Ixazomib, lenalidomide, and dexamethasone in patients with newly diagnosed multiple myeloma: long-term follow-up including ixazomib maintenance

Shaji K Kumar, Jesus G. Berdeja, Ruben Niesvizky, Sagar Lonial, Jacob P. Laubach, Mehdi Hamadani, Alexander Keith Stewart, Parameswaran Hari, Vivek Roy, Robert Vescio, Jonathan L. Kaufman, Deborah Berg, Eileen Liao, S Vincent Rajkumar, Paul G. Richardson

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Abstract

Triplet combinations containing a proteasome inhibitor are a standard of care in newly diagnosed multiple myeloma (NDMM). We examined the long-term efficacy and safety of the all-oral combination of weekly ixazomib plus lenalidomide-dexamethasone (IRd), followed by single-agent ixazomib maintenance in NDMM patients. Of 65 enrolled patients, 53 received ixazomib 4 mg (days 1, 8, and 15) plus lenalidomide 25 mg (days 1–21) and dexamethasone 40 mg (days 1, 8, 15, and 22) for up to twelve 28-day induction cycles. Twenty-three patients discontinued induction for stem cell transplantation (SCT). In the remaining 42 patients, overall response rate was 80%, including 63% ≥very good partial response (VGPR) and 32% complete responses. At a median follow-up of 56 months, median progression-free survival (PFS) was 35.4 months in the total population. Twenty-five patients received ixazomib maintenance; eight deepened their response (76% ≥VGPR), and median PFS was 37.2 months in this subgroup. Nine of 42 patients who did not proceed to SCT (14% of total population) had an adverse event requiring discontinuation. Ixazomib (median ≥ 96%) and lenalidomide (median 88–94%) relative dose intensities were maintained throughout treatment. Weekly IRd, followed by ixazomib maintenance, was highly active with acceptable toxicity, enabling long-term administration with no evidence of cumulative toxicities.

Original languageEnglish (US)
JournalLeukemia
DOIs
StatePublished - Jan 1 2019

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Multiple Myeloma
Dexamethasone
Maintenance
Stem Cell Transplantation
Disease-Free Survival
Proteasome Inhibitors
Standard of Care
Population
ixazomib
lenalidomide
Safety

ASJC Scopus subject areas

  • Hematology
  • Oncology
  • Cancer Research

Cite this

Ixazomib, lenalidomide, and dexamethasone in patients with newly diagnosed multiple myeloma : long-term follow-up including ixazomib maintenance. / Kumar, Shaji K; Berdeja, Jesus G.; Niesvizky, Ruben; Lonial, Sagar; Laubach, Jacob P.; Hamadani, Mehdi; Stewart, Alexander Keith; Hari, Parameswaran; Roy, Vivek; Vescio, Robert; Kaufman, Jonathan L.; Berg, Deborah; Liao, Eileen; Rajkumar, S Vincent; Richardson, Paul G.

In: Leukemia, 01.01.2019.

Research output: Contribution to journalArticle

Kumar, Shaji K ; Berdeja, Jesus G. ; Niesvizky, Ruben ; Lonial, Sagar ; Laubach, Jacob P. ; Hamadani, Mehdi ; Stewart, Alexander Keith ; Hari, Parameswaran ; Roy, Vivek ; Vescio, Robert ; Kaufman, Jonathan L. ; Berg, Deborah ; Liao, Eileen ; Rajkumar, S Vincent ; Richardson, Paul G. / Ixazomib, lenalidomide, and dexamethasone in patients with newly diagnosed multiple myeloma : long-term follow-up including ixazomib maintenance. In: Leukemia. 2019.
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abstract = "Triplet combinations containing a proteasome inhibitor are a standard of care in newly diagnosed multiple myeloma (NDMM). We examined the long-term efficacy and safety of the all-oral combination of weekly ixazomib plus lenalidomide-dexamethasone (IRd), followed by single-agent ixazomib maintenance in NDMM patients. Of 65 enrolled patients, 53 received ixazomib 4 mg (days 1, 8, and 15) plus lenalidomide 25 mg (days 1–21) and dexamethasone 40 mg (days 1, 8, 15, and 22) for up to twelve 28-day induction cycles. Twenty-three patients discontinued induction for stem cell transplantation (SCT). In the remaining 42 patients, overall response rate was 80{\%}, including 63{\%} ≥very good partial response (VGPR) and 32{\%} complete responses. At a median follow-up of 56 months, median progression-free survival (PFS) was 35.4 months in the total population. Twenty-five patients received ixazomib maintenance; eight deepened their response (76{\%} ≥VGPR), and median PFS was 37.2 months in this subgroup. Nine of 42 patients who did not proceed to SCT (14{\%} of total population) had an adverse event requiring discontinuation. Ixazomib (median ≥ 96{\%}) and lenalidomide (median 88–94{\%}) relative dose intensities were maintained throughout treatment. Weekly IRd, followed by ixazomib maintenance, was highly active with acceptable toxicity, enabling long-term administration with no evidence of cumulative toxicities.",
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AU - Niesvizky, Ruben

AU - Lonial, Sagar

AU - Laubach, Jacob P.

AU - Hamadani, Mehdi

AU - Stewart, Alexander Keith

AU - Hari, Parameswaran

AU - Roy, Vivek

AU - Vescio, Robert

AU - Kaufman, Jonathan L.

AU - Berg, Deborah

AU - Liao, Eileen

AU - Rajkumar, S Vincent

AU - Richardson, Paul G.

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AB - Triplet combinations containing a proteasome inhibitor are a standard of care in newly diagnosed multiple myeloma (NDMM). We examined the long-term efficacy and safety of the all-oral combination of weekly ixazomib plus lenalidomide-dexamethasone (IRd), followed by single-agent ixazomib maintenance in NDMM patients. Of 65 enrolled patients, 53 received ixazomib 4 mg (days 1, 8, and 15) plus lenalidomide 25 mg (days 1–21) and dexamethasone 40 mg (days 1, 8, 15, and 22) for up to twelve 28-day induction cycles. Twenty-three patients discontinued induction for stem cell transplantation (SCT). In the remaining 42 patients, overall response rate was 80%, including 63% ≥very good partial response (VGPR) and 32% complete responses. At a median follow-up of 56 months, median progression-free survival (PFS) was 35.4 months in the total population. Twenty-five patients received ixazomib maintenance; eight deepened their response (76% ≥VGPR), and median PFS was 37.2 months in this subgroup. Nine of 42 patients who did not proceed to SCT (14% of total population) had an adverse event requiring discontinuation. Ixazomib (median ≥ 96%) and lenalidomide (median 88–94%) relative dose intensities were maintained throughout treatment. Weekly IRd, followed by ixazomib maintenance, was highly active with acceptable toxicity, enabling long-term administration with no evidence of cumulative toxicities.

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