Infections

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Multiple Myeloma

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Anti-Bacterial Agents

Ciprofloxacin

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Trimethoprim

Sulfamethoxazole

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Quinolone:

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

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

The patient will receive no prophylactic antibiotics.

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.

ciprofloxacin

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.

ofloxacin

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..

160 mg trimethoprim and 800 mg sulfamethoxazole

Gary R. Morrow, PhD, MS

Martin M. Oken, MD

Claire Pomeroy, MD

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.

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.

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

Oral Antibiotic Prophylaxis of Early Infection in Multiple Myeloma

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.

National Cancer Institute (NCI)

Eastern Cooperative Oncology Group

Gary Morrow

Director, UR NCORP Research BAase

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.

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.

Ciprofloxacin or Ofloxacin

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..

TMP-SMX

No Prophylaxis: The patient will receive no prophylactic antibiotics.

Observation

No prophylaxis: The patient will receive no prophylactic antibiotics.

Total

Age, Continuous

Sex: Female, Male

White

Unknown

Race/Ethnicity, Customized

United States

Region of Enrollment

Infection in last 6 months

Melphalan, Prednisone

VBMCP

Vincristine, Adriamycin, Dexamethasone

Other

VBMCP=vincristine, carmustine, melphalan, cyclophosphamide, and prednisone

Chemotherapy regimen

ECOG PERFORMANCE STATUS: Used by doctors and researchers to assess how a patient's disease is progressing.

0: Fully active, able to carry on pre-disease performance

1. Restricted in physically strenuous activity but ambulatory; able to carry out work of a light or sedentary nature
2. Ambulatory and capable of all selfcare but unable to carry out any work activities. Up and about more than 50% of waking hours
3. Capable of limited selfcare, confined to bed or chair more than 50% of waking hours
4. Completely disabled. Cannot carry on selfcare. Confined to bed or chair
5. Dead

Eastern Cooperative Oncology Group (ECOG) performance status

Patients with symptomatic and untreated MM receiving chemotherapy without an active infection during the 7 days prior to initiation of chemotherapy and off antibiotics for the prior 7 days were eligable for this study. They were required to receive myelosuppressive and/or immunosuppressive chemotherapy, and were randomized on a 1:1 basis.

Charles E. Heckler, PhD, MS. Research Assistant Professor

H0: There is no significant difference in the incidence of severe bacterial infections among all three arms during the first 2 months of treatment at the two-sided 0.05 significance level.

Ha: There is a significant difference in the incidence of severe bacterial infections among all three arms during the first 2 months of treatment at the two-sided 0.05 significance level.

No Prophylaxis

Proportion of Patients Experiencing a Serious Bacterial Infection

Patients observed without intervention and evaluated for SBI for the first 2 months of treatment.

Overall Study

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Antibiotic Therapy in Preventing Early Infection in Patients With Multiple Myeloma Who Are Receiving Chemotherapy	NCT00002850	Infection Multiple Myelom...	ciprofloxacin ofloxacin 160 mg trimetho...	18 Years - 120 Years	University of Rochester
Antibiotic Therapy in Preventing Early Infection in Patients With Multiple Myeloma Who Are Receiving Chemotherapy	NCT00002850	Infection Multiple Myelom...	ciprofloxacin ofloxacin 160 mg trimetho...	18 Years - 120 Years	University of Rochester

Spots Global Cancer Trial Database for 160 mg trimethoprim and 800 mg sulfamethoxazole