Abstract
To improve the outcome of allogeneic stem cell transplantation (allo-SCT) in multiple myeloma as part of first-line treatment, we prospectively investigated the feasibility and efficacy of lenalidomide maintenance. Patients started maintenance 1 to 6 months after nonmyeloablative allo-SCT. Lenalidomide was dosed 10 mg on days 1 to 21 of a 28-day schedule for a total of 24 cycles. Peripheral blood samples were taken to evaluate immune modulating effects. Thirty-five eligible patients were enrolled, and 30 started with lenalidomide. After 2 cycles, 14 patients (47%) had to stop treatment, mainly because of the development of acute graft versus host disease (GVHD). In total, 13 patients (43%) stopped treatment because of development of GVHD, 5 patients (17%) because of other adverse events, and 5 patients (17%) because of progression. Responses improved in 37% of patients, and the estimated 1-year progression-free survival from start of maintenance was 69% (90% confidence interval, 53%-81%). Lenalidomide increased the frequency of human leukocyte antigen-DR(+) T cells and regulatory T cells, without correlation with clinical parameters. In conclusion, lenalidomide maintenance 10 mg daily after nonmyeloablative allo-SCT with unmanipulated graft in multiple myeloma patients is not feasible, mainly because of the induction of acute GVHD. This trial was registered at www.trialregister.nl as #NTR1645.
Publication types
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Clinical Trial, Phase II
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Multicenter Study
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Research Support, Non-U.S. Gov't
MeSH terms
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Acute Disease
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Adult
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Aged
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Antineoplastic Agents / administration & dosage
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Antineoplastic Agents / adverse effects*
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Antineoplastic Agents / therapeutic use
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Combined Modality Therapy
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Cyclophosphamide / administration & dosage
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Cyclophosphamide / therapeutic use
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Cyclosporine / administration & dosage
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Cyclosporine / therapeutic use
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Disease-Free Survival
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Drug Eruptions / etiology
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Feasibility Studies
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Female
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Graft vs Host Disease / epidemiology
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Graft vs Host Disease / etiology*
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Hematologic Diseases / chemically induced
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Hematopoietic Stem Cell Mobilization
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Hematopoietic Stem Cell Transplantation / methods*
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Humans
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Immunologic Factors / administration & dosage
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Immunologic Factors / adverse effects*
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Immunologic Factors / therapeutic use
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Immunosuppressive Agents / administration & dosage
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Immunosuppressive Agents / therapeutic use
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Lenalidomide
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Lymphocyte Count
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Male
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Melphalan / administration & dosage
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Melphalan / therapeutic use
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Middle Aged
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Multiple Myeloma / drug therapy*
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Multiple Myeloma / surgery
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Mycophenolic Acid / administration & dosage
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Mycophenolic Acid / analogs & derivatives
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Mycophenolic Acid / therapeutic use
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Prospective Studies
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Remission Induction
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Thalidomide / administration & dosage
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Thalidomide / adverse effects
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Thalidomide / analogs & derivatives*
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Thalidomide / therapeutic use
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Transplantation Conditioning / methods
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Transplantation, Autologous
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Transplantation, Homologous
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Whole-Body Irradiation
Substances
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Antineoplastic Agents
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Immunologic Factors
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Immunosuppressive Agents
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Thalidomide
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Cyclosporine
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Cyclophosphamide
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Lenalidomide
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Mycophenolic Acid
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Melphalan