Trial Outcomes & Findings for A Phase II Study of Daratumumab, Clarithromycin, Pomalidomide And Dexamethasone (D-ClaPd) In Multiple Myeloma Patients Previously Exposed to Daratumumab (NCT NCT04302324)

Last Updated: 2026-05-20

Results Overview

Very Good Partial Response or better defined as the number of participants with a documented Very Good Partial Response (VGPR) or better as best response per International Myeloma Working Group (IMWG) criteria, measured from date of enrollment through the end of the 8th induction cycle.

Recruitment status

ACTIVE_NOT_RECRUITING

Study phase

PHASE2

Target enrollment

11 participants

Primary outcome timeframe

up to end of 8th induction cycle (up to approximately 224 days)

Results posted on

2026-05-20

Participant Flow

1 participant withdrew consent prior to receiving the intervention and 1 participant was a screen fail

Participant milestones

Participant milestones
Measure	Daratumumab/Clarithromycin/Pomalidomide/Dexamethasone Induction Phase: 8 cycles (cycle length of 28 days) * Daratumumab SC: 1800mg SC weekly for 8 weeks for Cycle 1 and 2 1800mg SC every 2 weeks on Day 1 and 15 for Cycle 3-6 1800mg SC every 4 weeks on Day 1 for Cycle 7-8 * Clarithromycin 500mg PO BID until VGPR or 8 cycles, whichever occurs first * Pomalidomide 4mg PO on Days 1-21 * Dexamethasone 20mg IV as pre-medication on Day 1, 8 40mg PO on the day after daratumumab for Cycle 1 Days 15 and 22 40mg PO pre-daratumumab weekly for Cycle 2-6 20mg PO pre-daratumumab weekly for Cycle 7-8 Maintenance Phase (Cycle 9+): Up to 24 cycles (cycle length of 28 days) * Daratumumab 1800 mg SC on Day 1 * Pomalidomide 4mg PO on Day 1-21 * Dexamethasone 20mg PO pre-daratumumab weekly for Cycles 9 and beyond Daratumumab SC: Given as 1800mg via injection Clarithromycin: Given as 500mg oral capsule Pomalidomide: Given as 4mg oral capsule Dexamethasone: Given as 20mg IV and 20mg or 40mg oral tablets
Overall Study STARTED	9
Overall Study COMPLETED	9
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Phase II Study of Daratumumab, Clarithromycin, Pomalidomide And Dexamethasone (D-ClaPd) In Multiple Myeloma Patients Previously Exposed to Daratumumab

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Daratumumab/Clarithromycin/Pomalidomide/Dexamethasone n=9 Participants Induction Phase: 8 cycles (cycle length of 28 days) * Daratumumab SC: 1800mg SC weekly for 8 weeks for Cycle 1 and 2 1800mg SC every 2 weeks on Day 1 and 15 for Cycle 3-6 1800mg SC every 4 weeks on Day 1 for Cycle 7-8 * Clarithromycin 500mg PO BID until VGPR or 8 cycles, whichever occurs first * Pomalidomide 4mg PO on Days 1-21 * Dexamethasone 20mg IV as pre-medication on Day 1, 8 40mg PO on the day after daratumumab for Cycle 1 Days 15 and 22 40mg PO pre-daratumumab weekly for Cycle 2-6 20mg PO pre-daratumumab weekly for Cycle 7-8 Maintenance Phase (Cycle 9+): Up to 24 cycles (cycle length of 28 days) * Daratumumab 1800 mg SC on Day 1 * Pomalidomide 4mg PO on Day 1-21 * Dexamethasone 20mg PO pre-daratumumab weekly for Cycles 9 and beyond Daratumumab SC: Given as 1800mg via injection Clarithromycin: Given as 500mg oral capsule Pomalidomide: Given as 4mg oral capsule Dexamethasone: Given as 20mg IV and 20mg or 40mg oral tablets
Age, Categorical <=18 years	0 Participants n=30 Participants
Age, Categorical Between 18 and 65 years	4 Participants n=30 Participants
Age, Categorical >=65 years	5 Participants n=30 Participants
Sex: Female, Male Female	3 Participants n=30 Participants
Sex: Female, Male Male	6 Participants n=30 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	3 Participants n=30 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	6 Participants n=30 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=30 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=30 Participants
Race (NIH/OMB) Asian	1 Participants n=30 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=30 Participants
Race (NIH/OMB) Black or African American	1 Participants n=30 Participants
Race (NIH/OMB) White	4 Participants n=30 Participants
Race (NIH/OMB) More than one race	0 Participants n=30 Participants
Race (NIH/OMB) Unknown or Not Reported	3 Participants n=30 Participants
Region of Enrollment United States	9 participants n=30 Participants
Immunoglobulin Isotype IgG Lambda	3 Participants n=30 Participants
Immunoglobulin Isotype IgG Kappa	4 Participants n=30 Participants
Immunoglobulin Isotype IgA Lambda	1 Participants n=30 Participants
Immunoglobulin Isotype IgA Kappa	0 Participants n=30 Participants
Immunoglobulin Isotype IgD Kappa	0 Participants n=30 Participants
Immunoglobulin Isotype Kappa Free light Chain	1 Participants n=30 Participants
Immunoglobulin Isotype Lambda Free light Chain	0 Participants n=30 Participants

