Trial Outcomes & Findings for Study of Daratumumab Combined With Carfilzomib, Lenalidomide and Dexamethasone for Newly Diagnosed Multiple Myeloma (NCT NCT04113018)

Last Updated: 2026-02-03

Results Overview

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.

Recruitment status

ACTIVE_NOT_RECRUITING

Study phase

PHASE2

Target enrollment

39 participants

Primary outcome timeframe

From enrollment to best response determined at the end of induction (8 28-day cycles); the median length of induction was 32 weeks

Results posted on

2026-02-03

Participant Flow

Participant milestones

Participant milestones
Measure	KRd-Daratumumab Induction: Carfilzomib, lenalidomide, dexamethasone (KRd) + Daratumumab Carfilzomib, lenalidomide, dexamethasone (KRd) + Daratumumab: Experimental
Overall Study STARTED	39
Overall Study COMPLETED	0
Overall Study NOT COMPLETED	39

Reasons for withdrawal

Reasons for withdrawal
Measure	KRd-Daratumumab Induction: Carfilzomib, lenalidomide, dexamethasone (KRd) + Daratumumab Carfilzomib, lenalidomide, dexamethasone (KRd) + Daratumumab: Experimental
Overall Study Death	2
Overall Study Lost to Follow-up	1
Overall Study Still On Study (on study treatment)	24
Overall Study Still On Study (in follow up)	12

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	KRd-Daratumumab n=39 Participants Induction: Carfilzomib, lenalidomide, dexamethasone (KRd) + Daratumumab Carfilzomib, lenalidomide, dexamethasone (KRd) + Daratumumab: Experimental
Age, Categorical <=18 years	0 Participants n=13 Participants
Age, Categorical Between 18 and 65 years	23 Participants n=13 Participants
Age, Categorical >=65 years	16 Participants n=13 Participants
Age, Continuous	62 years n=13 Participants
Sex: Female, Male Female	12 Participants n=13 Participants
Sex: Female, Male Male	27 Participants n=13 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=13 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	37 Participants n=13 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=13 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=13 Participants
Race (NIH/OMB) Asian	1 Participants n=13 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=13 Participants
Race (NIH/OMB) Black or African American	12 Participants n=13 Participants
Race (NIH/OMB) White	26 Participants n=13 Participants
Race (NIH/OMB) More than one race	0 Participants n=13 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=13 Participants
Region of Enrollment United States	39 participants n=13 Participants

PRIMARY outcome

Timeframe: From enrollment to best response determined at the end of induction (8 28-day cycles); the median length of induction was 32 weeks

Population: The response evaluable population is defined as all subjects who initiate treatment with daratumumab and who have measurable disease at baseline.

Outcome measures

Outcome measures
Measure	KRd-Daratumumab n=39 Participants Induction: Carfilzomib, lenalidomide, dexamethasone (KRd) + Daratumumab Carfilzomib, lenalidomide, dexamethasone (KRd) + Daratumumab: Experimental
Number of Participants With Complete Response or Stringent Complete Response to Induction	21 Participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: From enrollment to completion of induction; evaluated for approximately 32 weeks (8 28-day cycles).

Population: The evaluable population is defined as all subjects who initiate treatment with daratumumab.

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.

Outcome measures

Outcome measures
Measure	KRd-Daratumumab n=39 Participants Induction: Carfilzomib, lenalidomide, dexamethasone (KRd) + Daratumumab Carfilzomib, lenalidomide, dexamethasone (KRd) + Daratumumab: Experimental
Number of Participants With Grade 3 or Higher Treatment-related Cardiovascular or Pulmonary-related Adverse Events During Induction	2 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: From enrollment to completion of induction; evaluated for approximately 32 weeks (8 28-day cycles).

Population: The evaluable population is defined as all subjects who initiate treatment with daratumumab.

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

Outcome measures

Outcome measures
Measure	KRd-Daratumumab n=39 Participants Induction: Carfilzomib, lenalidomide, dexamethasone (KRd) + Daratumumab Carfilzomib, lenalidomide, dexamethasone (KRd) + Daratumumab: Experimental
Number of Participants With Grade 5 Adverse Events During Induction	1 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 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.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

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.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

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.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

A binary variable will be determined for each participant indicating whether or not the subject discontinued study treatment due to adverse events.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: From enrollment to completion of induction; evaluated for approximately 32 weeks (8 28-day cycles).

Population: The evaluable population is defined as all subjects who initiate treatment with daratumumab

Descriptive summary of daratumumab administration. Number of cycles of daratumumab received.

Outcome measures

Outcome measures
Measure	KRd-Daratumumab n=39 Participants Induction: Carfilzomib, lenalidomide, dexamethasone (KRd) + Daratumumab Carfilzomib, lenalidomide, dexamethasone (KRd) + Daratumumab: Experimental
Daratumumab Administration - Number of Cycles Received	7 count of cycles Interval 1.0 to 8.0

OTHER_PRE_SPECIFIED outcome

Timeframe: From enrollment to completion of induction; evaluated for approximately 32 weeks (8 28-day cycles).

Population: The evaluable population is defined as all subjects who initiate treatment with daratumumab

Descriptive summary of daratumumab administration. Number of doses of daratumumab received.

Outcome measures

Outcome measures
Measure	KRd-Daratumumab n=39 Participants Induction: Carfilzomib, lenalidomide, dexamethasone (KRd) + Daratumumab Carfilzomib, lenalidomide, dexamethasone (KRd) + Daratumumab: Experimental
Daratumumab Administration - Number of Doses Received	17 count of doses Interval 1.0 to 19.0

Adverse Events

KRd-Daratumumab

Serious events: 15 serious events

Other events: 39 other events

Deaths: 2 deaths

Serious adverse events

Serious adverse events
Measure	KRd-Daratumumab n=39 participants at risk Induction: Carfilzomib, lenalidomide, dexamethasone (KRd) + Daratumumab Carfilzomib, lenalidomide, dexamethasone (KRd) + Daratumumab: Experimental
Blood and lymphatic system disorders Anemia	2.6% 1/39 • Baseline, during treatment, and through 30 days after study treatment is discontinued, an average of 27 months.
Cardiac disorders Heart failure	2.6% 1/39 • Baseline, during treatment, and through 30 days after study treatment is discontinued, an average of 27 months.
Gastrointestinal disorders Colitis	2.6% 1/39 • Baseline, during treatment, and through 30 days after study treatment is discontinued, an average of 27 months.
Gastrointestinal disorders Enterocolitis	2.6% 1/39 • Baseline, during treatment, and through 30 days after study treatment is discontinued, an average of 27 months.
Gastrointestinal disorders Ileus	2.6% 1/39 • Baseline, during treatment, and through 30 days after study treatment is discontinued, an average of 27 months.
Gastrointestinal disorders Upper gastrointestinal hemorrhage	2.6% 1/39 • Baseline, during treatment, and through 30 days after study treatment is discontinued, an average of 27 months.
General disorders and administration site conditions Fever	10.3% 4/39 • Baseline, during treatment, and through 30 days after study treatment is discontinued, an average of 27 months.
General disorders and administration site conditions Pain	2.6% 1/39 • Baseline, during treatment, and through 30 days after study treatment is discontinued, an average of 27 months.
Hepatobiliary disorders Cholecystitis	2.6% 1/39 • Baseline, during treatment, and through 30 days after study treatment is discontinued, an average of 27 months.
Infections and infestations Sepsis	5.1% 2/39 • Baseline, during treatment, and through 30 days after study treatment is discontinued, an average of 27 months.
Infections and infestations Upper respiratory infection	5.1% 2/39 • Baseline, during treatment, and through 30 days after study treatment is discontinued, an average of 27 months.
Infections and infestations Urinary tract infection	5.1% 2/39 • Baseline, during treatment, and through 30 days after study treatment is discontinued, an average of 27 months.
Infections and infestations Appendicitis	2.6% 1/39 • Baseline, during treatment, and through 30 days after study treatment is discontinued, an average of 27 months.
Infections and infestations Enterocolitis infectious	2.6% 1/39 • Baseline, during treatment, and through 30 days after study treatment is discontinued, an average of 27 months.
Infections and infestations Infections and infestations - Other	2.6% 1/39 • Baseline, during treatment, and through 30 days after study treatment is discontinued, an average of 27 months.
Infections and infestations Lung infection	2.6% 1/39 • Baseline, during treatment, and through 30 days after study treatment is discontinued, an average of 27 months.
Musculoskeletal and connective tissue disorders Arthritis	5.1% 2/39 • Baseline, during treatment, and through 30 days after study treatment is discontinued, an average of 27 months.
Musculoskeletal and connective tissue disorders Musculoskeletal and connective tissue disorder - Other	2.6% 1/39 • Baseline, during treatment, and through 30 days after study treatment is discontinued, an average of 27 months.
Nervous system disorders Intracranial hemorrhage	2.6% 1/39 • Baseline, during treatment, and through 30 days after study treatment is discontinued, an average of 27 months.
Nervous system disorders Paresthesia	2.6% 1/39 • Baseline, during treatment, and through 30 days after study treatment is discontinued, an average of 27 months.
Psychiatric disorders Confusion	2.6% 1/39 • Baseline, during treatment, and through 30 days after study treatment is discontinued, an average of 27 months.
Renal and urinary disorders Acute kidney injury	2.6% 1/39 • Baseline, during treatment, and through 30 days after study treatment is discontinued, an average of 27 months.
Respiratory, thoracic and mediastinal disorders Dyspnea	2.6% 1/39 • Baseline, during treatment, and through 30 days after study treatment is discontinued, an average of 27 months.
Respiratory, thoracic and mediastinal disorders Pneumonitis	2.6% 1/39 • Baseline, during treatment, and through 30 days after study treatment is discontinued, an average of 27 months.
Respiratory, thoracic and mediastinal disorders Pulmonary edema	2.6% 1/39 • Baseline, during treatment, and through 30 days after study treatment is discontinued, an average of 27 months.
Respiratory, thoracic and mediastinal disorders Respiratory failure	2.6% 1/39 • Baseline, during treatment, and through 30 days after study treatment is discontinued, an average of 27 months.
Respiratory, thoracic and mediastinal disorders Respiratory, thoracic and mediastinal disorders - Other	2.6% 1/39 • Baseline, during treatment, and through 30 days after study treatment is discontinued, an average of 27 months.

