VRD as Induction Followed by VR Maintenance in Patients With Newly Diagnosed High Risk Multiple Myeloma

Myeloma Clinical Trial

Official title: Lenalidomide, Bortezomib, and Dexamethasone Combination Therapy as Induction Followed by Bortezomib and Lenalidomide Maintenance in Patients With Newly Diagnosed High Risk Multiple Myeloma

Status Recruiting

Clinical Trial Summary

The phase 2 study evaluated the efficacy and safety of bortezomib in combination with lenalidomide as maintenance therapy in high risk newly diagnosed multiple myeloma patients who receive lenalidomide,bortezomib, and dexamethasone Combination as induction therapy.

Clinical Trial Description

The aim of front-line therapy for multiple myeloma (MM) is to substantially decrease tumor burden, either in preparation for consolidation with high-dose melphalan therapy with autologous stem cell transplantation (ASCT) or as a means in itself to provide long-term disease control. The degree of disease reduction is associated with improved outcome, including prolonged progression-free survival (PFS) and overall survival (OS),both after preparation for or after consolidation with ASCT,and in patients not proceeding to ASCT.The introduction of the proteasome inhibitor bortezomib and the immunomodulatory drugs thalidomide and lenalidomide has been associated with improved survival. Combinations of bortezomib or lenalidomide with conventional anti-MM drugs have demonstrated very high overall response rates and quality of response in the front-line setting, as reviewed recently.The phase 2 study evaluated the efficacy and safety of bortezomib in combination with lenalidomide as maintenance therapy in high risk newly diagnosed multiple myeloma patients who receive lenalidomide, bortezomib, and dexamethasone(VRD) Combination as induction therapy.The investigators gave patients subcutaneous bortezomib on days 1, 8,15, and 22; oral lenalidomide on days 1 to 21; and oral dexamethasone on days 1, 8, 15 and 12 of a 28-day cycle.Patients are allowed to interrupt therapy for collection of stem cells at any time after three cycles of induction, and to proceed to stem-cell transplantation after four cycles of induction at the discretion of the treating physician.Two months after hematologic recovery, nonprogressive patients are to receive consolidation therapy comprising two 4-week cycles of VRD or the second autologous hematopoietic stem cell transplantation (determined by the attending physician according to the patient's physical condition, willingness and the number of CD34 + cells collected).Patients who do not proceed to stem-cell transplantation receive a total of 12 courses of VRD induction therapy(dexamethasone dosage will be reduced to 20mg from the 9th course of treatment). Responding patients could receive maintenance therapy comprising 4-week cycles of bortezomib on days 1 and 15 at the dose level of 1.3mg/m2 and lenalidomide on days 1 to 21 at the dose level of 10mg.Participants discontinued treatment if participants had progressive disease or unacceptable toxic eff ects not controlled with dose modifications. ;

Related Conditions & MeSH terms

• High Risk
• Multiple Myeloma
• Myeloma
• Neoplasms, Plasma Cell
• Newly Diagnosed

• NCT number: NCT03641456
• Study type: Interventional
• Source: Sun Yat-sen University
• Contact: Hua wang, MD.
• Phone: 020-87342462
• Email: wanghua@sysucc.org.cn
• Status: Recruiting
• Phase: Phase 2
• Start date: September 25, 2020
• Completion date: December 30, 2025