PRIMARY outcome

Timeframe: up to end of 8th induction cycle (up to approximately 224 days)

Outcome measures

Outcome measures
Measure	Daratumumab/Clarithromycin/Pomalidomide/Dexamethasone n=9 Participants Induction Phase: 8 cycles (cycle length of 28 days) * Daratumumab SC: 1800mg SC weekly for 8 weeks for Cycle 1 and 2 1800mg SC every 2 weeks on Day 1 and 15 for Cycle 3-6 1800mg SC every 4 weeks on Day 1 for Cycle 7-8 * Clarithromycin 500mg PO BID until VGPR or 8 cycles, whichever occurs first * Pomalidomide 4mg PO on Days 1-21 * Dexamethasone 20mg IV as pre-medication on Day 1, 8 40mg PO on the day after daratumumab for Cycle 1 Days 15 and 22 40mg PO pre-daratumumab weekly for Cycle 2-6 20mg PO pre-daratumumab weekly for Cycle 7-8 Maintenance Phase (Cycle 9+): Up to 24 cycles (cycle length of 28 days) * Daratumumab 1800 mg SC on Day 1 * Pomalidomide 4mg PO on Day 1-21 * Dexamethasone 20mg PO pre-daratumumab weekly for Cycles 9 and beyond Daratumumab SC: Given as 1800mg via injection Clarithromycin: Given as 500mg oral capsule Pomalidomide: Given as 4mg oral capsule Dexamethasone: Given as 20mg IV and 20mg or 40mg oral tablets
Very Good Partial Response Rate or Better Within 8 Cycles of Induction Therapy	2 Participants

SECONDARY outcome

Timeframe: Approximately 3 years

Progression-Free Survival (PFS) is measured in months from the date of enrollment to the date of disease progression and/or death. Median estimate is calculated using the Kaplan-Meier methodology.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Approximately 1 year

The number of participants with a documented Complete Response (CR) or better, per International Myeloma Working Group (IMWG) criteria.

Outcome measures

Outcome measures
Measure	Daratumumab/Clarithromycin/Pomalidomide/Dexamethasone n=9 Participants Induction Phase: 8 cycles (cycle length of 28 days) * Daratumumab SC: 1800mg SC weekly for 8 weeks for Cycle 1 and 2 1800mg SC every 2 weeks on Day 1 and 15 for Cycle 3-6 1800mg SC every 4 weeks on Day 1 for Cycle 7-8 * Clarithromycin 500mg PO BID until VGPR or 8 cycles, whichever occurs first * Pomalidomide 4mg PO on Days 1-21 * Dexamethasone 20mg IV as pre-medication on Day 1, 8 40mg PO on the day after daratumumab for Cycle 1 Days 15 and 22 40mg PO pre-daratumumab weekly for Cycle 2-6 20mg PO pre-daratumumab weekly for Cycle 7-8 Maintenance Phase (Cycle 9+): Up to 24 cycles (cycle length of 28 days) * Daratumumab 1800 mg SC on Day 1 * Pomalidomide 4mg PO on Day 1-21 * Dexamethasone 20mg PO pre-daratumumab weekly for Cycles 9 and beyond Daratumumab SC: Given as 1800mg via injection Clarithromycin: Given as 500mg oral capsule Pomalidomide: Given as 4mg oral capsule Dexamethasone: Given as 20mg IV and 20mg or 40mg oral tablets
Complete Response Rate or Better	1 Participants

