Clinical trial · Interventional
Study of Ciforadenant in Combination With Daratumumab in Patients With Relapsed or Refractory Multiple Myeloma
An Open-Label Study of Ciforadenant in Combination With Daratumumab in Patients With Relapsed or Refractory Multiple Myeloma
NCT04280328CI-TRIAL-00057049completedPhase 1ClinicalTrials.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 Phase 1b open-label study of ciforadenant, an oral, small molecule inhibitor targeting adenosine-2A receptors (A2AR), on safety/tolerability and efficacy in combination with daratumumab, a monoclonal antibody targeting CD38, in 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 (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Ciforadenant | Drug | — | UNRESOLVED |
| daratumumab | Drug | Daratumumab | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Ciforadenant in combination with daratumumab
- description
- Ciforadenant 100 mg orally twice daily in combination with daratumumab IV 16 mg/kg.
- interventionNames
- Drug: Ciforadenant
- Drug: daratumumab
Primary outcomes (2)
- measure
- Safety and tolerability of ciforadenant in combination with daratumumab relapsed / refractory multiple myeloma.
- timeFrame
- From start of treatment to end of treatment, up to 24 months
- description
- Incidence of treatment-emergent adverse events, as assessed by NCI CTCAE v.5
- measure
- Safety and tolerability of ciforadenant in combination with daratumumab relapsed / refractory multiple myeloma.
- timeFrame
- 28 days following first administration of ciforadnenat in combination with daratumumab
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: * Relapsed or refractory myeloma. * Must have been exposed to at least 2 cycles of an IMiD containing regimen and PI containing regimen and must be refractory to at least one of the two. * Must have completed and tolerated 2 cycles of daratumumab or other anti-CD38 targeting antibodies. * Active myeloma requiring systemic treatment. * Measurable disease per protocol. * ECOG performance status of 0 - 2. * Life expectancy of at least 3 months. Exclusion Criteria: * POEMS syndrome; non-secretory myeloma (no measurable protein on sFLC assay); amyloidosis. * History of select prior malignancies. * Previous intolerance to daratumumab or any study drug. * Received an allogeneic stem cell transplant within 12 months, or an autologous stem cell transplant within 6 months, or have ongoing toxicity related to transplant. * Have an active infection or serious comorbid medical condition. * Any live attenuated vaccination against infectious diseases (e.g., influenza, varicella) within 4 weeks of initiation of study treatment; uncontrolled human immunodeficiency virus, or positive tests for hepatitis B or hepatitis C. * Female participants pregnant or breast-feeding. * Screening chemistry and blood counts within protocol limits * Treatment with systemic immunosuppressive medication within 2 weeks prior to initiation of study treatment or anticipation of need for systemic immunosuppressant medication during study treatment.
References
Publications (0)
Data not yet available
No reference posted for this study.