Trial · NCT04151667

Daratumumab Based Response Adapted Therapy for Older Adults With Newly Diagnosed Multiple Myeloma

NCT04151667, Phase 2, Completed, H. Lee Moffitt Cancer Center and Research Institute; results first posted 2024-12-30

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Daratumumab Based Response Adapted Therapy for Older Adults With Newly Diagnosed Multiple Myeloma. Trials, record NCT04151667. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04151667

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Trial

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

Title: Daratumumab Based Response Adapted Therapy for Older Adults With Newly Diagnosed Multiple Myeloma
NCT number: NCT04151667
Status: Completed
Phases: Phase 2
Enrollment: 33 participants, actual
Lead sponsor: H. Lee Moffitt Cancer Center and Research Institute
Conditions: Multiple Myeloma
Interventions: Daratumumab Injection, Dexamethasone Oral, Lenalidomide Pill, Bortezomib Injection
First posted: 2019-11-05
Last updated: 2026-08-20
Results first posted: 2024-12-30

Source ClinicalTrials.gov

Registered outcomes5

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

List	Outcome	Time frame	Description
Primary	Overall Response Rate	Up to 8 months	Overall Response Rate of the response adapted strategy using the uniform response criteria of the International Myeloma Working Group (IMWG). Stringent Complete Response (sCR): Below plus normal FLC ratio and absence of clonal cells in bone marrow3 by immunohistochemistry or immunofluorescence Complete Response (CR): Negative immunofixation on the serum and urine and disappearance of any soft tissue plasmacytomas and \< 5% plasma cells in bone marrow Very Good Partial Response (VGPR): Serum and urine M-protein detectable by immunofixation but not on electrophoresis or \> 90% reduction in serum M-protein plus urine M-protein level \< 100 mg/24 h Partial Response (PR): \> 50% reduction of serum M-protein and reduction in 24 hours urinary M-protein by \>90% or to \< 200 mg/24 h Minimal Response (MR): 25%-49% reduction of serum M-protein and 50%-89% reduction in 24 hours urinary M-protein Stable Disease (SD): Not meeting criteria for sCR, CR, VGPR, PR, MR, or Progressive Disease (PD)
Secondary	Progression Free Survival	Up to 2 years	Progression Free Survival (PFS) from start of treatment to death of any cause, disease progression or relapse of the date of last follow-up, whichever comes first. he PFS will be estimated by the Kaplan-Meier method and 95% confidence interval (CI) will be computed by complementary log-log transformation. The 1 and 2 year PFS and 95% Confidence Intervals will be reported.
Secondary	Overall Survival	Up to 2 years	Overall Survival (OS) from start of treatment to death of any cause or the date of last follow-up, whichever comes first. OS will be estimated by the Kaplan-Meier method and 95% confidence interval will be computed by complementary log-log transformation. The 2 year OS and 95% CI will be reported.
Other	Number of Participants Who Continue on Arm A After 2 Cycles	At the end of Cycle 2 (each cycle is 28 days)	The number of participants who continue on Daratumumab and Dexamethasone after 2 cycles
Other	Number of Participants Without Minimal Residual Disease	Up to 8 months	The number of patients who are without minimal residual disease (MRD) using Next Generation Sequencing (NGS) will be estimated and the 95% confidence interval will be computed by the Clopper-Pearson method.

Source ClinicalTrials.gov

Outcomes5

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

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Overall Response Rate	Up to 8 months	Evaluable Participants	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Progression Free Survival	Up to 2 years
SECONDARY	Overall Survival	Up to 2 years
OTHER_PRE_SPECIFIED	Number of Participants Who Continue on Arm A After 2 Cycles	At the end of Cycle 2 (each cycle is 28 days)
OTHER_PRE_SPECIFIED	Number of Participants Without Minimal Residual Disease	Up to 8 months

