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Monoclonal Antibodies

Magrolimab Combinations for Multiple Myeloma

Phase 2
Waitlist Available
Research Sponsored by Gilead Sciences
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Males and females of childbearing potential who engage in heterosexual intercourse must agree to use protocol-specified method(s) of contraception.
Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2.5 years
Awards & highlights

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.

Who is the study for?
This trial is for adults with relapsed/refractory multiple myeloma who've previously been diagnosed and need treatment. They must be willing to undergo bone marrow biopsies, have a life expectancy of at least 3 months, adequate organ function, and no recent major treatments or surgeries. Pregnant or breastfeeding individuals, those with certain other health conditions or infections, or on another clinical trial are excluded.Check my eligibility
What is being tested?
The study tests the safety and dosing of magrolimab in combination with other cancer drugs (Carfilzomib, Bortezomib, Daratumumab, Pomalidomide, Dexamethasone) in patients whose multiple myeloma has returned after treatment or didn't respond to previous therapy.See study design
What are the potential side effects?
Potential side effects may include immune system reactions due to Magrolimab's targeting of CD47 protein; effects from chemotherapy like nausea and hair loss; increased risk of infection; blood clots from Carfilzomib; peripheral neuropathy from Bortezomib; infusion-related reactions from Daratumumab.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I agree to use birth control as required by the study.
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I am able to get out of my bed or chair and move around.
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My kidney function is within the required range.
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I have been diagnosed with multiple myeloma and need treatment.
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My blood counts are within a healthy range.
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I am eligible for treatment with magrolimab and other specific drugs.
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My liver is working well, according to recent tests.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2.5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2.5 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Objective Response Rate (ORR) (Dose Expansion Cohorts)
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)
Percentage of Participants Experiencing Treatment-emergent Adverse Events (TEAE's) According to the NCI CTCAE Version 5.0 (Safety Run-in Cohorts)
+1 more
Secondary outcome measures
Antidrug Antibody (ADA) Against Magrolimab (Dose Expansion Cohorts)
Duration of Response (Dose Expansion Cohorts)
Percentage of Participants Experiencing TEAE's According to the NCI CTCAE Version 5.0 (Dose Expansion Cohorts)
+2 more

Side effects data

From 2020 Phase 1 & 2 trial • 78 Patients • NCT02953782
67%
Dry skin
44%
Diarrhoea
44%
Dermatitis acneiform
44%
Fatigue
44%
Lymphocyte count decreased
33%
Infusion related reaction
33%
Abdominal pain
22%
Decreased appetite
22%
Small intestinal obstruction
22%
Tinnitus
22%
Nausea
22%
Chills
22%
Oedema peripheral
22%
Back pain
22%
Myalgia
22%
Headache
22%
Pruritus
22%
Dehydration
22%
Rash maculo-papular
11%
Hypertension
11%
Dyspnoea
11%
Lymphopenia
11%
Malignant neoplasm progression
11%
Cerebrovascular accident
11%
Anaemia
11%
Palpitations
11%
Conjunctivitis allergic
11%
Dry eye
11%
Abdominal distension
11%
Constipation
11%
Dyspepsia
11%
Gastrooesophageal reflux disease
11%
Hypoaesthesia oral
11%
Folliculitis
11%
Sinusitis
11%
Gastrointestinal stoma complication
11%
Aspartate aminotransferase increased
11%
Blood bilirubin increased
11%
Hypokalaemia
11%
Hypomagnesaemia
11%
Hypophosphataemia
11%
Tumour pain
11%
Dizziness
11%
Confusional state
11%
Depression
11%
Haematuria
11%
Dysphonia
11%
Ingrowing nail
11%
Skin infection
11%
Tinea cruris
11%
Platelet count decreased
11%
Alanine aminotransferase increased
11%
Photopsia
11%
Conjunctivitis
11%
Gastroenteritis viral
11%
Hyperglycaemia
11%
Arthralgia
11%
Neck pain
11%
Somnolence
11%
Nasal congestion
11%
Deep vein thrombosis
11%
Oesophageal pain
11%
Vomiting
11%
Chest discomfort
100%
80%
60%
40%
20%
0%
Study treatment Arm
Magrolimab 10 mg/kg
Magrolimab 20 mg/kg
Magrolimab 30 mg/kg
Magrolimab 45 mg/kg
Magrolimab Priming Dose Only

