Clinical trial · Interventional
A Phase 1 Study in Subjects With Relapsed or Refractory Multiple Myeloma
A Phase 1 First in Human Study Evaluating the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AMG 224 in Subjects With Relapsed or Refractory Multiple Myeloma
NCT02561962CI-TRIAL-00073498completedPhase 1Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This is a first in human phase 1 multicenter open label study in subjects with relapsed or refractory multiple myeloma.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Multiple Myeloma | Multiple Myeloma | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| AMG 224 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (9)
- type
- EXPERIMENTAL
- label
- Dose Exploration: AMG 224 Dose A
- description
- 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.
- interventionNames
- Drug: AMG 224
- type
- EXPERIMENTAL
- label
- Dose Exploration: AMG 224 Dose B
- description
- Participants were administered AMG 224 Dose B as an IV infusion Q3W on Day 1 of each cycle, where each cycle is 3 weeks.
- interventionNames
- Drug: AMG 224
- type
- EXPERIMENTAL
- label
- Dose Exploration: AMG 224 Dose C
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: \- Pathologically documented,multiple myeloma relapsed or refractory progressive disease after at least 3 lines of therapy for multiple myeloma. Prior therapeutic treatment or regimens must include proteasome inhibitors (e.g. bortezomib) and immunomodulatory drugs (e.g. lenalidomide). * Willing and able to undergo bone marrow aspirate per protocol (with or without bone marrow biopsy per institutional guidelines). * Measurable disease per the International Myeloma Working Group (IMWG) response criteria * Hematological function, as follows, without transfusion support: * Absolute neutrophil count ≥ 1.0 X 10\^9/L, * Platelet count ≥ 75 X 10\^9/L (in patients with \< 50% of bone marrow nucleated cells were plasma cells) or ≥ 50 X 10\^9/L (in patients with ≥ 50% of bone marrow nucleated cells were plasma cells) without transfusion or growth factor support * Hemoglobin \> 8 g/dL (\> 80 g/L) * Adequate renal and hepatic function * Left ventricular ejection fraction (LVEF) \> 50% Exclusion Criteria: * Currently receiving treatment in another investigational device or drug study, or less than 28 days since ending treatment on another investigational device or drug study * Autologous stem cell transplant less than 90 days prior to study day 1 * Multiple myeloma with IgM subtype * POEMS (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes) syndrome, Plasma cell leukemia, Waldenstrom's macroglobulinemia or Amyloidosis * Glucocorticoid therapy (prednisone \> 30 mg/day or equivalent) within 7 days prior to study day * Myocardial infarction within 6 months of study day 1, symptomatic congestive heart failure (New York Heart Association \> class II) * A baseline ECG QTcF \> 470 msec * Anti-tumor therapy (chemotherapy, antibody therapy, molecular targeted therapy, or investigational agent) within 28 days prior to study day 1
References
Publications (1)
- BACKGROUNDLee HC, Raje NS, Landgren O, Upreti VV, Wang J, Avilion AA, Hu X, Rasmussen E, Ngarmchamnanrith G, Fujii H, Spencer A. Phase 1 study of the anti-BCMA antibody-drug conjugate AMG 224 in patients with relapsed/refractory multiple myeloma. Leukemia. 2021 Jan;35(1):255-258. doi: 10.1038/s41375-020-0834-9. Epub 2020 Apr 21. No abstract available. PMID 32317775