Clinical trial · Interventional
A Study to Compare Pharmacokinetics, Efficacy and Safety of Subcutaneous CT-P44 and Darzalex Faspro in Combination With Lenalidomide and Dexamethasone in Patients With Refractory or Relapsed Multiple Myeloma
A Double-Blind, Randomized, Active-Controlled, Parallel-group, Phase 1/3 Study to Compare Pharmacokinetics, Efficacy and Safety of Subcutaneous CT-P44 and Darzalex Faspro in Combination With Lenalidomide and Dexamethasone in Patients With Refractory or Relapsed 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)
This study is a phase 1/3 study to Compare Pharmacokinetics, Efficacy and Safety of Subcutaneous CT-P44 and Darzalex Faspro in Combination with Lenalidomide and Dexamethasone in Patients with Refractory or Relapsed 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 |
|---|---|---|---|
| Refractory or Relapsed Multiple Myeloma | Multiple Myeloma | CURATED_EXACT | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| CT-P44(Daratumumab) | Biological | — | UNRESOLVED |
| Darzalex Faspro(Daratumumab) | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- CT-P44
- description
- CT-P44 1800mg SC (subcutaneous)
- interventionNames
- Biological: CT-P44(Daratumumab)
- type
- ACTIVE_COMPARATOR
- label
- Darzalex Faspro
- description
- Darzalex Faspro 1800mg SC (subcutaneous)
- interventionNames
- Biological: Darzalex Faspro(Daratumumab)
Primary outcomes (2)
- measure
- PK equivalence of CT-P44 and Darzalex Faspro
- timeFrame
- Week 0 ~ Week 24
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
\[Main Inclusion Criteria\] * Male or female with 18 years of age or older. * Patient must have documented multiple myeloma (MM) according to IMWG criteria * Patient must have a documented relapsed or refractory disease. * Patient must have achieved a response (PR or better based on investigator's determination of response by the IMWG criteria) to at least one prior regimen. * Patient must have a PD as defined by the IMWG criteria on or after their last line of therapy. \[Main Exclusion Criteria\] * Patient has received daratumumab or any other drug specifically targeting CD38 previously. * Patient's disease shows evidence of refractoriness or intolerance to lenalidomide. * Patient is known or suspected of not being able to comply with the study protocol (e.g., psychological disorder) or the patient has any condition for which, in the opinion of the investigator, participation would not be in the best interest of the patient (e.g., compromise their well-being) or that could prevent, limit, or confound the protocol-specified assessments.
References
Publications (0)
Data not yet available