Trial Outcomes & Findings for A Study of Daratumumab in Patients With Relapsed or Refractory Waldenström Macroglobulinemia (NCT NCT03187262)

Last Updated: 2022-11-23

Results Overview

Overall Response Rate= Minor response (\>25%-50% reduction in serum IgM from baseline) + Partial Response (\>50-90% reduction in serum IgM from baseline) + Very Good Partial Response (\>90% reduction in serum IgM from baseline) + Complete Response (resolution of all symptoms, normalization of serum IgM with disappearance of IgM paraprotein, resolution of any adenopathy or splenomegaly).

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

13 participants

Primary outcome timeframe

2 years

Results posted on

2022-11-23

Participant Flow

Participant milestones

Participant milestones
Measure	Daratumumab * Daratumumab will be administered in three phases: Induction, consolidation and maintenance * During induction, participants will receive daratumumab on days 1, 8, 15 and 22 of each 28-day * During consolidation, daratumumab will be administered on days 1 and 15 of each 28-day cycle * During maintenance, daratumumab will be administered on day 1 of each 28-day cycle Daratumumab: Daratumumab is a monoclonal human antibody. Daratumumab has shown the ability to slow or stop the growth of cells that have CD38 on the cell surface when tested in laboratories
Induction STARTED	13
Induction COMPLETED	7
Induction NOT COMPLETED	6
Consolidation STARTED	7
Consolidation COMPLETED	2
Consolidation NOT COMPLETED	5
Maintenance STARTED	2
Maintenance COMPLETED	2
Maintenance NOT COMPLETED	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Daratumumab * Daratumumab will be administered in three phases: Induction, consolidation and maintenance * During induction, participants will receive daratumumab on days 1, 8, 15 and 22 of each 28-day * During consolidation, daratumumab will be administered on days 1 and 15 of each 28-day cycle * During maintenance, daratumumab will be administered on day 1 of each 28-day cycle Daratumumab: Daratumumab is a monoclonal human antibody. Daratumumab has shown the ability to slow or stop the growth of cells that have CD38 on the cell surface when tested in laboratories
Induction Lack of Efficacy	2
Induction Progressive Disease	4
Consolidation Progressive Disease	5

Baseline Characteristics

A Study of Daratumumab in Patients With Relapsed or Refractory Waldenström Macroglobulinemia

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Daratumumab n=13 Participants * Daratumumab will be administered in three phases: Induction, consolidation and maintenance * During induction, participants will receive daratumumab on days 1, 8, 15 and 22 of each 28-day * During consolidation, daratumumab will be administered on days 1 and 15 of each 28-day cycle * During maintenance, daratumumab will be administered on day 1 of each 28-day cycle Daratumumab: Daratumumab is a monoclonal human antibody. Daratumumab has shown the ability to slow or stop the growth of cells that have CD38 on the cell surface when tested in laboratories
Age, Categorical <=18 years	0 Participants n=99 Participants
Age, Categorical Between 18 and 65 years	3 Participants n=99 Participants
Age, Categorical >=65 years	10 Participants n=99 Participants
Age, Continuous	69 years n=99 Participants
Sex: Female, Male Female	3 Participants n=99 Participants
Sex: Female, Male Male	10 Participants n=99 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=99 Participants
Race (NIH/OMB) Asian	0 Participants n=99 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=99 Participants
Race (NIH/OMB) Black or African American	0 Participants n=99 Participants
Race (NIH/OMB) White	13 Participants n=99 Participants
Race (NIH/OMB) More than one race	0 Participants n=99 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=99 Participants
Region of Enrollment United States	13 participants n=99 Participants

PRIMARY outcome

Timeframe: 2 years

Population: Only participants who have measurable disease present at baseline, received at least one cycle of therapy, and had their disease re-evaluated were considered evaluable for response. 2 participants did not complete the first cycle of therapy and were unevaluable for the primary objective.