SECONDARY outcome

Timeframe: Approximately 3 years

Measured in months between the date of enrollment and the first efficacy evaluation at which the participant has met the criteria for Progressive Disease

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Approximately 3 years

Measured in months from the date of enrollment to the start date of subsequent treatment for relapsed/refractory multiple myeloma

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Approximately 3 years

Duration of Response (DoR) is defined as the time between the date of initial documentation of best response to the date of first documented evidence of disease progression.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Approximately 8 months

Defined as a number of MRD negative participants

Outcome measures

Outcome measures
Measure	Daratumumab/Clarithromycin/Pomalidomide/Dexamethasone n=9 Participants Induction Phase: 8 cycles (cycle length of 28 days) * Daratumumab SC: 1800mg SC weekly for 8 weeks for Cycle 1 and 2 1800mg SC every 2 weeks on Day 1 and 15 for Cycle 3-6 1800mg SC every 4 weeks on Day 1 for Cycle 7-8 * Clarithromycin 500mg PO BID until VGPR or 8 cycles, whichever occurs first * Pomalidomide 4mg PO on Days 1-21 * Dexamethasone 20mg IV as pre-medication on Day 1, 8 40mg PO on the day after daratumumab for Cycle 1 Days 15 and 22 40mg PO pre-daratumumab weekly for Cycle 2-6 20mg PO pre-daratumumab weekly for Cycle 7-8 Maintenance Phase (Cycle 9+): Up to 24 cycles (cycle length of 28 days) * Daratumumab 1800 mg SC on Day 1 * Pomalidomide 4mg PO on Day 1-21 * Dexamethasone 20mg PO pre-daratumumab weekly for Cycles 9 and beyond Daratumumab SC: Given as 1800mg via injection Clarithromycin: Given as 500mg oral capsule Pomalidomide: Given as 4mg oral capsule Dexamethasone: Given as 20mg IV and 20mg or 40mg oral tablets
Rate of Minimal Residual Disease (MRD) Negativity	1 Participants

SECONDARY outcome

Timeframe: Approximately 3 years

Percentage of patients that achieved an improved response during maintenance compared to end of induction.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Approximately 9.5 months

Measured in months between the date of enrollment and the first efficacy evaluation at which the participant has met criteria for best response per International Myeloma Working Group (IMWG) criteria.

Outcome measures

Outcome measures
Measure	Daratumumab/Clarithromycin/Pomalidomide/Dexamethasone n=9 Participants Induction Phase: 8 cycles (cycle length of 28 days) * Daratumumab SC: 1800mg SC weekly for 8 weeks for Cycle 1 and 2 1800mg SC every 2 weeks on Day 1 and 15 for Cycle 3-6 1800mg SC every 4 weeks on Day 1 for Cycle 7-8 * Clarithromycin 500mg PO BID until VGPR or 8 cycles, whichever occurs first * Pomalidomide 4mg PO on Days 1-21 * Dexamethasone 20mg IV as pre-medication on Day 1, 8 40mg PO on the day after daratumumab for Cycle 1 Days 15 and 22 40mg PO pre-daratumumab weekly for Cycle 2-6 20mg PO pre-daratumumab weekly for Cycle 7-8 Maintenance Phase (Cycle 9+): Up to 24 cycles (cycle length of 28 days) * Daratumumab 1800 mg SC on Day 1 * Pomalidomide 4mg PO on Day 1-21 * Dexamethasone 20mg PO pre-daratumumab weekly for Cycles 9 and beyond Daratumumab SC: Given as 1800mg via injection Clarithromycin: Given as 500mg oral capsule Pomalidomide: Given as 4mg oral capsule Dexamethasone: Given as 20mg IV and 20mg or 40mg oral tablets
Time to Best Response	4.5 months Interval 1.3 to 9.5

SECONDARY outcome

Timeframe: Approximately 1 year

The number of participants with a documented Overall Response (Partial Response or better), per International Myeloma Working Group (IMWG) criteria.

