InfectionPhase 3NCT00002850
Antibiotic Therapy in Preventing Early Infection in Patients With Multiple Myeloma Who Are Receiving Chemotherapy
A Phase 3 study testing ciprofloxacin, ofloxacin and 160 mg trimethoprim and 800 mg sulfamethoxazole in people with Infection and Multiple Myeloma, run by Gary Morrow at 45 sites in 3 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 120 years
- Conditions the study is for
- Infection, Multiple Myeloma
- What is being tested?
- ciprofloxacin, ofloxacin and 160 mg trimethoprim and 800 mg sulfamethoxazole
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 212 participants
- Where
- 45 sitesin 3 countries
- Study dates
- Mar 1997to Jan 2012
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 120 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
- Myeloma protein in the serum
- Myeloma protein in the urine (free monoclonal light chain)
- 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.
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- 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.
Who cannot join
- 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
Trial locations and contacts
45 sites in 3 countries.
45 sites in 3 countries
United States43 sites
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
Mercy Cancer Center at Mercy Medical Center
Canton, Ohio, 44708
Cedar Rapids Oncology Associates
Cedar Rapids, Iowa, 52403
MetroHealth Cancer Care Center at MetroHealth Medical Center
Cleveland, Ohio, 44109
CCOP - Columbus
Columbus, Ohio, 43215
CCOP - Dayton
Dayton, Ohio, 45429
CCOP - Hematology-Oncology Associates of Central New York
East Syracuse, New York, 13057
Green Bay Oncology, Limited - Escanaba
Escanaba, Michigan, 49431
Hunterdon Regional Cancer Center at Hunterdon Medical Center
Flemington, New Jersey, 08822
CCOP - Southeast Cancer Control Consortium
Goldsboro, North Carolina, 27534-9479
Green Bay Oncology, Limited at St. Vincent Hospital Regional Cancer Center
Green Bay, Wisconsin, 54301-3526
Green Bay Oncology, Limited at St. Mary's Hospital
Green Bay, Wisconsin, 54303
St. Mary's Hospital Medical Center - Green Bay
Green Bay, Wisconsin, 54303
St. Vincent Hospital Regional Cancer Center
Green Bay, Wisconsin, 54307-3508
CCOP - Greenville
Greenville, South Carolina, 29615
Penn State Cancer Institute at Milton S. Hershey Medical Center
Hershey, Pennsylvania, 17033-0850
Dickinson County Healthcare System
Iron Mountain, Michigan, 49801
CCOP - Kalamazoo
Kalamazoo, Michigan, 49007-3731
CCOP - Kansas City
Kansas City, Missouri, 64131
Lewistown Hospital
Lewistown, Pennsylvania, 17044
Bay Area Cancer Care Center at Bay Area Medical Center
Marinette, Wisconsin, 54143
CCOP - Marshfield Clinic Research Foundation
Marshfield, Wisconsin, 54449
MBCCOP - Gulf Coast
Mobile, Alabama, 36606
Mobile Infirmary Medical Center
Mobile, Alabama, 36652-2144
St. Vincent's Comprehensive Cancer Center - Manhattan
New York, New York, 10011
Green Bay Oncology, Limited - Oconto Falls
Oconto Falls, Wisconsin, 54154
McCreery Cancer Center at Ottumwa Regional
Ottumwa, Iowa, 52501
Warren Hospital
Phillipsburg, New Jersey, 08865
CCOP - Columbia River Oncology Program
Portland, Oregon, 97225
Mayo Clinic Cancer Center
Rochester, Minnesota, 55905
CCOP - Metro-Minnesota
Saint Louis Park, Minnesota, 55416
Siouxland Hematology-Oncology Associates, LLP
Sioux City, Iowa, 51101
Mercy Medical Center - Sioux City
Sioux City, Iowa, 51104
St. Luke's Regional Medical Center
Sioux City, Iowa, 51104
Avera Cancer Institute
Sioux Falls, South Dakota, 57105
Medical X-Ray Center, PC
Sioux Falls, South Dakota, 57105
Sanford Cancer Center at Sanford USD Medical Center
Sioux Falls, South Dakota, 57117-5039
Mount Nittany Medical Center
State College, Pennsylvania, 16803
Green Bay Oncology, Limited - Sturgeon Bay
Sturgeon Bay, Wisconsin, 54235
CCOP - Northwest
Tacoma, Washington, 98405-0986
Our Lady of Mercy Medical Center Comprehensive Cancer Center
The Bronx, New York, 10466
Chester County Hospital
West Chester, Pennsylvania, 19380
CCOP - Wichita
Wichita, Kansas, 67214-3882
About this study
Official title: Oral Antibiotic Prophylaxis of Early Infection in Multiple Myeloma
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.