Outcome measures

Outcome measures
Measure	Daratumumab n=11 Participants * Daratumumab will be administered in three phases: Induction, consolidation and maintenance * During induction, participants will receive daratumumab on days 1, 8, 15 and 22 of each 28-day * During consolidation, daratumumab will be administered on days 1 and 15 of each 28-day cycle * During maintenance, daratumumab will be administered on day 1 of each 28-day cycle Daratumumab: Daratumumab is a monoclonal human antibody. Daratumumab has shown the ability to slow or stop the growth of cells that have CD38 on the cell surface when tested in laboratories
Overall Response Rate	3 Participants

SECONDARY outcome

Timeframe: 4 years

Population: Only those participants who have measurable disease present at baseline, have received at least one cycle of therapy, and have had their disease re-evaluated will be considered evaluable for response.

Amount of time following daratumumab administration until \>25% increase in serum IgM

Outcome measures

Outcome measures
Measure	Daratumumab n=11 Participants * Daratumumab will be administered in three phases: Induction, consolidation and maintenance * During induction, participants will receive daratumumab on days 1, 8, 15 and 22 of each 28-day * During consolidation, daratumumab will be administered on days 1 and 15 of each 28-day cycle * During maintenance, daratumumab will be administered on day 1 of each 28-day cycle Daratumumab: Daratumumab is a monoclonal human antibody. Daratumumab has shown the ability to slow or stop the growth of cells that have CD38 on the cell surface when tested in laboratories
Progression Free Survival	2 months Interval 1.0 to 28.0

SECONDARY outcome

Timeframe: 2 years

A complete response is defined as having resolution of WM related symptoms, normalization of serum IgM levels with complete disappearance of IgM paraprotein by immunofixation, and resolution of any adenopathy or splenomegaly.

Outcome measures

Outcome measures
Measure	Daratumumab n=11 Participants * Daratumumab will be administered in three phases: Induction, consolidation and maintenance * During induction, participants will receive daratumumab on days 1, 8, 15 and 22 of each 28-day * During consolidation, daratumumab will be administered on days 1 and 15 of each 28-day cycle * During maintenance, daratumumab will be administered on day 1 of each 28-day cycle Daratumumab: Daratumumab is a monoclonal human antibody. Daratumumab has shown the ability to slow or stop the growth of cells that have CD38 on the cell surface when tested in laboratories
Number of Participants With Complete Response	0 Participants

SECONDARY outcome

Timeframe: 2 years

Partial response (PR) is defined as achieving a ≥50% reduction in serum IgM levels.

Outcome measures

Outcome measures
Measure	Daratumumab n=11 Participants * Daratumumab will be administered in three phases: Induction, consolidation and maintenance * During induction, participants will receive daratumumab on days 1, 8, 15 and 22 of each 28-day * During consolidation, daratumumab will be administered on days 1 and 15 of each 28-day cycle * During maintenance, daratumumab will be administered on day 1 of each 28-day cycle Daratumumab: Daratumumab is a monoclonal human antibody. Daratumumab has shown the ability to slow or stop the growth of cells that have CD38 on the cell surface when tested in laboratories
Number of Participants With Partial Response	2 Participants

SECONDARY outcome

Timeframe: 2 years

Very Good Partial Response (VGPR): is defined as ≥90% reduction in serum IgM levels, or normalization of serum IgM levels.

Outcome measures

Outcome measures
Measure	Daratumumab n=11 Participants * Daratumumab will be administered in three phases: Induction, consolidation and maintenance * During induction, participants will receive daratumumab on days 1, 8, 15 and 22 of each 28-day * During consolidation, daratumumab will be administered on days 1 and 15 of each 28-day cycle * During maintenance, daratumumab will be administered on day 1 of each 28-day cycle Daratumumab: Daratumumab is a monoclonal human antibody. Daratumumab has shown the ability to slow or stop the growth of cells that have CD38 on the cell surface when tested in laboratories
Number of Participants With Very Good Partial Response	0 Participants

SECONDARY outcome

Timeframe: 2 years

Minor Response (MR): A minor response (MR) is defined 25-49% reduction in serum IgM levels.

