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
Recruiting
Phase 3
Interventional Study
Refractory or Relapsed Multiple Myeloma
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 and older
- Sex
- Any
- Trial phase
- Phase 3
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 486 (estimated)
- Sponsor
- Celltrion · Industry
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About This Trial
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
Trial Locations
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Eligibility Criteria
\[Main Inclusion Criteria\]
* 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 …
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