Multiple Myeloma
Conditions
Interventions
VRD group:Induction Therapy:
VRD: Bortezomib 1.3 mg/m2 on days 1, 4, 8, 11 (for fit patients, 28-day cycle) or on days 1, 8, 15, 22 (for non-fit patients, 35-day cycle)
Lenalidomide: 10 mg on days 1-21
Dexamethasone: 20 mg on the days of bortezomib administration (days 1 and 2), reduced to 10 mg for frail patients.
Maintenance Therapy:
Standard-risk patients: Lenalidomide (R) 10 mg orally on a 21
DRD group:Induction Therapy:
DRD: Daratumumab (intravenous): 16 mg/kg weekly in Cycles 1-2, every two weeks in Cycles 3-6, every 4 weeks in Cycles 7-8
or Daratumumab (subcutaneous): 1800 mg weekly in Cycles 1-2, every two weeks in Cycles 3-6, every 4 weeks in Cycles 7-8. Lenalidomide: 10 mg on days 1-21. Dexamethasone: 20 mg weekly per 28-day cycle,
Sponsors
The First Affiliated Hospital, Zhejiang University School of Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 85 Years
Inclusion criteria
Inclusion criteria: 1. Age >= 65 years, or ineligible for autologous hematopoietic stem cell transplantation due to fitness, comorbidities, or other reasons. 2. Ability to understand and voluntarily provide written Informed Consent Form, and willingness to comply with the required follow-up procedures. 3. Diagnosis of multiple myeloma according to the IMWG 2014 criteria. 4. Presence of measurable disease for response assessment as per IMWG response criteria, defined by at least one of the following: Serum M-protein >= 10 g/L, or Urinary M-protein excretion >= 200 mg per 24 hours, or Abnormal serum free light chain (sFLC) levels, with involved free light chain (iFLC) >= 100 mg/L and an abnormal serum free light chain ratio (?/?). If none of the above are present (i.e., in cases of "oligo-secretory" or "non-secretory" myeloma), measurable disease must be confirmed by bone marrow plasma cell percentage (typically requiring >= 30%) or by the presence of a measurable plasmacytoma (as measured by imaging techniques such as CT, MRI, or PET-CT). 5. Life expectancy of more than 6 months, and being deemed suitable for enrollment in this study by the investigator.
Exclusion criteria
Exclusion criteria: 1. Diagnosis of non-multiple myeloma plasma cell disorders, such as smoldering multiple myeloma or plasma cell leukemia. 2. Prior systemic anti-myeloma therapy, with the exception of localized radiotherapy, surgical intervention, or a short course of dexamethasone (not exceeding 5 days in total and a cumulative dose not exceeding 100mg). 3. Severe cardiac or pulmonary insufficiency, or unstable/active cardiovascular disease, including but not limited to: poorly controlled cardiac symptoms or conditions such as: NYHA Class II or higher heart failure, Unstable angina, Myocardial infarction within the past year, clinically significant supraventricular or ventricular arrhythmias requiring treatment or intervention. 4. Active infection not effectively controlled by medication, or HIV infection. 5. Severe psychiatric or neurological disorders. 6. Concurrent other malignancies requiring active treatment. 7. Pregnancy, lactation, or patients of childbearing potential unwilling to use adequate contraception. 8. Inability to comply with follow-up procedures. 9. Known hypersensitivity to any of the study drugs. 10. Any other condition deemed by the investigator as unsuitable for participation in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-Free Survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall Response Rate;Complete Response Rate;Overall Survival;Minimal Residual Disease Negativity Rate;Sustained Minimal Residual Disease Negativity Rate (12 months) ;Patient-Reported Outcome; | — |
Countries
China
Contacts
Public ContactZhen Cai
The First Affiliated Hospital, Zhejiang University School of Medicine
Outcome results
None listed