Other adverse events

Other adverse events
Measure	KRd-Daratumumab n=39 participants at risk Induction: Carfilzomib, lenalidomide, dexamethasone (KRd) + Daratumumab Carfilzomib, lenalidomide, dexamethasone (KRd) + Daratumumab: Experimental
Infections and infestations Gum infection	5.1% 2/39 • Baseline, during treatment, and through 30 days after study treatment is discontinued, an average of 27 months.
Infections and infestations Lung infection	5.1% 2/39 • Baseline, during treatment, and through 30 days after study treatment is discontinued, an average of 27 months.
Infections and infestations Nail infection	5.1% 2/39 • Baseline, during treatment, and through 30 days after study treatment is discontinued, an average of 27 months.
Infections and infestations Skin infection	5.1% 2/39 • Baseline, during treatment, and through 30 days after study treatment is discontinued, an average of 27 months.
Infections and infestations Enterocolitis infectious	2.6% 1/39 • Baseline, during treatment, and through 30 days after study treatment is discontinued, an average of 27 months.
Infections and infestations Hepatitis viral	2.6% 1/39 • Baseline, during treatment, and through 30 days after study treatment is discontinued, an average of 27 months.
Infections and infestations Infections and infestations - Other	28.2% 11/39 • Baseline, during treatment, and through 30 days after study treatment is discontinued, an average of 27 months.
Infections and infestations Papulopustular rash	2.6% 1/39 • Baseline, during treatment, and through 30 days after study treatment is discontinued, an average of 27 months.
Infections and infestations Penile infection	2.6% 1/39 • Baseline, during treatment, and through 30 days after study treatment is discontinued, an average of 27 months.
Infections and infestations Phlebitis infective	2.6% 1/39 • Baseline, during treatment, and through 30 days after study treatment is discontinued, an average of 27 months.
Infections and infestations Rash pustular	2.6% 1/39 • Baseline, during treatment, and through 30 days after study treatment is discontinued, an average of 27 months.
Infections and infestations Sinusitis	2.6% 1/39 • Baseline, during treatment, and through 30 days after study treatment is discontinued, an average of 27 months.
Infections and infestations Tooth infection	2.6% 1/39 • Baseline, during treatment, and through 30 days after study treatment is discontinued, an average of 27 months.
Infections and infestations Vaginal infection	2.6% 1/39 • Baseline, during treatment, and through 30 days after study treatment is discontinued, an average of 27 months.
Injury, poisoning and procedural complications Fall	20.5% 8/39 • Baseline, during treatment, and through 30 days after study treatment is discontinued, an average of 27 months.
Injury, poisoning and procedural complications Bruising	7.7% 3/39 • Baseline, during treatment, and through 30 days after study treatment is discontinued, an average of 27 months.
Injury, poisoning and procedural complications Fracture	5.1% 2/39 • Baseline, during treatment, and through 30 days after study treatment is discontinued, an average of 27 months.
Injury, poisoning and procedural complications Spinal fracture	5.1% 2/39 • Baseline, during treatment, and through 30 days after study treatment is discontinued, an average of 27 months.
Injury, poisoning and procedural complications Ankle fracture	2.6% 1/39 • Baseline, during treatment, and through 30 days after study treatment is discontinued, an average of 27 months.
Investigations Creatinine increased	17.9% 7/39 • Baseline, during treatment, and through 30 days after study treatment is discontinued, an average of 27 months.
Investigations Blood bilirubin increased	12.8% 5/39 • Baseline, during treatment, and through 30 days after study treatment is discontinued, an average of 27 months.
Investigations Platelet count decreased	12.8% 5/39 • Baseline, during treatment, and through 30 days after study treatment is discontinued, an average of 27 months.
Investigations Alanine aminotransferase increased	7.7% 3/39 • Baseline, during treatment, and through 30 days after study treatment is discontinued, an average of 27 months.
Investigations Aspartate aminotransferase increased	7.7% 3/39 • Baseline, during treatment, and through 30 days after study treatment is discontinued, an average of 27 months.
Investigations Alkaline phosphatase increased	5.1% 2/39 • Baseline, during treatment, and through 30 days after study treatment is discontinued, an average of 27 months.
Investigations Investigations - Other	2.6% 1/39 • Baseline, during treatment, and through 30 days after study treatment is discontinued, an average of 27 months.
