Trial Outcomes & Findings for Intervention for Symptom Burden During Maintenance Therapy for Multiple Myeloma (NCT NCT01793051)
NCT ID: NCT01793051
Last Updated: 2021-11-24
Results Overview
Minocycline tested for its ability to reduce the value of a patient's 3 month (± two days) area under the curve (AUC) for the mean of 5 symptoms: fatigue, pain, muscle weakness, numbness, and bone aches. The AUC is calculated using a trapezoidal approximation, derived by multiplying half of the base with the sum of the two heights. The two heights correspond to the two mean symptom scores computed at each of these assessments. The AUC is measured in units of mean MDASI score in days. The area for the subsequent trapezoid can be calculated in the same way. Given a baseline, weekly assessment schedule over a three month period and end of trial assessment, there will be a total of 14 trapezoids. The AUC is the sum of the area of the 14 trapezoids. Each of the trapezoid has a maximum value of 70 (0.5\*7 days\*(10+10)). Hence, the AUC will have a minimum score of 0 and a maximum score of 980. Higher AUC values indicate worse outcomes.
COMPLETED
PHASE2
88 participants
Baseline to 3 months (three cycles with assessments made at beginning of each)
2021-11-24
Participant Flow
All recruitment done at the University of Texas MD Anderson Cancer
88 participants enrolled and randomized to either the intervention group or the control group. 1 patient withdrew before the study began.
Participant milestones
| Measure |
Minocycline
Minocycline 100 mg (capsule) two times a day to begin with start of maintenance therapy (3 months +/- 2 days)
|
Placebo
Placebo 100 mg (capsule) two times a day to begin with start of maintenance therapy (3 months +/- 2 days)
|
|---|---|---|
|
Overall Study
STARTED
|
43
|
44
|
|
Overall Study
COMPLETED
|
33
|
36
|
|
Overall Study
NOT COMPLETED
|
10
|
8
|
Reasons for withdrawal
| Measure |
Minocycline
Minocycline 100 mg (capsule) two times a day to begin with start of maintenance therapy (3 months +/- 2 days)
|
Placebo
Placebo 100 mg (capsule) two times a day to begin with start of maintenance therapy (3 months +/- 2 days)
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
6
|
4
|
|
Overall Study
Adverse Event
|
0
|
2
|
|
Overall Study
Too ill to continue
|
1
|
0
|
|
Overall Study
Switched chemo
|
1
|
1
|
|
Overall Study
Lack of compliance
|
1
|
0
|
|
Overall Study
Requested to be removed from the study
|
1
|
1
|
Baseline Characteristics
Intervention for Symptom Burden During Maintenance Therapy for Multiple Myeloma
Baseline characteristics by cohort
| Measure |
Minocycline
n=33 Participants
Minocycline 100 mg (capsule) two times a day to begin with start of maintenance therapy (3 months +/- 2 days)
|
Placebo
n=36 Participants
Placebo 100 mg (capsule) two times a day to begin with start of maintenance therapy (3 months +/- 2 days)
|
Total
n=69 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
62 years
n=5 Participants
|
60 years
n=7 Participants
|
61 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
22 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
51 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
26 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
53 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
5 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
33 participants
n=5 Participants
|
36 participants
n=7 Participants
|
69 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline to 3 months (three cycles with assessments made at beginning of each)Minocycline tested for its ability to reduce the value of a patient's 3 month (± two days) area under the curve (AUC) for the mean of 5 symptoms: fatigue, pain, muscle weakness, numbness, and bone aches. The AUC is calculated using a trapezoidal approximation, derived by multiplying half of the base with the sum of the two heights. The two heights correspond to the two mean symptom scores computed at each of these assessments. The AUC is measured in units of mean MDASI score in days. The area for the subsequent trapezoid can be calculated in the same way. Given a baseline, weekly assessment schedule over a three month period and end of trial assessment, there will be a total of 14 trapezoids. The AUC is the sum of the area of the 14 trapezoids. Each of the trapezoid has a maximum value of 70 (0.5\*7 days\*(10+10)). Hence, the AUC will have a minimum score of 0 and a maximum score of 980. Higher AUC values indicate worse outcomes.
Outcome measures
| Measure |
Minocycline
n=33 Participants
Minocycline 100 mg (capsule) two times a day to begin with start of maintenance therapy (3 months +/- 2 days)
|
Placebo
n=36 Participants
Placebo 100 mg (capsule) two times a day to begin with start of maintenance therapy (3 months +/- 2 days)
|
|---|---|---|
|
Symptom Reduction
|
26.02 units on a scale*month
Standard Deviation 17.72
|
26.65 units on a scale*month
Standard Deviation 21.19
|
Adverse Events
Minocycline
Placebo
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Minocycline
n=33 participants at risk
Minocycline 100 mg (capsule) two times a day to begin with start of maintenance therapy (3 months +/- 2 days)
|
Placebo
n=36 participants at risk
Placebo 100 mg (capsule) two times a day to begin with start of maintenance therapy (3 months +/- 2 days)
|
|---|---|---|
|
Nervous system disorders
Anxiety
|
3.0%
1/33 • From the start of the study medication, up to 30 days after last dose administered, up to a total of 4 months
|
2.8%
1/36 • From the start of the study medication, up to 30 days after last dose administered, up to a total of 4 months
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
3.0%
1/33 • From the start of the study medication, up to 30 days after last dose administered, up to a total of 4 months
|
0.00%
0/36 • From the start of the study medication, up to 30 days after last dose administered, up to a total of 4 months
|
|
Eye disorders
Blurred Vision
|
3.0%
1/33 • From the start of the study medication, up to 30 days after last dose administered, up to a total of 4 months
|
8.3%
3/36 • From the start of the study medication, up to 30 days after last dose administered, up to a total of 4 months
|
|
Gastrointestinal disorders
Constipation
|
6.1%
2/33 • From the start of the study medication, up to 30 days after last dose administered, up to a total of 4 months
|
11.1%
4/36 • From the start of the study medication, up to 30 days after last dose administered, up to a total of 4 months
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
3.0%
1/33 • From the start of the study medication, up to 30 days after last dose administered, up to a total of 4 months
|
2.8%
1/36 • From the start of the study medication, up to 30 days after last dose administered, up to a total of 4 months
|
|
Blood and lymphatic system disorders
Cytopenia
|
3.0%
1/33 • From the start of the study medication, up to 30 days after last dose administered, up to a total of 4 months
|
2.8%
1/36 • From the start of the study medication, up to 30 days after last dose administered, up to a total of 4 months
|
|
Gastrointestinal disorders
Diarrhea
|
6.1%
2/33 • From the start of the study medication, up to 30 days after last dose administered, up to a total of 4 months
|
5.6%
2/36 • From the start of the study medication, up to 30 days after last dose administered, up to a total of 4 months
|
|
Nervous system disorders
Dizziness
|
9.1%
3/33 • From the start of the study medication, up to 30 days after last dose administered, up to a total of 4 months
|
5.6%
2/36 • From the start of the study medication, up to 30 days after last dose administered, up to a total of 4 months
|
Additional Information
Dr. Robert Orlowski, Professor, Lymphoma-Myeloma
UT MD Anderson Cancer Center
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place