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

Status: Recruiting
Location: See all (6) locations...
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: 65
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
China
Changzhou Second People's Hospital
RECRUITING
Changzhou
Nanjing First People's Hospital
RECRUITING
Nanjing
The First Affiliated Hospital of Nanjing Medical University
RECRUITING
Nanjing
Affiliated Hospital of Nantong University
RECRUITING
Nantong
Taizhou People's Hospital
RECRUITING
Taizhou
Yancheng First People's Hospital
RECRUITING
Yancheng
Contact Information
Primary
Yuanyuan Jin, Doctor
827508088@qq.com
+86-025-68306091
Backup
Lijuan Chen
chenljb@126.com
+86-025-68306091
Time Frame
Start Date: 2024-05-01
Estimated Completion Date: 2027-06-01
Participants
Target number of participants: 112
Treatments
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.
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.
Related Therapeutic Areas
Sponsors
Leads: The First Affiliated Hospital with Nanjing Medical University

This content was sourced from clinicaltrials.gov

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