Investigations Electrocardiogram QT corrected interval prolonged	2.6% 1/39 • Baseline, during treatment, and through 30 days after study treatment is discontinued, an average of 27 months.
Injury, poisoning and procedural complications Injury, poisoning and procedural complications - Other	2.6% 1/39 • Baseline, during treatment, and through 30 days after study treatment is discontinued, an average of 27 months.
Injury, poisoning and procedural complications Vascular access complication	2.6% 1/39 • Baseline, during treatment, and through 30 days after study treatment is discontinued, an average of 27 months.
Investigations Neutrophil count decreased	35.9% 14/39 • Baseline, during treatment, and through 30 days after study treatment is discontinued, an average of 27 months.
Gastrointestinal disorders Nausea	30.8% 12/39 • Baseline, during treatment, and through 30 days after study treatment is discontinued, an average of 27 months.
Gastrointestinal disorders Vomiting	25.6% 10/39 • Baseline, during treatment, and through 30 days after study treatment is discontinued, an average of 27 months.
Gastrointestinal disorders Abdominal pain	10.3% 4/39 • Baseline, during treatment, and through 30 days after study treatment is discontinued, an average of 27 months.
Gastrointestinal disorders Dyspepsia	10.3% 4/39 • Baseline, during treatment, and through 30 days after study treatment is discontinued, an average of 27 months.
Gastrointestinal disorders Bloating	5.1% 2/39 • Baseline, during treatment, and through 30 days after study treatment is discontinued, an average of 27 months.
Gastrointestinal disorders Dry mouth	5.1% 2/39 • Baseline, during treatment, and through 30 days after study treatment is discontinued, an average of 27 months.
Psychiatric disorders Insomnia	20.5% 8/39 • Baseline, during treatment, and through 30 days after study treatment is discontinued, an average of 27 months.
Gastrointestinal disorders Stomach pain	5.1% 2/39 • Baseline, during treatment, and through 30 days after study treatment is discontinued, an average of 27 months.
Gastrointestinal disorders Toothache	5.1% 2/39 • Baseline, during treatment, and through 30 days after study treatment is discontinued, an average of 27 months.
Gastrointestinal disorders Fecal incontinence	2.6% 1/39 • Baseline, during treatment, and through 30 days after study treatment is discontinued, an average of 27 months.
Gastrointestinal disorders Flatulence	2.6% 1/39 • Baseline, during treatment, and through 30 days after study treatment is discontinued, an average of 27 months.
Gastrointestinal disorders Gastritis	2.6% 1/39 • Baseline, during treatment, and through 30 days after study treatment is discontinued, an average of 27 months.
Gastrointestinal disorders Gastroesophageal reflux disease	2.6% 1/39 • Baseline, during treatment, and through 30 days after study treatment is discontinued, an average of 27 months.
Gastrointestinal disorders Gastrointestinal disorders - Other	2.6% 1/39 • Baseline, during treatment, and through 30 days after study treatment is discontinued, an average of 27 months.
Gastrointestinal disorders Ileus	2.6% 1/39 • Baseline, during treatment, and through 30 days after study treatment is discontinued, an average of 27 months.
Gastrointestinal disorders Mucositis oral	2.6% 1/39 • Baseline, during treatment, and through 30 days after study treatment is discontinued, an average of 27 months.
Gastrointestinal disorders Oral pain	2.6% 1/39 • Baseline, during treatment, and through 30 days after study treatment is discontinued, an average of 27 months.
Psychiatric disorders Anxiety	2.6% 1/39 • Baseline, during treatment, and through 30 days after study treatment is discontinued, an average of 27 months.
General disorders and administration site conditions Fatigue	35.9% 14/39 • Baseline, during treatment, and through 30 days after study treatment is discontinued, an average of 27 months.
General disorders and administration site conditions Edema limbs	23.1% 9/39 • Baseline, during treatment, and through 30 days after study treatment is discontinued, an average of 27 months.
General disorders and administration site conditions Chills	15.4% 6/39 • Baseline, during treatment, and through 30 days after study treatment is discontinued, an average of 27 months.
General disorders and administration site conditions Fever	12.8% 5/39 • Baseline, during treatment, and through 30 days after study treatment is discontinued, an average of 27 months.
General disorders and administration site conditions Infusion related reaction	12.8% 5/39 • Baseline, during treatment, and through 30 days after study treatment is discontinued, an average of 27 months.
General disorders and administration site conditions Pain	10.3% 4/39 • Baseline, during treatment, and through 30 days after study treatment is discontinued, an average of 27 months.