Outcome measures

Outcome measures
Measure	Daratumumab n=11 Participants * Daratumumab will be administered in three phases: Induction, consolidation and maintenance * During induction, participants will receive daratumumab on days 1, 8, 15 and 22 of each 28-day * During consolidation, daratumumab will be administered on days 1 and 15 of each 28-day cycle * During maintenance, daratumumab will be administered on day 1 of each 28-day cycle Daratumumab: Daratumumab is a monoclonal human antibody. Daratumumab has shown the ability to slow or stop the growth of cells that have CD38 on the cell surface when tested in laboratories
Number of Participants With Minor Response	1 Participants

Adverse Events

Daratumumab

Serious events: 6 serious events

Other events: 13 other events

Deaths: 1 deaths

Serious adverse events

Serious adverse events
Measure	Daratumumab n=13 participants at risk * Daratumumab will be administered in three phases: Induction, consolidation and maintenance * During induction, participants will receive daratumumab on days 1, 8, 15 and 22 of each 28-day * During consolidation, daratumumab will be administered on days 1 and 15 of each 28-day cycle * During maintenance, daratumumab will be administered on day 1 of each 28-day cycle Daratumumab: Daratumumab is a monoclonal human antibody. Daratumumab has shown the ability to slow or stop the growth of cells that have CD38 on the cell surface when tested in laboratories
Blood and lymphatic system disorders Anemia	7.7% 1/13 • Number of events 1 • Adverse events were collected from baseline, throughout treatment with daratumumab, and for 30 days after last dose of daratumumab, up to 4 years
Investigations Thrombocytopenia	15.4% 2/13 • Number of events 2 • Adverse events were collected from baseline, throughout treatment with daratumumab, and for 30 days after last dose of daratumumab, up to 4 years
Infections and infestations Sepsis	15.4% 2/13 • Number of events 2 • Adverse events were collected from baseline, throughout treatment with daratumumab, and for 30 days after last dose of daratumumab, up to 4 years
Investigations Neutropenia	7.7% 1/13 • Number of events 1 • Adverse events were collected from baseline, throughout treatment with daratumumab, and for 30 days after last dose of daratumumab, up to 4 years
Nervous system disorders Transient Ischemic Attack	7.7% 1/13 • Number of events 1 • Adverse events were collected from baseline, throughout treatment with daratumumab, and for 30 days after last dose of daratumumab, up to 4 years
Musculoskeletal and connective tissue disorders Leg weakness	7.7% 1/13 • Number of events 1 • Adverse events were collected from baseline, throughout treatment with daratumumab, and for 30 days after last dose of daratumumab, up to 4 years
General disorders Infusion reaction	7.7% 1/13 • Number of events 1 • Adverse events were collected from baseline, throughout treatment with daratumumab, and for 30 days after last dose of daratumumab, up to 4 years
Infections and infestations Strep salvarius bacteremia	7.7% 1/13 • Number of events 1 • Adverse events were collected from baseline, throughout treatment with daratumumab, and for 30 days after last dose of daratumumab, up to 4 years
Blood and lymphatic system disorders Febrile neutropenia	7.7% 1/13 • Number of events 1 • Adverse events were collected from baseline, throughout treatment with daratumumab, and for 30 days after last dose of daratumumab, up to 4 years
General disorders Fever	7.7% 1/13 • Number of events 1 • Adverse events were collected from baseline, throughout treatment with daratumumab, and for 30 days after last dose of daratumumab, up to 4 years
Respiratory, thoracic and mediastinal disorders Pleural effusion	7.7% 1/13 • Number of events 1 • Adverse events were collected from baseline, throughout treatment with daratumumab, and for 30 days after last dose of daratumumab, up to 4 years

