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For patients with high-risk multiple myeloma (MM), the role of allogeneic hematopoietic stem cell transplantation (alloHCT) and subsequent maintenance therapy has not been fully established
.
A phase II study (NCT02440464) evaluated the efficacy of alloHCT and subsequent maintenance therapy with ixazomib in high-risk MM patients receiving a combination of low-dose fludarabine, malphalan, and bortezomib
.
The results of the study were announced at the recent 2021 American Society of Clinical Oncology (ASCO) annual meeting
.
The editor organizes the main content as follows for the reference of readers
.
Research methods The study included patients ≤70 years of age who had relapsed within 24 months after receiving autologous hematopoietic stem cell transplantation or were at high risk under the definition of cytogenetics and plasma cell leukemia (PCL)
.
The patients in the study received HLA-matched allogeneic peripheral blood stem cell transplantation after fludarabine, malphalan, and bortezomib combination regimen, and also received tacrolimus and methotrexate to prevent graft-versus-host disease (GVHD)
.
60-120 days after transplantation, patients will be randomly assigned to receive ixazomib (orally 3 mg ixazomib on days 1, 8, and 15 of the 28-day cycle) or placebo at a 1:1 ratio
.
Research results The study included 57 patients from 15 centers from 2015 to 2018, of which 52 (91.
2%) patients received alloHCT, and 43 (82.
7%) patients were randomized (21 patients in the ixazomib group, comfort 22 cases in the agent group)
.
Due to the toxicity of the combination of fludarabine, malphalan, and bortezomib, 17 patients were postponed after randomization.
These patients were re-enrolled after the bortezomib dose was adjusted
.
Due to the delayed enrollment of these patients and other delays in the study, the study was terminated early
.
The median age of the patients in the study was 56 years (range: 35-65 years), 33 (57.
9%) patients were high-risk MM, and 9 (15.
8%) patients were primary PCL
.
The 24-month progression-free survival (PFS) rate and overall survival (OS) rate of all patients who received alloHCT were 52% and 85%, respectively, and the transplant-related death (TRM) rate was 11%
.
21 months after randomization, PFS (55.
3% vs 59.
1%) and OS (95% vs 87%; P=0.
17) in the ixazomib group and the placebo group were similar
.
The cumulative incidence of grade III-IV acute GVHD at 100 days after transplantation (9.
5% vs 0%) and the cumulative incidence of chronic GVHD at 12 months after transplantation (69% vs 64%) were also similar in the two groups
.
The best response rate and disease progression rate of patients in the ixazomib group and the placebo group were similar.
The cumulative incidence of TRM at 21 months after transplantation in the two groups was 0% and 4.
5% (90%CI: 0.
5).
%-16.
5%)
.
Research conclusions: low-dose fludarabine, malphalan, bortezomib combined regimen sequential alloHCT is a safe treatment regimen, which can bring lasting disease stability to high-risk MM patients
.
Due to the early termination of the study, the efficacy of maintenance therapy with ixazomib after alloHCT cannot be evaluated, but there are no related factors that affect the outcome of the treatment in the study
.
Reference source: 1.
Taiga Nishihori, et al.
The results of multicenter phase II, double-blind placebo-controlled trial of maintenance ixazomib after allogeneic hematopoietic cell transplantation(alloHCT) for high-risk multiple myeloma (MM) from the Blood and Marrow Transplant Clinical Trials Network (BMT CTN 1302).
2021 ASCO Annual Meeting.
Abstract 7003.
Stamp "read the original text" and we will make progress together
.
A phase II study (NCT02440464) evaluated the efficacy of alloHCT and subsequent maintenance therapy with ixazomib in high-risk MM patients receiving a combination of low-dose fludarabine, malphalan, and bortezomib
.
The results of the study were announced at the recent 2021 American Society of Clinical Oncology (ASCO) annual meeting
.
The editor organizes the main content as follows for the reference of readers
.
Research methods The study included patients ≤70 years of age who had relapsed within 24 months after receiving autologous hematopoietic stem cell transplantation or were at high risk under the definition of cytogenetics and plasma cell leukemia (PCL)
.
The patients in the study received HLA-matched allogeneic peripheral blood stem cell transplantation after fludarabine, malphalan, and bortezomib combination regimen, and also received tacrolimus and methotrexate to prevent graft-versus-host disease (GVHD)
.
60-120 days after transplantation, patients will be randomly assigned to receive ixazomib (orally 3 mg ixazomib on days 1, 8, and 15 of the 28-day cycle) or placebo at a 1:1 ratio
.
Research results The study included 57 patients from 15 centers from 2015 to 2018, of which 52 (91.
2%) patients received alloHCT, and 43 (82.
7%) patients were randomized (21 patients in the ixazomib group, comfort 22 cases in the agent group)
.
Due to the toxicity of the combination of fludarabine, malphalan, and bortezomib, 17 patients were postponed after randomization.
These patients were re-enrolled after the bortezomib dose was adjusted
.
Due to the delayed enrollment of these patients and other delays in the study, the study was terminated early
.
The median age of the patients in the study was 56 years (range: 35-65 years), 33 (57.
9%) patients were high-risk MM, and 9 (15.
8%) patients were primary PCL
.
The 24-month progression-free survival (PFS) rate and overall survival (OS) rate of all patients who received alloHCT were 52% and 85%, respectively, and the transplant-related death (TRM) rate was 11%
.
21 months after randomization, PFS (55.
3% vs 59.
1%) and OS (95% vs 87%; P=0.
17) in the ixazomib group and the placebo group were similar
.
The cumulative incidence of grade III-IV acute GVHD at 100 days after transplantation (9.
5% vs 0%) and the cumulative incidence of chronic GVHD at 12 months after transplantation (69% vs 64%) were also similar in the two groups
.
The best response rate and disease progression rate of patients in the ixazomib group and the placebo group were similar.
The cumulative incidence of TRM at 21 months after transplantation in the two groups was 0% and 4.
5% (90%CI: 0.
5).
%-16.
5%)
.
Research conclusions: low-dose fludarabine, malphalan, bortezomib combined regimen sequential alloHCT is a safe treatment regimen, which can bring lasting disease stability to high-risk MM patients
.
Due to the early termination of the study, the efficacy of maintenance therapy with ixazomib after alloHCT cannot be evaluated, but there are no related factors that affect the outcome of the treatment in the study
.
Reference source: 1.
Taiga Nishihori, et al.
The results of multicenter phase II, double-blind placebo-controlled trial of maintenance ixazomib after allogeneic hematopoietic cell transplantation(alloHCT) for high-risk multiple myeloma (MM) from the Blood and Marrow Transplant Clinical Trials Network (BMT CTN 1302).
2021 ASCO Annual Meeting.
Abstract 7003.
Stamp "read the original text" and we will make progress together