General disorders and administration site conditions Localized edema	7.7% 3/39 • Baseline, during treatment, and through 30 days after study treatment is discontinued, an average of 27 months.
General disorders and administration site conditions Non-cardiac chest pain	5.1% 2/39 • Baseline, during treatment, and through 30 days after study treatment is discontinued, an average of 27 months.
General disorders and administration site conditions Flu like symptoms	2.6% 1/39 • Baseline, during treatment, and through 30 days after study treatment is discontinued, an average of 27 months.
General disorders and administration site conditions General disorders and administration site conditions - Other	2.6% 1/39 • Baseline, during treatment, and through 30 days after study treatment is discontinued, an average of 27 months.
Hepatobiliary disorders Cholecystitis	2.6% 1/39 • Baseline, during treatment, and through 30 days after study treatment is discontinued, an average of 27 months.
Immune system disorders Immune system disorders - Other	2.6% 1/39 • Baseline, during treatment, and through 30 days after study treatment is discontinued, an average of 27 months.
Infections and infestations Upper respiratory infection	33.3% 13/39 • Baseline, during treatment, and through 30 days after study treatment is discontinued, an average of 27 months.
Infections and infestations Urinary tract infection	10.3% 4/39 • Baseline, during treatment, and through 30 days after study treatment is discontinued, an average of 27 months.
Infections and infestations Conjunctivitis infective	5.1% 2/39 • Baseline, during treatment, and through 30 days after study treatment is discontinued, an average of 27 months.
Blood and lymphatic system disorders Anemia	10.3% 4/39 • Baseline, during treatment, and through 30 days after study treatment is discontinued, an average of 27 months.
Blood and lymphatic system disorders Febrile neutropenia	2.6% 1/39 • Baseline, during treatment, and through 30 days after study treatment is discontinued, an average of 27 months.
Cardiac disorders Sinus bradycardia	10.3% 4/39 • Baseline, during treatment, and through 30 days after study treatment is discontinued, an average of 27 months.
Cardiac disorders Palpitations	5.1% 2/39 • Baseline, during treatment, and through 30 days after study treatment is discontinued, an average of 27 months.
Cardiac disorders Atrial fibrillation	2.6% 1/39 • Baseline, during treatment, and through 30 days after study treatment is discontinued, an average of 27 months.
Cardiac disorders Cardiac disorders - Other	2.6% 1/39 • Baseline, during treatment, and through 30 days after study treatment is discontinued, an average of 27 months.
Cardiac disorders Sinus tachycardia	2.6% 1/39 • Baseline, during treatment, and through 30 days after study treatment is discontinued, an average of 27 months.
Ear and labyrinth disorders Ear pain	5.1% 2/39 • Baseline, during treatment, and through 30 days after study treatment is discontinued, an average of 27 months.
Ear and labyrinth disorders Hearing impaired	2.6% 1/39 • Baseline, during treatment, and through 30 days after study treatment is discontinued, an average of 27 months.
Ear and labyrinth disorders Vertigo	2.6% 1/39 • Baseline, during treatment, and through 30 days after study treatment is discontinued, an average of 27 months.
Endocrine disorders Endocrine disorders - Other	2.6% 1/39 • Baseline, during treatment, and through 30 days after study treatment is discontinued, an average of 27 months.
Eye disorders Blurred vision	17.9% 7/39 • Baseline, during treatment, and through 30 days after study treatment is discontinued, an average of 27 months.
Eye disorders Conjunctivitis	7.7% 3/39 • Baseline, during treatment, and through 30 days after study treatment is discontinued, an average of 27 months.
Eye disorders Cataract	2.6% 1/39 • Baseline, during treatment, and through 30 days after study treatment is discontinued, an average of 27 months.
Eye disorders Eye disorders - Other	2.6% 1/39 • Baseline, during treatment, and through 30 days after study treatment is discontinued, an average of 27 months.
Eye disorders Floaters	2.6% 1/39 • Baseline, during treatment, and through 30 days after study treatment is discontinued, an average of 27 months.
Eye disorders Uveitis	2.6% 1/39 • Baseline, during treatment, and through 30 days after study treatment is discontinued, an average of 27 months.
Eye disorders Watering eyes	2.6% 1/39 • Baseline, during treatment, and through 30 days after study treatment is discontinued, an average of 27 months.
Gastrointestinal disorders Diarrhea	64.1% 25/39 • Baseline, during treatment, and through 30 days after study treatment is discontinued, an average of 27 months.
