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Results of a multicenter, randomized, double-blind, dose-evaluating phase 2/3 study of lenalidomide in the treatment of metastatic malignant melanoma

  1. John Glaspy MD1,†,*,
  2. Michael B. Atkins MD2,
  3. Jon M. Richards MD, PHD3,
  4. Sanjiv S. Agarwala MD4,
  5. Steven O'Day MD5,
  6. Robert D. Knight MD, PHD6,
  7. J. Ulf Jungnelius MD6,
  8. Agop Y. Bedikian MD7

Article first published online: 2 SEP 2009

DOI: 10.1002/cncr.24576

Issue

Cancer

Cancer

Volume 115, Issue 22, pages 5228–5236, 15 November 2009

Additional Information

How to Cite

Glaspy, J., Atkins, M. B., Richards, J. M., Agarwala, S. S., O'Day, S., Knight, R. D., Jungnelius, J. U. and Bedikian, A. Y. (2009), Results of a multicenter, randomized, double-blind, dose-evaluating phase 2/3 study of lenalidomide in the treatment of metastatic malignant melanoma. Cancer, 115: 5228–5236. doi: 10.1002/cncr.24576

Author Information

  1. 1

    Department of Medicine, UCLA Medical Center, Los Angeles, California

  2. 2

    Harvard Medical School, Boston, Massachusetts

  3. 3

    Oncology Specialists, S.C., Park Ridge, Illinois

  4. 4

    St. Luke's Cancer Center, Bethlehem, Pennsylvania

  5. 5

    The Angeles Clinic and Research Institute, Santa Monica, California

  6. 6

    Celgene Corporation, Summit, New Jersey

  7. 7

    Department of Melanoma Oncology, The University of Texas M. D. Anderson Cancer Center, Houston, Texas

  1. †

    Fax: (310) 443-7300

*100 UCLA Medical Plaza, Suite 550, Los Angeles, CA 90095

Publication History

  1. Issue published online: 3 NOV 2009
  2. Article first published online: 2 SEP 2009
  3. Manuscript Revised: 22 JAN 2009
  4. Manuscript Accepted: 22 JAN 2009
  5. Manuscript Received: 3 DEC 2008

Funded by

  • Celgene. Grant Number: MEL-001

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Keywords:

  • metastatic malignant melanoma;
  • lenalidomide;
  • phase 2/3;
  • dose evaluation

Abstract

BACKGROUND:

There are currently no systemic treatments for stage IV melanoma, which have been proven in randomized trials to benefit overall survival (OS). Lenalidomide has efficacy against melanoma in animal models and safety in phase 1 trials. The authors reported the results of a phase 2/3 study comparing the safety and efficacy of 2 doses of lenalidomide in patients with relapsed metastatic melanoma disease refractory to previous treatment with dacarbazine, temozolomide, interleukin-2, or interferon-α.

METHODS:

A total of 294 patients were randomized to oral lenalidomide at 5 mg or 25 mg dose. Tumor response, time to progression, and OS were evaluated. Treatment continued until disease progression or unacceptable adverse events.

RESULTS:

No significant differences in response rate, OS, or time to progression were observed between lenalidomide 25 mg versus 5 mg (overall response rate: 5.5% vs 3.4%, P = .38; median OS: 6.8 months vs 7.2 months, P = .71; and median time to progression: 2.2 months vs 1.9 months, P = .24). Myelosuppression was observed in 37.0% of patients in the 25 mg group and 13.7% of patients in the 5 mg group. Treatment-related serious adverse events were seen in 39.0% of patients at the 25 mg dose and 35.4% of patients at the 5 mg dose.

CONCLUSIONS:

Despite the occurrence of treatment-related serious adverse events, ∼80% of patients continued treatment. The higher dose of lenalidomide did not improve response rate, time to progression, or OS of patients with relapsed/refractory stage IV melanoma. A parallel placebo-controlled study has been conducted to further assess the efficacy of lenalidomide in stage IV melanoma patients. Cancer 2009. © 2009 American Cancer Society.

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