NCT03582033

A Safety Study of SEA-BCMA in Patients With Multiple Myeloma

Terminated Phase 1 Results posted Last updated 24 December 2024

What this trial tests

Phase 1 trial testing SEA-BCMA in Multiple Myeloma in 83 participants. Terminated before completion.

Timeline

1 November 2018

Primary endpoint
9 November 2023

9 November 2023

Quick facts

Lead sponsor	Seagen Inc.
Phase	Phase 1
Status	Terminated
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	83
Start date	1 November 2018
Primary completion	9 November 2023
Estimated completion	9 November 2023
Sites	13 locations across United States

Drugs / interventions tested

• SEA-BCMA — full drug profile →
• dexamethasone (dexamethasone) — full drug profile →
• pomalidomide — full drug profile →

Conditions studied

• Multiple Myeloma — all drugs for Multiple Myeloma →

Sponsor

Seagen Inc. — full company profile →

Who can join

18 and older, any sex, with Multiple Myeloma. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Number of Participants With Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), Treatment Related TEAEs and Greater Than or Equal to (>=) Grade 3 TEAEs: Part A Primary · From first dose of the study treatment (Day 1) up to 30 days after the last dose of study treatment up to 44 months (maximum follow up of 45 months)

An adverse event (AE) was any untoward medical occurrence in a participant/ clinical investigational participant administered a medicinal product and which does not necessarily have a causal relationship with this treatment. TEAEs were defined as newly occurring (not present at baseline)/worsening after first dose of investigational product (IP). TESAEs were any untoward medical occurrence at any dose that: suspected to cause death; life-threatening; required hospitalization; persistent/significant disability/incapacity \& may cause congenital anomaly/birth defect. Treatment related TEAEs were

TEAEs

Group	Value	95% CI
Part A: SEA-BCMA 100mg	2
Part A: SEA-BCMA 200mg	2
Part A: SEA-BCMA 400mg	2
Part A: SEA-BCMA 800mg	6
Part A: SEA-BCMA 1600mg	20

TESAEs

Group	Value	95% CI
Part A: SEA-BCMA 100mg	1
Part A: SEA-BCMA 200mg	1
Part A: SEA-BCMA 400mg	2
Part A: SEA-BCMA 800mg	3
Part A: SEA-BCMA 1600mg	8

Treatment Related TEAEs

Group	Value	95% CI
Part A: SEA-BCMA 100mg	0
Part A: SEA-BCMA 200mg	0
Part A: SEA-BCMA 400mg	1
Part A: SEA-BCMA 800mg	4
Part A: SEA-BCMA 1600mg	13

TEAEs (>= Grade 3)

Group	Value	95% CI
Part A: SEA-BCMA 100mg	1
Part A: SEA-BCMA 200mg	1
Part A: SEA-BCMA 400mg	2
Part A: SEA-BCMA 800mg	4
Part A: SEA-BCMA 1600mg	13

Number of Participants With TEAEs, TESAEs, Treatment Related TEAEs and >=Grade 3 TEAEs: Part B Primary · From first dose of the study treatment (Day 1) up to 30 days after the last dose of study treatment up to 33 months (maximum follow up of 34 months)

An AE was any untoward medical occurrence in a participant/ clinical investigational participant administered a medicinal product and which does not necessarily have a causal relationship with this treatment. TEAEs were defined as newly occurring (not present at baseline)/worsening after first dose of IP. TESAEs were any untoward medical occurrence at any dose that: suspected to cause death; life-threatening; required hospitalization; persistent/significant disability/incapacity \& may cause congenital anomaly/birth defect. Treatment related TEAEs were related to study treatment and relatednes

TEAEs

Group	Value	95% CI
Part B: SEA-BCMA 1600mg	19

TESAEs

Group	Value	95% CI
Part B: SEA-BCMA 1600mg	5

Treatment Related TEAEs

Group	Value	95% CI
Part B: SEA-BCMA 1600mg	7

TEAEs (>= Grade 3)

