Combination of bendamustine, lenalidomide, anddexamethasone (BLD) in patients with relapsed or refractory multiple myeloma is feasible and highly effective

Results of phase 1/2 open-label, doseescalation study

Suzanne Lentzsch, Amy O'Sullivan, Ryan C. Kennedy, Mohammad Abbas, Lijun Dai, Silvana Lalo Pregja, Steve Burt, Michael Boyiadzis, G. David Roodman, Markus Y. Mapara, Mounzer Agha, John Waas, Yongli Shuai, Daniel Normolle, Jeffrey A. Zonder

Research output: Contribution to journalArticle

87 Citations (Scopus)

Abstract

This multicenter phase 1/2 trial investigated the combination of bendamustine, lenalidomide, and dexamethasone in repeating 4-week cycles as treatment for relapsed refractory multiple myeloma (MM). Phase 1 established maximum tolerated dose (MTD). Phase 2 assessed overall response rate at the MTD. Secondary endpoints included progression-free survival (PFS) and overall survival (OS). A total of 29 evaluable patients were enrolled. Median age was 63 years (range, 38-80 years). Median number of prior therapies was 3 (range, 1-6). MTD was bendamustine 75 mg/m 2 (days 1 and 2), lenalidomide 10 mg (days 1-21), and dexamethasone 40 mg (weekly) of a 28-day cycle. Partial response rate was 52%, with very good partial response achieved in 24%, and minimal response in an additional 24% of patients. Median follow-up was 13 months; median OS has not been reached. One-year OS is 93% (95% confidence interval [CI], 59%-99%). Median PFS is 6.1 months (95% CI, 3.7-9.4 months) with one-year PFS of 20% (95% CI, 6%-41%). Grade 3/4 adverse events included neutropenia, thrombocytopenia, anemia, hyperglycemia, and fatigue. This first phase 1/2 trial testing bendamustine, lenalidomide, and dexamethasone as treatment of relapsed refractory MM was feasible and highly active. This study is registered atwww.clinicaltrials.gov as #NCT01042704.

Original languageEnglish (US)
Pages (from-to)4608-4613
Number of pages6
JournalBlood
Volume119
Issue number20
DOIs
StatePublished - May 17 2012
Externally publishedYes

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Maximum Tolerated Dose
Multiple Myeloma
Refractory materials
Dexamethasone
Disease-Free Survival
Labels
Confidence Intervals
Survival
Neutropenia
Hyperglycemia
Thrombocytopenia
Fatigue
Anemia
Therapeutics
Fatigue of materials
Testing
Bendamustine Hydrochloride
lenalidomide

ASJC Scopus subject areas

  • Hematology
  • Biochemistry
  • Cell Biology
  • Immunology

Cite this

Combination of bendamustine, lenalidomide, anddexamethasone (BLD) in patients with relapsed or refractory multiple myeloma is feasible and highly effective : Results of phase 1/2 open-label, doseescalation study. / Lentzsch, Suzanne; O'Sullivan, Amy; Kennedy, Ryan C.; Abbas, Mohammad; Dai, Lijun; Pregja, Silvana Lalo; Burt, Steve; Boyiadzis, Michael; Roodman, G. David; Mapara, Markus Y.; Agha, Mounzer; Waas, John; Shuai, Yongli; Normolle, Daniel; Zonder, Jeffrey A.

In: Blood, Vol. 119, No. 20, 17.05.2012, p. 4608-4613.

