Magrolimab for Multiple Myeloma

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Multiple MyelomaMagrolimab - Biological
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial is studying magrolimab in combination with other drugs as a possible treatment for relapsed/refractory multiple myeloma. The goal is to see if it is safe and to find out what the best dose is. Another goal is to see if it is effective in treating relapsed/refractory multiple myeloma.

Eligible Conditions
  • Multiple Myeloma

Treatment Effectiveness

Study Objectives

4 Primary · 7 Secondary · Reporting Duration: Up to 2.5 years

Day 35
Percentage of Participants Experiencing Dose-limiting Toxicities (DLTs) According to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 (Safety Run-in Cohorts)
Year 5
Percentage of Participants Experiencing Treatment-emergent Laboratory Abnormalities According to the NCI CTCAE Version 5.0 (Dose Expansion Cohorts)
Percentage of Participants Experiencing Treatment-emergent Laboratory Abnormalities According to the NCI CTCAE Version 5.0 (Safety Run-in Cohorts)
Year 5
Percentage of Participants Experiencing Treatment-emergent Adverse Events (TEAE's) According to the NCI CTCAE Version 5.0 (Safety Run-in Cohorts)
Year 5
Percentage of Participants Experiencing TEAE's According to the NCI CTCAE Version 5.0 (Dose Expansion Cohorts)
Up to 2.5 years
Duration of Response (Dose Expansion Cohorts)
Objective Response Rate (ORR) (Dose Expansion Cohorts)
Overall Survival (Dose Expansion Cohorts)
Progression-free Survival (Dose Expansion Cohorts)
Year 5
Antidrug Antibody (ADA) Against Magrolimab (Dose Expansion Cohorts)
Serum Concentrations of Magrolimab (Dose Expansion Cohorts)

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Side Effects for

Magrolimab 10 mg/kg
67%Dry skin
44%Diarrhoea
44%Fatigue
44%Lymphocyte count decreased
44%Dermatitis acneiform
33%Abdominal pain
33%Infusion related reaction
22%Decreased appetite
22%Chills
22%Dehydration
22%Back pain
22%Pruritus
22%Rash maculo-papular
22%Headache
22%Oedema peripheral
22%Tinnitus
22%Nausea
22%Myalgia
22%Small intestinal obstruction
11%Haematuria
11%Gastrointestinal stoma complication
11%Sinusitis
11%Dry eye
11%Alanine aminotransferase increased
11%Confusional state
11%Cerebrovascular accident
11%Lymphopenia
11%Palpitations
11%Conjunctivitis allergic
11%Photopsia
11%Constipation
11%Dyspepsia
11%Oesophageal pain
11%Vomiting
11%Chest discomfort
11%Folliculitis
11%Tinea cruris
11%Hyperglycaemia
11%Hypokalaemia
11%Hypophosphataemia
11%Somnolence
11%Depression
11%Dysphonia
11%Dyspnoea
11%Nasal congestion
11%Ingrowing nail
11%Deep vein thrombosis
11%Hypertension
11%Arthralgia
11%Tumour pain
11%Conjunctivitis
11%Malignant neoplasm progression
11%Anaemia
11%Hypoaesthesia oral
11%Gastroenteritis viral
11%Skin infection
11%Aspartate aminotransferase increased
11%Platelet count decreased
11%Dizziness
11%Hypomagnesaemia
11%Abdominal distension
11%Blood bilirubin increased
11%Neck pain
11%Gastrooesophageal reflux disease
This histogram enumerates side effects from a completed 2020 Phase 1 & 2 trial (NCT02953782) in the Magrolimab 10 mg/kg ARM group. Side effects include: Dry skin with 67%, Diarrhoea with 44%, Fatigue with 44%, Lymphocyte count decreased with 44%, Dermatitis acneiform with 44%.

Trial Design

8 Treatment Groups

Dose Expansion Cohort (Magrolimab+Carfilzomib+Dexamethasone)
1 of 8
Dose Expansion Cohort (Magrolimab+Bortezomib+Dexamethasone)
1 of 8
Dose Expansion Cohort (Magrolimab+Pomalidomide+Dexamethasone)
1 of 8
Dose Expansion Cohort (Magrolimab+Daratumumab)
1 of 8
Safety Run-in Cohort (Magrolimab+Carfilzomib+Dexamethasone)
1 of 8
Safety Run-in Cohort (Magrolimab+Daratumumab)
1 of 8
Safety Run-in Cohort (Magrolimab+Bortezomib+Dexamethasone)
1 of 8
Safety Run-in Cohort (Magrolimab+Pomalidomide+Dexamethasone)
1 of 8

Experimental Treatment

153 Total Participants · 8 Treatment Groups

Primary Treatment: Magrolimab · No Placebo Group · Phase 2

Dose Expansion Cohort (Magrolimab+Carfilzomib+Dexamethasone)Experimental Group · 3 Interventions: Dexamethasone, Carfilzomib, Magrolimab · Intervention Types: Drug, Drug, Biological
Dose Expansion Cohort (Magrolimab+Bortezomib+Dexamethasone)Experimental Group · 3 Interventions: Dexamethasone, Magrolimab, Bortezomib · Intervention Types: Drug, Biological, Drug
Dose Expansion Cohort (Magrolimab+Pomalidomide+Dexamethasone)Experimental Group · 3 Interventions: Dexamethasone, Pomalidomide, Magrolimab · Intervention Types: Drug, Drug, Biological
Dose Expansion Cohort (Magrolimab+Daratumumab)Experimental Group · 2 Interventions: Daratumumab, Magrolimab · Intervention Types: Drug, Biological
Safety Run-in Cohort (Magrolimab+Carfilzomib+Dexamethasone)Experimental Group · 3 Interventions: Dexamethasone, Carfilzomib, Magrolimab · Intervention Types: Drug, Drug, Biological
Safety Run-in Cohort (Magrolimab+Daratumumab)Experimental Group · 2 Interventions: Daratumumab, Magrolimab · Intervention Types: Drug, Biological
Safety Run-in Cohort (Magrolimab+Bortezomib+Dexamethasone)Experimental Group · 3 Interventions: Dexamethasone, Magrolimab, Bortezomib · Intervention Types: Drug, Biological, Drug
Safety Run-in Cohort (Magrolimab+Pomalidomide+Dexamethasone)Experimental Group · 3 Interventions: Dexamethasone, Pomalidomide, Magrolimab · Intervention Types: Drug, Drug, Biological
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Daratumumab
FDA approved
Dexamethasone
FDA approved
Carfilzomib
2014
Completed Phase 3
~1400
Pomalidomide
FDA approved
Magrolimab
Not yet FDA approved
Bortezomib
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: up to 2.5 years

Who is running the clinical trial?

Gilead SciencesLead Sponsor
1,016 Previous Clinical Trials
659,788 Total Patients Enrolled
7 Trials studying Multiple Myeloma
390 Patients Enrolled for Multiple Myeloma
Gilead Study DirectorStudy DirectorGilead Sciences
320 Previous Clinical Trials
180,823 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have been diagnosed with MM and require treatment.
Urine M-protein > 200 mg/24 h.
You have a serum free light chain (SFLC) assay that is involved and abnormal.
You are willing and able to comply with the study protocol.
You have an Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2.
You have a life expectancy of 3 months or more.
You have a platelet count of 75,000 cells/uL or more.