Trials / Not Yet Recruiting

Not Yet RecruitingNCT07015021

The Efficacy and Safety of the Combination Therapy of Daratumumab, Cabozantinib, Pomalidomide, and Dexamethasone (D-KPd) in the Treatment of High-risk First-time Relapsed or Primary Refractory MM Patients

Status: Not Yet Recruiting
Phase: N/A
Study type: Interventional
Enrollment: 72 (estimated)

Sponsor: The First Affiliated Hospital of Soochow University · Academic / Other
Sex: All
Age: 18 Years
Healthy volunteers: Not accepted

Summary

This study is a prospective, single center, single arm phase II clinical trial. The study population consists of patients who have received treatment with VRd or VRd lite regimens for 2-8 courses in the past and have achieved therapeutic effects, but have progressed during treatment (primary refractory), experienced clinical recurrence for the first time after treatment, or progressed or recurred after the first transplant (without entering maintenance therapy). 72 patients are planned to be enrolled and receive 4 courses of induction therapy with D-KPd regimen for the first efficacy evaluation. For patients with ≥ SD, if the patient has ≥ PR and is suitable for ASCT, ASCT treatment will be given. For patients with\<PR or not suitable for ASCT, 4 courses of consolidation therapy with D-KPd regimen will be continued for the second efficacy evaluation SD patients continue to receive 4 courses of D-KPd regimen consolidation treatment. D-KPd dosing regimen: Daratumumab: 16mg/Kg, IV or 1800mg Sc; C1-2 d1,8,15,22; C3-6 d1,15; C7-12 d1。 Cafizomide: 20mg/m2; C1-8 d1,2,8,9,15,16； C9-12 d1,2,15,16； After tolerance to 20mg/m2, the dose of C1D1 and C1D2 can be adjusted to 27g/m2. Pomalidomide: 4mg, PO,d1-21。 Dexamethasone: 20mg, po,d1, 2,8,9,15,16,22,23. If the age is over 75 years old, the Dex dose is halved. The main efficacy endpoint after 12 treatment courses is: ORR； Secondary efficacy endpoint indicators: mPFS, mOS, ≥ VGPR rate, MRD negative rate, safety

Detailed description

Considering that the majority of initial treatment patients in China have already received pre-treatment with lenalidomide and bortezomib, the vast majority of patients who experience disease progression will be refractory to lenalidomide and exposed to bortezomib. Both carfilzomib and pomalidomide have been shown to be effective against lenalidomide resistance, and the combination of carfilzomib, pomalidomide, and dexamethasone has a combined anti myeloma effect. Currently, the combination of the three drugs has become a routine treatment for RRMM patients. Previous studies abroad have shown that the D-KPd regimen combined with four drugs can prolong the median PFS of RRMM patients (with a median prior treatment line of 2) to 30.9 months. Another study led by the University of Chicago showed that for patients with first-time recurrent RRMM, the D-KPd regimen had longer mPFS and mOS compared to the KPd regimen. However, there are currently no relevant reports on the efficacy data of D-KPD regimen in China. Considering regional and ethnic differences, as well as the lack of particularly good treatment options for high-risk first-time relapse and primary refractory MM patients in China, we plan to design this prospective, single center, single arm clinical trial to determine the effectiveness and safety of D-KPd regimen for high-risk first-time relapse or primary refractory MM patients.

Conditions

Interventions

Type	Name	Description
DRUG	Daratumumab	Daratumumab: 16mg/Kg, IV or 1800mg Sc; C1-2 d1,8,15,22; C3-6 d1,15; C7-12 d1
DRUG	Cafizomide	Cafizomide: 20mg/m2; C1-8 d1,2,8,9,15,16； C9-12 d1,2,15,16；After tolerance to 20mg/m2, the dose of C1D1 and C1D2 can be adjusted to 27g/m2.
DRUG	Pomalidomide	Pomalidomide: 4mg, PO,d1-21
DRUG	Dexamethasone	Dexamethasone: 20mg, po,d1, 2,8,9,15,16,22,23.

Timeline

Start date: 2025-06-01
Primary completion: 2026-09-30
Completion: 2026-09-30
First posted: 2025-06-11
Last updated: 2025-06-11

Source: ClinicalTrials.gov record NCT07015021. Inclusion in this directory is not an endorsement.