Phase
Condition
Multiple Myeloma
Lymphoproliferative Disorders
Bone Diseases
Treatment
N/AClinical Study ID
Ages > 65 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Age ≥ 65 years old
Newly diagnosed Multiple myeloma patients with measurable disease. Diagnosis ofmultiple myeloma as documented per International Myeloma Working Group (IMWG)criteria:Monoclonal plasma cells in the bone marrow greater than or equal to (>=)10percentage (%) or presence of a biopsy proven plasmacytoma and documented multiplemyeloma satisfying at least one of the calcium, renal, anemia, bone (CRAB) criteriaor SLiM. CRAB criteria: Hypercalcemia: serum calcium greater than (>) 0.25millimoles per liter (mmol/L) (>1 milligram per deciliter [mg/dL]) higher than upperlimit of normal (ULN) or >2.75 mmol/L (>11 mg/dL); Renal insufficiency: creatinineclearance less than (<) 40 milliliter per minute (mL/min) or serum creatinine >177micro millimoles per liter (umol/L) (>2 mg/dL); Anemia: hemoglobin >2 g/dL below thelower limit of normal or hemoglobin <10 g/dL; Bone lesions: one or more osteolyticlesions on skeletal radiography, computed tomography (CT), or positron emissiontomography (PET)-CT. SLiM: Clonal bone marrow plasma cell percentage >=60%;Involved: uninvolved serum free light chain (FLC) ratio >=100; >1 focal lesion onmagnetic resonance imaging (MRI) studies. Measurable disease: Immunoglobulin (Ig) G myeloma (serum monoclonal paraprotein [M-protein] level >= 0.5 gram/deciliter [g/dL] or urine M-protein level >= 200milligram[mg]/24 hours[hrs]); OR IgA, IgM, IgD, or IgE multiple myeloma (serumM-protein level >= 0.2 g/dL or urine M-protein level >= 200 mg/24 hrs); OR Lightchain multiple myeloma (serum immunoglobulin free light chain >= 10 mg/dL andabnormal serum immunoglobulin kappa lambda free light chain ratio)
Expected survival more than 3 months
No active infectious disease
Be able to understand the characteristics of the disease, voluntarily join thisstudy protocol for treatment and follow-up
Have signed informed consent. Informed consent was obtained from the patientsthemselves or their immediate family members.
Exclusion
Exclusion Criteria:
Patients with active hepatitis B (HBV), hepatitis C (HCV), and other acquired,congenital immunodeficiency diseases.
Peripheral neuropathy or neuropathic pain(except extramedullary disease compression)Grade 2 or higher, as defined by the National Cancer Institute Common TerminologyCriteria for Adverse Events (NCI-CTCAE) Version 5.
Plasma cell leukemia, non-bone-related extramedullary lesions
Severe thrombotic events before treatment
The presence of grade 2 or higher peripheral neuropathy before treatment
Liver dysfunction (alanine aminotransferase and aspartate aminotransferase ≥ 2.5times the upper limit of normal value)
Total bilirubin ≥ 1.5 times the upper limit of normal value
Major surgery within 30 days before enrollment
Epilepsy, dementia and other mental abnormalities requiring drug treatment andcannot understand or follow the study protocol
According to the protocol or the investigator's judgment, the patient has a seriousphysical or mental illness that may interfere with the participation in thisclinical study
Drug abuse, medical, psychological or social conditions that may interfere with thesubject's participation in the study or the evaluation of the study results
Patients who are receiving other experimental drug treatment
Lactating or pregnant women
The investigator believes that the participant is not suitable for enrollment
Study Design
Study Description
Connect with a study center
Changzhou Second People's Hospital
Changzhou, Jiangsu 213000
ChinaActive - Recruiting
Nanjing First People's Hospital
Nanjing, Jiangsu 21000
ChinaActive - Recruiting
The First Affiliated Hospital of Nanjing Medical University
Nanjing, Jiangsu 210000
ChinaActive - Recruiting
Affiliated Hospital of Nantong University
Nantong, Jiangsu 226001
ChinaActive - Recruiting
Taizhou People's Hospital
Taizhou, Jiangsu 225300
ChinaActive - Recruiting
Yancheng First People's Hospital
Yancheng, Jiangsu 224006
ChinaActive - Recruiting
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