Trial Outcomes & Findings for Denosumab for Smoldering Multiple Myeloma (NCT NCT03839459)
NCT ID: NCT03839459
Last Updated: 2026-06-15
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
2026-06-15
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=20 Participants
|
|
Age, Customized
40-49
|
1 Participants
n=20 Participants
|
|
Age, Customized
60-69
|
6 Participants
n=20 Participants
|
|
Age, Customized
70-79
|
9 Participants
n=20 Participants
|
|
Age, Customized
80-89
|
3 Participants
n=20 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=20 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=20 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=20 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
19 Participants
n=20 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=20 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=20 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=20 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=20 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=20 Participants
|
|
Race (NIH/OMB)
White
|
18 Participants
n=20 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=20 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=20 Participants
|
|
Region of Enrollment
United States
|
20 participants
n=20 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 yearPopulation: The analysis includes participants who completed the 1 year assessment period.
Skeletal related events were defined as pathological fractures, radiation to bone, surgery to bone, or fractures requiring stabilization, confirmed by imaging. Participants were counted once if they experienced at least one skeletal related event during the 1 year follow up period.
Outcome measures
| Measure |
Denosumab
n=15 Participants
Denosumab: 120mg of Denosumab will be administered subcutaneously once every 4 weeks
|
|---|---|
|
Proportion of Participants With Skeletal Related Events
|
0 Participants
|
SECONDARY outcome
Timeframe: 1 yearPopulation: The analysis includes participants with evaluable disease progression assessment data during the 1 year follow up period.
Progression to multiple myeloma was assessed according to International Myeloma Working Group criteria during the 1 year follow up period following treatment initiation.
Outcome measures
| Measure |
Denosumab
n=17 Participants
Denosumab: 120mg of Denosumab will be administered subcutaneously once every 4 weeks
|
|---|---|
|
Proportion of Participants With Progression to Multiple Myeloma
|
1 Participants
|
SECONDARY outcome
Timeframe: 3 yearsPopulation: The analysis includes participants with available progression free survival follow up data at the 3 year assessment time point.
Progression free survival was defined as the absence of disease progression or death from any cause at the 3 year assessment time point.
Outcome measures
| Measure |
Denosumab
n=8 Participants
Denosumab: 120mg of Denosumab will be administered subcutaneously once every 4 weeks
|
|---|---|
|
Proportion of Participants With Progression Free Survival at 3 Years
|
8 participants
|
SECONDARY outcome
Timeframe: 1 yearPopulation: The analysis includes participants with evaluable bone mineral density assessments at the 1 year time point.
Bone mineral density was assessed using dual energy X ray absorptiometry scans at screening and approximately 1 year after treatment initiation. Participants with evaluable scans within the protocol specified assessment window were included in the analysis.
Outcome measures
| Measure |
Denosumab
n=13 Participants
Denosumab: 120mg of Denosumab will be administered subcutaneously once every 4 weeks
|
|---|---|
|
Proportion of Participants With Change in Bone Mineral Density From Screening to 1 Year
|
13 participants
|
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
|
|---|---|
|
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
|
|
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
|
|
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