Outcome measures

Outcome measures
Measure	Daratumumab/Clarithromycin/Pomalidomide/Dexamethasone n=9 Participants Induction Phase: 8 cycles (cycle length of 28 days) * Daratumumab SC: 1800mg SC weekly for 8 weeks for Cycle 1 and 2 1800mg SC every 2 weeks on Day 1 and 15 for Cycle 3-6 1800mg SC every 4 weeks on Day 1 for Cycle 7-8 * Clarithromycin 500mg PO BID until VGPR or 8 cycles, whichever occurs first * Pomalidomide 4mg PO on Days 1-21 * Dexamethasone 20mg IV as pre-medication on Day 1, 8 40mg PO on the day after daratumumab for Cycle 1 Days 15 and 22 40mg PO pre-daratumumab weekly for Cycle 2-6 20mg PO pre-daratumumab weekly for Cycle 7-8 Maintenance Phase (Cycle 9+): Up to 24 cycles (cycle length of 28 days) * Daratumumab 1800 mg SC on Day 1 * Pomalidomide 4mg PO on Day 1-21 * Dexamethasone 20mg PO pre-daratumumab weekly for Cycles 9 and beyond Daratumumab SC: Given as 1800mg via injection Clarithromycin: Given as 500mg oral capsule Pomalidomide: Given as 4mg oral capsule Dexamethasone: Given as 20mg IV and 20mg or 40mg oral tablets
Overall Response Rate	6 Participants

SECONDARY outcome

Timeframe: Approximately 1 year

The number of participants with a documented Very Good Partial Response (VGPR) Rate or better, per International Myeloma Working Group (IMWG) criteria.

Outcome measures

Outcome measures
Measure	Daratumumab/Clarithromycin/Pomalidomide/Dexamethasone n=9 Participants Induction Phase: 8 cycles (cycle length of 28 days) * Daratumumab SC: 1800mg SC weekly for 8 weeks for Cycle 1 and 2 1800mg SC every 2 weeks on Day 1 and 15 for Cycle 3-6 1800mg SC every 4 weeks on Day 1 for Cycle 7-8 * Clarithromycin 500mg PO BID until VGPR or 8 cycles, whichever occurs first * Pomalidomide 4mg PO on Days 1-21 * Dexamethasone 20mg IV as pre-medication on Day 1, 8 40mg PO on the day after daratumumab for Cycle 1 Days 15 and 22 40mg PO pre-daratumumab weekly for Cycle 2-6 20mg PO pre-daratumumab weekly for Cycle 7-8 Maintenance Phase (Cycle 9+): Up to 24 cycles (cycle length of 28 days) * Daratumumab 1800 mg SC on Day 1 * Pomalidomide 4mg PO on Day 1-21 * Dexamethasone 20mg PO pre-daratumumab weekly for Cycles 9 and beyond Daratumumab SC: Given as 1800mg via injection Clarithromycin: Given as 500mg oral capsule Pomalidomide: Given as 4mg oral capsule Dexamethasone: Given as 20mg IV and 20mg or 40mg oral tablets
Very Good Partial Response (VGPR) Rate or Better	2 Participants

SECONDARY outcome

Timeframe: Approximately 5 years

Overall Survival (OS) is measured in months from the date of enrollment to the date of the participant's death. Greenwood's formula will be used to calculate 95% confidence intervals for the Kaplan-Meier survival estimates.

