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Monoclonal Antibodies

AMG 224 for Multiple Myeloma

Phase 1
Waitlist Available
Research Sponsored by Amgen
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up amg 224 and anti-bcma antibody: pre-dose, 0.5 hours, eoi, 4 hours, 24 hours, 96 hours, 168 hours, and 336 hours post-dose (cycle 1 + 2); dm1: pre-dose, 0.5 hours, eoi, 4 hours, 24 hours, and 96 hours post-dose (cycles 1 + 2)
Awards & highlights

Study Summary

This trial is for people with multiple myeloma who have tried other treatments that haven't worked. It's the first time this particular treatment is being tried on humans.

Eligible Conditions
  • Multiple Myeloma

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~amg 224 and anti-bcma antibody: pre-dose, 0.5 hours, eoi, 4 hours, 24 hours, 96 hours, 168 hours, and 336 hours post-dose (cycle 1 + 2); dm1: pre-dose, 0.5 hours, eoi, 4 hours, 24 hours, and 96 hours post-dose (cycles 1 + 2)
This trial's timeline: 3 weeks for screening, Varies for treatment, and amg 224 and anti-bcma antibody: pre-dose, 0.5 hours, eoi, 4 hours, 24 hours, 96 hours, 168 hours, and 336 hours post-dose (cycle 1 + 2); dm1: pre-dose, 0.5 hours, eoi, 4 hours, 24 hours, and 96 hours post-dose (cycles 1 + 2) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of Participants Who Experienced a Dose-Limiting Toxicity (DLT)
Number of Participants With a Treatment-emergent Adverse Event (TEAE)
Secondary outcome measures
Area Under the Concentration-time Curve (AUC) of AMG 224 Conjugated Antibody, Total Anti-BCMA Antibody, and Total Unconjugated DM1
Best Overall Response (BOR) According to International Myeloma Working Group Uniform Response Criteria (IMWG-URC)
Clearance (CL) of AMG 224 Conjugated Antibody, Total Anti-BCMA Antibody, and Total Unconjugated DM1
+7 more

Side effects data

From 2022 Phase 1 trial • 42 Patients • NCT02561962
100%
Fatigue
67%
Constipation
67%
Dizziness
67%
Thrombocytopenia
33%
Dyspnoea
33%
Pyrexia
33%
Hypomagnesaemia
33%
Hypokalaemia
33%
Basal cell carcinoma
33%
Rash
33%
Seborrhoeic keratosis
33%
Neck pain
33%
Proctalgia
33%
Actinic keratosis
33%
Urinary tract infection bacterial
33%
Phimosis
33%
Acrochordon
33%
Pain
33%
Left ventricular failure
33%
Skin infection
33%
Urinary tract infection
33%
Hypercalcaemia
33%
Cough
33%
Skin papilloma
33%
Hypervolaemia
33%
Rectal haemorrhage
33%
Haemorrhoidal haemorrhage
33%
Dry eye
33%
Infusion related reaction
33%
Dehydration
33%
Fluid overload
33%
Anaemia
33%
Abdominal pain upper
33%
Nausea
33%
Chest pain
33%
Oedema peripheral
33%
Beta haemolytic streptococcal infection
33%
Cellulitis
33%
Upper respiratory tract infection
33%
Contusion
33%
Wound
33%
Alanine aminotransferase increased
33%
Blood creatinine increased
33%
Hyperglycaemia
33%
Hypermagnesaemia
33%
Hypernatraemia
33%
Back pain
33%
Neuropathy peripheral
33%
Epistaxis
33%
Skin lesion
33%
Lymphocyte count decreased
33%
Lacrimation increased
33%
Oedema
33%
Aspartate aminotransferase increased
33%
Blood alkaline phosphatase increased
33%
Blood potassium decreased
33%
Blood urea increased
33%
Hyperuricaemia
33%
Nasal congestion
33%
Lower respiratory tract infection
33%
Mucosal inflammation
33%
Herpes ophthalmic
33%
Haematuria
33%
Nasal dryness
33%
Hypoalbuminaemia
33%
Rash maculo-papular
33%
Hot flush
100%
80%
60%
40%
20%
0%
Study treatment Arm
Dose Exploration: AMG 224 Dose D
Dose Exploration: AMG 224 Dose C
Dose Exploration: AMG 224 Dose A
Dose Exploration: AMG 224 Dose B
Dose Exploration: AMG 224 Dose G
Dose Expansion: AMG 224 Dose H + no Prior CD38 Targeting Antibody Treatment
Dose Exploration: AMG 224 Dose F
Dose Exploration: AMG 224 Dose E
Dose Expansion: AMG 224 Dose H + Prior CD38 Targeting Antibody Treatment

