Trial Outcomes & Findings for Celecoxib in Preventing Multiple Myeloma in Patients With Monoclonal Gammopathy or Smoldering Myeloma (NCT NCT00099047)
NCT ID: NCT00099047
Last Updated: 2016-12-30
Results Overview
For a given biomarker (or a suitable transformation of it, e.g. log transform) t-tests and Wilcoxon tests (2-sample t-test and Wilcoxon rank sum test for between treatment comparisons, and paired 1-sample t-test and Wilcoxon signed rank test for within treatment comparisons) will be used to detect statistically significant differences between (or within) treatments.
COMPLETED
PHASE2
23 participants
Baseline and 6 months
2016-12-30
Participant Flow
23 asymptomatic adult patients with a serum monoclonal protein \>1g/dL from Cleveland Clinic, Mayo Clinic, or University of Arkansas Medical Center were randomized between August 2005 and April 2008
There were no significant events or approaches utilized following enrollment but prior to group assignment.
Participant milestones
| Measure |
Arm I (Celecoxib)
Patients receive celecoxib PO BID for 6 months in the absence of unacceptable toxicity or progression to malignancy.
|
Arm II (Placebo)
Patients receive placebo PO BID for 6 months in the absence of unacceptable toxicity or progression to malignancy.
|
|---|---|---|
|
Overall Study
STARTED
|
11
|
12
|
|
Overall Study
COMPLETED
|
11
|
12
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Celecoxib in Preventing Multiple Myeloma in Patients With Monoclonal Gammopathy or Smoldering Myeloma
Baseline characteristics by cohort
| Measure |
Arm I (Celecoxib)
n=11 Participants
Patients receive celecoxib PO BID for 6 months in the absence of unacceptable toxicity or progression to malignancy.
|
Arm II (Placebo)
n=12 Participants
Patients receive placebo PO BID for 6 months in the absence of unacceptable toxicity or progression to malignancy.
|
Total
n=23 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
8 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Gender
Female
|
5 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Gender
Male
|
6 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
10 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
11 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
11 participants
n=5 Participants
|
12 participants
n=7 Participants
|
23 participants
n=5 Participants
|
|
serum monoclonal protein >1g/dL
|
11 participants
n=5 Participants
|
12 participants
n=7 Participants
|
23 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline and 6 monthsPopulation: One patient on the celecoxib arm was considered inevaluable and not included in this participants analyzed.
For a given biomarker (or a suitable transformation of it, e.g. log transform) t-tests and Wilcoxon tests (2-sample t-test and Wilcoxon rank sum test for between treatment comparisons, and paired 1-sample t-test and Wilcoxon signed rank test for within treatment comparisons) will be used to detect statistically significant differences between (or within) treatments.
Outcome measures
| Measure |
Arm I (Celecoxib)
n=10 Participants
Patients receive celecoxib PO BID for 6 months in the absence of unacceptable toxicity or progression to malignancy.
|
Arm II (Placebo)
n=12 Participants
Patients receive placebo PO BID for 6 months in the absence of unacceptable toxicity or progression to malignancy.
|
|---|---|---|
|
Changes in M-protein Levels
|
1.65 g/dL
Standard Deviation 0.36
|
2.24 g/dL
Standard Deviation 0.36
|
Adverse Events
Arm I (Celecoxib)
Arm II (Placebo)
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Arm I (Celecoxib)
n=11 participants at risk
Patients receive celecoxib PO BID for 6 months in the absence of unacceptable toxicity or progression to malignancy.
|
Arm II (Placebo)
n=12 participants at risk
Patients receive placebo PO BID for 6 months in the absence of unacceptable toxicity or progression to malignancy.
|
|---|---|---|
|
Nervous system disorders
headache
|
18.2%
2/11 • Number of events 2
|
33.3%
4/12 • Number of events 4
|
|
General disorders
Fatigue
|
9.1%
1/11 • Number of events 1
|
16.7%
2/12 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Pruritus/Itching
|
18.2%
2/11 • Number of events 2
|
8.3%
1/12 • Number of events 1
|
|
Gastrointestinal disorders
Diarrhea
|
18.2%
2/11 • Number of events 2
|
8.3%
1/12 • Number of events 1
|
|
Gastrointestinal disorders
Constipation
|
18.2%
2/11 • Number of events 2
|
0.00%
0/12
|
|
Nervous system disorders
Dizziness
|
9.1%
1/11 • Number of events 1
|
8.3%
1/12 • Number of events 1
|
|
Nervous system disorders
Neuorpathy
|
18.2%
2/11 • Number of events 2
|
0.00%
0/12
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
9.1%
1/11 • Number of events 1
|
8.3%
1/12 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Exremity Limb Pain
|
0.00%
0/11
|
16.7%
2/12 • Number of events 5
|
|
Musculoskeletal and connective tissue disorders
Neck Pain
|
18.2%
2/11 • Number of events 2
|
8.3%
1/12 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Pain NOS
|
0.00%
0/11
|
16.7%
2/12 • Number of events 2
|
|
Infections and infestations
Upper Respiratory
|
9.1%
1/11 • Number of events 1
|
8.3%
1/12 • Number of events 1
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60