Clinical Trials Logo

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. ;


Study Design


Related Conditions & MeSH terms


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

See also
  Status Clinical Trial Phase
Recruiting NCT03832127 - Evaluation of PET 18F-Fludarabine for the Initial Assessment and End-treatment of Symptomatic Multiple Myeloma Patients Phase 1
Completed NCT01413178 - A Randomized Trial to Compare Busulfan + Melphalan 140 mg/m2 With Melphalan 200 mg/m2 as Preparative Regimen for Autologous Hematopoietic Stem Cell Transplantation for Multiple Myeloma Phase 3
Terminated NCT02907073 - Positron Emission Tomography (PET) Imaging Studies With NIS Reporter Phase 1/Phase 2
Completed NCT03135925 - Feasibility of Pre Transplant Exercise (Pre-habilitation) for Multiple Myeloma Patients Awaiting Autologous Stem Cell Transplantation N/A
Withdrawn NCT02114502 - Carfilzomib/SAHA Combined With High-Dose Gemcitabine/Busulfan/Melphalan With Autologous Stem Cell Transplant in Myeloma Phase 2
Completed NCT01700608 - Prospective Observational Study on Plerixafor After Chemotherapy N/A
Completed NCT00800839 - Busulfan and Fludarabine Followed by Post-transplant Cyclophosphamide Phase 2
Completed NCT00794261 - Stem Cell Mobilization With Pegfilgrastim in Lymphoma and Myeloma Phase 2
Completed NCT00606437 - Total Body Irradiation With Fludarabine Followed by Combined Umbilical Cord Blood (UCB) Transplants Phase 1
Recruiting NCT05528887 - Study of CAR-T Cell Therapy in the Treatment of Relapsed/Refractory Hematological Malignancies Phase 1
Recruiting NCT05625971 - Non-invasive MRD Assessment in Multiple Myeloma
Active, not recruiting NCT02931942 - Changing Over Time of Ascorbic Acid After Chemotherapy
Active, not recruiting NCT05889221 - Multicenter Phase 2 Study of Subcutaneous Isatuximab Plus Bortezomib, Lenalidomide and Dexamethasone in the Treatment of Newly Diagnosed Transplant Ineligible Multiple Myeloma N/A
Recruiting NCT03836690 - Transfer of Effector Memory T Cells (Tem) Following Allogeneic Stem Cell Transplantation Phase 1
Active, not recruiting NCT02542657 - Ixazomib With Pomalidomide, Clarithromycin and Dexamethasone in Treating Patients With Multiple Myeloma Phase 1/Phase 2
Completed NCT01279694 - Trial of Carfilzomib Plus Melphalan and Prednisone in Elderly Untreated Patients With Multiple Myeloma (CARMYSAP) Phase 1/Phase 2
Completed NCT01191060 - Study Comparing Conventional Dose Combination RVD to High-Dose Treatment With ASCT in the Initial Myeloma up to 65 Years Phase 3
Terminated NCT00983346 - Effect of Low Dose Bortezomib on Bone Formation in Smoldering Myeloma Patients Phase 2
Completed NCT00476294 - Long-Term Follow Up Study for AMD3100 Patients N/A
Completed NCT00344422 - Vincristine, DOXIL (Doxorubicin HCl Liposome Injection) and Dexamethasone vs. Vincristine, Doxorubicin, and Dexamethasone in Patients With Newly Diagnosed Multiple Myeloma Phase 3