Comparing two treatment options for elderly patients with 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

This study is testing two different treatment options for older patients with newly diagnosed multiple myeloma to see which one works better and is safer.

Quick facts

• Study type: Observational
• Enrollment: 112 (estimated)
• Ages: 65 Years and up
• Sex: All
• Sponsor: The First Affiliated Hospital with Nanjing Medical University (Academic / other)
• Drugs / interventions: daratumumab
• Locations: 6 sites (Changzhou, Jiangsu and 5 other locations)
• Trial ID: NCT06497738 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are elderly patients aged 65 and older with newly diagnosed multiple myeloma and measurable disease.

Not a fit: Patients who are younger than 65 or those with multiple myeloma who are candidates for hematopoietic stem cell transplant may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a more effective treatment option for elderly patients with newly diagnosed multiple myeloma.

How similar studies have performed: Other studies have shown promising results with similar treatment regimens, indicating potential for success in this approach.

Eligibility criteria

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 this trial is running

Changzhou, Jiangsu and 5 other locations

• 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

Conditions Multiple Myeloma