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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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • KPD (carfilzomib, pomalidomide, and dexamethasone) consolidation

    Drug

    After post-transplant randomization, patients will receive either KPD (carfilzomib, pomalidomide, and dexamethasone) consolidation then maintenance or no consolidation and maintenance.

Treatment groups

202 Participants
are divided into 2 treatment groups
Group A: KPD consolidationExperimental treatment 1 intervention
Group B: No consolidationNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Minimal residual disease (MRD) negativity rate prior to maintenance therapy

The primary endpoint of this study is to compare the minimal residual disease (MRD) negativity rate prior to maintenance therapy in transplant-eligible newly diagnosed multiple myeloma (NDMM) patients who receive KPD consolidation therapy versus those who do not receive consolidation therapy after triplet or quadraplet induction therapy and autologous stem cell transplantation (ASCT).

Time frame
36 months
2

Overall Response Rate (ORR)

Compare the overall response rate (ORR) including the rates of stringent complete response (sCR), complete response (CR), very good partial response (VGPR) and partial response (PR), prior to maintenance therapy according to the IMWG (International Myeloma Working Group) assessment criteria, between the two treatment groups。

Time frame
36 months

Secondary outcomes

1

Progression-free survival (PFS)

Time interval from ASCT to disease progression or death.

Time frame
36 months
2

Overall Survival (OS)

Time interval from ASCT to death

Time frame
36 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Peking University People's Hospital

Lead sponsor

Source ClinicalTrials.gov
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