Gastrointestinal disorders Constipation	41.0% 16/39 • Baseline, during treatment, and through 30 days after study treatment is discontinued, an average of 27 months.
Investigations Weight gain	2.6% 1/39 • Baseline, during treatment, and through 30 days after study treatment is discontinued, an average of 27 months.
Investigations Weight loss	2.6% 1/39 • Baseline, during treatment, and through 30 days after study treatment is discontinued, an average of 27 months.
Investigations White blood cell decreased	2.6% 1/39 • Baseline, during treatment, and through 30 days after study treatment is discontinued, an average of 27 months.
Metabolism and nutrition disorders Hypophosphatemia	28.2% 11/39 • Baseline, during treatment, and through 30 days after study treatment is discontinued, an average of 27 months.
Metabolism and nutrition disorders Hypokalemia	25.6% 10/39 • Baseline, during treatment, and through 30 days after study treatment is discontinued, an average of 27 months.
Metabolism and nutrition disorders Hypocalcemia	20.5% 8/39 • Baseline, during treatment, and through 30 days after study treatment is discontinued, an average of 27 months.
Metabolism and nutrition disorders Hypomagnesemia	20.5% 8/39 • Baseline, during treatment, and through 30 days after study treatment is discontinued, an average of 27 months.
Metabolism and nutrition disorders Hyperglycemia	12.8% 5/39 • Baseline, during treatment, and through 30 days after study treatment is discontinued, an average of 27 months.
Metabolism and nutrition disorders Anorexia	10.3% 4/39 • Baseline, during treatment, and through 30 days after study treatment is discontinued, an average of 27 months.
Metabolism and nutrition disorders Metabolism and nutrition disorders - Other	2.6% 1/39 • Baseline, during treatment, and through 30 days after study treatment is discontinued, an average of 27 months.
Metabolism and nutrition disorders Dehydration	2.6% 1/39 • Baseline, during treatment, and through 30 days after study treatment is discontinued, an average of 27 months.
Metabolism and nutrition disorders Hypercalcemia	2.6% 1/39 • Baseline, during treatment, and through 30 days after study treatment is discontinued, an average of 27 months.
Metabolism and nutrition disorders Hypoalbuminemia	2.6% 1/39 • Baseline, during treatment, and through 30 days after study treatment is discontinued, an average of 27 months.
Metabolism and nutrition disorders Hypoglycemia	2.6% 1/39 • Baseline, during treatment, and through 30 days after study treatment is discontinued, an average of 27 months.
Metabolism and nutrition disorders Hyponatremia	2.6% 1/39 • Baseline, during treatment, and through 30 days after study treatment is discontinued, an average of 27 months.
Musculoskeletal and connective tissue disorders Pain in extremity	23.1% 9/39 • Baseline, during treatment, and through 30 days after study treatment is discontinued, an average of 27 months.
Musculoskeletal and connective tissue disorders Myalgia	20.5% 8/39 • Baseline, during treatment, and through 30 days after study treatment is discontinued, an average of 27 months.
Musculoskeletal and connective tissue disorders Back pain	15.4% 6/39 • Baseline, during treatment, and through 30 days after study treatment is discontinued, an average of 27 months.
Musculoskeletal and connective tissue disorders Bone pain	12.8% 5/39 • Baseline, during treatment, and through 30 days after study treatment is discontinued, an average of 27 months.
Musculoskeletal and connective tissue disorders Generalized muscle weakness	12.8% 5/39 • Baseline, during treatment, and through 30 days after study treatment is discontinued, an average of 27 months.
Musculoskeletal and connective tissue disorders Arthritis	10.3% 4/39 • Baseline, during treatment, and through 30 days after study treatment is discontinued, an average of 27 months.
Musculoskeletal and connective tissue disorders Chest wall pain	10.3% 4/39 • Baseline, during treatment, and through 30 days after study treatment is discontinued, an average of 27 months.
Musculoskeletal and connective tissue disorders Arthralgia	7.7% 3/39 • Baseline, during treatment, and through 30 days after study treatment is discontinued, an average of 27 months.
Musculoskeletal and connective tissue disorders Muscle weakness lower limb	5.1% 2/39 • Baseline, during treatment, and through 30 days after study treatment is discontinued, an average of 27 months.
Musculoskeletal and connective tissue disorders Musculoskeletal and connective tissue disorder - Other	2.6% 1/39 • Baseline, during treatment, and through 30 days after study treatment is discontinued, an average of 27 months.
Musculoskeletal and connective tissue disorders Flank pain	2.6% 1/39 • Baseline, during treatment, and through 30 days after study treatment is discontinued, an average of 27 months.
