Trial Outcomes & Findings for UARK 2009-09 Myeloma Cure Project: Prospective Trial of Indefinite Revlimid Maintenance Versus Observation for Currently Event-Free Patients With Multiple Myeloma (NCT NCT01621672)
NCT ID: NCT01621672
Last Updated: 2015-10-19
Results Overview
Progression was defined as any one or more of the following: * Serum M protein increase ≥ 25% from baseline (or an increase of ≥ 1 g/dL if serum M protein was ≥ 5 g/dL at baseline), with an absolute increase of ≥ 0.5 g/dL; or * Urine M protein increase ≥ 25% from baseline, with an absolute increase of ≥ 200 mg/24 hrs; or * If patient had serum M protein \< 1 g/dL, urine M protein \< 200 mg/24 hrs, and an involved serum free light chain level ≥ 10 mg/dL at baseline: ≥ 25% increase in the difference between involved and uninvolved serum free light chain level, with an absolute increase of ≥ 10 mg/dL; or * Bone marrow plasma cell percentage increase ≥ 25% from baseline, with the absolute plasma cell % ≥ 10%; or * New bone lesions or soft tissue plasmacytomas, or definite increase in size of existing bone lesions or soft tissue plasmacytomas; or * Development of hypercalcemia (corrected serum calcium \> 11.5 mg/dL or 2.65 mmol/L) that can be attributed solely to multiple myeloma.
COMPLETED
PHASE3
42 participants
2 years
2015-10-19
Participant Flow
Participant milestones
| Measure |
Revlimid
Revlimid: 10 mg/day in the morning same time each day
|
Observation
No treatment
|
|---|---|---|
|
Overall Study
STARTED
|
25
|
17
|
|
Overall Study
COMPLETED
|
25
|
17
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
UARK 2009-09 Myeloma Cure Project: Prospective Trial of Indefinite Revlimid Maintenance Versus Observation for Currently Event-Free Patients With Multiple Myeloma
Baseline characteristics by cohort
| Measure |
Revlimid
n=25 Participants
Revlimid: 10 mg/day in the morning same time each day
|
Observation
n=17 Participants
No treatment
|
Total
n=42 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
14 Participants
n=39 Participants
|
11 Participants
n=41 Participants
|
25 Participants
n=35 Participants
|
|
Age, Categorical
>=65 years
|
11 Participants
n=39 Participants
|
6 Participants
n=41 Participants
|
17 Participants
n=35 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=39 Participants
|
5 Participants
n=41 Participants
|
14 Participants
n=35 Participants
|
|
Sex: Female, Male
Male
|
16 Participants
n=39 Participants
|
12 Participants
n=41 Participants
|
28 Participants
n=35 Participants
|
|
Race/Ethnicity, Customized
White
|
24 participants
n=39 Participants
|
17 participants
n=41 Participants
|
41 participants
n=35 Participants
|
|
Race/Ethnicity, Customized
Other
|
1 participants
n=39 Participants
|
0 participants
n=41 Participants
|
1 participants
n=35 Participants
|
PRIMARY outcome
Timeframe: 2 yearsProgression was defined as any one or more of the following: * Serum M protein increase ≥ 25% from baseline (or an increase of ≥ 1 g/dL if serum M protein was ≥ 5 g/dL at baseline), with an absolute increase of ≥ 0.5 g/dL; or * Urine M protein increase ≥ 25% from baseline, with an absolute increase of ≥ 200 mg/24 hrs; or * If patient had serum M protein \< 1 g/dL, urine M protein \< 200 mg/24 hrs, and an involved serum free light chain level ≥ 10 mg/dL at baseline: ≥ 25% increase in the difference between involved and uninvolved serum free light chain level, with an absolute increase of ≥ 10 mg/dL; or * Bone marrow plasma cell percentage increase ≥ 25% from baseline, with the absolute plasma cell % ≥ 10%; or * New bone lesions or soft tissue plasmacytomas, or definite increase in size of existing bone lesions or soft tissue plasmacytomas; or * Development of hypercalcemia (corrected serum calcium \> 11.5 mg/dL or 2.65 mmol/L) that can be attributed solely to multiple myeloma.
