Initial treatment of myeloma
Conditions
Interventions
4 drug combination regimen (ATO-VTD) group:arsenic trioxide 10mg/d on days 1-3, 8-10, and 15-17
thalidomide 100mg on days 1-28
Bortezomib 1.6 mg/m2 subcutaneously on days 1, 8, and 15
and dexamethasone 40 mg/day on days 1–4, 8–11, and 15–18. For patients over 65 years or those with diabetes, dexamethasone dosage was reduced to 20 mg/day
Traditional 3-drug regimen (VRD) group:Bortezomib was given at 1.6 mg/mg2 on days 1, 8 and 15, combined with oral lenalidomide 10 mg daily on days 1-28 plus oral dexamethasone 40mg daily on days 1-4,
Sponsors
Huadong hospital
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1) Diagnosed with multiple myeloma, no previous treatment, 18-80 years old, ECOG score 60%, no arrhythmia or unstable heart rhythm, serum bilirubin <2× upper limit of normal, serum alanine aminotransferase <2× upper limit of normal, no chronic active hepatitis or cirrhosis, renal function below stage 4 CKD; If the pregnancy test is negative, it is necessary to obtain the consent of the woman and her family members who have fertility potential. 2) Sign informed consent. 3)Bone marrow aspiration and blood routine examination were performed before enrollment. All patients had good proliferation of hematopoietic cells and no other hematopoietic diseases. Such as myelodysplastic syndrome
Exclusion criteria
Exclusion criteria: 1) Myeloma patients who did not meet the enrollment criteria. 2) Patients who cannot be guaranteed regular treatment and follow-up according to the requirements of the trial. 3)Patients with other tumor types except superficial bladder cancer, basal cell or squamous cell carcinoma of the skin, cervical intraepithelial cancer (CIN), or prostate intraepithelial cancer (PIN) 4)An active viral or bacterial infection that is not controlled with appropriate anti-infective treatment 5)Be serologically positive with known HIV or active HCV; Active hepatitis B virus, manifested as elevated HBV titer and abnormal liver function, such patients need strict anti-hepatitis B virus treatment, and only after the control of hepatitis B virus (HBV titer decreased) can be considered for enrollment. Hepatitis B big three positive, small three positive patients, such as HBV-DNA<500, after the need for formal antiviral treatment can be included.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| objective response rate;security; | — |
Secondary
| Measure | Time frame |
|---|---|
| time to progress;progression-free survival;overall survival; | — |
Countries
China
Contacts
Public ContactJiexian Ma
Shanghai Huadong hospital
Outcome results
None listed