Musculoskeletal and connective tissue disorders Joint range of motion decreased	2.6% 1/39 • Baseline, during treatment, and through 30 days after study treatment is discontinued, an average of 27 months.
Musculoskeletal and connective tissue disorders Muscle weakness left-sided	2.6% 1/39 • Baseline, during treatment, and through 30 days after study treatment is discontinued, an average of 27 months.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other	2.6% 1/39 • Baseline, during treatment, and through 30 days after study treatment is discontinued, an average of 27 months.
Nervous system disorders Peripheral sensory neuropathy	23.1% 9/39 • Baseline, during treatment, and through 30 days after study treatment is discontinued, an average of 27 months.
Nervous system disorders Headache	20.5% 8/39 • Baseline, during treatment, and through 30 days after study treatment is discontinued, an average of 27 months.
Nervous system disorders Dysgeusia	15.4% 6/39 • Baseline, during treatment, and through 30 days after study treatment is discontinued, an average of 27 months.
Nervous system disorders Tremor	15.4% 6/39 • Baseline, during treatment, and through 30 days after study treatment is discontinued, an average of 27 months.
Nervous system disorders Syncope	12.8% 5/39 • Baseline, during treatment, and through 30 days after study treatment is discontinued, an average of 27 months.
Nervous system disorders Dizziness	10.3% 4/39 • Baseline, during treatment, and through 30 days after study treatment is discontinued, an average of 27 months.
Nervous system disorders Paresthesia	10.3% 4/39 • Baseline, during treatment, and through 30 days after study treatment is discontinued, an average of 27 months.
Nervous system disorders Presyncope	7.7% 3/39 • Baseline, during treatment, and through 30 days after study treatment is discontinued, an average of 27 months.
Nervous system disorders Spasticity	7.7% 3/39 • Baseline, during treatment, and through 30 days after study treatment is discontinued, an average of 27 months.
Nervous system disorders Lethargy	5.1% 2/39 • Baseline, during treatment, and through 30 days after study treatment is discontinued, an average of 27 months.
Nervous system disorders Concentration impairment	2.6% 1/39 • Baseline, during treatment, and through 30 days after study treatment is discontinued, an average of 27 months.
Nervous system disorders Extrapyramidal disorder	2.6% 1/39 • Baseline, during treatment, and through 30 days after study treatment is discontinued, an average of 27 months.
Nervous system disorders Neuralgia	2.6% 1/39 • Baseline, during treatment, and through 30 days after study treatment is discontinued, an average of 27 months.
Nervous system disorders Vasovagal reaction	2.6% 1/39 • Baseline, during treatment, and through 30 days after study treatment is discontinued, an average of 27 months.
Psychiatric disorders Depression	2.6% 1/39 • Baseline, during treatment, and through 30 days after study treatment is discontinued, an average of 27 months.
Psychiatric disorders Restlessness	2.6% 1/39 • Baseline, during treatment, and through 30 days after study treatment is discontinued, an average of 27 months.
Renal and urinary disorders Urinary frequency	5.1% 2/39 • Baseline, during treatment, and through 30 days after study treatment is discontinued, an average of 27 months.
Renal and urinary disorders Hematuria	2.6% 1/39 • Baseline, during treatment, and through 30 days after study treatment is discontinued, an average of 27 months.
Renal and urinary disorders Urinary incontinence	2.6% 1/39 • Baseline, during treatment, and through 30 days after study treatment is discontinued, an average of 27 months.
Renal and urinary disorders Urinary retention	2.6% 1/39 • Baseline, during treatment, and through 30 days after study treatment is discontinued, an average of 27 months.
Reproductive system and breast disorders Erectile dysfunction	2.6% 1/39 • Baseline, during treatment, and through 30 days after study treatment is discontinued, an average of 27 months.
Reproductive system and breast disorders Reproductive system and breast disorders - Other	2.6% 1/39 • Baseline, during treatment, and through 30 days after study treatment is discontinued, an average of 27 months.
Reproductive system and breast disorders Vaginal dryness	2.6% 1/39 • Baseline, during treatment, and through 30 days after study treatment is discontinued, an average of 27 months.
Respiratory, thoracic and mediastinal disorders Cough	30.8% 12/39 • Baseline, during treatment, and through 30 days after study treatment is discontinued, an average of 27 months.
Respiratory, thoracic and mediastinal disorders Allergic rhinitis	15.4% 6/39 • Baseline, during treatment, and through 30 days after study treatment is discontinued, an average of 27 months.