Outcome measures
| Measure |
Revlimid
n=25 Participants
Revlimid: 10 mg/day in the morning same time each day
|
Observation
n=17 Participants
No treatment
|
|---|---|---|
|
Progression Free Survival (PFS)
|
88 percentage of participants
|
71 percentage of participants
|
Adverse Events
Revlimid
Observation
Serious adverse events
| Measure |
Revlimid
n=25 participants at risk
Revlimid: 10 mg/day in the morning same time each day
|
Observation
n=17 participants at risk
No treatment
|
|---|---|---|
|
Immune system disorders
Grade 3 Allergic reaction/Hypersensitivity
|
4.0%
1/25
|
0.00%
0/17
|
|
Blood and lymphatic system disorders
Grade 4 Neutropenia/granulocytopenia
|
4.0%
1/25
|
0.00%
0/17
|
|
Blood and lymphatic system disorders
Grade 4 Thrombocyopenia
|
8.0%
2/25
|
11.8%
2/17
|
|
Blood and lymphatic system disorders
Grade 4 Leukopenia
|
12.0%
3/25
|
11.8%
2/17
|
|
Skin and subcutaneous tissue disorders
Grade 3 Skin Rash/desquamation
|
4.0%
1/25
|
0.00%
0/17
|
|
Gastrointestinal disorders
Grade 3 Dysphagia
|
4.0%
1/25
|
0.00%
0/17
|
|
Metabolism and nutrition disorders
Grade 4 Hypocalcemia
|
4.0%
1/25
|
5.9%
1/17
|
|
Metabolism and nutrition disorders
Grade 3 Hypokalemia
|
4.0%
1/25
|
0.00%
0/17
|
|
Metabolism and nutrition disorders
Grade 3 Hypophosphatemia
|
4.0%
1/25
|
23.5%
4/17
|
|
Musculoskeletal and connective tissue disorders
Grade 3 Gait/ walking
|
8.0%
2/25
|
0.00%
0/17
|
|
Nervous system disorders
Grade 3 CNS Ischemia
|
4.0%
1/25
|
0.00%
0/17
|
|
Nervous system disorders
Grade 3 Mood alteration
|
4.0%
1/25
|
0.00%
0/17
|
|
Nervous system disorders
Grade 3 Sensory/Neuropathy
|
4.0%
1/25
|
11.8%
2/17
|
|
General disorders
Grade 3 Extremity/limb
|
4.0%
1/25
|
0.00%
0/17
|
|
Cardiac disorders
Gade 3 Hypertension
|
0.00%
0/25
|
5.9%
1/17
|
|
Hepatobiliary disorders
Grade 3 SGPT (ALT) increase
|
0.00%
0/25
|
5.9%
1/17
|
|
Infections and infestations
Grade 3 Skin Infection UNK ANC
|
0.00%
0/25
|
5.9%
1/17
|
|
Metabolism and nutrition disorders
Grade 3 Hyperglycemia
|
0.00%
0/25
|
5.9%
1/17
|
|
Metabolism and nutrition disorders
Grade 3 Hyponatremia
|
0.00%
0/25
|
17.6%
3/17
|
|
Nervous system disorders
Grade 3 Apnea
|
0.00%
0/25
|
5.9%
1/17
|
Other adverse events
| Measure |
Revlimid
n=25 participants at risk
Revlimid: 10 mg/day in the morning same time each day
|
Observation
n=17 participants at risk
No treatment
|
|---|---|---|
|
Immune system disorders
Grade 1 Rhinitis
|
8.0%
2/25
|
0.00%
0/17
|
|
Blood and lymphatic system disorders
Grade 1 Anemia
|
32.0%
8/25
|
5.9%
1/17
|
|
Blood and lymphatic system disorders
Grade 3 Anemia
|
8.0%
2/25
|
0.00%
0/17
|
|
Blood and lymphatic system disorders
Grade 1 Thrombocytopenia
|
52.0%
13/25
|
0.00%
0/17
|
|
Blood and lymphatic system disorders
Grade 2 Leukopenia
|
36.0%
9/25
|
0.00%
0/17
|
|
General disorders
Grade 1 Fatigue
|
8.0%
2/25
|
5.9%
1/17
|
|
Endocrine disorders
Grade 2 Hypothyroidism
|
8.0%
2/25
|
0.00%
0/17
|
|
Gastrointestinal disorders
Grade 1 Constipation
|
0.00%
0/25
|
5.9%
1/17
|
|
Gastrointestinal disorders
Grade 1 Diarrhea
|
12.0%
3/25
|
0.00%
0/17
|
|
Gastrointestinal disorders
Grade 2 Diarrhea
|
8.0%
2/25
|
0.00%
0/17
|
|
Hepatobiliary disorders
Grade 1 Alkaline phosphatase increase
|
12.0%
3/25
|
11.8%
2/17
|
|
Hepatobiliary disorders
Grade 1 Bilirubin increase
|
16.0%
4/25
|
5.9%
1/17
|
|
Hepatobiliary disorders
Grade 1 Hypoalbuminemia