Group	Value	95% CI
Part B: SEA-BCMA 1600mg	6

Number of Participants With TEAEs, TESAEs, Treatment Related TEAEs and >=Grade 3 TEAEs: Part C Primary · From first dose of the study treatment (Day 1) up to 30 days after the last dose of study treatment up to 36 months (maximum follow up of 37 months)

An AE was any untoward medical occurrence in a participant/ clinical investigational participant administered a medicinal product and which does not necessarily have a causal relationship with this treatment. TEAEs were defined as newly occurring (not present at baseline)/worsening after first dose of IP. TESAEs were any untoward medical occurrence at any dose that: suspected to cause death; life-threatening; required hospitalization; persistent/significant disability/incapacity \& may cause congenital anomaly/birth defect. Treatment related TEAEs were related to study treatment and relatednes

TEAEs

Group	Value	95% CI
Part C: SEA-BCMA 1600mg and Dexamethasone	11
Part C: SEA-BCMA 800mg and Dexamethasone	6
Part C: SEA-BCMA 1600 mg and Dexamethasone	5

TESAEs

Group	Value	95% CI
Part C: SEA-BCMA 1600mg and Dexamethasone	5
Part C: SEA-BCMA 800mg and Dexamethasone	3
Part C: SEA-BCMA 1600 mg and Dexamethasone	2

Treatment Related TEAEs

Group	Value	95% CI
Part C: SEA-BCMA 1600mg and Dexamethasone	4
Part C: SEA-BCMA 800mg and Dexamethasone	0
Part C: SEA-BCMA 1600 mg and Dexamethasone	3

TEAEs (>= Grade 3)

Group	Value	95% CI
Part C: SEA-BCMA 1600mg and Dexamethasone	8
Part C: SEA-BCMA 800mg and Dexamethasone	5
Part C: SEA-BCMA 1600 mg and Dexamethasone	3

Number of Participants With TEAEs, TESAEs, Treatment Related TEAEs and >=Grade 3 TEAEs: Part D Primary · From first dose of the study treatment (Day 1) up to 30 days after the last dose of study treatment up to 19 months (maximum follow up of 20 months)

An AE was any untoward medical occurrence in a participant/ clinical investigational participant administered a medicinal product and which does not necessarily have a causal relationship with this treatment. TEAEs were defined as newly occurring (not present at baseline)/worsening after first dose of IP. TESAEs were any untoward medical occurrence at any dose that: suspected to cause death; life-threatening; required hospitalization; persistent/significant disability/incapacity \& may cause congenital anomaly/birth defect. Treatment related TEAEs were related to study treatment and relatednes

TEAEs

Group	Value	95% CI
Part D: SEA-BCMA 1600 mg, Pomalidomide and Dexamethasone	5

TESAEs

Group	Value	95% CI
Part D: SEA-BCMA 1600 mg, Pomalidomide and Dexamethasone	3

Treatment Related TEAEs

Group	Value	95% CI
Part D: SEA-BCMA 1600 mg, Pomalidomide and Dexamethasone	3

TEAEs (>= Grade 3)

Group	Value	95% CI
Part D: SEA-BCMA 1600 mg, Pomalidomide and Dexamethasone	3

Number of Participants With Maximum Laboratory Toxicity Grade, by NCI-CTCAE v4.03- Serum Chemistry: Part A Primary · From first dose of the study treatment (Day 1) up to 30 days after the last dose of study treatment up to 44 months (maximum follow up of 45 months)

The following serum chemistry laboratory parameters were assessed: Alanine aminotransferase high, albumin low, alkaline phosphatase high, amylase high, aspartate aminotransferase high, calcium corrected for albumin high, calcium corrected for albumin low, creatinine high, glucose high, glucose low, lipase high, phosphate low, potassium high, potassium low, sodium high, sodium low, total bilirubin high and urate high. Chemistry laboratory parameters abnormalities were graded according to NCI CTCAE v 4.03 (grade 1= mild, grade 2= moderate, grade 3= severe and grade 4= life-threatening). Particip

Grade 1

Group	Value	95% CI
Part A: SEA-BCMA 100mg	0
Part A: SEA-BCMA 200mg	1
Part A: SEA-BCMA 400mg	0
Part A: SEA-BCMA 800mg	1
Part A: SEA-BCMA 1600mg	4