Respiratory, thoracic and mediastinal disorders Dyspnea	12.8% 5/39 • Baseline, during treatment, and through 30 days after study treatment is discontinued, an average of 27 months.
Respiratory, thoracic and mediastinal disorders Nasal congestion	7.7% 3/39 • Baseline, during treatment, and through 30 days after study treatment is discontinued, an average of 27 months.
Respiratory, thoracic and mediastinal disorders Hiccups	5.1% 2/39 • Baseline, during treatment, and through 30 days after study treatment is discontinued, an average of 27 months.
Respiratory, thoracic and mediastinal disorders Productive cough	5.1% 2/39 • Baseline, during treatment, and through 30 days after study treatment is discontinued, an average of 27 months.
Respiratory, thoracic and mediastinal disorders Epistaxis	2.6% 1/39 • Baseline, during treatment, and through 30 days after study treatment is discontinued, an average of 27 months.
Respiratory, thoracic and mediastinal disorders Hoarseness	2.6% 1/39 • Baseline, during treatment, and through 30 days after study treatment is discontinued, an average of 27 months.
Respiratory, thoracic and mediastinal disorders Sleep apnea	2.6% 1/39 • Baseline, during treatment, and through 30 days after study treatment is discontinued, an average of 27 months.
Respiratory, thoracic and mediastinal disorders Sore throat	2.6% 1/39 • Baseline, during treatment, and through 30 days after study treatment is discontinued, an average of 27 months.
Respiratory, thoracic and mediastinal disorders Wheezing	2.6% 1/39 • Baseline, during treatment, and through 30 days after study treatment is discontinued, an average of 27 months.
Skin and subcutaneous tissue disorders Rash maculo-papular	23.1% 9/39 • Baseline, during treatment, and through 30 days after study treatment is discontinued, an average of 27 months.
Skin and subcutaneous tissue disorders Pruritus	15.4% 6/39 • Baseline, during treatment, and through 30 days after study treatment is discontinued, an average of 27 months.
Skin and subcutaneous tissue disorders Dry skin	10.3% 4/39 • Baseline, during treatment, and through 30 days after study treatment is discontinued, an average of 27 months.
Skin and subcutaneous tissue disorders Urticaria	7.7% 3/39 • Baseline, during treatment, and through 30 days after study treatment is discontinued, an average of 27 months.
Skin and subcutaneous tissue disorders Rash acneiform	5.1% 2/39 • Baseline, during treatment, and through 30 days after study treatment is discontinued, an average of 27 months.
Skin and subcutaneous tissue disorders Photosensitivity	2.6% 1/39 • Baseline, during treatment, and through 30 days after study treatment is discontinued, an average of 27 months.
Skin and subcutaneous tissue disorders Purpura	2.6% 1/39 • Baseline, during treatment, and through 30 days after study treatment is discontinued, an average of 27 months.
Skin and subcutaneous tissue disorders Skin and subcutaneous tissue disorders - Other	2.6% 1/39 • Baseline, during treatment, and through 30 days after study treatment is discontinued, an average of 27 months.
Skin and subcutaneous tissue disorders Skin ulceration	2.6% 1/39 • Baseline, during treatment, and through 30 days after study treatment is discontinued, an average of 27 months.
Surgical and medical procedures Surgical and medical procedures - Other	2.6% 1/39 • Baseline, during treatment, and through 30 days after study treatment is discontinued, an average of 27 months.
Vascular disorders Hypertension	15.4% 6/39 • Baseline, during treatment, and through 30 days after study treatment is discontinued, an average of 27 months.
Vascular disorders Hypotension	15.4% 6/39 • Baseline, during treatment, and through 30 days after study treatment is discontinued, an average of 27 months.
Vascular disorders Thromboembolic event	7.7% 3/39 • Baseline, during treatment, and through 30 days after study treatment is discontinued, an average of 27 months.
Vascular disorders Hot flashes	5.1% 2/39 • Baseline, during treatment, and through 30 days after study treatment is discontinued, an average of 27 months.
Vascular disorders Phlebitis	5.1% 2/39 • Baseline, during treatment, and through 30 days after study treatment is discontinued, an average of 27 months.
Vascular disorders Superficial thrombophlebitis	5.1% 2/39 • Baseline, during treatment, and through 30 days after study treatment is discontinued, an average of 27 months.
Vascular disorders Vascular disorders - Other	2.6% 1/39 • Baseline, during treatment, and through 30 days after study treatment is discontinued, an average of 27 months.

Additional Information

Chair of Biostatistics Department

Atrium Health Levine Cancer

Phone: 9804422371

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place