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Oral Antibiotic Prophylaxis of Early Infection in Multiple Myeloma


Phase 3
18 Years
N/A
Open (Enrolling)
Both
Infection, Multiple Myeloma and Plasma Cell Neoplasm

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Trial Information

Oral Antibiotic Prophylaxis of Early Infection in Multiple Myeloma


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Proportion of patients experiencing a serious bacterial infection

Outcome Time Frame:

during the first three months of chemotherapy

Safety Issue:

No

Principal Investigator

Gary R. Morrow, PhD, MS

Investigator Role:

Study Chair

Investigator Affiliation:

University of Rochester

Authority:

United States: Federal Government

Study ID:

CDR0000065093

NCT ID:

NCT00002850

Start Date:

March 1997

Completion Date:

August 2015

Related Keywords:

  • Infection
  • Multiple Myeloma and Plasma Cell Neoplasm
  • stage I multiple myeloma
  • stage II multiple myeloma
  • stage III multiple myeloma
  • infection
  • Neoplasms
  • Multiple Myeloma
  • Neoplasms, Plasma Cell
  • Plasmacytoma

Name

Location

Mayo Clinic Cancer CenterRochester, Minnesota  55905
CCOP - WichitaWichita, Kansas  67214-3882
CCOP - Kansas CityKansas City, Missouri  64131
CCOP - Southeast Cancer Control ConsortiumWinston-Salem, North Carolina  27104-4241
Beth Israel Deaconess Medical CenterBoston, Massachusetts  02215
CCOP - KalamazooKalamazoo, Michigan  49007-3731
CCOP - Metro-MinnesotaSaint Louis Park, Minnesota  55416
Cedar Rapids Oncology AssociatesCedar Rapids, Iowa  52403
Mercy Medical Center - Sioux CitySioux City, Iowa  51104
Siouxland Hematology-Oncology Associates, LLPSioux City, Iowa  51101
St. Luke's Regional Medical CenterSioux City, Iowa  51104
Mercy Cancer Center at Mercy Medical CenterCanton, Ohio  44708
MetroHealth Cancer Care Center at MetroHealth Medical CenterCleveland, Ohio  44109
Penn State Cancer Institute at Milton S. Hershey Medical CenterHershey, Pennsylvania  17033-0850
Sanford Cancer Center at Sanford USD Medical CenterSioux Falls, South Dakota  57117-5039
Medical X-Ray Center, PCSioux Falls, South Dakota  57105
Avera Cancer InstituteSioux Falls, South Dakota  57105
CCOP - ColumbusColumbus, Ohio  43206
CCOP - DaytonKettering, Ohio  45429
CCOP - GreenvilleGreenville, South Carolina  29615
CCOP - Columbia River Oncology ProgramPortland, Oregon  97225
MBCCOP - Gulf CoastMobile, Alabama  36688
CCOP - NorthwestTacoma, Washington  98405-0986
Mobile Infirmary Medical CenterMobile, Alabama  36640-0460
St. Vincent Hospital Regional Cancer CenterGreen Bay, Wisconsin  54307-3508
CCOP - Marshfield Clinic Research FoundationMarshfield, Wisconsin  54449
McCreery Cancer Center at Ottumwa RegionalOttumwa, Iowa  52501
Green Bay Oncology, Limited - EscanabaEscanaba, Michigan  49431
Dickinson County Healthcare SystemIron Mountain, Michigan  49801
Hunterdon Regional Cancer Center at Hunterdon Medical CenterFlemington, New Jersey  08822
Warren HospitalPhillipsburg, New Jersey  08865
Our Lady of Mercy Medical Center Comprehensive Cancer CenterBronx, New York  10466
CCOP - Hematology-Oncology Associates of Central New YorkEast Syracuse, New York  13057
St. Vincent's Comprehensive Cancer Center - ManhattanNew York, New York  10011
Lewistown HospitalLewistown, Pennsylvania  17044
Mount Nittany Medical CenterState College, Pennsylvania  16803
Chester County HospitalWest Chester, Pennsylvania  19380
St. Mary's Hospital Medical Center - Green BayGreen Bay, Wisconsin  54303
Green Bay Oncology, Limited at St. Vincent Hospital Regional Cancer CenterGreen Bay, Wisconsin  54301-3526
Green Bay Oncology, Limited at St. Mary's HospitalGreen Bay, Wisconsin  54303
Bay Area Cancer Care Center at Bay Area Medical CenterMarinette, Wisconsin  54143
Green Bay Oncology, Limited - Oconto FallsOconto Falls, Wisconsin  54154
Green Bay Oncology, Limited - Sturgeon BaySturgeon Bay, Wisconsin  54235