Trial · NCT04113018

Study of Daratumumab Combined With Carfilzomib, Lenalidomide and Dexamethasone for Newly Diagnosed Multiple Myeloma

NCT04113018, Phase 2, Active not recruiting, Wake Forest University Health Sciences; results first posted 2024-07-16

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Study of Daratumumab Combined With Carfilzomib, Lenalidomide and Dexamethasone for Newly Diagnosed Multiple Myeloma. Trials, record NCT04113018. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04113018

On this page

Trial

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

Title: Study of Daratumumab Combined With Carfilzomib, Lenalidomide and Dexamethasone for Newly Diagnosed Multiple Myeloma
NCT number: NCT04113018
Status: Active not recruiting
Phases: Phase 2
Enrollment: 39 participants, actual
Lead sponsor: Wake Forest University Health Sciences
Conditions: Multiple Myeloma
Interventions: Carfilzomib, lenalidomide, dexamethasone (KRd) + Daratumumab
First posted: 2019-10-02
Last updated: 2026-08-13
Results first posted: 2024-07-16

Source ClinicalTrials.gov

Registered outcomes15

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

List	Outcome	Time frame	Description
Primary	Number of Participants With Complete Response or Stringent Complete Response to Induction	From enrollment to best response determined at the end of induction (8 28-day cycles); the median length of induction was 32 weeks	The primary endpoint is a binary variable determined for each subject indicating whether the subject achieved a complete response (CR) or stringent complete response (sCR) to induction treatment with KRd-Dara, as defined by the IMWG 2016 response criteria. Per IMWG 2016 criteria, CR is defined as negative immunofixation on serum and urine, disappearance of any soft tissue plasmacytomas, and \<5% plasma cells in bone marrow aspirates. sCR is defined as CR plus normal FLC ratio and absence of clonal cells in bone marrow by immunohistochemistry.
Secondary	Number of Participants With an Objective Response (OR)	From enrollment to best response while on study treatment; subjects remained on treatment until disease progression or death or unacceptable toxicity; assessed for approximately 5 years	Objective response is determined for each subject as a binary variable indicating whether or not the subject achieved a best overall response of stringent complete response (sCR), complete response (CR) or partial response (PR) as determined by IMWG 2016 response criteria.
Secondary	Overall Survival (OS)	From date of treatment start to date of death, or censored as described; assessed for approximately 5 years	OS is defined as the duration from enrollment to the study (treatment start date) to the date of death from any cause. Participants who are alive or lost to follow-up at the time of the analysis will be censored at the last known date they were alive.
Secondary	Progression Free Survival (PFS)	From date of treatment start to date of progression or death, or censored as described; assessed for approximately 5 years	PFS is defined as the duration of time from treatment start date to first occurrence of either progressive disease (PD) or death. PD must be objectively determined per IMWG 2016 criteria, where progression date is date of last assessment that identified PD. If subject died without documented PD, progression date will be death date. For surviving subjects who do not have PD, PFS will be censored at the date of last disease assessment. For subjects who received subsequent anti-cancer therapy prior to documented PD, PFS will be censored at the date of last disease assessment prior to commencement of subsequent therapy. Subjects who have an initial PFS event immediately following 2 or more consecutive missed assessments will be censored at date of last assessment prior to missed assessments.
Secondary	Time to Disease Progression (TTP)	From date of start of treatment to date of disease progression or death, or censored as described; assessed for approximately 5 years	TTP is defined as the duration of time from treatment start date to first occurrence of either progressive disease (PD) or death related to disease progression. PD must be objectively determined per IMWG 2016 criteria, where progression date is date of last assessment that identified PD. If a subject died for causes related to disease progression then progression date will be date of death. If a subject died for causes other than disease progression, TTP will be censored at the date of other cause mortality. For surviving subjects who do not have PD, TTP will be censored at the date of last disease assessment. For subjects who received subsequent anti-cancer therapy prior to documented PD, TTP will be censored at the date of last disease assessment prior to commencement of subsequent therapy. Subjects who have an initial TTP event immediately following 2 or more consecutive missed assessments will be censored at date of last assessment prior to missed assessments.
Secondary	Duration of Response (DoR)	From date of first response to date of progression or death, or censored as described; assessed for approximately 5 years	Duration of response (DoR) will be calculated for each subject achieving a PR or better and will be calculated from the time of the first assessment that identified response until disease progression or death. The censoring mechanism will be the same as described for PFS.
Secondary	Time to Next Treatment (TTNT)	From treatment start date to date of next treatment, or censored as described; assessed for approximately 5 years	Time to next treatment (TTNT) will be calculated from the time of treatment start until the start of the first subsequent anti-cancer therapy after all protocol directed therapy is completed. For surviving subjects who do not receive subsequent therapy, TTNT will be censored at the last contact date. For subjects who die before beginning subsequent anti-cancer therapy, TTNT will be censored at the date of death.
Other	Number of Participants With Grade 3 or Higher Treatment-related Cardiovascular or Pulmonary-related Adverse Events During Induction	From enrollment to completion of induction; evaluated for approximately 32 weeks (8 28-day cycles).	A binary variable will be determined for each subject indicating whether or not the subject experienced at least one grade 3 or higher study treatment-related cardiovascular or pulmonary-related adverse event according to the NCI Common Terminology for Adverse Events version 4.03 during induction. Only select CTCAE terms will be considered for this safety outcome including heart failure, pneumonia, dyspnea, peripheral edema, or hypertension.
Other	Number of Participants With Grade 5 Adverse Events During Induction	From enrollment to completion of induction; evaluated for approximately 32 weeks (8 28-day cycles).	A binary variable will be determined for each participant indicating whether or not the subject died due to an adverse event during induction. This will include any grade 5 adverse event (according to NCI Common Terminology for Adverse Events version 4.03), regardless of causality
Other	Number of Participants With at Least One Serious Adverse Event	From enrollment to 30 days following cessation of study treatment. Reasons for study treatment discontinuation include progression, toxicity, consent withdrawal, or investigator decision; assessed for approximately 5 years.	A binary variable will be determined for each participant indicating whether or not the subject had at least one adverse event that was categorized as serious, regardless of causality. Serious is defined per the study protocol and includes events that the investigator deems serious and results in the following outcomes: death, life-threatening situation, persistent or significant disability/incapacity, requires or prolongs hospitalization, congenital anomaly/birth defect in the offspring of a study participant, suspected transmission of any infectious agent via medial product, or based upon medical judgement, may jeopardize the subject and may require medical or surgical intervention to prevent one of the afore listed outcomes from occurring.