Research output: Contribution to journalArticle

Lentzsch, S, O'Sullivan, A, Kennedy, RC, Abbas, M, Dai, L, Pregja, SL, Burt, S, Boyiadzis, M, Roodman, GD, Mapara, MY, Agha, M, Waas, J, Shuai, Y, Normolle, D & Zonder, JA 2012, 'Combination of bendamustine, lenalidomide, anddexamethasone (BLD) in patients with relapsed or refractory multiple myeloma is feasible and highly effective: Results of phase 1/2 open-label, doseescalation study', Blood, vol. 119, no. 20, pp. 4608-4613. https://doi.org/10.1182/blood-2011-12-395715
Lentzsch, Suzanne ; O'Sullivan, Amy ; Kennedy, Ryan C. ; Abbas, Mohammad ; Dai, Lijun ; Pregja, Silvana Lalo ; Burt, Steve ; Boyiadzis, Michael ; Roodman, G. David ; Mapara, Markus Y. ; Agha, Mounzer ; Waas, John ; Shuai, Yongli ; Normolle, Daniel ; Zonder, Jeffrey A. / Combination of bendamustine, lenalidomide, anddexamethasone (BLD) in patients with relapsed or refractory multiple myeloma is feasible and highly effective : Results of phase 1/2 open-label, doseescalation study. In: Blood. 2012 ; Vol. 119, No. 20. pp. 4608-4613.
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abstract = "This multicenter phase 1/2 trial investigated the combination of bendamustine, lenalidomide, and dexamethasone in repeating 4-week cycles as treatment for relapsed refractory multiple myeloma (MM). Phase 1 established maximum tolerated dose (MTD). Phase 2 assessed overall response rate at the MTD. Secondary endpoints included progression-free survival (PFS) and overall survival (OS). A total of 29 evaluable patients were enrolled. Median age was 63 years (range, 38-80 years). Median number of prior therapies was 3 (range, 1-6). MTD was bendamustine 75 mg/m 2 (days 1 and 2), lenalidomide 10 mg (days 1-21), and dexamethasone 40 mg (weekly) of a 28-day cycle. Partial response rate was 52{\%}, with very good partial response achieved in 24{\%}, and minimal response in an additional 24{\%} of patients. Median follow-up was 13 months; median OS has not been reached. One-year OS is 93{\%} (95{\%} confidence interval [CI], 59{\%}-99{\%}). Median PFS is 6.1 months (95{\%} CI, 3.7-9.4 months) with one-year PFS of 20{\%} (95{\%} CI, 6{\%}-41{\%}). Grade 3/4 adverse events included neutropenia, thrombocytopenia, anemia, hyperglycemia, and fatigue. This first phase 1/2 trial testing bendamustine, lenalidomide, and dexamethasone as treatment of relapsed refractory MM was feasible and highly active. This study is registered atwww.clinicaltrials.gov as #NCT01042704.",
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AU - Lentzsch, Suzanne

AU - O'Sullivan, Amy

AU - Kennedy, Ryan C.

AU - Abbas, Mohammad

AU - Dai, Lijun

AU - Pregja, Silvana Lalo

AU - Burt, Steve

AU - Boyiadzis, Michael

AU - Roodman, G. David

AU - Mapara, Markus Y.

AU - Agha, Mounzer

AU - Waas, John

AU - Shuai, Yongli

AU - Normolle, Daniel

AU - Zonder, Jeffrey A.

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N2 - This multicenter phase 1/2 trial investigated the combination of bendamustine, lenalidomide, and dexamethasone in repeating 4-week cycles as treatment for relapsed refractory multiple myeloma (MM). Phase 1 established maximum tolerated dose (MTD). Phase 2 assessed overall response rate at the MTD. Secondary endpoints included progression-free survival (PFS) and overall survival (OS). A total of 29 evaluable patients were enrolled. Median age was 63 years (range, 38-80 years). Median number of prior therapies was 3 (range, 1-6). MTD was bendamustine 75 mg/m 2 (days 1 and 2), lenalidomide 10 mg (days 1-21), and dexamethasone 40 mg (weekly) of a 28-day cycle. Partial response rate was 52%, with very good partial response achieved in 24%, and minimal response in an additional 24% of patients. Median follow-up was 13 months; median OS has not been reached. One-year OS is 93% (95% confidence interval [CI], 59%-99%). Median PFS is 6.1 months (95% CI, 3.7-9.4 months) with one-year PFS of 20% (95% CI, 6%-41%). Grade 3/4 adverse events included neutropenia, thrombocytopenia, anemia, hyperglycemia, and fatigue. This first phase 1/2 trial testing bendamustine, lenalidomide, and dexamethasone as treatment of relapsed refractory MM was feasible and highly active. This study is registered atwww.clinicaltrials.gov as #NCT01042704.

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