Trial Outcomes & Findings for Denosumab for Smoldering Multiple Myeloma (NCT NCT03839459)
NCT ID: NCT03839459
Last Updated: 2026-01-28
Results Overview
Risk Categories: Low Risk:Patient has SMM, but none of the listed risk factors Low-Intermediate Risk: 1 risk factor is present High-Intermediate Risk: 2 risk factors are present High Risk: 3 risk factors are present Risk Factors: 1. BM plasma cell % ≥50 2. M-protein ≥ 3g/dL 3. Involved/ un-involved free light chains ≥ 8
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
20 participants
Primary outcome timeframe
1 year
Results posted on
2026-01-28
Participant Flow
Participant milestones
| Measure |
Denosumab
Denosumab: 120mg of Denosumab will be administered subcutaneously once every 4 weeks
|
|---|---|
|
Overall Study
STARTED
|
20
|
|
Overall Study
COMPLETED
|
15
|
|
Overall Study
NOT COMPLETED
|
5
|
Reasons for withdrawal
| Measure |
Denosumab
Denosumab: 120mg of Denosumab will be administered subcutaneously once every 4 weeks
|
|---|---|
|
Overall Study
Withdrawal by Subject
|
2
|
|
Overall Study
progression of disease
|
3
|
Baseline Characteristics
Denosumab for Smoldering Multiple Myeloma
Baseline characteristics by cohort
| Measure |
Denosumab
n=20 Participants
Denosumab: 120mg of Denosumab will be administered subcutaneously once every 4 weeks
|
|---|---|
|
Age, Customized
30-39
|
1 Participants
n=158 Participants
|
|
Age, Customized
40-49
|
1 Participants
n=158 Participants
|
|
Age, Customized
60-69
|
6 Participants
n=158 Participants
|
|
Age, Customized
70-79
|
9 Participants
n=158 Participants
|
|
Age, Customized
80-89
|
3 Participants
n=158 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=158 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=158 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=158 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
19 Participants
n=158 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=158 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=158 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=158 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=158 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=158 Participants
|
|
Race (NIH/OMB)
White
|
18 Participants
n=158 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=158 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=158 Participants
|
|
Region of Enrollment
United States
|
20 participants
n=158 Participants
|
PRIMARY outcome
Timeframe: 1 yearRisk Categories: Low Risk:Patient has SMM, but none of the listed risk factors Low-Intermediate Risk: 1 risk factor is present High-Intermediate Risk: 2 risk factors are present High Risk: 3 risk factors are present Risk Factors: 1. BM plasma cell % ≥50 2. M-protein ≥ 3g/dL 3. Involved/ un-involved free light chains ≥ 8
Outcome measures
| Measure |
Denosumab
n=15 Participants
Denosumab: 120mg of Denosumab will be administered subcutaneously once every 4 weeks
|
|---|---|
|
Proportion of Subjects With a Downgraded Risk of Progression of Smoldering Multiple Myeloma if the Risk Category Decreases.
