Phase
Condition
Multiple Myeloma
Cancer
Lymphoproliferative Disorders
Treatment
KPD (carfilzomib, pomalidomide, and dexamethasone) consolidation
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
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:
Alanine aminotransferase (ALT) / Aspartate aminotransferase (AST) ≤ 2.5 × UNL (upper limit of normal);
Serum total bilirubin ≤ 1.5 × UNL. If the patient has congenitally highbilirubin, direct bilirubin must be ≤ 1.5 × UNL;
Left ventricular ejection fraction (LVEF) ≥ 50% as diagnosed byechocardiography, with no clinically significant electrocardiogram (ECG)abnormalities;
Basal oxygen saturation > 95% in room air;
Women of childbearing age agree to use effective contraceptive measures during theperiod of using the study drug and within 3 months after the last administration ofthe study drug; and to use highly effective contraceptive measures for at least 1year thereafter. Male participants with fertile partners must agree to use effectivebarrier contraception during the period of using the study drug and within 3 monthsafter the last administration of the study drug;
The participant is willing and able to comply with the study procedures andvoluntarily signs the written informed consent form.
Exclusion
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 ofcentral nervous system (CNS) diseases such as epileptic seizures, cerebral vascularischemia/ hemorrhage, dementia, cerebellar diseases, or any autoimmune diseasesinvolving the CNS;
Patients with a history of the following genetic diseases: Fanconi anemia,Shwachman-Diamond syndrome, Costello syndrome, or any other known bone marrowfailure syndrome;
Patients who underwent a diagnosis or treatment for another malignancy within 1 yearprior to randomization, or had a previous diagnosis of another malignancy withevidence of residual disease (excluding patients with any type of non-melanoma skincancer 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 anyexcipients 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 mayinterfere with the participant's ability to participate in the study or theassessment of study outcomes;
Pregnant or lactating women;
Any other conditions deemed by the investigator as unsuitable for enrollment.
Study Design
Study Description
Connect with a study center
Fuxing Hospital affiliated to Capital Medical University
Beijing, Beijing 100045
ChinaActive - Recruiting
Peking University People's Hospital
Beijing, Beijing 100044
ChinaActive - Recruiting
Shanghai Changzheng Hospital
Shanghai, Shanghai 021
ChinaActive - Recruiting
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