Grade 2

Group	Value	95% CI
Part A: SEA-BCMA 100mg	0
Part A: SEA-BCMA 200mg	0
Part A: SEA-BCMA 400mg	0
Part A: SEA-BCMA 800mg	3
Part A: SEA-BCMA 1600mg	7

Grade 3

Group	Value	95% CI
Part A: SEA-BCMA 100mg	0
Part A: SEA-BCMA 200mg	1
Part A: SEA-BCMA 400mg	2
Part A: SEA-BCMA 800mg	2
Part A: SEA-BCMA 1600mg	11

Grade 4

Group	Value	95% CI
Part A: SEA-BCMA 100mg	2
Part A: SEA-BCMA 200mg	0
Part A: SEA-BCMA 400mg	0
Part A: SEA-BCMA 800mg	1
Part A: SEA-BCMA 1600mg	0

Number of Participants With Maximum Laboratory Toxicity Grade, by NCI-CTCAE v4.03- Serum Chemistry: Part B Primary · From first dose of the study treatment (Day 1) up to 30 days after the last dose of study treatment up to 33 months (maximum follow up of 34 months)

The following serum chemistry laboratory parameters were assessed: Alanine aminotransferase high, albumin low, alkaline phosphatase high, amylase high, aspartate aminotransferase high, calcium corrected for albumin high, calcium corrected for albumin low, creatinine high, glucose high, glucose low, lipase high, phosphate low, potassium high, potassium low, sodium high, sodium low, total bilirubin high and urate high. Chemistry laboratory parameters abnormalities were graded according to NCI CTCAE v 4.03 (grade 1= mild, grade 2= moderate, grade 3= severe and grade 4= life-threatening). Particip

Grade 1

Group	Value	95% CI
Part B: SEA-BCMA 1600mg	5

Grade 2

Group	Value	95% CI
Part B: SEA-BCMA 1600mg	8

Grade 3

Group	Value	95% CI
Part B: SEA-BCMA 1600mg	6

Grade 4

Group	Value	95% CI
Part B: SEA-BCMA 1600mg	1

Number of Participants With Maximum Laboratory Toxicity Grade, by NCI-CTCAE v4.03- Serum Chemistry: Part C Primary · From first dose of the study treatment (Day 1) up to 30 days after the last dose of study treatment up to 36 months (maximum follow up of 37 months)

The following serum chemistry laboratory parameters were assessed: Alanine aminotransferase high, albumin low, alkaline phosphatase high, amylase high, aspartate aminotransferase high, calcium corrected for albumin high, calcium corrected for albumin low, creatinine high, glucose high, glucose low, lipase high, phosphate low, potassium high, potassium low, sodium high, sodium low, total bilirubin high and urate high. Chemistry laboratory parameters abnormalities were graded according to NCI CTCAE v 4.03 (grade 1= mild, grade 2= moderate, grade 3= severe and grade 4= life-threatening). Particip

Grade 1

Group	Value	95% CI
Part C: SEA-BCMA 1600mg and Dexamethasone	0
Part C: SEA-BCMA 800mg and Dexamethasone	1
Part C: SEA-BCMA 1600 mg and Dexamethasone	1

Grade 2

Group	Value	95% CI
Part C: SEA-BCMA 1600mg and Dexamethasone	5
Part C: SEA-BCMA 800mg and Dexamethasone	1
Part C: SEA-BCMA 1600 mg and Dexamethasone	2

Grade 3

Group	Value	95% CI
Part C: SEA-BCMA 1600mg and Dexamethasone	5
Part C: SEA-BCMA 800mg and Dexamethasone	3
Part C: SEA-BCMA 1600 mg and Dexamethasone	2

Grade 4

Group	Value	95% CI
Part C: SEA-BCMA 1600mg and Dexamethasone	2
Part C: SEA-BCMA 800mg and Dexamethasone	1
Part C: SEA-BCMA 1600 mg and Dexamethasone	0

Number of Participants With Maximum Laboratory Toxicity Grade, by NCI-CTCAE v4.03- Serum Chemistry: Part D Primary · From first dose of the study treatment (Day 1) up to 30 days after the last dose of study treatment up to 19 months (maximum follow up of 20 months)

