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

Information source: University of Rochester
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Infection; Multiple Myeloma

Intervention: ciprofloxacin (Drug); ofloxacin (Drug); 160 mg trimethoprim and 800 mg sulfamethoxazole (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Gary Morrow

Official(s) and/or principal investigator(s):
Gary R. Morrow, PhD, MS, Study Chair, Affiliation: University of Rochester
Martin M. Oken, MD, Study Chair, Affiliation: CCOP - Metro-Minnesota
Claire Pomeroy, MD, Study Chair, Affiliation: University of California, Davis


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.

Clinical Details

Official title: Oral Antibiotic Prophylaxis of Early Infection in Multiple Myeloma

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Primary outcome: Proportion of Patients Experiencing a Serious Bacterial Infection

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.


Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.



- 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.


- 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

Locations and Contacts

Instituto Nacional de Enfermedades Neoplasicas, Lima Lima 34, Peru

Pretoria Academic Hospital, Pretoria 0001, South Africa

MBCCOP - Gulf Coast, Mobile, Alabama 36606, United States

Mobile Infirmary Medical Center, Mobile, Alabama 36652-2144, United States

Cedar Rapids Oncology Associates, Cedar Rapids, Iowa 52403, United States

McCreery Cancer Center at Ottumwa Regional, Ottumwa, Iowa 52501, United States

Mercy Medical Center - Sioux City, Sioux City, Iowa 51104, United States

Siouxland Hematology-Oncology Associates, LLP, Sioux City, Iowa 51101, United States

St. Luke's Regional Medical Center, Sioux City, Iowa 51104, United States

CCOP - Wichita, Wichita, Kansas 67214-3882, United States

Beth Israel Deaconess Medical Center, Boston, Massachusetts 02215, United States

Green Bay Oncology, Limited - Escanaba, Escanaba, Michigan 49431, United States

Dickinson County Healthcare System, Iron Mountain, Michigan 49801, United States

CCOP - Kalamazoo, Kalamazoo, Michigan 49007-3731, United States

Mayo Clinic Cancer Center, Rochester, Minnesota 55905, United States

CCOP - Metro-Minnesota, St. Louis Park, Minnesota 55416, United States

CCOP - Kansas City, Kansas City, Missouri 64131, United States

Hunterdon Regional Cancer Center at Hunterdon Medical Center, Flemington, New Jersey 08822, United States

Warren Hospital, Phillipsburg, New Jersey 08865, United States

Our Lady of Mercy Medical Center Comprehensive Cancer Center, Bronx, New York 10466, United States

CCOP - Hematology-Oncology Associates of Central New York, East Syracuse, New York 13057, United States

St. Vincent's Comprehensive Cancer Center - Manhattan, New York, New York 10011, United States

CCOP - Southeast Cancer Control Consortium, Goldsboro, North Carolina 27534-9479, United States

Mercy Cancer Center at Mercy Medical Center, Canton, Ohio 44708, United States

MetroHealth Cancer Care Center at MetroHealth Medical Center, Cleveland, Ohio 44109, United States

CCOP - Columbus, Columbus, Ohio 43215, United States

CCOP - Dayton, Dayton, Ohio 45429, United States

CCOP - Columbia River Oncology Program, Portland, Oregon 97225, United States

Penn State Cancer Institute at Milton S. Hershey Medical Center, Hershey, Pennsylvania 17033-0850, United States

Lewistown Hospital, Lewistown, Pennsylvania 17044, United States

Mount Nittany Medical Center, State College, Pennsylvania 16803, United States

Chester County Hospital, West Chester, Pennsylvania 19380, United States

CCOP - Greenville, Greenville, South Carolina 29615, United States

Avera Cancer Institute, Sioux Falls, South Dakota 57105, United States

Medical X-Ray Center, PC, Sioux Falls, South Dakota 57105, United States

Sanford Cancer Center at Sanford USD Medical Center, Sioux Falls, South Dakota 57117-5039, United States

CCOP - Northwest, Tacoma, Washington 98405-0986, United States

Green Bay Oncology, Limited at St. Mary's Hospital, Green Bay, Wisconsin 54303, United States

Green Bay Oncology, Limited at St. Vincent Hospital Regional Cancer Center, Green Bay, Wisconsin 54301-3526, United States

St. Mary's Hospital Medical Center - Green Bay, Green Bay, Wisconsin 54303, United States

St. Vincent Hospital Regional Cancer Center, Green Bay, Wisconsin 54307-3508, United States

Bay Area Cancer Care Center at Bay Area Medical Center, Marinette, Wisconsin 54143, United States

CCOP - Marshfield Clinic Research Foundation, Marshfield, Wisconsin 54449, United States

Green Bay Oncology, Limited - Oconto Falls, Oconto Falls, Wisconsin 54154, United States

Green Bay Oncology, Limited - Sturgeon Bay, Sturgeon Bay, Wisconsin 54235, United States

Additional Information

Clinical trial summary from the National Cancer Institute's PDQ® database

Starting date: March 1997
Last updated: February 11, 2015

Page last updated: August 23, 2015

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