A study to compare Efficacy, Safety and How the Body Absorbs, Distributes, and Eliminates of Subcutaneous CT-P44 and Darzalex Faspro in Combination with Lenalidomide and Dexamethasone in Patients with Refractory or Relapsed Multiple Myeloma
EU CTIS ID: 2024-518588-36-00
What this study is testing
The primary objective of this study is to demonstrate the PK similarity of CT-P44 and Darzalex Faspro in the PK Group and therapeutic equivalence of CT-P44 and Darzalex Faspro in the Main Study Group. All patients in the PK Group and non-PK Group will be included in the Main Study Group. The PK equivalence of CT-P44 and Darzalex Faspro will be demonstrated in terms of area under the concentration-time curve from Week 0 to Week 1 (AUCWeek0-1) and area under the concentration-time curve from Week 8 to Week 10 (AUCWeek8-10) of daratumumab in the PK set–PK Group at 1st dose, and PK set–PK Group up to 9th doses, respectively. The therapeutic equivalence of CT-P44 and Darzalex Faspro will be demonstrated in terms of proportion of patients who will achieve very good partial response (VGPR) or better based on the confirmed best overall response (BOR) up to Week 24 from the last patient’s randomization according to the IMWG criteria in the intent-to-treat (ITT) set.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Male or female with 18 years of age or older.
- Patient must have documented multiple myeloma (MM).
- 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.
- Patient must have received at least 1, but maximum 3 prior lines of therapy for MM.
You likely can't join if
- Patient has received daratumumab or any other drug specifically targeting CD38 previously.
- Patient’s disease shows evidence of refractoriness or intolerance to lenalidomide. If previously treated with a lenalidomide-containing regimen, the patient is excluded if he or she: a) Discontinued due to any AEs related to prior lenalidomide treatment, or b) If, at any time point, the patient was refractory to any dose of lenalidomide.
- Patient has received a prior treatment with one or more of the followings: a) Approved anti-myeloma agents within 14 days or 5 PK half-lives of the treatment, whichever is longer, before the date of randomization. Note. The only exception is emergency use of a short course of corticosteroids (equivalent of dexamethasone 40 mg/day for a maximum 4 days) before Day 1 of Cycle 1. b) Current or recent treatment (within 28 days before randomization or 5 half-lives, whichever is longer) with any other investigational medicinal product or device. c) Radiation therapy within 14 days of randomization. Patients must have recovered from all radiation-related toxicities. d) Plasmapheresis within 28 days of randomization. e) Live or live-attenuated vaccine, or all coronavirus disease-19 (COVID-19) vaccines within 14 days prior to randomization.
- Patient has received ASCT within 12 weeks before the date of randomization, or the patient’s immune system has not sufficiently recovered after ASCT under the investigator's judgment.
- Patient has previously received an allogenic stem cell transplant regardless of timing.
The study team makes the final eligibility decision.
Where it's taking place
- Taiwan
- Chile
- India
- Philippines
- Bosnia and Herzegovina
- Mexico
- Brazil
- Serbia
- Georgia
- Colombia
- Argentina
- North Macedonia
- Korea, Republic of
- Thailand
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Taiwan; Chile; India; Philippines; Bosnia and Herzegovina; Mexico and 8 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.