Comparing two treatment options for elderly patients with newly diagnosed multiple myeloma

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study aims to compare the efficacy and safety of two treatment regimens: daratumumab, lenalidomide, and dexamethasone (DRd) versus modified bortezomib, lenalidomide, and dexamethasone (VRd-lite) in elderly patients diagnosed with multiple myeloma. It is a prospective, open-label, multicentered cohort study that allows participants to choose their treatment option. The primary endpoints include progression-free survival and the rate of minimal residual disease negativity. Safety assessments will be conducted throughout the study to monitor participant well-being.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Age ≥ 65 years old
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:

1. Patients with active hepatitis B (HBV), hepatitis C (HCV), and other acquired, congenital immunodeficiency diseases.
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

Where it's running

• Changzhou Second People's Hospital
  Changzhou, Jiangsu, China Recruiting
• The First Affiliated Hospital of Nanjing Medical University
  Nanjing, Jiangsu, China Recruiting
• Nanjing First People's Hospital
  Nanjing, Jiangsu, China Recruiting
• Affiliated Hospital of Nantong University
  Nantong, Jiangsu, China Recruiting
• Taizhou People's Hospital
  Taizhou, Jiangsu, China Recruiting
• Yancheng First People's Hospital
  Yancheng, Jiangsu, China Recruiting

Study contacts

• Study coordinator: Yuanyuan Jin, Doctor
• Email: 827508088@qq.com
• Phone: +86-025-68306091

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Maintaining myeloma with less frequent daratumumab plus lenalidomide

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• GR1803 injection versus daratumumab plus pomalidomide and dexamethasone for relapsed or refractory multiple myeloma

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  Recruiting Phase 3 Genrix (Shanghai) Biopharmaceutical Co., Ltd. · Tianjin · NCT07452198

• Belantamab Mafodotin or Daratumumab with VRd for Newly Diagnosed High-Risk Myeloma

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• Etentamig plus daratumumab versus daratumumab‑lenalidomide‑dexamethasone for newly diagnosed multiple myeloma in patients not eligible for transplant

  This trial will test whether adding the investigational drug etentamig to daratumumab helps control disease and is safe in adults newly diagnosed with multiple myeloma who cannot have a transplant.

  Recruiting at 49 sites Phase 2/3 AbbVie · Scottsdale, Arizona and 48 other locations · NCT07095452

• Linvoseltamab versus standard daratumumab‑lenalidomide‑dexamethasone for adults with newly diagnosed, transplant‑ineligible multiple myeloma

  This trial tests whether linvoseltamab works better or is safer than the standard daratumumab‑lenalidomide‑dexamethasone combination in adults newly diagnosed with multiple myeloma who are not eligible for transplant.

  Recruiting at 59 sites Phase 3 European Myeloma Network B.V. · Adelaide and 58 other locations · NCT06932562

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.