RecruitingNCT06497738
A Prospective Study Comparing DRd With VRd-lite in Elderly Newly Diagnosed Multiple Myeloma
A Prospective, Multi-center, Open-label, Cohort Study to Compare Daratumumab-Lenalidomide-Dexamethasone (DRd) With Modified Bortezomib-Lenalidomide-Dexamethasone (VRd-lite) in Elderly Newly Diagnosed Multiple Myeloma
Sponsor
The First Affiliated Hospital with Nanjing Medical University
Enrollment
112 participants
Start Date
May 1, 2024
Study Type
OBSERVATIONAL
Conditions
Summary
The purpose of the study is to compare the efficacy and safety of daratumumab, lenalidomide and dexamethasone (DRd) to that of modified bortezomib, lenalidomide and dexamethasone (VRd-lite), in terms of progression-free survival and minimal residual disease negativity rate in elderly participants with newly diagnosed multiple myeloma.
Eligibility
Min Age: 65 Years
Inclusion Criteria7
- Age ≥ 65 years old
- Newly diagnosed Multiple myeloma patients with measurable disease. Diagnosis of multiple myeloma as documented per International Myeloma Working Group (IMWG) criteria：Monoclonal plasma cells in the bone marrow greater than or equal to (\>=)10 percentage (%) or presence of a biopsy proven plasmacytoma and documented multiple myeloma satisfying at least one of the calcium, renal, anemia, bone (CRAB) criteria or SLiM. CRAB criteria: Hypercalcemia: serum calcium greater than (\>) 0.25 millimoles per liter (mmol/L) (\>1 milligram per deciliter \[mg/dL\]) higher than upper limit of normal (ULN) or \>2.75 mmol/L (\>11 mg/dL); Renal insufficiency: creatinine clearance less than (\<) 40 milliliter per minute (mL/min) or serum creatinine \>177 micro millimoles per liter (umol/L) (\>2 mg/dL); Anemia: hemoglobin \>2 g/dL below the lower limit of normal or hemoglobin \<10 g/dL; Bone lesions: one or more osteolytic lesions on skeletal radiography, computed tomography (CT), or positron emission tomography (PET)-CT. SLiM: Clonal bone marrow plasma cell percentage \>=60%; Involved: uninvolved serum free light chain (FLC) ratio \>=100; \>1 focal lesion on magnetic 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 \>= 200 milligram\[mg\]/24 hours\[hrs\]); OR IgA, IgM, IgD, or IgE multiple myeloma (serum M-protein level \>= 0.2 g/dL or urine M-protein level \>= 200 mg/24 hrs); OR Light chain multiple myeloma (serum immunoglobulin free light chain \>= 10 mg/dL and abnormal 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 this study protocol for treatment and follow-up
- Have signed informed consent. Informed consent was obtained from the patients themselves or their immediate family members.
Exclusion Criteria14
- 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 Terminology Criteria 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 ≥ 2.5 times 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 and cannot understand or follow the study protocol
- According to the protocol or the investigator's judgment, the patient has a serious physical or mental illness that may interfere with the participation in this clinical study
- Drug abuse, medical, psychological or social conditions that may interfere with the subject'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
Locations(6)
View Full Details on ClinicalTrials.gov
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NCT06497738
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