A Prospective Study Comparing DRd With VRd-lite in Elderly Newly Diagnosed Multiple Myeloma
NCT ID: NCT06497738
Last Updated: 2025-08-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
112 participants
OBSERVATIONAL
2024-05-01
2027-06-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Daratumumab + lenalidomide + dexamethasone
Drug: Daratumumab Daratumumab will be administered at a dose of 16 milligram per kilogram (mg/kg) by intravenous (IV) infusion, once a week for 8 weeks, then once every other week for 16 weeks, thereafter once every 4 weeks. The total induction cycle is 8.
Drug: Lenalidomide Lenalidomide will be self-administered at a dose of 25 mg orally on Day 1 to Day 21 of each 28-day cycle.
Drug: Dexamethasone Dexamethasone 20 mg orally or intravenously on Days 1, 2, 8, 9, 15, 16, 22, 23 of each 21-day cycle for Cycles 1-8. For participant\>75, dexamethasone will be reduced to 10mg twice a week.
Then according to the risk stratification, standard risk participants will receive lenalidomide maintenance therapy while high risk participants will receive daratumumab combined with lenalidomide until progression.
No interventions assigned to this group
Modified Bortezomib+Lenalidomide+dexamethasone
Drug: Bortezomib Bortezomib 1.3 mg/m\^2 will be administered by subcutaneous(SC) injection injection weekly on Days 1, 8, 15, 22 of each 21-day cycle for Cycles 1-8.
Drug: Dexamethasone Dexamethasone 20 mg orally or intravenously on Days 1, 2, 8, 9, 15, 16, 22, 23 of each 21-day cycle for Cycles 1-8. For participant\>75, dexamethasone will be reduced to 10mg twice a week.
Then according to the risk stratification, standard risk participants will receive lenalidomide maintenance therapy while high risk participants will receive bortezomib combined with lenalidomide until progression.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
2. 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)
3. Expected survival more than 3 months
4. No active infectious disease
5. Be able to understand the characteristics of the disease, voluntarily join this study protocol for treatment and follow-up
6. Have signed informed consent. Informed consent was obtained from the patients themselves or their immediate family members.
Exclusion Criteria
2. 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.
3. Plasma cell leukemia, non-bone-related extramedullary lesions
4. Severe thrombotic events before treatment
5. The presence of grade 2 or higher peripheral neuropathy before treatment
6. Liver dysfunction (alanine aminotransferase and aspartate aminotransferase ≥ 2.5 times the upper limit of normal value)
7. Total bilirubin ≥ 1.5 times the upper limit of normal value
8. Major surgery within 30 days before enrollment
9. Epilepsy, dementia and other mental abnormalities requiring drug treatment and cannot understand or follow the study protocol
10. 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
11. 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
12. Patients who are receiving other experimental drug treatment
13. Lactating or pregnant women
14. The investigator believes that the participant is not suitable for enrollment
65 Years
ALL
No
Sponsors
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The First Affiliated Hospital with Nanjing Medical University
OTHER
Responsible Party
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Principal Investigators
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Lijuan Chen
Role: STUDY_CHAIR
The First Affiliated Hospital with Nanjing Medical University
Locations
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Changzhou Second People's Hospital
Changzhou, Jiangsu, China
The First Affiliated Hospital of Nanjing Medical University
Nanjing, Jiangsu, China
Nanjing First People's Hospital
Nanjing, Jiangsu, China
Affiliated Hospital of Nantong University
Nantong, Jiangsu, China
Taizhou People's Hospital
Taizhou, Jiangsu, China
Yancheng First People's Hospital
Yancheng, Jiangsu, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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DRd
Identifier Type: -
Identifier Source: org_study_id
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