Trial Outcomes & Findings for Phase II Study of the CD38 Antibody Daratumumab in Patients With High-Risk MGUS and Low-Risk Smoldering Multiple Myeloma (NCT NCT03236428)
NCT ID: NCT03236428
Last Updated: 2026-03-27
Results Overview
To determine the proportion of patients who are in VGPR or better after twenty cycles of therapy with Daratumumab. This will be determined at the time of best overall response.
Recruitment status
ACTIVE_NOT_RECRUITING
Study phase
PHASE2
Target enrollment
42 participants
Primary outcome timeframe
2 years
Results posted on
2026-03-27
Participant Flow
Participant milestones
| Measure |
Daratumumab
Daratumumab will be administered by IV infusion weekly during cycles 1 and 2 Daratumumab will be administered by IV infusion every other week during cycles 3 through 6 Daratumumab will be administered by IV infusion monthly during cycles 7 through 20
Daratumumab: Daratumumab is a drug that may kill or stop cancer cells from growing through a variety of mechanisms by attaching to the CD38 molecule
|
|---|---|
|
Overall Study
STARTED
|
41
|
|
Overall Study
COMPLETED
|
39
|
|
Overall Study
NOT COMPLETED
|
2
|
Reasons for withdrawal
| Measure |
Daratumumab
Daratumumab will be administered by IV infusion weekly during cycles 1 and 2 Daratumumab will be administered by IV infusion every other week during cycles 3 through 6 Daratumumab will be administered by IV infusion monthly during cycles 7 through 20
Daratumumab: Daratumumab is a drug that may kill or stop cancer cells from growing through a variety of mechanisms by attaching to the CD38 molecule
|
|---|---|
|
Overall Study
Withdrawal by Subject
|
2
|
Baseline Characteristics
Phase II Study of the CD38 Antibody Daratumumab in Patients With High-Risk MGUS and Low-Risk Smoldering Multiple Myeloma
Baseline characteristics by cohort
| Measure |
Daratumumab
n=41 Participants
Daratumumab will be administered by IV infusion weekly during cycles 1 and 2 Daratumumab will be administered by IV infusion every other week during cycles 3 through 6 Daratumumab will be administered by IV infusion monthly during cycles 7 through 20
Daratumumab: Daratumumab is a drug that may kill or stop cancer cells from growing through a variety of mechanisms by attaching to the CD38 molecule
|
|---|---|
|
Age, Continuous
|
59 years
n=56 Participants
|
|
Sex: Female, Male
Female
|
19 Participants
n=56 Participants
|
|
Sex: Female, Male
Male
|
22 Participants
n=56 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=56 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
38 Participants
n=56 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=56 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=56 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=56 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=56 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=56 Participants
|
|
Race (NIH/OMB)
White
|
36 Participants
n=56 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=56 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=56 Participants
|
|
Region of Enrollment
United States
|
41 participants
n=56 Participants
|
PRIMARY outcome
Timeframe: 2 yearsTo determine the proportion of patients who are in VGPR or better after twenty cycles of therapy with Daratumumab. This will be determined at the time of best overall response.
Outcome measures
| Measure |
Daratumumab
n=41 Participants
Daratumumab will be administered by IV infusion weekly during cycles 1 and 2 Daratumumab will be administered by IV infusion every other week during cycles 3 through 6 Daratumumab will be administered by IV infusion monthly during cycles 7 through 20
Daratumumab: Daratumumab is a drug that may kill or stop cancer cells from growing through a variety of mechanisms by attaching to the CD38 molecule
|
|---|---|
|
The Proportion Of Patients In Deep Response
|
7 Participants
|
SECONDARY outcome
Timeframe: 2 yearsThe objective response rate (partial response or better according to the modified IMWG criteria) and the proportion of patients with a MRD, CR, PR or MR will be reported with 90% exact binominal confidence interval (CI). The exact two-sided 90% CI around response rate will be no wider than 28% with 40 eligible patients.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 2 yearsTo estimate the duration of response (time from objective response to disease progression or death, or date last known progression-free and alive for those who have not progressed or died) the Kaplan-Meier method will be used.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 2 yearsThe duration of overall CR is progression or death. Patients who have not progressed or died are censored at the date last known progression-free.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 2 yearsThe duration of overall response is measured as the time from initiation of first response to first documentation of disease progression or death. Patients who have not progressed or died are censored at the date last known progression-free.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 2 yearsPFS is defined as the time from first-dose to the disease progression or death from any cause. Patients who have not progressed or died are censored at the date last known progression-free.
