Clinical trial · Interventional
Study Evaluating AMG 424 in Subjects With Multiple Myeloma
A Phase 1, First-in-Human, Open-Label Study Evaluating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of AMG 424 in Subjects With Multiple Myeloma
NCT03445663CI-TRIAL-00064516terminatedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Previous sponsor business decision not to proceed with the AMG 424 asset.
Summary
Brief summary (as posted)
A multi-center Phase 1, First-in-Human study conducted in 2 Parts, testing AMG 424 in subjects with relapsed/ 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 |
|---|---|---|---|
| Relapsed/ Refractory Multiple Myeloma | Multiple Myeloma | CURATED_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| AMG 424 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- AMG 424
- description
- Comparison of different dosages of AMG 424
- interventionNames
- Drug: AMG 424
Primary outcomes (2)
- measure
- Subject incidence of treatment emergent and treatment related adverse events as assessed by CTCAE version 4.0
- timeFrame
- 12 Months
- description
- Measure of Safety
- measure
- Subject incidence of dose limiting toxicities (DLTs)
- timeFrame
- 28 Days
- description
- Measure of Safety
Secondary outcomes (9)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Multiple myeloma meeting the following criteria: * Pathologically-documented diagnosis of multiple myeloma that has relapsed after at least two prior lines of therapy that must include a proteasome inhibitor (PI), immunomodulatory drug (IMiD), and, where approved and available, anti-CD38 therapy in any order OR that is refractory to PI, IMiD, and anti-CD38 therapy. ◾Subjects who could not tolerate a PI, IMiDs, or a CD38-directed therapeutic antibody due to unacceptable toxicities are eligible to enroll in the study. * Measurable disease as per IMWG response criteria * Eastern Cooperative Oncology Group (ECOG) Performance Status of ≤ 2 Exclusion Criteria: * Known central nervous system involvement by multiple myeloma * Previously received allogeneic stem cell transplant and one or more of the following: * received the transplant \< 6 months prior to study Day 1 * received immunosuppressive therapy \< 3 months prior to study Day 1 * any active acute graft versus host disease (GvHD), grade 2- 4, according to the Glucksberg criteria or active chronic GvHD requiring systemic treatment * any systemic therapy against GvHD \< 2 weeks prior to study Day 1 * Autologous stem cell transplantation less than 90 days prior to study day 1 * Multiple myeloma with IgM subtype * POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes) * Evidence of primary or secondary plasma cell leukemia at the time of screening * Waldenstrom's macroglobulinemia * Amyloidosis * Dexamethasone at cumulative doses of greater than 160 mg or equivalent \<3 weeks prior to study Day 1 is not allowed. Use of topical or inhaled steroids is acceptable * Anticancer treatment (chemotherapy, IMiD, PI, molecular targeted therapy) \< 2 weeks prior to study Day 1 * Treatment with a therapeutic antibody targeting CD38 \< 12 weeks prior to study Day 1 * Systemic radiation therapy or major surgery \< 28 days prior to study Day 1 as well as focal radiotherapy \< 14 days prior to study Day 1. * Major surgery within 28 days prior to study Day 1
References
Publications (0)
Data not yet available
No reference posted for this study.