Trial Design

8Treatment groups
Experimental Treatment
Group I: Safety Run-in Cohort (Magrolimab+Pomalidomide+Dexamethasone)Experimental Treatment3 Interventions
Participants with relapsed/refractory MM who have had 3 or more prior therapies including an IMiD and a PI will receive magrolimab as per protocol and pomalidomide 4 mg on Days 1 to 21 (daily) of Cycle 1, Days 1 to 21 (daily) of Cycle 2 and onward and dexamethasone 40 mg on Days 1, 8, 15, 22, 29 of Cycle 1, Days 1, 8, 15, 22 of Cycle 2 and onward. (Cycle 1=35 days, All other Cycles=28 days)
Group II: Safety Run-in Cohort (Magrolimab+Daratumumab)Experimental Treatment2 Interventions
Participants with relapsed/refractory multiple myeloma who have had 3 or more prior therapies including an immunomodulatory drug (IMiD) and a proteasome inhibitor (PI) will receive magrolimab as per protocol and daratumumab 1800 mg subcutaneously (SC) or 16 milligrams per kilogram (mg/kg) intravenously (IV) on Days 8, 15, 22, 29 of Cycle 1, Days 1, 8, 15, 22 of Cycle 2 and Days 1 and 15 (every 2 weeks) until Cycle 6 (total of 8 doses) followed by Day 1 (every 4 weeks) for subsequent cycles. (Cycle 1=35 days, All other Cycles=28 days) .
Group III: Safety Run-in Cohort (Magrolimab+Carfilzomib+Dexamethasone)Experimental Treatment3 Interventions
Participants with relapsed/refractory multiple myeloma who have had 3 or more prior therapies including an IMiD and a PI will receive magrolimab as per protocol and carfilzomib 20 mg/m^2 on Days 8, 15, 22 of Cycle 1, Days 1, 8, 15 of Cycle 2 and onward (if the carfilzomib starting dose of 20 mg/m^2 is tolerated after Cycle 1, Day 8, the dose will be escalated to 70 mg/m^2 on Cycle 1, Day 15 and thereafter) and dexamethasone 40 mg on Days 1, 8, 15, 22, 29 of Cycle 1, Days 1, 8, 15, 22 of Cycles 2 to 9 and then Days 1, 8, 15 from Cycle 10 and onward. (Cycle 1=35 days, All other Cycles=28 days)
Group IV: Safety Run-in Cohort (Magrolimab+Bortezomib+Dexamethasone)Experimental Treatment3 Interventions
Bortezomib + Dexamethasone may be initiated based on the preliminary safety and efficacy of the Carfilzomib + Dexamethasone cohort. Participants with relapsed/refractory multiple myeloma who have had 1 or more prior therapies including an IMiD and a PI will receive magrolimab as per protocol and carfilzomib 1.3 mg/m^2 on Days 8, 15, 22, 29 of Cycle 1, Days 1, 8, 15, 22 of Cycle 2 and onward (Maximum of 8 cycles in those who have previously received bortezomib) and dexamethasone 40 mg on Days 1, 8, 15, 22, 29 of Cycle 1, Days 1, 8, 15, 22 of Cycles 2 to 9 and then Days 1, 8, and 15 from Cycle 10 and onward. (Cycle 1=35 days, All other Cycles=28 days)
Group V: Dose Expansion Cohort (Magrolimab+Pomalidomide+Dexamethasone)Experimental Treatment3 Interventions
Participants with relapsed/refractory MM who have had 3 or more prior therapies including an IMiD and a PI will receive magrolimab as per protocol and pomalidomide 4 mg on Days 1 to 21 (daily) of Cycle 1, Days 1 to 21 (daily) of Cycle 2 and onward and dexamethasone 40 mg on Days 1, 8, 15, 22, 29 of Cycle 1, Days 1, 8, 15, 22 of Cycle 2 and onward. (Cycle 1=35 days, All other Cycles=28 days)
Group VI: Dose Expansion Cohort (Magrolimab+Daratumumab)Experimental Treatment2 Interventions
Participants with relapsed/refractory multiple myeloma who have had 3 or more prior therapies including an IMiD and a PI will receive magrolimab at the RP2D determined in the Safety Run-in Cohort and daratumumab 1800 mg SC or 16 mg/kg IV on Days 8, 15, 22, 29 of Cycle 1, Days 1, 8, 15, 22 of Cycle 2 and Days 1 and 15 (every 2 weeks) until Cycle 6 (total of 8 doses) followed by Day 1 (every 4 weeks) for subsequent cycles. (Cycle 1=35 days, All other Cycles=28 days)
Group VII: Dose Expansion Cohort (Magrolimab+Carfilzomib+Dexamethasone)Experimental Treatment3 Interventions
Participants with relapsed/refractory multiple myeloma who have had 3 or more prior therapies including an IMiD and a PI will receive magrolimab at the RP2D determined in the Safety Run-in Cohort and carfilzomib 20 mg/m^2 on Days 8, 15, 22 of Cycle 1, Days 1, 8, 15 of Cycle 2 and onward (if the carfilzomib starting dose of 20 mg/m^2 is tolerated after Cycle 1, Day 8, the dose will be escalated to 70 mg/m^2 on Cycle 1, Day 15 and thereafter) and dexamethasone 40 mg on Days 1, 8, 15, 22, 29 of Cycle 1, Days 1, 8, 15, 22 of Cycles 2 to 9 and then Days 1, 8, 15 from Cycle 10 and onward. (Cycle 1=35 days, All other Cycles=28 days)
Group VIII: Dose Expansion Cohort (Magrolimab+Bortezomib+Dexamethasone)Experimental Treatment3 Interventions
Bortezomib + Dexamethasone may be initiated based on the preliminary safety and efficacy of the Carfilzomib + Dexamethasone cohort. Participants with relapsed/refractory multiple myeloma who have had 1 or more prior therapies including an IMiD and a PI will receive magrolimab at the RP2D determined in the Safety Run-in Cohort and bortezomib 1.3 mg/m^2 on Days 8, 15, 22, 29 of Cycle 1, Days 1, 8, 15, 22 of Cycle 2 and onward (Maximum of 8 cycles in those who have previously received bortezomib) and dexamethasone 40 mg on Days 1, 8, 15, 22, 29 of Cycle 1, Days 1, 8, 15, 22 of Cycles 2 to 9 and then Days 1, 8, and 15 from Cycle 10 and onward. (Cycle 1=35 days, All other Cycles=28 days)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Carfilzomib
2017
Completed Phase 3
~1440
Bortezomib
2005
Completed Phase 2
~1140
Magrolimab
2018
Completed Phase 2
~120
Daratumumab
2014
Completed Phase 3
~1860
Pomalidomide
2011
Completed Phase 2
~1020
Dexamethasone
2007
Completed Phase 4
~2590

