - Metro-Minnesota

Saint Louis Park, Minnesota, United States

CCOP - Kansas City

Kansas City, Missouri, United States

Hunterdon Regional Cancer Center at Hunterdon Medical Center

Flemington, New Jersey, United States

Warren Hospital

Phillipsburg, New Jersey, United States

CCOP - Hematology-Oncology Associates of Central New York

East Syracuse, New York, United States

St. Vincent's Comprehensive Cancer Center - Manhattan

New York, New York, United States

Our Lady of Mercy Medical Center Comprehensive Cancer Center

The Bronx, New York, United States

CCOP - Southeast Cancer Control Consortium

Goldsboro, North Carolina, United States

Mercy Cancer Center at Mercy Medical Center

Canton, Ohio, United States

MetroHealth Cancer Care Center at MetroHealth Medical Center

Cleveland, Ohio, United States

CCOP - Columbus

Columbus, Ohio, United States

CCOP - Dayton

Dayton, Ohio, United States

CCOP - Columbia River Oncology Program

Portland, Oregon, United States

Penn State Cancer Institute at Milton S. Hershey Medical Center

Hershey, Pennsylvania, United States

Lewistown Hospital

Lewistown, Pennsylvania, United States

Mount Nittany Medical Center

State College, Pennsylvania, United States

Chester County Hospital

West Chester, Pennsylvania, United States

CCOP - Greenville

Greenville, South Carolina, United States

Avera Cancer Institute

Sioux Falls, South Dakota, United States

Medical X-Ray Center, PC

Sioux Falls, South Dakota, United States

Sanford Cancer Center at Sanford USD Medical Center

Sioux Falls, South Dakota, United States

CCOP - Northwest

Tacoma, Washington, United States

Green Bay Oncology, Limited at St. Vincent Hospital Regional Cancer Center

Green Bay, Wisconsin, United States

Green Bay Oncology, Limited at St. Mary's Hospital

Green Bay, Wisconsin, United States

St. Mary's Hospital Medical Center - Green Bay

Green Bay, Wisconsin, United States

St. Vincent Hospital Regional Cancer Center

Green Bay, Wisconsin, United States

Bay Area Cancer Care Center at Bay Area Medical Center

Marinette, Wisconsin, United States

CCOP - Marshfield Clinic Research Foundation

Marshfield, Wisconsin, United States

Green Bay Oncology, Limited - Oconto Falls

Oconto Falls, Wisconsin, United States

Green Bay Oncology, Limited - Sturgeon Bay

Sturgeon Bay, Wisconsin, United States

Instituto Nacional de Enfermedades Neoplasicas

Lima, , Peru

Pretoria Academic Hospital

Pretoria, , South Africa

Countries

United States; Peru; South Africa

Other Identifiers

U10CA037420

Identifier Type: NIH

Identifier Source: secondary_id

View Link

URCC-U10994

Identifier Type: OTHER

Identifier Source: secondary_id

NCI-C95-0001

Identifier Type: OTHER

Identifier Source: secondary_id

URCC-URRSRB-6993

Identifier Type: OTHER

Identifier Source: secondary_id

NCI-P96-0073

Identifier Type: OTHER

Identifier Source: secondary_id

ECOG-U1099

Identifier Type: OTHER

Identifier Source: secondary_id

CDR0000065093

Identifier Type: -

Identifier Source: org_study_id