Trial · NCT03301220

A Study of Subcutaneous Daratumumab Versus Active Monitoring in Participants With High-Risk Smoldering Multiple Myeloma

NCT03301220, Phase 3, Completed, Janssen Research & Development, LLC; results first posted 2025-12-23

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. A Study of Subcutaneous Daratumumab Versus Active Monitoring in Participants With High-Risk Smoldering Multiple Myeloma. Trials, record NCT03301220. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03301220

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: A Study of Subcutaneous Daratumumab Versus Active Monitoring in Participants With High-Risk Smoldering Multiple Myeloma
NCT number: NCT03301220
Status: Completed
Phases: Phase 3
Enrollment: 390 participants, actual
Lead sponsor: Janssen Research & Development, LLC
Conditions: Smoldering Multiple Myeloma
Interventions: Daratumumab SC: daratumumab + rHuPH20
First posted: 2017-10-04
Last updated: 2026-06-08
Other registries' IDs: eudract:2016-001205-16
Results first posted: 2025-12-23

Source ClinicalTrials.gov

Registered outcomes18

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Progression-Free Survival (PFS) as Assessed by the Independent Review Committee (IRC)	From randomization (Day -5) up to 77 months	PFS was defined as the duration from the date of randomization to either progressive to multiple myeloma (MM), according to the International Myeloma Working Group (IMWG) diagnostic criteria for MM, or death due to any cause, whichever occurred first. Per IMWG criteria, active MM by SLiM-CRAB defined as: greater than or equal to (\>=) 60 percent (%) bone marrow plasma cells (BMPCs), free light chain (FLC) involved/uninvolved ratio \>=100, greater than (\>)1 focal bone lesions on magnetic resonance imaging (MRI), calcium elevation, renal insufficiency by creatinine clearance, anemia, or bone disease due to lytic bone lesions. Kaplan-Meier estimate was used.
Secondary	Time to Biochemical or Diagnostic (SLiM-CRAB) Progression Per Computerized Algorithm Analyses	From randomization (Day -5) up to 8 years
Secondary	Overall Response Rate (ORR)	From randomization (Day -5) up to 8 years
Secondary	Complete Response (CR) Rate	From randomization (Day -5) up to 8 years
Secondary	Time to First-Line Treatment for Multiple Myeloma	From randomization (Day -5) up to 8 years
Secondary	Progression-Free Survival on First-Line Treatment for Multiple Myeloma (PFS2)	From randomization (Day -5) up to 8 years
Secondary	Best Response on First-line Therapy for Multiple Myeloma	From randomization (Day -5) up to 8 years
Secondary	Overall Survival (OS)	From randomization (Day -5) up to 8 years
Secondary	Percentage of Participants Who Progressed to Multiple Myeloma With Adverse Prognostic Features	From randomization (Day -5) up to 8 years
Secondary	Maximum Observed Serum Concentration (Cmax) of Daratumumab	Cycles 1 and 3 : Day 1 predose, and Day 4 postdose; Cycles 5, 7, 12, and 24: Day 1 predose; end of the treatment (EOT, 37.11 months); and 8 weeks after the last daratumumab dose (up to 38.11 months). Each Cycle was 28 days