Outcome measures

Outcome data not reported

Adverse Events

Daratumumab/Clarithromycin/Pomalidomide/Dexamethasone

Serious events: 6 serious events

Other events: 9 other events

Deaths: 1 deaths

Serious adverse events

Serious adverse events
Measure	Daratumumab/Clarithromycin/Pomalidomide/Dexamethasone n=9 participants at risk Induction Phase: 8 cycles (cycle length of 28 days) * Daratumumab SC: 1800mg SC weekly for 8 weeks for Cycle 1 and 2 1800mg SC every 2 weeks on Day 1 and 15 for Cycle 3-6 1800mg SC every 4 weeks on Day 1 for Cycle 7-8 * Clarithromycin 500mg PO BID until VGPR or 8 cycles, whichever occurs first * Pomalidomide 4mg PO on Days 1-21 * Dexamethasone 20mg IV as pre-medication on Day 1, 8 40mg PO on the day after daratumumab for Cycle 1 Days 15 and 22 40mg PO pre-daratumumab weekly for Cycle 2-6 20mg PO pre-daratumumab weekly for Cycle 7-8 Maintenance Phase (Cycle 9+): Up to 24 cycles (cycle length of 28 days) * Daratumumab 1800 mg SC on Day 1 * Pomalidomide 4mg PO on Day 1-21 * Dexamethasone 20mg PO pre-daratumumab weekly for Cycles 9 and beyond Daratumumab SC: Given as 1800mg via injection Clarithromycin: Given as 500mg oral capsule Pomalidomide: Given as 4mg oral capsule Dexamethasone: Given as 20mg IV and 20mg or 40mg oral tablets
Infections and infestations Pneumonitis	11.1% 1/9 • Number of events 1 • Adverse events were collected from the time of informed consent until 30 days of last treatment, up to 3 years
Metabolism and nutrition disorders Hypercalcemia	11.1% 1/9 • Number of events 1 • Adverse events were collected from the time of informed consent until 30 days of last treatment, up to 3 years
Infections and infestations Respiratory infection	11.1% 1/9 • Number of events 1 • Adverse events were collected from the time of informed consent until 30 days of last treatment, up to 3 years
Gastrointestinal disorders Small bowel obstruction	11.1% 1/9 • Number of events 1 • Adverse events were collected from the time of informed consent until 30 days of last treatment, up to 3 years
Metabolism and nutrition disorders Hyperkalemia	11.1% 1/9 • Number of events 1 • Adverse events were collected from the time of informed consent until 30 days of last treatment, up to 3 years
Cardiac disorders Atrial Fibrillation	11.1% 1/9 • Number of events 2 • Adverse events were collected from the time of informed consent until 30 days of last treatment, up to 3 years
Vascular disorders Hypotension	11.1% 1/9 • Number of events 1 • Adverse events were collected from the time of informed consent until 30 days of last treatment, up to 3 years
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous Cell Carcinoma	11.1% 1/9 • Number of events 1 • Adverse events were collected from the time of informed consent until 30 days of last treatment, up to 3 years
Gastrointestinal disorders Perforated Diverticulitis	11.1% 1/9 • Number of events 1 • Adverse events were collected from the time of informed consent until 30 days of last treatment, up to 3 years
Respiratory, thoracic and mediastinal disorders Lung infection	11.1% 1/9 • Number of events 1 • Adverse events were collected from the time of informed consent until 30 days of last treatment, up to 3 years
Gastrointestinal disorders Strangulated Inguinal hernia	11.1% 1/9 • Number of events 1 • Adverse events were collected from the time of informed consent until 30 days of last treatment, up to 3 years
Gastrointestinal disorders Abdominal pain	11.1% 1/9 • Number of events 1 • Adverse events were collected from the time of informed consent until 30 days of last treatment, up to 3 years

