Registered outcomes15

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

1 to 15 of 15

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.
Other	Number of Participants With at Least One Treatment Emergent 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 treatment-emergent adverse event, regardless of causality. Adverse events will be categorized per NCI Common Terminology for Adverse Events version 4.03. Treatment-emergent is defined per the study protocol and includes AEs that occur after treatment start that were not present at the time of treatment start or AEs that increase in severity after treatment start if the event was present at the time of treatment start.
Other	Number of Participants With at Least One Grade 3 or Higher Treatment Emergent 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 grade 3 or higher treatment-emergent adverse event, regardless of causality. Adverse events will be categorized per NCI Common Terminology for Adverse Events version 4.03. Treatment-emergent is defined per the study protocol and includes AEs that occur after treatment start that were not present at the time of treatment start or AEs that increase in severity after treatment start if the event was present at the time of treatment start.
Other	Number of Participants Who Discontinued Study Treatment Due to Adverse Events	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 discontinued study treatment due to adverse events.
Other	Daratumumab Administration - Number of Cycles Received	From enrollment to completion of induction; evaluated for approximately 32 weeks (8 28-day cycles).	Descriptive summary of daratumumab administration. Number of cycles of daratumumab received.
Other	Daratumumab Administration - Number of Doses Received	From enrollment to completion of induction; evaluated for approximately 32 weeks (8 28-day cycles).	Descriptive summary of daratumumab administration. Number of doses of daratumumab received.

Source ClinicalTrials.govtrials-2026-11-12-0.5.0

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 list from software.

Twenty rows a page, as JSON. No key.

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

API reference For AI assistants