The following serum chemistry laboratory parameters were assessed: Alanine aminotransferase high, albumin low, alkaline phosphatase high, amylase high, aspartate aminotransferase high, calcium corrected for albumin high, calcium corrected for albumin low, creatinine high, glucose high, glucose low, lipase high, phosphate low, potassium high, potassium low, sodium high, sodium low, total bilirubin high and urate high. Chemistry laboratory parameters abnormalities were graded according to NCI CTCAE v 4.03 (grade 1= mild, grade 2= moderate, grade 3= severe and grade 4= life-threatening). Particip

Grade 1

Group	Value	95% CI
Part D: SEA-BCMA 1600 mg, Pomalidomide and Dexamethasone	1

Grade 2

Group	Value	95% CI
Part D: SEA-BCMA 1600 mg, Pomalidomide and Dexamethasone	1

Grade 3

Group	Value	95% CI
Part D: SEA-BCMA 1600 mg, Pomalidomide and Dexamethasone	3

Grade 4

Group	Value	95% CI
Part D: SEA-BCMA 1600 mg, Pomalidomide and Dexamethasone	0

Number of Participants With Maximum Laboratory Toxicity Grade, by NCI-CTCAE v4.03- Hematology: Part A Primary · From first dose of the study treatment (Day 1) up to 30 days after the last dose of study treatment up to 44 months (maximum follow up of 45 months)

The following hematology laboratory parameters were assessed: hemoglobin high, hemoglobin low, leukocytes high, leukocytes low, lymphocytes high, lymphocytes low, neutrophils low and platelets low. Laboratory abnormality events were graded according to NCI CTCAE v 4.03 (grade 1=mild, grade 2=moderate, grade 3= severe and grade 4= life-threatening). Participants with any hematology parameter meeting CTCAE grade 1 to 4 were reported.

Grade 1

Group	Value	95% CI
Part A: SEA-BCMA 100mg	0
Part A: SEA-BCMA 200mg	1
Part A: SEA-BCMA 400mg	1
Part A: SEA-BCMA 800mg	0
Part A: SEA-BCMA 1600mg	0

Grade 2

Group	Value	95% CI
Part A: SEA-BCMA 100mg	0
Part A: SEA-BCMA 200mg	0
Part A: SEA-BCMA 400mg	0
Part A: SEA-BCMA 800mg	1
Part A: SEA-BCMA 1600mg	12

Grade 3

Group	Value	95% CI
Part A: SEA-BCMA 100mg	1
Part A: SEA-BCMA 200mg	1
Part A: SEA-BCMA 400mg	1
Part A: SEA-BCMA 800mg	4
Part A: SEA-BCMA 1600mg	9

Grade 4

Group	Value	95% CI
Part A: SEA-BCMA 100mg	1
Part A: SEA-BCMA 200mg	0
Part A: SEA-BCMA 400mg	0
Part A: SEA-BCMA 800mg	2
Part A: SEA-BCMA 1600mg	1

Number of Participants With Maximum Laboratory Toxicity Grade, by NCI-CTCAE v4.03- Hematology: Part B Primary · From first dose of the study treatment (Day 1) up to 30 days after the last dose of study treatment up to 33 months (maximum follow up of 34 months)

The following hematology laboratory parameters were assessed: hemoglobin high, hemoglobin low, leukocytes high, leukocytes low, lymphocytes high, lymphocytes low, neutrophils low and platelets low. Laboratory abnormality events were graded according to NCI CTCAE v 4.03 (grade 1=mild, grade 2=moderate, grade 3= severe and grade 4= life-threatening). Participants with any hematology parameter meeting CTCAE grade 1 to 4 were reported.

