RDD Versus VDD in Newly Diagnosed Patients With Multiple Myeloma

• Status: Recruiting
• Trial end date: 2022-12-31
• Target enrollment: 0
• Participant gender: All

Summary

Multiple myeloma (MM) is a common malignant hematology disease. The development of proteasome inhibitors (PIs) and immunomodulatory drugs (IMiDs) significantly improved the survival of MM patients. IMiDs have multiple effects in MM therapy. Except for direct cytotoxicity, IMiDs also play a variety of immune regulatory roles. Lenalidomide, a kind of IMiDs, was usually used in the therapy of relapsed/refractory MM. The efficacy and safety of RDD (lenalidomide, pegylated liposomal doxorubicin, dexamethasone) in newly diagnosed patients with MM still needs to be further validated.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Shandong Provincial Hospital
• Treatments: BB 1101; Dexamethasone; Dexamethasone acetate; Doxorubicin; Lenalidomide; Liposomal doxorubicin

Criteria

Inclusion Criteria:

• Clinical diagnosis of symptomatic (active) MM;

• Ages ≥18 years old, ≤65 years old;

• ECOG score: 0-2;

• Liver function: transaminase≤2.5×upper limit of normal value，bilirubin≤1.5×upper limit of normal value;

• Renal function: serum creatinine is 44-176 mmol/L;

• LVEF≥50%;

• New York Heart Association (NYHA) heart function classification is I-II grade;

• Signed informed consent.

Exclusion Criteria:

• Severe complications or severe infection;

• Severe heart disease history, including ventricular tachycardia (VT), atrial fibrillation (AF), heart block, myocardial infarction (MI), congestive heart failure (CHF), coronary heart disease patients needed therapy;

• Severe allergic constitution, or those who are allergic to or intolerant of drug composition in chemotherapy regimens; with other malignant tumors in the past 5 years;

• Patients participate in other clinical studies;

• Patients are not suitable for the study;

• Other contraindications for ASCT therapy.