A Prospective Study Comparing DRd With VRd-lite in Elderly Newly Diagnosed Multiple Myeloma

Recruiting now

Conditions studied: Multiple Myeloma

In brief

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.

Key facts

Study ID: NCT06497738
Run by: The First Affiliated Hospital with Nanjing Medical University
People needed: 112
Starts: 2024-05-01
Expected to finish: 2027-06-01
Last updated by the study team: 2025-08-17

Who can join

Age: 65 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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.

You may not qualify if…

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

Where it is running

Changzhou Second People's Hospital — Changzhou, Jiangsu, China (enrolling)
The First Affiliated Hospital of Nanjing Medical University — Nanjing, Jiangsu, China (enrolling)
Nanjing First People's Hospital — Nanjing, Jiangsu, China (enrolling)
Affiliated Hospital of Nantong University — Nantong, Jiangsu, China (enrolling)
Taizhou People's Hospital — Taizhou, Jiangsu, China (enrolling)
Yancheng First People's Hospital — Yancheng, Jiangsu, China (enrolling)

Full record on ClinicalTrials.gov

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