Refractory or Relapsed Multiple Myeloma
Conditions
Brief 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
Interventions
BIOLOGICALCT-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.
BIOLOGICALDarzalex 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.
Sponsors
Celltrion
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| PK equivalence of CT-P44 and Darzalex Faspro | Week 0 ~ Week 24 | AUCWeek0-1 and AUCWeek8-10 of daratumumab. |
| Therapeutic equivalence of CT-P44 and Darzalex Faspro | Week 0 ~ Week 24 | Proportion of patients who will achieve VGPR or better (sCR + CR + VGPR) based on the confirmed BOR. |
Countries
Taiwan
Contacts
Primary ContactJoonSoo Ha
Backup ContactNaRae Ryu
Outcome results
None listed