TY - JOUR
T1 - Safety and Efficacy of Combination Maintenance Therapy with Ixazomib and Lenalidomide in Patients with Posttransplant Myeloma
AU - Patel, Krina K.
AU - Shah, Jatin J.
AU - Feng, Lei
AU - Lee, Hans C.
AU - Manasanch, Elisabet M.
AU - Olsem, Jasper
AU - Morphey, Ashley
AU - Huo, Xiao Jiao
AU - Thomas, Sheeba K.
AU - Bashir, Qaiser
AU - Qazilbash, Muzaffar H.
AU - Weber, Donna M.
AU - Orlowski, Robert Z.
N1 - Publisher Copyright:
© 2022 The Authors.
PY - 2022/4/1
Y1 - 2022/4/1
N2 - Purpose: In this study, the addition of ixazomib to lenalidomide maintenance post-autologous stem cell transplant (ASCT) in 64 patients with newly diagnosed multiple myeloma was evaluated on the basis of the observed benefit of lenalidomide-only maintenance in prior studies. Patients and Methods: Patients were started on maintenance therapy with lenalidomide and ixazomib within 60–180 days of stem cell infusion. Results: Response rates deepened over time from baseline post-ASCT for 39 patients. The complete response (CR)/stringent CR rate was 43% and median overall survival was not reached with a median follow-up of 62 months (range, 25–82 months). Median PFS (mPFS) for all patients was 73 months and has not been reached for those with International Staging System (ISS) stage 1 disease. mPFS in 9 patients who had ISS stage 3 disease and 14 patients who had high-risk cytogenetics was 34 and 25 months, respectively. Twenty-two patients had progressive disease, while 19 patients continue to receive dual maintenance. The most common grade 3/4 adverse events included neutropenia, leukopenia, thrombocytopenia, lung infections, diarrhea, and maculopapular rash. Second primary malignancies occurred in 9 patients. Toxicity led to dose reductions in ixazomib and lenalidomide in 20 and 31 patients, respectively. Discontinuation of ixazomib due to toxicity occurred in 4 patients. Grade 1/2 neuropathy occurred in 22 patients and led to reduction or discontinuation of ixazomib in 2 patients. Conclusions: The addition of ixazomib to lenalidomide maintenance demonstrated a better than expected PFS compared with historical data using lenalidomide alone and was safe and tolerable.
AB - Purpose: In this study, the addition of ixazomib to lenalidomide maintenance post-autologous stem cell transplant (ASCT) in 64 patients with newly diagnosed multiple myeloma was evaluated on the basis of the observed benefit of lenalidomide-only maintenance in prior studies. Patients and Methods: Patients were started on maintenance therapy with lenalidomide and ixazomib within 60–180 days of stem cell infusion. Results: Response rates deepened over time from baseline post-ASCT for 39 patients. The complete response (CR)/stringent CR rate was 43% and median overall survival was not reached with a median follow-up of 62 months (range, 25–82 months). Median PFS (mPFS) for all patients was 73 months and has not been reached for those with International Staging System (ISS) stage 1 disease. mPFS in 9 patients who had ISS stage 3 disease and 14 patients who had high-risk cytogenetics was 34 and 25 months, respectively. Twenty-two patients had progressive disease, while 19 patients continue to receive dual maintenance. The most common grade 3/4 adverse events included neutropenia, leukopenia, thrombocytopenia, lung infections, diarrhea, and maculopapular rash. Second primary malignancies occurred in 9 patients. Toxicity led to dose reductions in ixazomib and lenalidomide in 20 and 31 patients, respectively. Discontinuation of ixazomib due to toxicity occurred in 4 patients. Grade 1/2 neuropathy occurred in 22 patients and led to reduction or discontinuation of ixazomib in 2 patients. Conclusions: The addition of ixazomib to lenalidomide maintenance demonstrated a better than expected PFS compared with historical data using lenalidomide alone and was safe and tolerable.
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U2 - 10.1158/1078-0432.CCR-21-3420
DO - 10.1158/1078-0432.CCR-21-3420
M3 - Article
C2 - 34992070
AN - SCOPUS:85128148661
SN - 1078-0432
VL - 28
SP - 1277
EP - 1284
JO - Clinical Cancer Research
JF - Clinical Cancer Research
IS - 7
ER -