Outcome measures
| Measure |
Daratumumab
n=41 Participants
Daratumumab will be administered by IV infusion weekly during cycles 1 and 2 Daratumumab will be administered by IV infusion every other week during cycles 3 through 6 Daratumumab will be administered by IV infusion monthly during cycles 7 through 20
Daratumumab: Daratumumab is a drug that may kill or stop cancer cells from growing through a variety of mechanisms by attaching to the CD38 molecule
|
|---|---|
|
Progression Free Survival
|
59.5 months
Interval 5.5 to 76.3
|
SECONDARY outcome
Timeframe: 2 yearsSafety analysis will be conducted using the Safety Population defined as any patient receiving one dose of study treatment. For toxicity reporting, all adverse events and laboratory abnormalities will be graded and analyzed using CTCAE version 4 as appropriate.
Outcome measures
Outcome data not reported
Adverse Events
Daratumumab
Serious events: 8 serious events
Other events: 41 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Daratumumab
n=41 participants at risk
Daratumumab will be administered by IV infusion weekly during cycles 1 and 2 Daratumumab will be administered by IV infusion every other week during cycles 3 through 6 Daratumumab will be administered by IV infusion monthly during cycles 7 through 20
Daratumumab: Daratumumab is a drug that may kill or stop cancer cells from growing through a variety of mechanisms by attaching to the CD38 molecule
|
|---|---|
|
Infections and infestations
Skin infection
|
2.4%
1/41 • Adverse Events assessed/monitored from the day of consent through 30 days after the last dose of the investigational agent, an average of 22 months.
|
|
General disorders
Flu like symptoms
|
2.4%
1/41 • Adverse Events assessed/monitored from the day of consent through 30 days after the last dose of the investigational agent, an average of 22 months.
|
|
Metabolism and nutrition disorders
Hyperuricemia
|
2.4%
1/41 • Adverse Events assessed/monitored from the day of consent through 30 days after the last dose of the investigational agent, an average of 22 months.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify
|
2.4%
1/41 • Adverse Events assessed/monitored from the day of consent through 30 days after the last dose of the investigational agent, an average of 22 months.
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other, specify
|
2.4%
1/41 • Adverse Events assessed/monitored from the day of consent through 30 days after the last dose of the investigational agent, an average of 22 months.
|
|
Psychiatric disorders
Insomnia
|
2.4%
1/41 • Adverse Events assessed/monitored from the day of consent through 30 days after the last dose of the investigational agent, an average of 22 months.
|
|
Nervous system disorders
Cerebrospinal fluid leakage
|
2.4%
1/41 • Adverse Events assessed/monitored from the day of consent through 30 days after the last dose of the investigational agent, an average of 22 months.
|
|
Infections and infestations
Lung infection
|
2.4%
1/41 • Adverse Events assessed/monitored from the day of consent through 30 days after the last dose of the investigational agent, an average of 22 months.
|
Other adverse events
| Measure |
Daratumumab
n=41 participants at risk
Daratumumab will be administered by IV infusion weekly during cycles 1 and 2 Daratumumab will be administered by IV infusion every other week during cycles 3 through 6 Daratumumab will be administered by IV infusion monthly during cycles 7 through 20
Daratumumab: Daratumumab is a drug that may kill or stop cancer cells from growing through a variety of mechanisms by attaching to the CD38 molecule
|
|---|---|
|
Investigations
Neutrophil count decreased
|
29.3%
12/41 • Adverse Events assessed/monitored from the day of consent through 30 days after the last dose of the investigational agent, an average of 22 months.
|
|
Gastrointestinal disorders
Constipation
|
26.8%
11/41 • Adverse Events assessed/monitored from the day of consent through 30 days after the last dose of the investigational agent, an average of 22 months.
|
|
Musculoskeletal and connective tissue disorders
Arthalgia
|
22.0%
9/41 • Adverse Events assessed/monitored from the day of consent through 30 days after the last dose of the investigational agent, an average of 22 months.
|
|
Infections and infestations
Upper respiratory infection
|
22.0%
9/41 • Adverse Events assessed/monitored from the day of consent through 30 days after the last dose of the investigational agent, an average of 22 months.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
19.5%
8/41 • Adverse Events assessed/monitored from the day of consent through 30 days after the last dose of the investigational agent, an average of 22 months.
