KPD Consolidation After ASCT in NDMM Patients

Launched by PEKING UNIVERSITY PEOPLE'S HOSPITAL · Mar 14, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a treatment approach for patients with newly diagnosed multiple myeloma, a type of blood cancer. The researchers want to find out if a specific combination of medications (called the KPD regimen, which includes carfilzomib, pomalidomide, and dexamethasone) works better when given after a stem cell transplant compared to not using this treatment. They will mainly look at how many patients reach a state where no cancer cells can be detected (known as minimal residual disease negativity) and how well patients overall respond to the treatment.

To participate in this trial, patients need to be at least 18 years old, have been diagnosed with multiple myeloma, and have received specific initial treatments before undergoing a stem cell transplant. They should also meet certain health criteria, such as having good organ function and being able to comply with study procedures. Participants will receive either the KPD treatment or no additional treatment after their transplant, followed by maintenance therapy. It’s important for potential participants to discuss any questions or concerns with their healthcare team before considering joining the trial.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Age ≥18 years.
• • Newly diagnosed MM eligible for transplantation.
• • Received upfront triplet or quadraplet induction regimen.
• • Received upfront ASCT after induction.
• • ECOG score \< 2.
• * Adequate Organ Function Reserve:
• • 1. Alanine aminotransferase (ALT) / Aspartate aminotransferase (AST) ≤ 2.5 × UNL (upper limit of normal);
• • 2. Serum total bilirubin ≤ 1.5 × UNL. If the patient has congenitally high bilirubin, direct bilirubin must be ≤ 1.5 × UNL;
• • 3. Left ventricular ejection fraction (LVEF) ≥ 50% as diagnosed by echocardiography, with no clinically significant electrocardiogram (ECG) abnormalities;
• • 4. Basal oxygen saturation \> 95% in room air;
• • Women of childbearing age agree to use effective contraceptive measures during the period of using the study drug and within 3 months after the last administration of the study drug; and to use highly effective contraceptive measures for at least 1 year thereafter. Male participants with fertile partners must agree to use effective barrier contraception during the period of using the study drug and within 3 months after the last administration of the study drug;
• • The participant is willing and able to comply with the study procedures and voluntarily signs the written informed consent form.
• Exclusion Criteria:
• • 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;
• • Patients who underwent a diagnosis or treatment for another malignancy within 1 year prior to randomization, or had a previous diagnosis of another malignancy with evidence of residual disease (excluding patients with any type of non-melanoma skin cancer or completely resected carcinoma in situ);
• • Patients with active infectious diseases, known human immunodeficiency virus (HIV) positivity, or active hepatitis B or C infection;
• • Patients known to be allergic to any of the study drugs, their analogs, or any excipients of the study drugs in various formulations;
• • Patients with concurrent or suspected central nervous system infiltration;
• • Patients with drug use, medical, psychological, or social conditions that may interfere with the participant's ability to participate in the study or the assessment of study outcomes;
• • Pregnant or lactating women;
• • Any other conditions deemed by the investigator as unsuitable for enrollment.