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
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: CT-P44(Daratumumab), Darzalex Faspro(Daratumumab).
- Who it may be relevant to
- Registry conditions: Refractory or Relapsed Multiple Myeloma. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Taiwan
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
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
Overview
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
Interventions
- Biological CT-P44(Daratumumab)
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. - Biological Darzalex Faspro(Daratumumab)
Darzalex Faspro 1800 mg will be administered as SC injection in combination with Rd until each patient's PD, unacceptable toxicity or Cycle 13, whichever occurs first.
Primary outcome measures
- PK equivalence of CT-P44 and Darzalex Faspro [Time frame: Week 0 ~ Week 24]
- Therapeutic equivalence of CT-P44 and Darzalex Faspro [Time frame: Week 0 ~ Week 24]
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 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Treatment
Study locations
Taiwan · 1 center
- Taipei Veterans General Hospital — Taipei
Identifiers
NCT: NCT06952478 · CT-P44 3.1 · 2024-518588-36-00