1 to 10 of 18Source ClinicalTrials.gov

See all 18 registered outcomes

Outcomes18

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Progression-Free Survival (PFS) as Assessed by the Independent Review Committee (IRC)	From randomization (Day -5) up to 77 months	Intent-to-treat (ITT) analysis set included all participants randomized into the study.	Months	MEDIAN
SECONDARY	Time to Biochemical or Diagnostic (SLiM-CRAB) Progression Per Computerized Algorithm Analyses	From randomization (Day -5) up to 8 years
SECONDARY	Overall Response Rate (ORR)	From randomization (Day -5) up to 8 years
SECONDARY	Complete Response (CR) Rate	From randomization (Day -5) up to 8 years
SECONDARY	Time to First-Line Treatment for Multiple Myeloma	From randomization (Day -5) up to 8 years
SECONDARY	Progression-Free Survival on First-Line Treatment for Multiple Myeloma (PFS2)	From randomization (Day -5) up to 8 years
SECONDARY	Best Response on First-line Therapy for Multiple Myeloma	From randomization (Day -5) up to 8 years
SECONDARY	Overall Survival (OS)	From randomization (Day -5) up to 8 years
SECONDARY	Percentage of Participants Who Progressed to Multiple Myeloma With Adverse Prognostic Features	From randomization (Day -5) up to 8 years
SECONDARY	Maximum Observed Serum Concentration (Cmax) of Daratumumab	Cycles 1 and 3 : Day 1 predose, and Day 4 postdose; Cycles 5, 7, 12, and 24: Day 1 predose; end of the treatment (EOT, 37.11 months); and 8 weeks after the last daratumumab dose (up to 38.11 months). Each Cycle was 28 days

1 to 10 of 18Source ClinicalTrials.gov

See all 18 outcomes

Results by group2

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
Progression-Free Survival (PFS) as Assessed by the Independent Review Committee (IRC)	Arm A: Active Monitoring (ACTM)		41.46	95% Confidence Interval 26.41 to 53.32	Months
Progression-Free Survival (PFS) as Assessed by the Independent Review Committee (IRC)	Arm B: Daratumumab SC		NA	95% Confidence Interval 66.69 to NA	Months

Source ClinicalTrials.gov

Participant flow8

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Arm A: Active Monitoring (ACTM)	196
Overall Study	STARTED	Arm B: Daratumumab SC	194
Overall Study	Treated	Arm A: Active Monitoring (ACTM)	196
Overall Study	Treated	Arm B: Daratumumab SC	193
Overall Study	COMPLETED	Arm A: Active Monitoring (ACTM)	0
Overall Study	COMPLETED	Arm B: Daratumumab SC	0
Overall Study	NOT COMPLETED	Arm A: Active Monitoring (ACTM)	196
Overall Study	NOT COMPLETED	Arm B: Daratumumab SC	194

Source ClinicalTrials.gov

Adverse events308

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
other	Anaemia	Blood and lymphatic system disorders	Arm A: Active Monitoring (ACTM)	19	196
other	Anaemia	Blood and lymphatic system disorders	Arm B: Daratumumab SC	9	193
other	Neutropenia	Blood and lymphatic system disorders	Arm A: Active Monitoring (ACTM)	5	196
other	Neutropenia	Blood and lymphatic system disorders	Arm B: Daratumumab SC	13	193
other	Palpitations	Cardiac disorders	Arm A: Active Monitoring (ACTM)	1	196
other	Palpitations	Cardiac disorders	Arm B: Daratumumab SC	13	193
other	Cataract	Eye disorders	Arm A: Active Monitoring (ACTM)	6	196
other	Cataract	Eye disorders	Arm B: Daratumumab SC	10	193
other	Abdominal Pain	Gastrointestinal disorders	Arm A: Active Monitoring (ACTM)	12	196
other	Abdominal Pain	Gastrointestinal disorders	Arm B: Daratumumab SC	18	193

1 to 10 of 308Source ClinicalTrials.gov

See all 308 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Arm A: Active Monitoring (ACTM)	26	196
Total, all-cause mortality	Arm B: Daratumumab SC	15	194
Total, other adverse events	Arm A: Active Monitoring (ACTM)	140	196
Total, other adverse events	Arm B: Daratumumab SC	178	193
Total, serious adverse events	Arm A: Active Monitoring (ACTM)	38	196
Total, serious adverse events	Arm B: Daratumumab SC	56	193

Source ClinicalTrials.gov

Papers2

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
39652675	DERIVED	PubMed
42747040	DERIVED	PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons2

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
Arm A: Active Monitoring (ACTM) vs Arm B: Daratumumab SC: deaths from any cause	Trial comparisons
Arm A: Active Monitoring (ACTM) vs Arm B: Daratumumab SC: serious adverse events	Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT03301220

GET https://conductscience.org/api/trials/v1/NCT03301220/events?page=2

API reference For AI assistants