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
19.5%
8/41 • Adverse Events assessed/monitored from the day of consent through 30 days after the last dose of the investigational agent, an average of 22 months.
|
|
Blood and lymphatic system disorders
Anemia
|
17.1%
7/41 • Adverse Events assessed/monitored from the day of consent through 30 days after the last dose of the investigational agent, an average of 22 months.
|
|
General disorders
Fatigue
|
58.5%
24/41 • Adverse Events assessed/monitored from the day of consent through 30 days after the last dose of the investigational agent, an average of 22 months.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
46.3%
19/41 • Adverse Events assessed/monitored from the day of consent through 30 days after the last dose of the investigational agent, an average of 22 months.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
41.5%
17/41 • Adverse Events assessed/monitored from the day of consent through 30 days after the last dose of the investigational agent, an average of 22 months.
|
|
Nervous system disorders
Headache
|
34.1%
14/41 • Adverse Events assessed/monitored from the day of consent through 30 days after the last dose of the investigational agent, an average of 22 months.
|
|
Gastrointestinal disorders
Nausea
|
31.7%
13/41 • Adverse Events assessed/monitored from the day of consent through 30 days after the last dose of the investigational agent, an average of 22 months.
|
|
Investigations
White blood cell decreased
|
31.7%
13/41 • Adverse Events assessed/monitored from the day of consent through 30 days after the last dose of the investigational agent, an average of 22 months.
|
|
Gastrointestinal disorders
Diarrhea
|
29.3%
12/41 • Adverse Events assessed/monitored from the day of consent through 30 days after the last dose of the investigational agent, an average of 22 months.
|
|
Vascular disorders
Hypertension
|
29.3%
12/41 • Adverse Events assessed/monitored from the day of consent through 30 days after the last dose of the investigational agent, an average of 22 months.
|
|
Nervous system disorders
Dizziness
|
17.1%
7/41 • Adverse Events assessed/monitored from the day of consent through 30 days after the last dose of the investigational agent, an average of 22 months.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
14.6%
6/41 • Adverse Events assessed/monitored from the day of consent through 30 days after the last dose of the investigational agent, an average of 22 months.
|
|
Respiratory, thoracic and mediastinal disorders
Postnasal drip
|
14.6%
6/41 • Adverse Events assessed/monitored from the day of consent through 30 days after the last dose of the investigational agent, an average of 22 months.
|
|
General disorders
Non-cardiac chest pain
|
12.2%
5/41 • Adverse Events assessed/monitored from the day of consent through 30 days after the last dose of the investigational agent, an average of 22 months.
|
|
Investigations
Platelet count decreased
|
12.2%
5/41 • Adverse Events assessed/monitored from the day of consent through 30 days after the last dose of the investigational agent, an average of 22 months.
|
|
General disorders
Chills
|
9.8%
4/41 • Adverse Events assessed/monitored from the day of consent through 30 days after the last dose of the investigational agent, an average of 22 months.
|
|
Infections and infestations
Sinusitis
|
9.8%
4/41 • Adverse Events assessed/monitored from the day of consent through 30 days after the last dose of the investigational agent, an average of 22 months.
|
|
Nervous system disorders
Dysgeusia
|
7.3%
3/41 • Adverse Events assessed/monitored from the day of consent through 30 days after the last dose of the investigational agent, an average of 22 months.
|
|
Respiratory, thoracic and mediastinal disorders
Dsypnea
|
7.3%
3/41 • Adverse Events assessed/monitored from the day of consent through 30 days after the last dose of the investigational agent, an average of 22 months.