Other adverse events

Other adverse events
Measure	Daratumumab n=13 participants at risk * Daratumumab will be administered in three phases: Induction, consolidation and maintenance * During induction, participants will receive daratumumab on days 1, 8, 15 and 22 of each 28-day * During consolidation, daratumumab will be administered on days 1 and 15 of each 28-day cycle * During maintenance, daratumumab will be administered on day 1 of each 28-day cycle Daratumumab: Daratumumab is a monoclonal human antibody. Daratumumab has shown the ability to slow or stop the growth of cells that have CD38 on the cell surface when tested in laboratories
Blood and lymphatic system disorders Anemia	30.8% 4/13 • Number of events 4 • Adverse events were collected from baseline, throughout treatment with daratumumab, and for 30 days after last dose of daratumumab, up to 4 years
Cardiac disorders Atrial Fibrillation	7.7% 1/13 • Number of events 1 • Adverse events were collected from baseline, throughout treatment with daratumumab, and for 30 days after last dose of daratumumab, up to 4 years
Cardiac disorders Tachycardia	7.7% 1/13 • Number of events 1 • Adverse events were collected from baseline, throughout treatment with daratumumab, and for 30 days after last dose of daratumumab, up to 4 years
Cardiac disorders Chest pain	7.7% 1/13 • Number of events 1 • Adverse events were collected from baseline, throughout treatment with daratumumab, and for 30 days after last dose of daratumumab, up to 4 years
Cardiac disorders Palpitations	15.4% 2/13 • Number of events 2 • Adverse events were collected from baseline, throughout treatment with daratumumab, and for 30 days after last dose of daratumumab, up to 4 years
Ear and labyrinth disorders Ear pain	15.4% 2/13 • Number of events 2 • Adverse events were collected from baseline, throughout treatment with daratumumab, and for 30 days after last dose of daratumumab, up to 4 years
Ear and labyrinth disorders Decreased Hearting	7.7% 1/13 • Number of events 1 • Adverse events were collected from baseline, throughout treatment with daratumumab, and for 30 days after last dose of daratumumab, up to 4 years
Ear and labyrinth disorders Vertigo	7.7% 1/13 • Number of events 1 • Adverse events were collected from baseline, throughout treatment with daratumumab, and for 30 days after last dose of daratumumab, up to 4 years
Eye disorders Floaters	7.7% 1/13 • Number of events 1 • Adverse events were collected from baseline, throughout treatment with daratumumab, and for 30 days after last dose of daratumumab, up to 4 years
Gastrointestinal disorders Abdominal distention	7.7% 1/13 • Number of events 1 • Adverse events were collected from baseline, throughout treatment with daratumumab, and for 30 days after last dose of daratumumab, up to 4 years
Gastrointestinal disorders Abdominal pain	7.7% 1/13 • Number of events 1 • Adverse events were collected from baseline, throughout treatment with daratumumab, and for 30 days after last dose of daratumumab, up to 4 years
Gastrointestinal disorders Constipation	7.7% 1/13 • Number of events 1 • Adverse events were collected from baseline, throughout treatment with daratumumab, and for 30 days after last dose of daratumumab, up to 4 years
Gastrointestinal disorders Dry mouth	7.7% 1/13 • Number of events 1 • Adverse events were collected from baseline, throughout treatment with daratumumab, and for 30 days after last dose of daratumumab, up to 4 years
Gastrointestinal disorders GERD	7.7% 1/13 • Number of events 1 • Adverse events were collected from baseline, throughout treatment with daratumumab, and for 30 days after last dose of daratumumab, up to 4 years
Gastrointestinal disorders Increased appetite	7.7% 1/13 • Number of events 1 • Adverse events were collected from baseline, throughout treatment with daratumumab, and for 30 days after last dose of daratumumab, up to 4 years
Gastrointestinal disorders Nausea	23.1% 3/13 • Number of events 3 • Adverse events were collected from baseline, throughout treatment with daratumumab, and for 30 days after last dose of daratumumab, up to 4 years
Gastrointestinal disorders Vomiting	7.7% 1/13 • Number of events 1 • Adverse events were collected from baseline, throughout treatment with daratumumab, and for 30 days after last dose of daratumumab, up to 4 years
General disorders Chills	15.4% 2/13 • Number of events 2 • Adverse events were collected from baseline, throughout treatment with daratumumab, and for 30 days after last dose of daratumumab, up to 4 years