Read the 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
- Being tested
- ciprofloxacin, ofloxacin, 160 mg trimethoprim and 800 mg sulfamethoxazole
- Keywords
- stage I multiple myeloma, stage II multiple myeloma, stage III multiple myeloma, infection
- Medical subject headings
- Infections, Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ciprofloxacinDrug
Also called Cipro
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.
ofloxacinDrug
Also called Floxin
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.
160 mg trimethoprim and 800 mg sulfamethoxazoleDrug
Also called TMP-SMX, Septra, Bactrim
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..
| Study group | Role | What they receive |
|---|---|---|
| Ciprofloxacin or ofloxacin | Experimental | Quinolone:
Ciprofloxacin 500 mg every 12 hours or Ofloxacin400 mg every 12 hours. Receives: Drug: ciprofloxacin; Drug: ofloxacin |
| TMP-SMX | Experimental | TMP-SMX: 160 mg trimethoprim and 800 mg sulfamethoxazole every 12 hours Receives: Drug: 160 mg trimethoprim and 800 mg sulfamethoxazole |
| No prophylaxis | No intervention | The patient will receive no prophylactic antibiotics. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of Patients Experiencing a Serious Bacterial Infection
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.
Measured: First three months of chemotherapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2003 (estimated)
- Study startMar 1997
- Primary completionApr 2011
- Study completionJan 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 212 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gary Morrow
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI), Eastern Cooperative Oncology Group
- Responsible party
- Sponsor-investigator, Gary Morrow, University of Rochester NCORP Research Base
- Investigators
- Gary R. Morrow, PhD, MS, Study chair, University of RochesterMartin M. Oken, MD, Study chair, CCOP - Metro-MinnesotaClaire Pomeroy, MD, Study chair, University of California, Davis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00002850
- Sponsor's protocol ID
- CDR0000065093
- Other IDs
- U10CA037420, URCC-U10994, NCI-C95-0001, URCC-URRSRB-6993, NCI-P96-0073, ECOG-U1099
- Status last verified
- Oct 2015
- First submitted
- 1 Nov 1999
- Last updated
- 11 Nov 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oral Antibiotic Prophylaxis of Early Infection in Multiple Myeloma
- ClinicalTrials.gov ID
- NCT00002850
- Acronym / sponsor ID
- CDR0000065093
- Conditions
- Infection, Multiple Myeloma
- Keywords
- stage I multiple myeloma, stage II multiple myeloma, stage III multiple myeloma, infection
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 212 participants (actual)
- Lead sponsor
- Gary MorrowUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI), Eastern Cooperative Oncology Group
- Study start
- Mar 1997
- Primary completion
- Apr 2011 (actual)
- Study completion
- Jan 2012 (actual)
- First posted
- 27 Jan 2003 (estimated)
- Results
- Posted 13 Feb 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Ciprofloxacin or ofloxacin | Experimental | Drug: ciprofloxacin, Drug: ofloxacinQuinolone: Ciprofloxacin 500 mg every 12 hours or Ofloxacin400 mg every 12 hours. |
| TMP-SMX | Experimental | Drug: 160 mg trimethoprim and 800 mg sulfamethoxazoleTMP-SMX: 160 mg trimethoprim and 800 mg sulfamethoxazole every 12 hours |
| No prophylaxis | No intervention | –The patient will receive no prophylactic antibiotics. |
Who may qualify
- Ages
- 18 to 120 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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:
- 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.
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ciprofloxacinAlso: CiproBegin 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. | Drug | Ciprofloxacin or ofloxacin |
| ofloxacinAlso: FloxinBegin 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. | Drug | Ciprofloxacin or ofloxacin |
| 160 mg trimethoprim and 800 mg sulfamethoxazoleAlso: TMP-SMX, Septra, BactrimBegin 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.. | Drug | TMP-SMX |
Primary outcome
Proportion of Patients Experiencing a Serious Bacterial Infection
Time frame: First three months of chemotherapy
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Nov 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gary R. Morrow, PhD, MS study chair
University of Rochester
Martin M. Oken, MD study chair
CCOP - Metro-Minnesota
Claire Pomeroy, MD study chair
University of California, Davis
45 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing ciprofloxacin, ofloxacin and 160 mg trimethoprim and 800 mg sulfamethoxazole in people with Infection and Multiple Myeloma, run by Gary Morrow at 45 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Nov 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 45 sites in United States, Peru, South Africa. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 13 Feb 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of Patients Experiencing a Serious Bacterial Infection (time frame: First three months of chemotherapy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Nov 2015.