Source ClinicalTrials.gov

Results by group24

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

Outcome	Group	Category	Value	Units
Overall Response Rate	A: Daratumumab & Dexamethasone	Stringent Complete Response	1	Participants
Overall Response Rate	B: Daratumumab, Dexamethasone and Lenalidomide	Stringent Complete Response	1	Participants
Overall Response Rate	C: Daratumumab, Dexamethasone and Bortezomib	Stringent Complete Response	0	Participants
Overall Response Rate	A: Daratumumab & Dexamethasone	Complete Response	1	Participants
Overall Response Rate	B: Daratumumab, Dexamethasone and Lenalidomide	Complete Response	1	Participants
Overall Response Rate	C: Daratumumab, Dexamethasone and Bortezomib	Complete Response	0	Participants
Overall Response Rate	A: Daratumumab & Dexamethasone	Very Good Partial Response	7	Participants
Overall Response Rate	B: Daratumumab, Dexamethasone and Lenalidomide	Very Good Partial Response	9	Participants
Overall Response Rate	C: Daratumumab, Dexamethasone and Bortezomib	Very Good Partial Response	5	Participants
Overall Response Rate	A: Daratumumab & Dexamethasone	Partial Response	3	Participants

1 to 10 of 24Source ClinicalTrials.gov

See all 24 results by group

Participant flow9

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

Period	Milestone	Group	Participants
Overall Study	STARTED	A: Daratumumab & Dexamethasone	14
Overall Study	STARTED	B: Daratumumab, Dexamethasone and Lenalidomide	12
Overall Study	STARTED	C: Daratumumab, Dexamethasone and Bortezomib	7
Overall Study	COMPLETED	A: Daratumumab & Dexamethasone	14
Overall Study	COMPLETED	B: Daratumumab, Dexamethasone and Lenalidomide	12
Overall Study	COMPLETED	C: Daratumumab, Dexamethasone and Bortezomib	7
Overall Study	NOT COMPLETED	A: Daratumumab & Dexamethasone	0
Overall Study	NOT COMPLETED	B: Daratumumab, Dexamethasone and Lenalidomide	0
Overall Study	NOT COMPLETED	C: Daratumumab, Dexamethasone and Bortezomib	0

Source ClinicalTrials.gov

Adverse events630

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	Events
other	Investigations, Other	Investigations	A: Daratumumab & Dexamethasone	20	33	106
other	Investigations, Other	Investigations	B: Daratumumab, Dexamethasone and Lenalidomide	8	12	51
other	Investigations, Other	Investigations	C: Daratumumab, Dexamethasone and Bortezomib	6	7	32
other	Blood lactate dehydrogenase increased	Investigations	A: Daratumumab & Dexamethasone	15	33	33
other	Blood lactate dehydrogenase increased	Investigations	B: Daratumumab, Dexamethasone and Lenalidomide	5	12	7
other	Blood lactate dehydrogenase increased	Investigations	C: Daratumumab, Dexamethasone and Bortezomib	4	7	11
other	Lymphocyte count decreased	Investigations	A: Daratumumab & Dexamethasone	6	33	14
other	Lymphocyte count decreased	Investigations	B: Daratumumab, Dexamethasone and Lenalidomide	5	12	13
other	Lymphocyte count decreased	Investigations	C: Daratumumab, Dexamethasone and Bortezomib	1	7	1
other	Neutrophil count decreased	Investigations	A: Daratumumab & Dexamethasone	5	33	10

1 to 10 of 630Source ClinicalTrials.gov

See all 630 adverse events

Adverse event totals9

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	A: Daratumumab & Dexamethasone	1	33
Total, all-cause mortality	B: Daratumumab, Dexamethasone and Lenalidomide	1	12
Total, all-cause mortality	C: Daratumumab, Dexamethasone and Bortezomib	0	7
Total, other adverse events	A: Daratumumab & Dexamethasone	31	33
Total, other adverse events	B: Daratumumab, Dexamethasone and Lenalidomide	12	12
Total, other adverse events	C: Daratumumab, Dexamethasone and Bortezomib	7	7
Total, serious adverse events	A: Daratumumab & Dexamethasone	4	33
Total, serious adverse events	B: Daratumumab, Dexamethasone and Lenalidomide	6	12
Total, serious adverse events	C: Daratumumab, Dexamethasone and Bortezomib	2	7

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
40983035	DERIVED

Source 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 comparisons0

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

None in this release.

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.

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