General disorders Peripheral edema	15.4% 2/13 • Number of events 2 • Adverse events were collected from baseline, throughout treatment with daratumumab, and for 30 days after last dose of daratumumab, up to 4 years
General disorders Fatigue	69.2% 9/13 • Number of events 9 • Adverse events were collected from baseline, throughout treatment with daratumumab, and for 30 days after last dose of daratumumab, up to 4 years
General disorders Fever	30.8% 4/13 • Number of events 4 • Adverse events were collected from baseline, throughout treatment with daratumumab, and for 30 days after last dose of daratumumab, up to 4 years
General disorders Infusion related reaction	38.5% 5/13 • Number of events 5 • Adverse events were collected from baseline, throughout treatment with daratumumab, and for 30 days after last dose of daratumumab, up to 4 years
Infections and infestations Thrush	7.7% 1/13 • Number of events 1 • Adverse events were collected from baseline, throughout treatment with daratumumab, and for 30 days after last dose of daratumumab, up to 4 years
Infections and infestations Otitis media	7.7% 1/13 • Number of events 1 • Adverse events were collected from baseline, throughout treatment with daratumumab, and for 30 days after last dose of daratumumab, up to 4 years
Infections and infestations Sinusitis	15.4% 2/13 • Number of events 2 • Adverse events were collected from baseline, throughout treatment with daratumumab, and for 30 days after last dose of daratumumab, up to 4 years
Infections and infestations Upper respiratory infection	23.1% 3/13 • Number of events 3 • Adverse events were collected from baseline, throughout treatment with daratumumab, and for 30 days after last dose of daratumumab, up to 4 years
Injury, poisoning and procedural complications Fall	7.7% 1/13 • Number of events 1 • Adverse events were collected from baseline, throughout treatment with daratumumab, and for 30 days after last dose of daratumumab, up to 4 years
Injury, poisoning and procedural complications Fracture	7.7% 1/13 • Number of events 1 • Adverse events were collected from baseline, throughout treatment with daratumumab, and for 30 days after last dose of daratumumab, up to 4 years
Investigations Alanine aminotransferase increased	7.7% 1/13 • Number of events 1 • Adverse events were collected from baseline, throughout treatment with daratumumab, and for 30 days after last dose of daratumumab, up to 4 years
Investigations Alkaline pohosphatase increased	15.4% 2/13 • Number of events 2 • Adverse events were collected from baseline, throughout treatment with daratumumab, and for 30 days after last dose of daratumumab, up to 4 years
Investigations Aspartate aminotransferase increased	7.7% 1/13 • Number of events 1 • Adverse events were collected from baseline, throughout treatment with daratumumab, and for 30 days after last dose of daratumumab, up to 4 years
Investigations Blood bilirubin increased	7.7% 1/13 • Number of events 1 • Adverse events were collected from baseline, throughout treatment with daratumumab, and for 30 days after last dose of daratumumab, up to 4 years
Investigations Lymphocyte count decreased	15.4% 2/13 • Number of events 2 • Adverse events were collected from baseline, throughout treatment with daratumumab, and for 30 days after last dose of daratumumab, up to 4 years
Investigations Neutrophil count decreased	23.1% 3/13 • Number of events 3 • Adverse events were collected from baseline, throughout treatment with daratumumab, and for 30 days after last dose of daratumumab, up to 4 years
Investigations Platelet count decreased	7.7% 1/13 • Number of events 1 • Adverse events were collected from baseline, throughout treatment with daratumumab, and for 30 days after last dose of daratumumab, up to 4 years
Investigations Weight loss	15.4% 2/13 • Number of events 2 • Adverse events were collected from baseline, throughout treatment with daratumumab, and for 30 days after last dose of daratumumab, up to 4 years
Investigations White blood cell decreased	7.7% 1/13 • Number of events 1 • Adverse events were collected from baseline, throughout treatment with daratumumab, and for 30 days after last dose of daratumumab, up to 4 years
Metabolism and nutrition disorders Anorexia	23.1% 3/13 • Number of events 3 • Adverse events were collected from baseline, throughout treatment with daratumumab, and for 30 days after last dose of daratumumab, up to 4 years
Metabolism and nutrition disorders Hyperkalemia	7.7% 1/13 • Number of events 1 • Adverse events were collected from baseline, throughout treatment with daratumumab, and for 30 days after last dose of daratumumab, up to 4 years