Grade 1

Group	Value	95% CI
Part B: SEA-BCMA 1600mg	6

Grade 2

Group	Value	95% CI
Part B: SEA-BCMA 1600mg	6

Grade 3

Group	Value	95% CI
Part B: SEA-BCMA 1600mg	7

Grade 4

Group	Value	95% CI
Part B: SEA-BCMA 1600mg	1

Number of Participants With Maximum Laboratory Toxicity Grade, by NCI-CTCAE v4.03- Hematology: Part C Primary · From first dose of the study treatment (Day 1) up to 30 days after the last dose of study treatment up to 36 months (maximum follow up of 37 months)

The following hematology laboratory parameters were assessed: hemoglobin high, hemoglobin low, leukocytes high, leukocytes low, lymphocytes high, lymphocytes low, neutrophils low and platelets low. Laboratory abnormality events were graded according to NCI CTCAE v 4.03 (grade 1=mild, grade 2=moderate, grade 3= severe and grade 4= life-threatening). Participants with any hematology parameter meeting CTCAE grade 1 to 4 were reported.

Grade 1

Group	Value	95% CI
Part C: SEA-BCMA 1600mg and Dexamethasone	1
Part C: SEA-BCMA 800mg and Dexamethasone	1
Part C: SEA-BCMA 1600 mg and Dexamethasone	1

Grade 2

Group	Value	95% CI
Part C: SEA-BCMA 1600mg and Dexamethasone	3
Part C: SEA-BCMA 800mg and Dexamethasone	3
Part C: SEA-BCMA 1600 mg and Dexamethasone	0

Grade 3

Group	Value	95% CI
Part C: SEA-BCMA 1600mg and Dexamethasone	4
Part C: SEA-BCMA 800mg and Dexamethasone	2
Part C: SEA-BCMA 1600 mg and Dexamethasone	3

Grade 4

Group	Value	95% CI
Part C: SEA-BCMA 1600mg and Dexamethasone	4
Part C: SEA-BCMA 800mg and Dexamethasone	0
Part C: SEA-BCMA 1600 mg and Dexamethasone	1

Number of Participants With Maximum Laboratory Toxicity Grade, by NCI-CTCAE v4.03- Hematology: Part D Primary · From first dose of the study treatment (Day 1) up to 30 days after the last dose of study treatment up to 19 months (maximum follow up of 20 months)

The following hematology laboratory parameters were assessed: hemoglobin high, hemoglobin low, leukocytes high, leukocytes low, lymphocytes high, lymphocytes low, neutrophils low and platelets low. Laboratory abnormality events were graded according to NCI CTCAE v 4.03 (grade 1=mild, grade 2=moderate, grade 3= severe and grade 4= life-threatening). Participants with any hematology parameter meeting CTCAE grade 1 to 4 were reported.

Grade 1

Group	Value	95% CI
Part D: SEA-BCMA 1600 mg, Pomalidomide and Dexamethasone	0

Grade 2

Group	Value	95% CI
Part D: SEA-BCMA 1600 mg, Pomalidomide and Dexamethasone	2

Grade 3

Group	Value	95% CI
Part D: SEA-BCMA 1600 mg, Pomalidomide and Dexamethasone	1

Grade 4

Group	Value	95% CI
Part D: SEA-BCMA 1600 mg, Pomalidomide and Dexamethasone	2

Adverse events — posted to ClinicalTrials.gov

Time frame: From first dose of the study treatment (Day 1) up to 30 days after the last dose of study treatment for Part A: up to 44 months (maximum follow up of 45 months); Part B: up to 33 months (maximum follow up of 34 months); Part C: up to 36 months (maximum follow up of 37 months) and Part D: up to 19 months (maximum follow up of 20 months). Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Part A: SEA-BCMA 100mg

Serious: 1/2 (50%)

Deaths: 1/2

Part A: SEA-BCMA 200mg

Serious: 1/2 (50%)

Deaths: 1/2

Part A: SEA-BCMA 400mg

Serious: 2/2 (100%)

Deaths: 2/2

Part A: SEA-BCMA 800mg

Serious: 3/7 (43%)

Deaths: 4/7

Part A: SEA-BCMA 1600mg

Serious: 8/22 (36%)

Deaths: 11/22

Part B: SEA-BCMA 1600mg

Serious: 5/20 (25%)

Deaths: 2/20

Part C: SEA-BCMA 1600mg and Dexamethasone

Serious: 5/12 (42%)

Deaths: 6/12

Part C: SEA-BCMA 800mg and Dexamethasone

Serious: 3/6 (50%)