Find a Location

Who is running the clinical trial?

Gilead SciencesLead Sponsor
1,077 Previous Clinical Trials
837,376 Total Patients Enrolled
9 Trials studying Multiple Myeloma
396 Patients Enrolled for Multiple Myeloma
Gilead Study DirectorStudy DirectorGilead Sciences
341 Previous Clinical Trials
185,675 Total Patients Enrolled

Media Library

Magrolimab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT04892446 — Phase 2
Multiple Myeloma Research Study Groups: Safety Run-in Cohort (Magrolimab+Pomalidomide+Dexamethasone), Safety Run-in Cohort (Magrolimab+Bortezomib+Dexamethasone), Safety Run-in Cohort (Magrolimab+Daratumumab), Safety Run-in Cohort (Magrolimab+Carfilzomib+Dexamethasone), Dose Expansion Cohort (Magrolimab+Daratumumab), Dose Expansion Cohort (Magrolimab+Pomalidomide+Dexamethasone), Dose Expansion Cohort (Magrolimab+Carfilzomib+Dexamethasone), Dose Expansion Cohort (Magrolimab+Bortezomib+Dexamethasone)
Multiple Myeloma Clinical Trial 2023: Magrolimab Highlights & Side Effects. Trial Name: NCT04892446 — Phase 2
Magrolimab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04892446 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has Magrolimab received official sanction from the FDA?

"Our assessment of Magrolimab's safety levels is 2, which indicates that while some data exists to support its safety profile, there are currently no studies demonstrating the efficacy."

Answered by AI

What maladies has Magrolimab been proven to alleviate?

"Magrolimab is a medication that effectively and reliably treats ophthalmia, sympathetic as well as branch retinal vein occlusion, macular edema, and communicable diseases."

Answered by AI

What is the current sample size for this therapeutic trial?

"In order to execute this trial, Gilead Sciences needs 153 participants that meet the study's criteria. They will be recruiting from two locations: Portland, Oregon and Tucson Arizona."

Answered by AI

Are there any opportunities for enrolment in this trial yet?

"Data hosted on clinicaltrials.gov reveals that this research endeavour, initially posted on November 9th 2021 and recently modified on November 10th 2022, is currently searching for participants."

Answered by AI

What precedent has been established with regards to Magrolimab research?

"Currently, there are 673 active clinical studies relating to Magrolimab with 153 of those trials in their third and final stage. Of these trials, a majority are being conducted at sites located in Joliet, Illinois; however worldwide the total number of trial locations comes out to 21897."

Answered by AI

In what geographical areas is this research trial being conducted?

"This study is taking place at 12 locations, including Oregon Health and Science University in Portland, Arizona Oncology Associates , PC - HOPE in Tucson, and Roswell Park Cancer Institute in Buffalo. Additionally, there are 9 other sites where patients can receive the medication."

Answered by AI
~34 spots leftby Dec 2024