Bendamustine, Low-dose dexamethasone, and lenalidomide (BdL) for the treatment of patients with relapsed/refractory multiple myeloma confirms very promising results in a phase I/II study

S. Pozzi, M. Gentile, S. Sacchi, R. Marcheselli, A. Corso, F. Cocito, P. Musto, A. Guarini, C. Minoia, I. Vincelli, R. Ria, E. Rivolti, G. Mele, A. Bari, C. Mazzone, S. Badiali, L. Marcheselli, A. Palumbo, F. Morabito

Research output: Contribution to journalArticle

Abstract

Lenalidomide and dexamethasone are an effective treatment for naive and relapsed multiple myeloma (MM) patients. Bendamustine is a good option for B-cell malignancies showing only partial cross resistance with alkylating agents used in MM patients. Based on these considerations, we proposed a phase I/II study testing escalating doses of bendamustine and lenalidomide and fixed low doses of dexamethasone (BdL). Fifteen patients were enrolled in phase I study. Maximum tolerated dose was established at dose "level 0": bendamustine 40 mg/m(2) days 1,2; lenalidomide 10 mg days 1-21; d 40 mg days 1,8,15,22 every 28-day cycle, for six cycles. We enrolled 23 patients in the phase II study. BdL combination showed mainly hematological toxicities, fever and infections. Overall response rate was 47%. After median follow up of 22 months, median PFS was 10 months. Two-years OS rate was 65%. BdL combination confirmed to be a promising treatment for patients with relapsed/refractory MM.
Original languageEnglish
Pages (from-to)552-559
Number of pages8
JournalLeukemia and Lymphoma
Volume58
Issue number3
DOIs
Publication statusPublished - Mar 1 2017

Fingerprint

Multiple Myeloma
Dexamethasone
Therapeutics
Maximum Tolerated Dose
Alkylating Agents
B-Lymphocytes
Fever
lenalidomide
Bendamustine Hydrochloride
Infection
Neoplasms

Keywords

  • Adult
  • Aged
  • Aged, 80 and over
  • Antineoplastic Combined Chemotherapy Protocols/adverse effects/therapeutic use
  • Bendamustine Hydrochloride/administration & dosage
  • Biomarkers
  • Dexamethasone/administration & dosage
  • Disease Progression
  • Drug Resistance, Neoplasm
  • Female
  • Humans
  • Male
  • Maximum Tolerated Dose
  • Middle Aged
  • Multiple Myeloma/drug therapy/mortality/pathology
  • Neoplasm Staging
  • Recurrence
  • Retreatment
  • Survival Analysis
  • Thalidomide/administration & dosage/analogs & derivatives
  • Treatment Outcome
  • Multiple myeloma
  • bendamustine
  • clinical trial
  • lenalidomide

Cite this

Bendamustine, Low-dose dexamethasone, and lenalidomide (BdL) for the treatment of patients with relapsed/refractory multiple myeloma confirms very promising results in a phase I/II study. / Pozzi, S.; Gentile, M.; Sacchi, S.; Marcheselli, R.; Corso, A.; Cocito, F.; Musto, P.; Guarini, A.; Minoia, C.; Vincelli, I.; Ria, R.; Rivolti, E.; Mele, G.; Bari, A.; Mazzone, C.; Badiali, S.; Marcheselli, L.; Palumbo, A.; Morabito, F.

In: Leukemia and Lymphoma, Vol. 58, No. 3, 01.03.2017, p. 552-559.

Research output: Contribution to journalArticle

Pozzi, S. ; Gentile, M. ; Sacchi, S. ; Marcheselli, R. ; Corso, A. ; Cocito, F. ; Musto, P. ; Guarini, A. ; Minoia, C. ; Vincelli, I. ; Ria, R. ; Rivolti, E. ; Mele, G. ; Bari, A. ; Mazzone, C. ; Badiali, S. ; Marcheselli, L. ; Palumbo, A. ; Morabito, F. / Bendamustine, Low-dose dexamethasone, and lenalidomide (BdL) for the treatment of patients with relapsed/refractory multiple myeloma confirms very promising results in a phase I/II study. In: Leukemia and Lymphoma. 2017 ; Vol. 58, No. 3. pp. 552-559.
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T1 - Bendamustine, Low-dose dexamethasone, and lenalidomide (BdL) for the treatment of patients with relapsed/refractory multiple myeloma confirms very promising results in a phase I/II study

AU - Pozzi, S.

AU - Gentile, M.

AU - Sacchi, S.

AU - Marcheselli, R.

AU - Corso, A.

AU - Cocito, F.

AU - Musto, P.

AU - Guarini, A.

AU - Minoia, C.

AU - Vincelli, I.

AU - Ria, R.

AU - Rivolti, E.

AU - Mele, G.

AU - Bari, A.

AU - Mazzone, C.

AU - Badiali, S.

AU - Marcheselli, L.

AU - Palumbo, A.

AU - Morabito, F.

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N2 - Lenalidomide and dexamethasone are an effective treatment for naive and relapsed multiple myeloma (MM) patients. Bendamustine is a good option for B-cell malignancies showing only partial cross resistance with alkylating agents used in MM patients. Based on these considerations, we proposed a phase I/II study testing escalating doses of bendamustine and lenalidomide and fixed low doses of dexamethasone (BdL). Fifteen patients were enrolled in phase I study. Maximum tolerated dose was established at dose "level 0": bendamustine 40 mg/m(2) days 1,2; lenalidomide 10 mg days 1-21; d 40 mg days 1,8,15,22 every 28-day cycle, for six cycles. We enrolled 23 patients in the phase II study. BdL combination showed mainly hematological toxicities, fever and infections. Overall response rate was 47%. After median follow up of 22 months, median PFS was 10 months. Two-years OS rate was 65%. BdL combination confirmed to be a promising treatment for patients with relapsed/refractory MM.

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KW - Male

KW - Maximum Tolerated Dose

KW - Middle Aged

KW - Multiple Myeloma/drug therapy/mortality/pathology

KW - Neoplasm Staging

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KW - Retreatment

KW - Survival Analysis

KW - Thalidomide/administration & dosage/analogs & derivatives

KW - Treatment Outcome

KW - Multiple myeloma

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KW - clinical trial

KW - lenalidomide

U2 - 10.1080/10428194.2016.1205741 [doi]

DO - 10.1080/10428194.2016.1205741 [doi]

M3 - Article

VL - 58

SP - 552

EP - 559

JO - Leukemia and Lymphoma

JF - Leukemia and Lymphoma

SN - 1042-8194

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ER -