Trial Design

9Treatment groups
Experimental Treatment
Group I: Dose Exploration: AMG 224 Dose GExperimental Treatment1 Intervention
Participants were administered AMG 224 Dose G as an IV infusion Q3W on Day 1 of each cycle, where each cycle is 3 weeks.
Group II: Dose Exploration: AMG 224 Dose FExperimental Treatment1 Intervention
Participants were administered AMG 224 Dose F as an IV infusion Q3W on Day 1 of each cycle, where each cycle is 3 weeks.
Group III: Dose Exploration: AMG 224 Dose EExperimental Treatment1 Intervention
Participants were administered AMG 224 Dose E as an IV infusion Q3W on Day 1 of each cycle, where each cycle is 3 weeks.
Group IV: Dose Exploration: AMG 224 Dose DExperimental Treatment1 Intervention
Participants were administered AMG 224 Dose D as an IV infusion Q3W on Day 1 of each cycle, where each cycle is 3 weeks.
Group V: Dose Exploration: AMG 224 Dose CExperimental Treatment1 Intervention
Participants were administered AMG 224 Dose C as an IV infusion Q3W on Day 1 of each cycle, where each cycle is 3 weeks.
Group VI: Dose Exploration: AMG 224 Dose BExperimental Treatment1 Intervention
Participants were administered AMG 224 Dose B as an IV infusion Q3W on Day 1 of each cycle, where each cycle is 3 weeks.
Group VII: Dose Exploration: AMG 224 Dose AExperimental Treatment1 Intervention
Participants were administered AMG 224 Dose A as an intravenous (IV) infusion once every 3 weeks (Q3W) on Day 1 of each cycle, where each cycle is 3 weeks.
Group VIII: Dose Expansion: AMG 224 Dose H + prior CD38 targeting antibody treatmentExperimental Treatment1 Intervention
Participants who had prior treatment with CD38-targeting antibody were administered AMG 224 Dose H (the maximum tolerated dose [MTD] based on the dose exploration phase) as an IV infusion Q3W on Day 1 of each cycle, where each cycle is 3 weeks.
Group IX: Dose Expansion: AMG 224 Dose H + no prior CD38 targeting antibody treatmentExperimental Treatment1 Intervention
Participants who had no prior treatment with CD38-targeting antibody were administered AMG 224 Dose H (the MTD based on the dose exploration phase) as an IV infusion Q3W on Day 1 of each cycle, where each cycle is 3 weeks.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
AMG 224
2015
Completed Phase 1
~50

Find a Location

Who is running the clinical trial?

AmgenLead Sponsor
1,367 Previous Clinical Trials
1,386,211 Total Patients Enrolled
96 Trials studying Multiple Myeloma
20,698 Patients Enrolled for Multiple Myeloma
MDStudy DirectorAmgen
910 Previous Clinical Trials
923,744 Total Patients Enrolled
44 Trials studying Multiple Myeloma
11,303 Patients Enrolled for Multiple Myeloma

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
LeukemiaJournal
Phase 1 Study of the Anti-bcma Antibody-drug Conjugate AMG 224 in Patients with Relapsed/refractory Multiple Myeloma
Lee, Hans C., Noopur S. Raje, Ola Landgren, Vijay V. Upreti, Jin Wang, Ariel A. Avilion, Xuguang Hu, et al.. 2020. “Phase 1 Study of the Anti-bcma Antibody-drug Conjugate AMG 224 in Patients with Relapsed/refractory Multiple Myeloma”. Leukemia. Springer Science and Business Media LLC. doi:10.1038/s41375-020-0834-9.
clinicaltrials.govStudy
A Phase 1 Study in Subjects With Relapsed or Refractory Multiple Myeloma
2015. "A Phase 1 Study in Subjects With Relapsed or Refractory Multiple Myeloma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02561962.
~4 spots leftby Apr 2025
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