Comparing two subcutaneous daratumumab formulations given with lenalidomide and dexamethasone for relapsed or refractory 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
This test will see if a new subcutaneous daratumumab (CT-P44) works as well and is as safe as Darzalex Faspro when given with lenalidomide and dexamethasone in adults whose multiple myeloma has come back or stopped responding.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 486 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Celltrion Industry-sponsored |
| Drugs / interventions | daratumumab |
| Locations | 1 site (Taipei, Beitou District) |
| Trial ID | NCT06952478 on ClinicalTrials.gov |
What this trial studies
This phase 3 interventional trial compares the pharmacokinetics, efficacy, and safety of CT-P44 versus Darzalex Faspro, both given subcutaneously with lenalidomide and dexamethasone, in adults with relapsed or refractory multiple myeloma. Eligible participants must be at least 18 years old, have prior documented response to at least one regimen, have progressive disease after their last therapy, and must not have received prior anti‑CD38 therapy. Participants are treated with one of the two daratumumab formulations plus lenalidomide and dexamethasone and are followed for drug levels, response by IMWG criteria, and adverse events. Primary comparisons focus on pharmacokinetic similarity as well as clinical response rates and safety profiles between the two subcutaneous preparations.
Who should consider this trial
Good fit: Adults (≥18) with relapsed or refractory multiple myeloma who previously achieved at least a partial response to one or more regimens, now have progressive disease after their last therapy, and who have not previously received anti‑CD38 agents are the intended participants.
Not a fit: Patients who previously received daratumumab or other CD38‑targeting drugs, who are refractory or intolerant to lenalidomide, or who have major comorbidities or inability to follow the protocol are unlikely to benefit from participation.
Why it matters
Potential benefit: If CT-P44 is comparable to Darzalex Faspro, patients could have an additional subcutaneous daratumumab option that may improve access or reduce cost while maintaining similar effectiveness and safety.
How similar studies have performed: Subcutaneous daratumumab (Darzalex Faspro) is already approved and shown effective in prior studies, while biosimilar formulations like CT-P44 have limited head‑to‑head phase 3 comparative data to date.
Eligibility criteria
Show full inclusion / exclusion 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 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.
Where this trial is running
Taipei, Beitou District
- Taipei Veterans General Hospital — Taipei, Beitou District, Taiwan (Recruiting)
Study contacts
- Study coordinator: JoonSoo Ha
- Email: joonsoo.ha@celltrion.com
- Phone: +82 32 850 5727
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.