Other adverse events

Other adverse events
Measure	Daratumumab/Clarithromycin/Pomalidomide/Dexamethasone n=9 participants at risk Induction Phase: 8 cycles (cycle length of 28 days) * Daratumumab SC: 1800mg SC weekly for 8 weeks for Cycle 1 and 2 1800mg SC every 2 weeks on Day 1 and 15 for Cycle 3-6 1800mg SC every 4 weeks on Day 1 for Cycle 7-8 * Clarithromycin 500mg PO BID until VGPR or 8 cycles, whichever occurs first * Pomalidomide 4mg PO on Days 1-21 * Dexamethasone 20mg IV as pre-medication on Day 1, 8 40mg PO on the day after daratumumab for Cycle 1 Days 15 and 22 40mg PO pre-daratumumab weekly for Cycle 2-6 20mg PO pre-daratumumab weekly for Cycle 7-8 Maintenance Phase (Cycle 9+): Up to 24 cycles (cycle length of 28 days) * Daratumumab 1800 mg SC on Day 1 * Pomalidomide 4mg PO on Day 1-21 * Dexamethasone 20mg PO pre-daratumumab weekly for Cycles 9 and beyond Daratumumab SC: Given as 1800mg via injection Clarithromycin: Given as 500mg oral capsule Pomalidomide: Given as 4mg oral capsule Dexamethasone: Given as 20mg IV and 20mg or 40mg oral tablets
Eye disorders Blurred vision	11.1% 1/9 • Number of events 1 • Adverse events were collected from the time of informed consent until 30 days of last treatment, up to 3 years
General disorders Chills	11.1% 1/9 • Number of events 1 • Adverse events were collected from the time of informed consent until 30 days of last treatment, up to 3 years
Nervous system disorders Cognitive disturbance	11.1% 1/9 • Number of events 1 • Adverse events were collected from the time of informed consent until 30 days of last treatment, up to 3 years
Psychiatric disorders Confusion	22.2% 2/9 • Number of events 2 • Adverse events were collected from the time of informed consent until 30 days of last treatment, up to 3 years
Gastrointestinal disorders Constipation	44.4% 4/9 • Number of events 5 • Adverse events were collected from the time of informed consent until 30 days of last treatment, up to 3 years
Respiratory, thoracic and mediastinal disorders Cough	33.3% 3/9 • Number of events 5 • Adverse events were collected from the time of informed consent until 30 days of last treatment, up to 3 years
Infections and infestations Respiratory infection	22.2% 2/9 • Number of events 2 • Adverse events were collected from the time of informed consent until 30 days of last treatment, up to 3 years
Gastrointestinal disorders Diarrhea	11.1% 1/9 • Number of events 1 • Adverse events were collected from the time of informed consent until 30 days of last treatment, up to 3 years
Nervous system disorders Dizziness	22.2% 2/9 • Number of events 2 • Adverse events were collected from the time of informed consent until 30 days of last treatment, up to 3 years
Skin and subcutaneous tissue disorders Eczema	11.1% 1/9 • Number of events 1 • Adverse events were collected from the time of informed consent until 30 days of last treatment, up to 3 years
Eye disorders Eye pain	11.1% 1/9 • Number of events 1 • Adverse events were collected from the time of informed consent until 30 days of last treatment, up to 3 years
General disorders Face edema	11.1% 1/9 • Number of events 1 • Adverse events were collected from the time of informed consent until 30 days of last treatment, up to 3 years
General disorders Fatigue	55.6% 5/9 • Number of events 5 • Adverse events were collected from the time of informed consent until 30 days of last treatment, up to 3 years
General disorders Fever	22.2% 2/9 • Number of events 2 • Adverse events were collected from the time of informed consent until 30 days of last treatment, up to 3 years
Gastrointestinal disorders Gastroenteritis	22.2% 2/9 • Number of events 2 • Adverse events were collected from the time of informed consent until 30 days of last treatment, up to 3 years
Respiratory, thoracic and mediastinal disorders Hiccups	22.2% 2/9 • Number of events 2 • Adverse events were collected from the time of informed consent until 30 days of last treatment, up to 3 years
Psychiatric disorders Anxiety	11.1% 1/9 • Number of events 1 • Adverse events were collected from the time of informed consent until 30 days of last treatment, up to 3 years
Cardiac disorders Atrial fibrillation	11.1% 1/9 • Number of events 1 • Adverse events were collected from the time of informed consent until 30 days of last treatment, up to 3 years
Metabolism and nutrition disorders Hyperglycemia	22.2% 2/9 • Number of events 2 • Adverse events were collected from the time of informed consent until 30 days of last treatment, up to 3 years
Musculoskeletal and connective tissue disorders Back pain	33.3% 3/9 • Number of events 3 • Adverse events were collected from the time of informed consent until 30 days of last treatment, up to 3 years
Gastrointestinal disorders Abdominal distension	11.1% 1/9 • Number of events 2 • Adverse events were collected from the time of informed consent until 30 days of last treatment, up to 3 years
Psychiatric disorders Agitation	22.2% 2/9 • Number of events 2 • Adverse events were collected from the time of informed consent until 30 days of last treatment, up to 3 years
Blood and lymphatic system disorders Anemia	33.3% 3/9 • Number of events 5 • Adverse events were collected from the time of informed consent until 30 days of last treatment, up to 3 years
Metabolism and nutrition disorders Anorexia	11.1% 1/9 • Number of events 1 • Adverse events were collected from the time of informed consent until 30 days of last treatment, up to 3 years
Metabolism and nutrition disorders Hypokalemia	11.1% 1/9 • Number of events 1 • Adverse events were collected from the time of informed consent until 30 days of last treatment, up to 3 years
