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Myeloma

A phase 2 study of pegylated liposomal doxorubicin, bortezomib, dexamethasone and lenalidomide for patients with relapsed/refractory multiple myeloma

Leukemia volume 26, pages 1675–1680 (2012)Cite this article

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Abstract

Our previous studies have shown that lowering the dose of pegylated liposomal doxorubicin (PLD) and bortezomib in combination with intravenous dexamethasone on a longer 4-week cycle maintained efficacy and improved tolerability in both previously untreated and relapsed/refractory (R/R) multiple myeloma (MM) patients. Lenalidomide has shown efficacy in combination with bortezomib and dexamethasone but this combination has been poorly tolerated. We conducted this phase 2 study (clinicaltrials.gov identifier: NCT01160484) to evaluate whether a longer 4-week schedule using modified doses and schedules of IV dexamethasone (40 mg), bortezomib (1.0 mg/m2) and PLD (4.0 mg/m2) administered on days 1, 4, 8, and 11 with lenalidomide 10 mg daily on days 1–14 (DVD-R) would be effective and tolerated for patients with R/R MM. A total of 40 heavily pretreated patients were enrolled and 84.6% showed clinical benefit (complete response, 20.5%; very good partial response, 10.3%; partial response, 17.9%; minimal response, 35.9%) to the combination regimen. An additional 10.3% showed stable disease and 5.1% progressed while on study. The regimen was well tolerated, with a low incidence of adverse events such as fatigue (40%), thrombocytopenia (35%), neutropenia (35%), anemia (30%), peripheral neuropathy (25%) and pneumonia (15%). Thus, the DVD-R regimen is well tolerated and produces high response rates for patients with R/R MM.

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Acknowledgements

This work was supported by funding provided by the Celgene Corporation.

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Authors and Affiliations

  1. Oncotherapeutics, West Hollywood, CA, USA

    J R Berenson, O Yellin, T Kazamel & J D Hilger

  2. James R Berenson, MD, Inc., West Hollywood, CA, USA

    J R Berenson, Y Nassir & R A Swift

  3. Institute for Myeloma and Bone Cancer Research, West Hollywood, CA, USA

    J R Berenson

  4. Loma Linda University Cancer Center, Loma Linda, CA, USA

    C-S Chen

  5. Comprehensive Blood and Cancer Center, Bakersfield, CA, USA

    A Cartmell

  6. Cancer Center of Santa Barbara, Santa Barbara, CA, USA

    T Woliver

  7. Hematology-Oncology Medical Group of Fresno, Fresno, CA, USA

    M Flam

  8. Bassett Cancer Institute, Cooperstown, NY, USA

    E Bravin

  9. Cancer Care Institute, Los Angeles, CA, USA

    Y Nassir

  10. Cedars-Sinai Medical Center, Los Angeles, CA, USA

    R Vescio

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Correspondence to J R Berenson.

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Competing interests

JRB is on the speakers’ bureau, and receives research grants and is a consultant for Celgene, Takeda and Janssen. RAS is on the speakers’ bureau for Takeda. All the other authors declare no conflict of interest.

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Berenson, J., Yellin, O., Kazamel, T. et al. A phase 2 study of pegylated liposomal doxorubicin, bortezomib, dexamethasone and lenalidomide for patients with relapsed/refractory multiple myeloma. Leukemia 26, 1675–1680 (2012). https://doi.org/10.1038/leu.2012.51

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