Metabolism and nutrition disorders Hypernatremia	7.7% 1/13 • Number of events 1 • Adverse events were collected from baseline, throughout treatment with daratumumab, and for 30 days after last dose of daratumumab, up to 4 years
Metabolism and nutrition disorders Hypoalbuminemia	15.4% 2/13 • Number of events 2 • Adverse events were collected from baseline, throughout treatment with daratumumab, and for 30 days after last dose of daratumumab, up to 4 years
Metabolism and nutrition disorders Hyponatremia	30.8% 4/13 • Number of events 4 • Adverse events were collected from baseline, throughout treatment with daratumumab, and for 30 days after last dose of daratumumab, up to 4 years
Musculoskeletal and connective tissue disorders Arthralgia	7.7% 1/13 • Number of events 1 • Adverse events were collected from baseline, throughout treatment with daratumumab, and for 30 days after last dose of daratumumab, up to 4 years
Musculoskeletal and connective tissue disorders Arthritis	7.7% 1/13 • Number of events 1 • Adverse events were collected from baseline, throughout treatment with daratumumab, and for 30 days after last dose of daratumumab, up to 4 years
Musculoskeletal and connective tissue disorders Back pain	15.4% 2/13 • Number of events 2 • Adverse events were collected from baseline, throughout treatment with daratumumab, and for 30 days after last dose of daratumumab, up to 4 years
Musculoskeletal and connective tissue disorders Generalized muscle weakness	15.4% 2/13 • Number of events 2 • Adverse events were collected from baseline, throughout treatment with daratumumab, and for 30 days after last dose of daratumumab, up to 4 years
Musculoskeletal and connective tissue disorders AC joint separation	7.7% 1/13 • Number of events 1 • Adverse events were collected from baseline, throughout treatment with daratumumab, and for 30 days after last dose of daratumumab, up to 4 years
Musculoskeletal and connective tissue disorders Body aches	7.7% 1/13 • Number of events 1 • Adverse events were collected from baseline, throughout treatment with daratumumab, and for 30 days after last dose of daratumumab, up to 4 years
Musculoskeletal and connective tissue disorders Muscle cramping	7.7% 1/13 • Number of events 1 • Adverse events were collected from baseline, throughout treatment with daratumumab, and for 30 days after last dose of daratumumab, up to 4 years
Musculoskeletal and connective tissue disorders Myalgia	15.4% 2/13 • Number of events 2 • Adverse events were collected from baseline, throughout treatment with daratumumab, and for 30 days after last dose of daratumumab, up to 4 years
Musculoskeletal and connective tissue disorders Pain in extremity	7.7% 1/13 • Number of events 1 • Adverse events were collected from baseline, throughout treatment with daratumumab, and for 30 days after last dose of daratumumab, up to 4 years
Renal and urinary disorders Painful urination	7.7% 1/13 • Number of events 1 • Adverse events were collected from baseline, throughout treatment with daratumumab, and for 30 days after last dose of daratumumab, up to 4 years
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Ganglion cyst	7.7% 1/13 • Number of events 1 • Adverse events were collected from baseline, throughout treatment with daratumumab, and for 30 days after last dose of daratumumab, up to 4 years
Nervous system disorders Ataxia	7.7% 1/13 • Number of events 1 • Adverse events were collected from baseline, throughout treatment with daratumumab, and for 30 days after last dose of daratumumab, up to 4 years
Nervous system disorders Dysgeusia	15.4% 2/13 • Number of events 2 • Adverse events were collected from baseline, throughout treatment with daratumumab, and for 30 days after last dose of daratumumab, up to 4 years
Nervous system disorders Headache	23.1% 3/13 • Number of events 3 • Adverse events were collected from baseline, throughout treatment with daratumumab, and for 30 days after last dose of daratumumab, up to 4 years
Nervous system disorders Memory loss	7.7% 1/13 • Number of events 1 • Adverse events were collected from baseline, throughout treatment with daratumumab, and for 30 days after last dose of daratumumab, up to 4 years
Nervous system disorders Peripheral sensory neuropathy	15.4% 2/13 • Number of events 2 • Adverse events were collected from baseline, throughout treatment with daratumumab, and for 30 days after last dose of daratumumab, up to 4 years
Nervous system disorders Presyncope	7.7% 1/13 • Number of events 1 • Adverse events were collected from baseline, throughout treatment with daratumumab, and for 30 days after last dose of daratumumab, up to 4 years