|
68.0%
17/25
|
47.1%
8/17
|
|
Hepatobiliary disorders
Grade 2 Hypoalbuminemia
|
8.0%
2/25
|
11.8%
2/17
|
|
Hepatobiliary disorders
Grade 1 SGOT (AST) increase
|
20.0%
5/25
|
23.5%
4/17
|
|
Hepatobiliary disorders
Grade 1 SGPT (ALT) increase
|
24.0%
6/25
|
23.5%
4/17
|
|
Metabolism and nutrition disorders
Grade 1 Hyperglycemia
|
20.0%
5/25
|
23.5%
4/17
|
|
Metabolism and nutrition disorders
Grade 2 Hypocalcemia
|
12.0%
3/25
|
11.8%
2/17
|
|
Metabolism and nutrition disorders
Grade 1 Hypokalemia
|
20.0%
5/25
|
41.2%
7/17
|
|
Metabolism and nutrition disorders
Grade 1 Hyponatremia
|
8.0%
2/25
|
0.00%
0/17
|
|
Metabolism and nutrition disorders
Grade 2 Hypophosphatemia
|
8.0%
2/25
|
17.6%
3/17
|
|
Nervous system disorders
Grade 1 Sensory/Neuropathy
|
8.0%
2/25
|
5.9%
1/17
|
|
Nervous system disorders
Grade 2 Sensory/Neuropathy
|
20.0%
5/25
|
35.3%
6/17
|
|
General disorders
Grade 1 Joint
|
8.0%
2/25
|
0.00%
0/17
|
|
General disorders
Grade 2 Upper Back
|
8.0%
2/25
|
5.9%
1/17
|
|
Respiratory, thoracic and mediastinal disorders
Grade 1 Cough
|
12.0%
3/25
|
0.00%
0/17
|
|
Renal and urinary disorders
Grade 1 Creatinine increase
|
28.0%
7/25
|
41.2%
7/17
|
|
Renal and urinary disorders
Grade 2 Creatinine increase
|
8.0%
2/25
|
0.00%
0/17
|
|
Immune system disorders
Grade 1 Allergic reaction/Hypersensitivity
|
0.00%
0/25
|
5.9%
1/17
|
|
Ear and labyrinth disorders
Grade 1 Hearing (monitoring program)
|
0.00%
0/25
|
5.9%
1/17
|
|
Ear and labyrinth disorders
Grade 2 Hearing (w/o monitoring program)
|
0.00%
0/25
|
5.9%
1/17
|
|
Blood and lymphatic system disorders
Grade 2 Anemia
|
0.00%
0/25
|
11.8%
2/17
|
|
General disorders
Grade 2 Fatigue
|
0.00%
0/25
|
11.8%
2/17
|
|
Hepatobiliary disorders
Grade 2 Bilirubin increase
|
0.00%
0/25
|
17.6%
3/17
|
|
Hepatobiliary disorders
Grade 2 SGOT (AST) increase
|
0.00%
0/25
|
5.9%
1/17
|
|
Infections and infestations
Grade 2 Infection , normal ANC lung
|
0.00%
0/25
|
5.9%
1/17
|
|
Infections and infestations
Grade 2 Lung infection UNK ANC
|
0.00%
0/25
|
5.9%
1/17
|
|
Metabolism and nutrition disorders
Grade 1 Bicarbonate decrease
|
0.00%
0/25
|
17.6%
3/17
|
|
Metabolism and nutrition disorders
Grade 2 Hyperglycemia
|
0.00%
0/25
|
11.8%
2/17
|
|
Metabolism and nutrition disorders
Grade 1 Hypermagnesemia
|
0.00%
0/25
|
17.6%
3/17
|
|
Metabolism and nutrition disorders
Grade 1 Hypomagnesemia
|
0.00%
0/25
|
5.9%
1/17
|
|
Metabolism and nutrition disorders
Grade 2 Hypomagnesemia
|
0.00%
0/25
|
5.9%
1/17
|
|
Metabolism and nutrition disorders
Grade 1 Hypophosphatemia
|
0.00%
0/25
|
11.8%
2/17
|
|
Musculoskeletal and connective tissue disorders
Grade 2 Fracture
|
0.00%
0/25
|
5.9%
1/17
|
|
Musculoskeletal and connective tissue disorders
Grade 1 Gait/walking
|
0.00%
0/25
|
5.9%
1/17
|
|
Eye disorders
Grade 2 Dry eye
|
0.00%
0/25
|
5.9%
1/17
|
|
General disorders
Grade 2 Extremity/limb
|
0.00%
0/25
|
5.9%
1/17
|
|
General disorders
Grade 1 Muscle
|
0.00%
0/25
|
5.9%
1/17
|
|
General disorders
Grade 1 Neuralgia/peripheral
|
0.00%
0/25
|
11.8%
2/17
|
|
Respiratory, thoracic and mediastinal disorders
Grade 1 Dyspnea
|
0.00%
0/25
|
5.9%
1/17
|
|
Respiratory, thoracic and mediastinal disorders
Grade 2 Dyspnea
|
0.00%
0/25
|
5.9%
1/17
|
|
Respiratory, thoracic and mediastinal disorders
Grade 2 Pulmonary/other
|
0.00%
0/25
|
5.9%
1/17
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place