Clinical trial · Interventional
Safety and Efficacy Study of Imexon for Treatment of Multiple Myeloma Patients
A Phase 1/2 Trial of Amplimexon® (Imexon, Inj.) for Patients With Previously Treated Multiple Myeloma
- 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)
AMP-007 is a Phase 1/2 study for the treatment of advanced, previously treated multiple myeloma. The first phase of the study is designed to determine a safe dose of imexon that can be given to patients with advanced, previously-treated multiple myeloma. The Phase 2 part of the study is designed to provide additional safety data and to gain an understanding of whether imexon can improve the outcome for patients with 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 |
|---|---|---|---|
| imexon | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (3)
- measure
- Determine the maximally tolerated dose of imexon in multiple myeloma patients
- measure
- evaluate the toxicity of imexon
- measure
- Preliminarily evaluate efficacy in terms of response and progression free survival.
Secondary outcomes (1)
- measure
- Evaluate biomarker responses.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Advanced myeloma, with measurable disease as defined in the protocol. * Prior treatment, at least 2 prior regimens are required. This may include prior treatment with investigational products. * Able to perform the activities of daily living. * Off prior therapy for at least 2-4 weeks depending on the drug. * Blood counts and blood chemistries in or near normal range. * If female, neither pregnant nor nursing. * Willing to use contraceptives to prevent pregnancy. * No other serious illnesses. * No other active malignancy. * No serious infections. * No current other drug therapy for the myeloma except for steroid therapy under certain circumstances. Biphosphonate therapy is permitted. * Prior radiation is permitted. Exclusion Criteria: * Use of corticosteroids for amyloid disorders, or high dose chronic steroids.
References
Publications (0)
Data not yet available