Metabolism and nutrition disorders Hyponatremia	11.1% 1/9 • Number of events 1 • Adverse events were collected from the time of informed consent until 30 days of last treatment, up to 3 years
Cardiac disorders Hypotension	11.1% 1/9 • Number of events 2 • Adverse events were collected from the time of informed consent until 30 days of last treatment, up to 3 years
Psychiatric disorders Insomnia	22.2% 2/9 • Number of events 2 • Adverse events were collected from the time of informed consent until 30 days of last treatment, up to 3 years
Musculoskeletal and connective tissue disorders Pain in extremitiy	44.4% 4/9 • Number of events 7 • Adverse events were collected from the time of informed consent until 30 days of last treatment, up to 3 years
Nervous system disorders Lethargy	11.1% 1/9 • Number of events 1 • Adverse events were collected from the time of informed consent until 30 days of last treatment, up to 3 years
Musculoskeletal and connective tissue disorders Lower back pain	11.1% 1/9 • Number of events 1 • Adverse events were collected from the time of informed consent until 30 days of last treatment, up to 3 years
Investigations Lymphocyte count decreased	44.4% 4/9 • Number of events 6 • Adverse events were collected from the time of informed consent until 30 days of last treatment, up to 3 years
Skin and subcutaneous tissue disorders Rash maculo papular	22.2% 2/9 • Number of events 3 • Adverse events were collected from the time of informed consent until 30 days of last treatment, up to 3 years
General disorders Malaise	11.1% 1/9 • Number of events 2 • Adverse events were collected from the time of informed consent until 30 days of last treatment, up to 3 years
Musculoskeletal and connective tissue disorders Myalgia	11.1% 1/9 • Number of events 1 • Adverse events were collected from the time of informed consent until 30 days of last treatment, up to 3 years
Respiratory, thoracic and mediastinal disorders Nasal congestion	22.2% 2/9 • Number of events 2 • Adverse events were collected from the time of informed consent until 30 days of last treatment, up to 3 years
Gastrointestinal disorders Nausea	33.3% 3/9 • Number of events 4 • Adverse events were collected from the time of informed consent until 30 days of last treatment, up to 3 years
Investigations Neutrophil count decreased	100.0% 9/9 • Number of events 29 • Adverse events were collected from the time of informed consent until 30 days of last treatment, up to 3 years
General disorders Non cardiac chest pain	11.1% 1/9 • Number of events 1 • Adverse events were collected from the time of informed consent until 30 days of last treatment, up to 3 years
Nervous system disorders Peripheral neuropathy	11.1% 1/9 • Number of events 1 • Adverse events were collected from the time of informed consent until 30 days of last treatment, up to 3 years
Respiratory, thoracic and mediastinal disorders Pharyngitis	11.1% 1/9 • Number of events 1 • Adverse events were collected from the time of informed consent until 30 days of last treatment, up to 3 years
Investigations Platelet count decreased	33.3% 3/9 • Number of events 4 • Adverse events were collected from the time of informed consent until 30 days of last treatment, up to 3 years
Respiratory, thoracic and mediastinal disorders Productive cough	11.1% 1/9 • Number of events 1 • Adverse events were collected from the time of informed consent until 30 days of last treatment, up to 3 years
Skin and subcutaneous tissue disorders Pruritus	11.1% 1/9 • Number of events 1 • Adverse events were collected from the time of informed consent until 30 days of last treatment, up to 3 years
Eye disorders Retinal detachment	11.1% 1/9 • Number of events 1 • Adverse events were collected from the time of informed consent until 30 days of last treatment, up to 3 years
Infections and infestations Rhinovirus	11.1% 1/9 • Number of events 1 • Adverse events were collected from the time of informed consent until 30 days of last treatment, up to 3 years
Infections and infestations Skin infection	11.1% 1/9 • Number of events 1 • Adverse events were collected from the time of informed consent until 30 days of last treatment, up to 3 years
Respiratory, thoracic and mediastinal disorders Sore throat	22.2% 2/9 • Number of events 2 • Adverse events were collected from the time of informed consent until 30 days of last treatment, up to 3 years
Ear and labyrinth disorders Tinnitus	11.1% 1/9 • Number of events 1 • Adverse events were collected from the time of informed consent until 30 days of last treatment, up to 3 years
Infections and infestations Upper respiratory infection	33.3% 3/9 • Number of events 3 • Adverse events were collected from the time of informed consent until 30 days of last treatment, up to 3 years
Renal and urinary disorders Urinary frequency	11.1% 1/9 • Number of events 1 • Adverse events were collected from the time of informed consent until 30 days of last treatment, up to 3 years
Renal and urinary disorders Urinary tract infection	22.2% 2/9 • Number of events 3 • Adverse events were collected from the time of informed consent until 30 days of last treatment, up to 3 years
Gastrointestinal disorders Vomiting	22.2% 2/9 • Number of events 3 • Adverse events were collected from the time of informed consent until 30 days of last treatment, up to 3 years
Respiratory, thoracic and mediastinal disorders Wheezing	11.1% 1/9 • Number of events 1 • Adverse events were collected from the time of informed consent until 30 days of last treatment, up to 3 years

Additional Information

Mateo Mejia Saldarriaga,M.D

Weill Cornell Medicine

Phone: 6469626500

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place