|
|
General disorders
Fever
|
7.3%
3/41 • Adverse Events assessed/monitored from the day of consent through 30 days after the last dose of the investigational agent, an average of 22 months.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
7.3%
3/41 • Adverse Events assessed/monitored from the day of consent through 30 days after the last dose of the investigational agent, an average of 22 months.
|
|
General disorders
Pain
|
7.3%
3/41 • Adverse Events assessed/monitored from the day of consent through 30 days after the last dose of the investigational agent, an average of 22 months.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
7.3%
3/41 • Adverse Events assessed/monitored from the day of consent through 30 days after the last dose of the investigational agent, an average of 22 months.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
7.3%
3/41 • Adverse Events assessed/monitored from the day of consent through 30 days after the last dose of the investigational agent, an average of 22 months.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
7.3%
3/41 • Adverse Events assessed/monitored from the day of consent through 30 days after the last dose of the investigational agent, an average of 22 months.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
7.3%
3/41 • Adverse Events assessed/monitored from the day of consent through 30 days after the last dose of the investigational agent, an average of 22 months.
|
|
Nervous system disorders
Cognitive disturbance
|
4.9%
2/41 • Adverse Events assessed/monitored from the day of consent through 30 days after the last dose of the investigational agent, an average of 22 months.
|
|
Ear and labyrinth disorders
Ear pain
|
4.9%
2/41 • Adverse Events assessed/monitored from the day of consent through 30 days after the last dose of the investigational agent, an average of 22 months.
|
|
General disorders
Edema limbs
|
4.9%
2/41 • Adverse Events assessed/monitored from the day of consent through 30 days after the last dose of the investigational agent, an average of 22 months.
|
|
General disorders
Flu like symptoms
|
4.9%
2/41 • Adverse Events assessed/monitored from the day of consent through 30 days after the last dose of the investigational agent, an average of 22 months.
|
|
Vascular disorders
Flushing
|
4.9%
2/41 • Adverse Events assessed/monitored from the day of consent through 30 days after the last dose of the investigational agent, an average of 22 months.
|
|
Gastrointestinal disorders
Gastrointestinal disorders- Other, specify
|
4.9%
2/41 • Adverse Events assessed/monitored from the day of consent through 30 days after the last dose of the investigational agent, an average of 22 months.
|
|
Respiratory, thoracic and mediastinal disorders
Hoarseness
|
4.9%
2/41 • Adverse Events assessed/monitored from the day of consent through 30 days after the last dose of the investigational agent, an average of 22 months.
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
4.9%
2/41 • Adverse Events assessed/monitored from the day of consent through 30 days after the last dose of the investigational agent, an average of 22 months.
|
|
General disorders
Localized edema
|
4.9%
2/41 • Adverse Events assessed/monitored from the day of consent through 30 days after the last dose of the investigational agent, an average of 22 months.
|
|
Investigations
Lymphocyte count decreased
|
4.9%
2/41 • Adverse Events assessed/monitored from the day of consent through 30 days after the last dose of the investigational agent, an average of 22 months.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
4.9%
2/41 • Adverse Events assessed/monitored from the day of consent through 30 days after the last dose of the investigational agent, an average of 22 months.
|
|
Skin and subcutaneous tissue disorders
Pain of skin
|
4.9%
2/41 • Adverse Events assessed/monitored from the day of consent through 30 days after the last dose of the investigational agent, an average of 22 months.
|
|
Cardiac disorders
Palpitations
|
4.9%
2/41 • Adverse Events assessed/monitored from the day of consent through 30 days after the last dose of the investigational agent, an average of 22 months.
|
|
Infections and infestations
Urinary tract infection
|
4.9%
2/41 • Adverse Events assessed/monitored from the day of consent through 30 days after the last dose of the investigational agent, an average of 22 months.
|
|
Gastrointestinal disorders
Vomiting
|
4.9%
2/41 • Adverse Events assessed/monitored from the day of consent through 30 days after the last dose of the investigational agent, an average of 22 months.
|
Additional Information
Senior Clinical Research Program Manager
Dana-Farber Cancer Institute
Phone: (617) 632-4101
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place