Trial Outcomes & Findings for Antibiotic Therapy in Preventing Early Infection in Patients With Multiple Myeloma Who Are Receiving Chemotherapy (NCT NCT00002850)
NCT ID: NCT00002850
Last Updated: 2015-11-11
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
212 participants
Primary outcome timeframe
First three months of chemotherapy
Results posted on
2015-11-11
Participant Flow
Participant milestones
| Measure |
Ciprofloxacin or Ofloxacin
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.
|
TMP-SMX
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..
|
Observation
Patients observed without intervention and evaluated for SBI for the first 2 months of treatment.
|
|---|---|---|---|
|
Overall Study
STARTED
|
69
|
76
|
67
|
|
Overall Study
COMPLETED
|
64
|
74
|
63
|
|
Overall Study
NOT COMPLETED
|
5
|
2
|
4
|
Reasons for withdrawal
| Measure |
Ciprofloxacin or Ofloxacin
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.
|
TMP-SMX
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..
|
Observation
Patients observed without intervention and evaluated for SBI for the first 2 months of treatment.
|
|---|---|---|---|
|
Overall Study
Death
|
4
|
1
|
3
|
|
Overall Study
Protocol Violation
|
1
|
0
|
1
|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
0
|
Baseline Characteristics
Antibiotic Therapy in Preventing Early Infection in Patients With Multiple Myeloma Who Are Receiving Chemotherapy
Baseline characteristics by cohort
| Measure |
Ciprofloxacin or Ofloxacin
n=69 Participants
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.
|
TMP-SMX
n=76 Participants
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..
|
Observation
n=67 Participants
No prophylaxis: The patient will receive no prophylactic antibiotics.
|
Total
n=212 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
63.7 years
n=93 Participants
|
62.6 years
n=4 Participants
|
65.0 years
n=27 Participants
|
63.2 years
n=483 Participants
|
|
Sex: Female, Male
Female
|
23 Participants
n=93 Participants
|
32 Participants
n=4 Participants
|
24 Participants
n=27 Participants
|
79 Participants
n=483 Participants
|
|
Sex: Female, Male
Male
|
46 Participants
n=93 Participants
|
44 Participants
n=4 Participants
|
43 Participants
n=27 Participants
|
133 Participants
n=483 Participants
|
|
Race/Ethnicity, Customized
White
|
54 participants
n=93 Participants
|
51 participants
n=4 Participants
|
55 participants
n=27 Participants
|
160 participants
n=483 Participants
|
|
Race/Ethnicity, Customized
Unknown
|
15 participants
n=93 Participants
|
25 participants
n=4 Participants
|
12 participants
n=27 Participants
|
52 participants
n=483 Participants
|
|
Region of Enrollment
United States
|
69 participants
n=93 Participants
|
76 participants
n=4 Participants
|
67 participants
n=27 Participants
|
212 participants
n=483 Participants
|
|
Infection in last 6 months
Yes
|
13 participants
n=93 Participants
|
7 participants
n=4 Participants
|
8 participants
n=27 Participants
|
28 participants
n=483 Participants
|
|
Infection in last 6 months
Unknown
|
56 participants
n=93 Participants
|
69 participants
n=4 Participants
|
59 participants
n=27 Participants
|
184 participants
n=483 Participants
|
|
Chemotherapy regimen
Melphalan, Prednisone
|
11 participants
n=93 Participants
|
13 participants
n=4 Participants
|
10 participants
n=27 Participants
|
34 participants
n=483 Participants
|
|
Chemotherapy regimen
VBMCP
|
6 participants
n=93 Participants
|
8 participants
n=4 Participants
|
8 participants
n=27 Participants
|
22 participants
n=483 Participants
|
|
Chemotherapy regimen
Vincristine, Adriamycin, Dexamethasone
|
24 participants
n=93 Participants
|
17 participants
n=4 Participants
|
22 participants
n=27 Participants
|
63 participants
n=483 Participants
|
|
Chemotherapy regimen
Other
|
28 participants
n=93 Participants
|
38 participants
n=4 Participants
|
27 participants
n=27 Participants
|
93 participants
n=483 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) performance status
|
1.0 units on a scale
n=93 Participants
|
1.1 units on a scale
n=4 Participants
|
0.8 units on a scale
n=27 Participants
|
1.0 units on a scale
n=483 Participants
|
PRIMARY outcome
Timeframe: First three months of chemotherapyThis 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.
Outcome measures
| Measure |
Ciprofloxacin or Ofloxacin
n=64 Participants
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.
|
TMP-SMX
n=74 Participants
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..
|
No Prophylaxis
n=63 Participants
The patient will receive no prophylactic antibiotics.
|
|---|---|---|---|
|
Proportion of Patients Experiencing a Serious Bacterial Infection
|
12.5 percentage of participants
Interval 5.6 to 23.2
|
6.8 percentage of participants
Interval 2.2 to 15.1
|
15.9 percentage of participants
Interval 7.9 to 27.3
|
Adverse Events
Ciprofloxacin or Ofloxacin
Serious events: 1 serious events
Other events: 1 other events
Deaths: 0 deaths
TMP-SMX
Serious events: 2 serious events
Other events: 1 other events
Deaths: 0 deaths
Observation
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Ciprofloxacin or Ofloxacin
n=69 participants at risk
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.
|
TMP-SMX
n=76 participants at risk
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..
|
Observation
n=67 participants at risk
No Prophylaxis: The patient will receive no prophylactic antibiotics.
|
|---|---|---|---|
|
General disorders
Death
|
1.4%
1/69 • Three months.
|
0.00%
0/76 • Three months.
|
0.00%
0/67 • Three months.
|
|
Renal and urinary disorders
Renal failure
|
0.00%
0/69 • Three months.
|
1.3%
1/76 • Three months.
|
0.00%
0/67 • Three months.
|
|
Infections and infestations
Infection, thrush, allergic reaction
|
0.00%
0/69 • Three months.
|
1.3%
1/76 • Three months.
|
0.00%
0/67 • Three months.
|
Other adverse events
| Measure |
Ciprofloxacin or Ofloxacin
n=69 participants at risk
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.
|
TMP-SMX
n=76 participants at risk
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..
|
Observation
n=67 participants at risk
No Prophylaxis: The patient will receive no prophylactic antibiotics.
|
|---|---|---|---|
|
Infections and infestations
Thrush
|
0.00%
0/69 • Three months.
|
1.3%
1/76 • Three months.
|
0.00%
0/67 • Three months.
|
|
Gastrointestinal disorders
GI bleed
|
1.4%
1/69 • Three months.
|
0.00%
0/76 • Three months.
|
0.00%
0/67 • Three months.
|
Additional Information
Charles E. Heckler, PhD, MS. Research Assistant Professor
University of Rochester Medical Center
Phone: 585-273-1141
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place