Deaths: 1/6

Part C: SEA-BCMA 1600 mg and Dexamethasone

Serious: 2/5 (40%)

Deaths: 2/5

Part D: SEA-BCMA 1600 mg, Pomalidomide and Dexamethasone

Serious: 3/5 (60%)

Deaths: 1/5

Serious adverse events (50 terms)

Reaction	System	Part A: SEA-BCMA 100mg	Part A: SEA-BCMA 200mg	Part A: SEA-BCMA 400mg	Part A: SEA-BCMA 800mg	Part A: SEA-BCMA 1600mg	Part B: SEA-BCMA 1600mg	Part C: SEA-BCMA 1600mg an…	Part C: SEA-BCMA 800mg and…	Part C: SEA-BCMA 1600 mg a…	Part D: SEA-BCMA 1600 mg, …
Pneumonia	Infections and infestations	—	—	—	—	—	—	—	—	—	—
Influenza	Infections and infestations	—	—	—	—	—	—	—	—	—	—
Fall	Injury, poisoning and procedural complications	—	—	—	—	—	—	—	—	—	—
Febrile neutropenia	Blood and lymphatic system disorders	—	—	—	—	—	—	—	—	—	—
Neutropenia	Blood and lymphatic system disorders	—	—	—	—	—	—	—	—	—	—
Acute myocardial infarction	Cardiac disorders	—	—	—	—	—	—	—	—	—	—
Atrial fibrillation	Cardiac disorders	—	—	—	—	—	—	—	—	—	—
Cardiac failure congestive	Cardiac disorders	—	—	—	—	—	—	—	—	—	—
Cystic fibrosis	Congenital, familial and genetic disorders	—	—	—	—	—	—	—	—	—	—
Colitis	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—
Ileus	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—
Vomiting	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—
Fatigue	General disorders	—	—	—	—	—	—	—	—	—	—
Pyrexia	General disorders	—	—	—	—	—	—	—	—	—	—
Cholelithiasis obstructive	Hepatobiliary disorders	—	—	—	—	—	—	—	—	—	—
Hypersensitivity	Immune system disorders	—	—	—	—	—	—	—	—	—	—
Bacteraemia	Infections and infestations	—	—	—	—	—	—	—	—	—	—
COVID-19	Infections and infestations	—	—	—	—	—	—	—	—	—	—
COVID-19 pneumonia	Infections and infestations	—	—	—	—	—	—	—	—	—	—
Campylobacter colitis	Infections and infestations	—	—	—	—	—	—	—	—	—	—
Cellulitis	Infections and infestations	—	—	—	—	—	—	—	—	—	—
Infectious pleural effusion	Infections and infestations	—	—	—	—	—	—	—	—	—	—
Pneumonia aspiration	Infections and infestations	—	—	—	—	—	—	—	—	—	—
Pneumonia viral	Infections and infestations	—	—	—	—	—	—	—	—	—	—
Rhinovirus infection	Infections and infestations	—	—	—	—	—	—	—	—	—	—

Other adverse events (193 terms — click to expand)