1 to 10 of 15Source ClinicalTrials.gov

See all 15 registered outcomes

Outcomes15

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

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Number of Participants With Complete Response or Stringent Complete Response to Induction	From enrollment to best response determined at the end of induction (8 28-day cycles); the median length of induction was 32 weeks	The response evaluable population is defined as all subjects who initiate treatment with daratumumab and who have measurable disease at baseline.	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Number of Participants With an Objective Response (OR)	From enrollment to best response while on study treatment; subjects remained on treatment until disease progression or death or unacceptable toxicity; assessed for approximately 5 years
SECONDARY	Overall Survival (OS)	From date of treatment start to date of death, or censored as described; assessed for approximately 5 years
SECONDARY	Progression Free Survival (PFS)	From date of treatment start to date of progression or death, or censored as described; assessed for approximately 5 years
SECONDARY	Time to Disease Progression (TTP)	From date of start of treatment to date of disease progression or death, or censored as described; assessed for approximately 5 years
SECONDARY	Duration of Response (DoR)	From date of first response to date of progression or death, or censored as described; assessed for approximately 5 years
SECONDARY	Time to Next Treatment (TTNT)	From treatment start date to date of next treatment, or censored as described; assessed for approximately 5 years
OTHER_PRE_SPECIFIED	Number of Participants With Grade 3 or Higher Treatment-related Cardiovascular or Pulmonary-related Adverse Events During Induction	From enrollment to completion of induction; evaluated for approximately 32 weeks (8 28-day cycles).	The evaluable population is defined as all subjects who initiate treatment with daratumumab.	Participants	COUNT_OF_PARTICIPANTS
OTHER_PRE_SPECIFIED	Number of Participants With Grade 5 Adverse Events During Induction	From enrollment to completion of induction; evaluated for approximately 32 weeks (8 28-day cycles).	The evaluable population is defined as all subjects who initiate treatment with daratumumab.	Participants	COUNT_OF_PARTICIPANTS
OTHER_PRE_SPECIFIED	Number of Participants With at Least One Serious Adverse Event	From enrollment to 30 days following cessation of study treatment. Reasons for study treatment discontinuation include progression, toxicity, consent withdrawal, or investigator decision; assessed for approximately 5 years.

1 to 10 of 15Source ClinicalTrials.gov

See all 15 outcomes

Results by group5

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

Outcome	Group	Value	Spread	Units
Number of Participants With Complete Response or Stringent Complete Response to Induction	KRd-Daratumumab	21		Participants
Number of Participants With Grade 3 or Higher Treatment-related Cardiovascular or Pulmonary-related Adverse Events During Induction	KRd-Daratumumab	2		Participants
Number of Participants With Grade 5 Adverse Events During Induction	KRd-Daratumumab	1		Participants
Daratumumab Administration - Number of Cycles Received	KRd-Daratumumab	7	Full Range 1 to 8	count of cycles
Daratumumab Administration - Number of Doses Received	KRd-Daratumumab	17	Full Range 1 to 19	count of doses

Source ClinicalTrials.gov

Participant flow3

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

Period	Milestone	Group	Participants
Overall Study	STARTED	KRd-Daratumumab	39
Overall Study	COMPLETED	KRd-Daratumumab	0
Overall Study	NOT COMPLETED	KRd-Daratumumab	39

Source ClinicalTrials.gov

Adverse events229

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	Anemia	Blood and lymphatic system disorders	KRd-Daratumumab	4	39
other	Febrile neutropenia	Blood and lymphatic system disorders	KRd-Daratumumab	1	39
other	Sinus bradycardia	Cardiac disorders	KRd-Daratumumab	4	39
other	Palpitations	Cardiac disorders	KRd-Daratumumab	2	39
other	Atrial fibrillation	Cardiac disorders	KRd-Daratumumab	1	39
other	Cardiac disorders - Other	Cardiac disorders	KRd-Daratumumab	1	39
other	Cardiac disorders - Other	Cardiac disorders	KRd-Daratumumab	1	39
other	Sinus tachycardia	Cardiac disorders	KRd-Daratumumab	1	39
other	Ear pain	Ear and labyrinth disorders	KRd-Daratumumab	2	39
other	Hearing impaired	Ear and labyrinth disorders	KRd-Daratumumab	1	39

1 to 10 of 229Source ClinicalTrials.gov

See all 229 adverse events

Adverse event totals3

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	KRd-Daratumumab	2	39
Total, other adverse events	KRd-Daratumumab	39	39
Total, serious adverse events	KRd-Daratumumab	15	39

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
39576965	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.

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

GET https://conductscience.org/api/trials/v1/NCT04113018

GET https://conductscience.org/api/trials/v1/NCT04113018/events?page=2

API reference For AI assistants