A Prospective Study Comparing DRd With VRd-lite in Elderly Newly Diagnosed Multiple Myeloma
NCT Number: NCT06497738
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Multiple Myeloma
Sponsor: The First Affiliated Hospital with Nanjing Medical University
Sex: ALL
Age: OLDER_ADULT
Enrollment: 112
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-05-01
Completion Date: 2027-06-01
Locations: Changzhou Second People's Hospital, Changzhou, Jiangsu, 213000, China|The First Affiliated Hospital of Nanjing Medical University, Nanjing, Jiangsu, 210000, China|Nanjing First People's Hospital, Nanjing, Jiangsu, 21000, China|Affiliated Hospital of Nantong University, Nantong, Jiangsu, 226001, China|Taizhou People's Hospital, Taizhou, Jiangsu, 225300, China|Yancheng First People's Hospital, Yancheng, Jiangsu, 224006, China

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.

Primary Outcome Measures: Progression-free Survival (PFS), PFS is defined as the duration from date of enrollment to either progression disease(PD) or death, whichever comes first. International Myeloma Working Group (IMWG) criteria for PD: Increase of 25 percentage (%) from lowest response value in any one of following: Serum M-component (absolute increase must be \>= 0.5 g/dL) Urine M-component (absolute increase must be \>=200 mg/24 hours), participants without measurable serum and urine M-protein levels: the difference between involved and uninvolved free light chain(FLC) levels (absolute increase must be \>10 mg/dL), participants without measurable serum and urine M-protein levels and without measurable disease by FLC levels, bone marrow plasma cell(PC)% (absolute percentage must be \>=10%), definite development of new bone lesions or soft tissue plasmacytomas or increase in size of bone lesions or tissue plasmacytomas and development of hypercalcemia (serum calcium \>11.5 mg/dL) that can be attributed solely to PC proliferative disorder., From enrollment to either disease progression or death whichever occurs first (approximately 5 years, or 8 years if the adaptive approach is decided at the interim)|MRD Negative Rate, Percentage of participants who have achieved MRD negative status will be assessed. MRD negativity will be evaluated as a potential surrogate for PFS and overall survival (OS) in multiple myeloma treatment., First time reached VGPR, then12,18,24 Months and every 6 months
Secondary Outcome Measures: Very Good Partial Response (VGPR) or Better Rate, VGPR or better rate is defined as the percentage of participants achieving VGPR and complete response (CR) (including stringent complete response \[sCR\]) prior to subsequent anti-myeloma therapy in accordance with the IMWG criteria during or after the study treatment. IMWG criteria for VGPR: Serum and urine M-component detectable by immunofixation but not on electrophoresis, or greater than or equal to (\>=) 90 % reduction in serum M-protein plus urine M-protein \<100 milligram per 24 hours (mg/24 hours); CR: Negative immunofixation on the serum and urine, disappearance of any soft tissue plasmacytomas and \<5% PCs in bone marrow. sCR: CR plus normal FLC ratio, and absence of clonal PCs by immunohistochemistry (IHC), immunofluorescence or 2- to 4 color flow cytometry., Approximately 5 years|Overall Response Rate, ORR is defined as the percentage of participants who achieve partial response (PR) or better responses prior to subsequent anti-myeloma therapy in accordance with IMWG criteria, during or after the study treatment. IMWG criteria for PR: greater than or equal to (\>=) 50 reduction of serum M-protein and reduction in 24-hour urinary M-protein by \>=90 % or to less than (\<) 200 mg/24 hours, If the serum and urine M-protein are not measurable, a decrease of \>=50% in the difference between involved and uninvolved free light chain (FLC) levels is required in place of the M-protein criteria, If serum and urine M-protein are not measurable, and serum free light assay is also not measurable, \>=50% reduction in bone marrow plasma cells (PCs) is required in place of M-protein, provided baseline bone marrow plasma cell percentage was \>=30%. In addition to the above criteria, if present at baseline, a \>=50% reduction in the size of soft tissue plasmacytomas is also required., Up to the end of the study (approximately 5 years)|Duration of Response(DOR), DOR is calculated from the date of initial documentation of a response (PR or better) to the date of first documented evidence of PD, as defined in the IMWG evaluation before the start of any subsequent anti-myeloma therapy., From initial documentation of response to the date of PD until approximately 5 years|Overall Survival (OS), OS is defined as the time from the date of enrollment to the date of the participant's death due to any cause., From enrollment until the participant's death from any cause (up to approximately 5 years, or 8 years if the adaptive approach is decided at the interim)|Complete Response (CR) or Better Rate, CR or better rate is defined as the percentage of participants achieving CR or sCR prior to subsequent anti-myeloma therapy in accordance with the IMWG criteria during or after the study treatment., Approximately 5 years