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.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

42 participants

Primary outcome timeframe

2 years

Results posted on

2015-10-19

Participant Flow

Participant milestones

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

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 years

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.

Outcome measures

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

Serious events: 18 serious events
Other events: 25 other events
Deaths: 0 deaths

Observation

Serious events: 17 serious events
Other events: 17 other events
Deaths: 0 deaths

Serious adverse events

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

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

Bart Barlogie

University of Arkansas for Medical Sciences

Phone: 526-6990

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place