Reaction	System	Part A: SEA-BCMA 100mg	Part A: SEA-BCMA 200mg	Part A: SEA-BCMA 400mg	Part A: SEA-BCMA 800mg	Part A: SEA-BCMA 1600mg	Part B: SEA-BCMA 1600mg	Part C: SEA-BCMA 1600mg an…	Part C: SEA-BCMA 800mg and…	Part C: SEA-BCMA 1600 mg a…	Part D: SEA-BCMA 1600 mg, …
Fatigue	General disorders	—	—	—	—	—	—	—	—	—	—
Anaemia	Blood and lymphatic system disorders	—	—	—	—	—	—	—	—	—	—
Pain in extremity	Musculoskeletal and connective tissue disorders	—	—	—	—	—	—	—	—	—	—
Hypertension	Vascular disorders	—	—	—	—	—	—	—	—	—	—
Nausea	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—
Chills	General disorders	—	—	—	—	—	—	—	—	—	—
Pyrexia	General disorders	—	—	—	—	—	—	—	—	—	—
Infusion related reaction	Injury, poisoning and procedural complications	—	—	—	—	—	—	—	—	—	—
Back pain	Musculoskeletal and connective tissue disorders	—	—	—	—	—	—	—	—	—	—
Myalgia	Musculoskeletal and connective tissue disorders	—	—	—	—	—	—	—	—	—	—
Cough	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—	—	—	—	—	—
Dyspnoea	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—	—	—	—	—	—
Constipation	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—
Diarrhoea	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—
Upper respiratory tract infection	Infections and infestations	—	—	—	—	—	—	—	—	—	—
Urinary tract infection	Infections and infestations	—	—	—	—	—	—	—	—	—	—
Fall	Injury, poisoning and procedural complications	—	—	—	—	—	—	—	—	—	—
Blood creatinine increased	Investigations	—	—	—	—	—	—	—	—	—	—
Hyponatraemia	Metabolism and nutrition disorders	—	—	—	—	—	—	—	—	—	—
Arthralgia	Musculoskeletal and connective tissue disorders	—	—	—	—	—	—	—	—	—	—
Musculoskeletal chest pain	Musculoskeletal and connective tissue disorders	—	—	—	—	—	—	—	—	—	—
Headache	Nervous system disorders	—	—	—	—	—	—	—	—	—	—
Vomiting	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—
Oedema peripheral	General disorders	—	—	—	—	—	—	—	—	—	—
COVID-19	Infections and infestations	—	—	—	—	—	—	—	—	—	—
Pneumonia	Infections and infestations	—	—	—	—	—	—	—	—	—	—
Decreased appetite	Metabolism and nutrition disorders	—	—	—	—	—	—	—	—	—	—
Hypercalcaemia	Metabolism and nutrition disorders	—	—	—	—	—	—	—	—	—	—
Hypokalaemia	Metabolism and nutrition disorders	—	—	—	—	—	—	—	—	—	—
Hypophosphataemia	Metabolism and nutrition disorders	—	—	—	—	—	—	—	—	—	—
Bone pain	Musculoskeletal and connective tissue disorders	—	—	—	—	—	—	—	—	—	—
Muscle spasms	Musculoskeletal and connective tissue disorders	—	—	—	—	—	—	—	—	—	—
Muscular weakness	Musculoskeletal and connective tissue disorders	—	—	—	—	—	—	—	—	—	—
Dizziness	Nervous system disorders	—	—	—	—	—	—	—	—	—	—
Syncope	Nervous system disorders	—	—	—	—	—	—	—	—	—	—
Anxiety	Psychiatric disorders	—	—	—	—	—	—	—	—	—	—
Confusional state	Psychiatric disorders	—	—	—	—	—	—	—	—	—	—
Insomnia	Psychiatric disorders	—	—	—	—	—	—	—	—	—	—
Acute kidney injury	Renal and urinary disorders	—	—	—	—	—	—	—	—	—	—
Nasal congestion	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—	—	—	—	—	—

Most-reported serious reactions: Pneumonia, Influenza, Fall, Febrile neutropenia, Neutropenia, Acute myocardial infarction, Atrial fibrillation, Cardiac failure congestive.

Data from ClinicalTrials.gov NCT03582033 adverse events section.

Sponsor's own description

This trial will study SEA-BCMA to find out whether it is an effective treatment for multiple myeloma (MM) and what side effects (unwanted effects) may occur.

The study will have several parts. In Parts A and B, participants get SEA-BCMA by itself. This part of the study will find out how much SEA-BCMA should be given for treatment and how often. It will also find out how safe the treatment is and how well it works.

In Part C of the study, participants will get SEA-BCMA and dexamethasone. In Part D, participants will get SEA-BCMA, dexamethasone, and pomalidomide. Dexamethasone and pomalidomide are both drugs that can be used to treat multiple myeloma. These parts of the study will find out whether these drugs are safe when used together.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Fc-Engineered Antibodies with Enhanced Fc-Effector Function for the Treatment of B-Cell Malignancies.
   van der Horst HJ, Nijhof IS, Mutis T, Chamuleau MED. · · 2020 · cited 56× · PMID 33086644 · DOI 10.3390/cancers12103041
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