KPD Consolidation After ASCT in NDMM Patients
ConditionMultiple Myeloma, Newly Diagnosed
Trial statusRecruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorPeking University People's Hospital
About this trial
This study aims to evaluate the efficacy and safety of post-transplant consolidation therapy with the KPD regimen (carfilzomib, pomalidomide, and dexamethasone) versus no consolidation, followed by maintenance therapy, in patients with transplant-eligible newly diagnosed multiple myeloma (TE-NDMM). The primary goal is to compare minimal residual disease (MRD) negativity rates and overall treatment outcomes between the two groups.
Eligibility criteria
Qualifiers
Age ≥18 years.
Newly diagnosed MM eligible for transplantation.
Received upfront triplet or quadraplet induction regimen.
Received upfront ASCT after induction.
Disqualifiers
Patients with primary plasma cell leukemia or POEMs syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes);
Patients diagnosed with primary amyloidosis, Waldenström's macroglobulinemia, monoclonal gammopathy of undetermined significance, or smoldering multiple myeloma;
Patients with severe mental disorders, altered mental status, or a history of central nervous system (CNS) diseases such as epileptic seizures, cerebral vascular ischemia/ hemorrhage, dementia, cerebellar diseases, or any autoimmune diseases involving the CNS;
Patients with a history of the following genetic diseases: Fanconi anemia, Shwachman-Diamond syndrome, Costello syndrome, or any other known bone marrow failure syndrome;
Trial design
Treatments tested in this trial
- KPD (carfilzomib, pomalidomide, and dexamethasone) consolidation
Treatment groups
202 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov