Phase
Condition
Multiple Myeloma
Cancer
Cancer/tumors
Treatment
N/AClinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Subject must be at least 18 years of age.
Subject must have documented newly diagnosed symptomatic multiple myeloma as definedby 2014 International Myeloma Working Group criteria.
Subject must have achieved a response (partial response [PR] or better based oninvestigator's determination of response by the IMWG criteria) to at one priorregimen.
Women of childbearing potential must commit to either abstain continuously fromheterosexual sexual intercourse or to use 2 methods of reliable birth controlsimultaneously. Contraception must begin 4 weeks prior to dosing and continue untilat least 3 months after receiving the last dose of the study drug. A woman ofchildbearing potential must have a negative serum or urine pregnancy tests atscreening within 14 days prior to randomization.
Each subject (or their legally acceptable representative) must sign an informedconsent form (ICF) indicating that he or she understands the purpose of andprocedures required for the study and are willing to participate in the study.
Exclusion
Exclusion Criteria:
Subject has a diagnosis of primary amyloidosis, monoclonal gammopathy ofundetermined significance, or smoldering multiple myeloma. Monoclonal gammopathy ofundetermined significance is defined by presence of serum M-protein <3 g/dL; absenceof lytic bone lesions, anemia, hypercalcemia, and renal insufficiency related to theM-protein; and (if determined) proportion of plasma cells in the bone marrow of 10%or less. Smoldering multiple myeloma is defined as asymptomatic multiple myelomawith absence of related organ or tissue impairment or end-organ damage.
Relapsed and refractory myeloma:Relapsed and refractory myeloma is defined asdisease that is nonresponsive while on salvage therapy, or progresses within 60 daysof last therapy in patients who have achieved minimal response (MR) or better atsome point previously before then progressing in their disease course.
Primary refractory myeloma:Primary refractory myeloma is defined as disease that isnonresponsive in patients who have never achieved a minimal response or better withany therapy.
Subject is known or suspected of not being able to comply with the study protocol。Subject has any condition for which, in the opinion of the investigator,participation would not be in the best interest of the subject or that couldprevent, limit, or confound the protocol-specified assessments.
Study Design
Study Description
Connect with a study center
The First Hospital of Jilin University
Changchun, Jilin 130021
ChinaActive - Recruiting
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