|
0 proportion of participants
|
SECONDARY outcome
Timeframe: 1 yearTo be determined by the investigator
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 1 yearRisk Categories: Low Risk:Patient has SMM, but none of the listed risk factors Low-Intermediate Risk: 1 risk factor is present High-Intermediate Risk: 2 risk factors are present High Risk: 3 risk factors are present Risk Factors: 1. BM plasma cell % ≥50 2. M-protein ≥ 3g/dL 3. Involved/ un-involved free light chains ≥ 8
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 3 yeartime to progression or death from any cause, whichever occurs first.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 1 yearbaseline and each post-treatment point
Outcome measures
Outcome data not reported
Adverse Events
Denosumab
Serious events: 6 serious events
Other events: 20 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Denosumab
n=20 participants at risk
Denosumab: 120mg of Denosumab will be administered subcutaneously once every 4 weeks
|
|---|---|
|
Metabolism and nutrition disorders
Hyperglycemia
|
5.0%
1/20 • 3 years
|
|
Vascular disorders
Hypertension
|
5.0%
1/20 • 3 years
|
|
Blood and lymphatic system disorders
Leukocytosis
|
5.0%
1/20 • 3 years
|
|
Investigations
Neutrophil count decreased
|
10.0%
2/20 • 3 years
|
|
Infections and infestations
Lung infection
|
5.0%
1/20 • 3 years
|
|
Nervous system disorders
Somnolence
|
5.0%
1/20 • 3 years
|
|
Infections and infestations
urinary tract infection
|
5.0%
1/20 • 3 years
|
|
Infections and infestations
Kidney infection
|
5.0%
1/20 • 3 years
|
|
Investigations
Lymphocyte count decreased
|
5.0%
1/20 • 3 years
|
Other adverse events
| Measure |
Denosumab
n=20 participants at risk
Denosumab: 120mg of Denosumab will be administered subcutaneously once every 4 weeks
|
|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
5.0%
1/20 • 3 years
|
|
Endocrine disorders
Adrenal insufficiency
|
5.0%
1/20 • 3 years
|
|
Investigations
Alanine aminotransferase increased
|
10.0%
2/20 • 3 years
|
|
Investigations
Alkaline phosphatase increased
|
5.0%
1/20 • 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis
|
5.0%
1/20 • 3 years
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
5.0%
1/20 • 3 years
|
|
Nervous system disorders
Amnesia
|
10.0%
2/20 • 3 years
|
|
Blood and lymphatic system disorders
Anemia
|
55.0%
11/20 • 3 years
|
|
Metabolism and nutrition disorders
Anorexia
|
5.0%
1/20 • 3 years
|
|
Psychiatric disorders
Anxiety
|
5.0%
1/20 • 3 years
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
10.0%
2/20 • 3 years
|
|
Investigations
Aspartate aminotransferase increased
|
15.0%
3/20 • 3 years
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
20.0%
4/20 • 3 years
|
|
Investigations
Blood bilirubin increased
|
10.0%
2/20 • 3 years
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
5.0%
1/20 • 3 years
|
|
Infections and infestations
Bronchial infection
|
5.0%
1/20 • 3 years
|
|
Musculoskeletal and connective tissue disorders
Buttock pain
|
5.0%
1/20 • 3 years
|
|
Cardiac disorders
Cardiac disorders - Other
|
5.0%
1/20 • 3 years
|
|
Cardiac disorders
Chest pain - cardiac
|
5.0%
1/20 • 3 years
|
|
Gastrointestinal disorders
Constipation
|
15.0%
3/20 • 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
20.0%
4/20 • 3 years
|
|
Investigations
Creatinine increased
|
25.0%
5/20 • 3 years
|
|
Gastrointestinal disorders
Dental caries
|
5.0%
1/20 • 3 years
|
|
Gastrointestinal disorders
Diarrhea
|
15.0%
3/20 • 3 years
|
|
Nervous system disorders
Dizziness
|
15.0%
3/20 • 3 years
|
|
Nervous system disorders
Dysgeusia
|
5.0%
1/20 • 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
25.0%
5/20 • 3 years
|
|
Ear and labyrinth disorders
Ear and labyrinth disorders - Other
|
5.0%
1/20 • 3 years
|
|
Ear and labyrinth disorders
Ear pain
|
5.0%
1/20 • 3 years
|
|
General disorders
Edema limbs
|
30.0%
