Refractory or Relapsed Multiple MyelomaPhase 3NCT06952478
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 Phase 3 study testing CT-P44(Daratumumab) and Darzalex Faspro(Daratumumab) in people with Refractory or Relapsed Multiple Myeloma, run by Celltrion at 1 site in Taiwan.
Trial summary
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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Refractory or Relapsed Multiple Myeloma
- What is being tested?
- CT-P44(Daratumumab) and Darzalex Faspro(Daratumumab)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 473 participants
- Where
- 1 siteTaiwan
- Study dates
- 12 Aug 2025to 18 Sep 2028
- Phase
- Phase 3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
[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 or clinical relapse, as defined by the IMWG criteria on or after their last line of therapy.
[Main Exclusion Criteria]
- Patient whose body weight is of >120 kg
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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 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
- Refractory or Relapsed Multiple Myeloma
- Being tested
- CT-P44(Daratumumab), Darzalex Faspro(Daratumumab)
- Medical subject headings
- Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CT-P44(Daratumumab)Biological
CT-P44 1800 mg will be administered as SC injection in combination with Rd until each patient's PD, unacceptable toxicity or Cycle 26, whichever occurs first.
Darzalex Faspro(Daratumumab)Biological
Darzalex Faspro 1800 mg will be administered as SC injection in combination with Rd until each patient's PD, unacceptable toxicity or Cycle 6, whichever occurs first.
| Study group | Role | What they receive |
|---|---|---|
| CT-P44 | Experimental | CT-P44 1800mg SC (subcutaneous) Receives: Biological: CT-P44(Daratumumab) |
| Darzalex Faspro | Active comparator | Darzalex Faspro 1800mg SC (subcutaneous) Receives: Biological: Darzalex Faspro(Daratumumab) |
What is being measured
The primary outcome is the main question the study is designed to answer.
PK equivalence of CT-P44 and Darzalex Faspro
AUCWeek0-1 and AUCWeek8-10 of daratumumab.
Measured: Week 0 ~ Week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2025
- Study start12 Aug 2025
- Primary completion8 Mar 2027 (estimated)
- Study completion18 Sep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Refractory or Relapsed Multiple MyelomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 473 participants (actual)
Sponsor and investigators
- Lead sponsor
- Celltrion
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06952478
- Sponsor's protocol ID
- CT-P44 3.1
- Other IDs
- 2024-518588-36-00
- Status last verified
- Oct 2026
- First submitted
- 29 Apr 2025
- Last updated
- 21 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No