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NCT06497738Recruiting

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

Source: ClinicalTrials.gov · Last updated 17 Aug 2025 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Study type
Observational
Enrollment
112 (estimated)
First submitted
26 Jun 2024
Start date
1 May 2024
Primary completion date
1 Jun 2026
Lead sponsor
The First Affiliated Hospital with Nanjing Medical University
NCT number
NCT06497738

What you commit to

  • Study type: Observational
  • Planned participants: 112
  • From 1 May 2024 to the primary completion date, 1 Jun 2026
  • 6 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Major surgery within 30 days before enrollment
  • Patients who are receiving other experimental drug treatment

Other illness

  • 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.
  • 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

Lab values

  • Total bilirubin ≥ 1.5 times the upper limit of normal value

Other

  • 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)
  • Lactating or pregnant women
  • The investigator believes that the participant is not suitable for enrollment

Who the study is looking for

  • 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.

Age in the registry: 65 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (6)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Changzhou Second People's Hospital
Coordinator of this site? Confirm its status
ChangzhouChinaRecruiting
The First Affiliated Hospital of Nanjing Medical University
Coordinator of this site? Confirm its status
NanjingChinaRecruiting
Nanjing First People's Hospital
Coordinator of this site? Confirm its status
NanjingChinaRecruiting
Affiliated Hospital of Nantong University
Coordinator of this site? Confirm its status
NantongChinaRecruiting
Taizhou People's Hospital
Coordinator of this site? Confirm its status
TaizhouChinaRecruiting
Yancheng First People's Hospital
Coordinator of this site? Confirm its status
YanchengChinaRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.