6/20 • 3 years
|
|
Endocrine disorders
Endocrine disorders - Other
|
15.0%
3/20 • 3 years
|
|
Injury, poisoning and procedural complications
Fall
|
20.0%
4/20 • 3 years
|
|
General disorders
Fatigue
|
60.0%
12/20 • 3 years
|
|
Infections and infestations
Fever
|
5.0%
1/20 • 3 years
|
|
Injury, poisoning and procedural complications
Fracture
|
5.0%
1/20 • 3 years
|
|
General disorders
Gait disturbance
|
5.0%
1/20 • 3 years
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other
|
20.0%
4/20 • 3 years
|
|
General disorders
General disorders and administration site conditions - Other
|
20.0%
4/20 • 3 years
|
|
Investigations
Hemoglobin increased
|
5.0%
1/20 • 3 years
|
|
Gastrointestinal disorders
Hemorrhoids
|
5.0%
1/20 • 3 years
|
|
Investigations
Hepatobiliary disorders - Other
|
5.0%
1/20 • 3 years
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
35.0%
7/20 • 3 years
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
20.0%
4/20 • 3 years
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
25.0%
5/20 • 3 years
|
|
Metabolism and nutrition disorders
Hypermagnesemia
|
5.0%
1/20 • 3 years
|
|
Vascular disorders
Hypertension
|
10.0%
2/20 • 3 years
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
10.0%
2/20 • 3 years
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
30.0%
6/20 • 3 years
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
5.0%
1/20 • 3 years
|
|
Metabolism and nutrition disorders
Hypokalemia
|
5.0%
1/20 • 3 years
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
10.0%
2/20 • 3 years
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
55.0%
11/20 • 3 years
|
|
Vascular disorders
Hypotension
|
5.0%
1/20 • 3 years
|
|
Infections and infestations
Infections and infestations - Other
|
10.0%
2/20 • 3 years
|
|
Injury, poisoning and procedural complications
Injury, poisoning and procedural complications - Other
|
15.0%
3/20 • 3 years
|
|
Psychiatric disorders
Insomnia
|
5.0%
1/20 • 3 years
|
|
Investigations
Investigations - Other
|
10.0%
2/20 • 3 years
|
|
Blood and lymphatic system disorders
Leukocytosis
|
5.0%
1/20 • 3 years
|
|
Infections and infestations
Lung infection
|
5.0%
1/20 • 3 years
|
|
Investigations
Lymphocyte count decreased
|
45.0%
9/20 • 3 years
|
|
General disorders
Malaise
|
5.0%
1/20 • 3 years
|
|
Metabolism and nutrition disorders
Metabolism and nutrition disorders - Other
|
15.0%
3/20 • 3 years
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorder - Other
|
30.0%
6/20 • 3 years
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
10.0%
2/20 • 3 years
|
|
Infections and infestations
Nail infection
|
5.0%
1/20 • 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
5.0%
1/20 • 3 years
|
|
Gastrointestinal disorders
Nausea
|
25.0%
5/20 • 3 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other
|
20.0%
4/20 • 3 years
|
|
Nervous system disorders
Nervous system disorders - Other
|
20.0%
4/20 • 3 years
|
|
Investigations
Neutrophil count decreased
|
10.0%
2/20 • 3 years
|
|
General disorders
Non-cardiac chest pain
|
5.0%
1/20 • 3 years
|
|
Gastrointestinal disorders
Oral hemorrhage
|
5.0%
1/20 • 3 years
|
|
Gastrointestinal disorders
Oral pain
|
5.0%
1/20 • 3 years
|
|
Musculoskeletal and connective tissue disorders
Osteoporosis
|
10.0%
2/20 • 3 years
|
|
Infections and infestations
Otitis externa
|
5.0%
1/20 • 3 years
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
15.0%
3/20 • 3 years
|
|
Nervous system disorders
Paresthesia
|
15.0%
3/20 • 3 years
|
|
Nervous system disorders
Peripheral motor neuropathy
|
5.0%
1/20 • 3 years
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
10.0%
2/20 • 3 years
|
|
Infections and infestations
Pharyngitis
|
5.0%
1/20 • 3 years
|
|
Investigations
Platelet count decreased
|
10.0%
2/20 • 3 years
|
|
Nervous system disorders
Presyncope
|
5.0%
1/20 • 3 years
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place