Nervous system disorders Sinus pain	7.7% 1/13 • Number of events 1 • Adverse events were collected from baseline, throughout treatment with daratumumab, and for 30 days after last dose of daratumumab, up to 4 years
Psychiatric disorders Agitation	7.7% 1/13 • Number of events 1 • Adverse events were collected from baseline, throughout treatment with daratumumab, and for 30 days after last dose of daratumumab, up to 4 years
Psychiatric disorders Anxiety	7.7% 1/13 • Number of events 1 • Adverse events were collected from baseline, throughout treatment with daratumumab, and for 30 days after last dose of daratumumab, up to 4 years
Psychiatric disorders Confusion	30.8% 4/13 • Number of events 4 • Adverse events were collected from baseline, throughout treatment with daratumumab, and for 30 days after last dose of daratumumab, up to 4 years
Psychiatric disorders Insomnia	15.4% 2/13 • Number of events 2 • Adverse events were collected from baseline, throughout treatment with daratumumab, and for 30 days after last dose of daratumumab, up to 4 years
Psychiatric disorders Restlessness	7.7% 1/13 • Number of events 1 • Adverse events were collected from baseline, throughout treatment with daratumumab, and for 30 days after last dose of daratumumab, up to 4 years
Renal and urinary disorders Urinary frequency	7.7% 1/13 • Number of events 1 • Adverse events were collected from baseline, throughout treatment with daratumumab, and for 30 days after last dose of daratumumab, up to 4 years
Reproductive system and breast disorders PSA elevation	7.7% 1/13 • Number of events 1 • Adverse events were collected from baseline, throughout treatment with daratumumab, and for 30 days after last dose of daratumumab, up to 4 years
Respiratory, thoracic and mediastinal disorders Cough	15.4% 2/13 • Number of events 2 • Adverse events were collected from baseline, throughout treatment with daratumumab, and for 30 days after last dose of daratumumab, up to 4 years
Respiratory, thoracic and mediastinal disorders Dyspnea	15.4% 2/13 • Number of events 2 • Adverse events were collected from baseline, throughout treatment with daratumumab, and for 30 days after last dose of daratumumab, up to 4 years
Respiratory, thoracic and mediastinal disorders Epistaxis	15.4% 2/13 • Number of events 2 • Adverse events were collected from baseline, throughout treatment with daratumumab, and for 30 days after last dose of daratumumab, up to 4 years
Respiratory, thoracic and mediastinal disorders Postnasal drip	7.7% 1/13 • Number of events 1 • Adverse events were collected from baseline, throughout treatment with daratumumab, and for 30 days after last dose of daratumumab, up to 4 years
Respiratory, thoracic and mediastinal disorders Sore throat	7.7% 1/13 • Number of events 1 • Adverse events were collected from baseline, throughout treatment with daratumumab, and for 30 days after last dose of daratumumab, up to 4 years
Skin and subcutaneous tissue disorders Hyperhidrosis	23.1% 3/13 • Number of events 3 • Adverse events were collected from baseline, throughout treatment with daratumumab, and for 30 days after last dose of daratumumab, up to 4 years
Skin and subcutaneous tissue disorders Rash	7.7% 1/13 • Number of events 1 • Adverse events were collected from baseline, throughout treatment with daratumumab, and for 30 days after last dose of daratumumab, up to 4 years
Skin and subcutaneous tissue disorders Tender feeling on skin	7.7% 1/13 • Number of events 1 • Adverse events were collected from baseline, throughout treatment with daratumumab, and for 30 days after last dose of daratumumab, up to 4 years
Skin and subcutaneous tissue disorders Toe blister	7.7% 1/13 • Number of events 1 • Adverse events were collected from baseline, throughout treatment with daratumumab, and for 30 days after last dose of daratumumab, up to 4 years
Vascular disorders Flushing	7.7% 1/13 • Number of events 1 • Adverse events were collected from baseline, throughout treatment with daratumumab, and for 30 days after last dose of daratumumab, up to 4 years
Vascular disorders Hot flashes	7.7% 1/13 • Number of events 1 • Adverse events were collected from baseline, throughout treatment with daratumumab, and for 30 days after last dose of daratumumab, up to 4 years
Vascular disorders Hypotension	7.7% 1/13 • Number of events 1 • Adverse events were collected from baseline, throughout treatment with daratumumab, and for 30 days after last dose of daratumumab, up to 4 years

Additional Information

Dr. Jorge Castillo

Dana-Farber Cancer Institute

Phone: 617-632-2681

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place