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2012 119: 4860-4867 Prepublished online April 13, 2012; doi:10.1182/blood-2012-01-407791

Lenalidomide, cyclophosphamide, and dexamethasone (CRd) for light-chain amyloidosis: long-term results from a phase 2 trial
Shaji K. Kumar, Suzanne R. Hayman, Francis K. Buadi, Vivek Roy, Martha Q. Lacy, Morie A.Gertz, Jacob Allred, Kristina M. Laumann, Leif P. Bergsagel, David Dingli, Joseph R. Mikhael, Craig B. Reeder, A. Keith Stewart, Steven R. Zeldenrust, Philip R. Greipp, John A. Lust, Rafael Fonseca, Stephen J. Russell, S. Vincent Rajkumar and Angela Dispenzieri

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From bloodjournal.hematologylibrary.org by guest on June 13, 2012. For personal use only.
CLINICAL TRIALS AND OBSERVATIONS

Lenalidomide, cyclophosphamide, and dexamethasone (CRd) for light-chain amyloidosis: long-term results from a phase 2 trial
Shaji K. Kumar,1 Suzanne R. Hayman,1 Francis K. Buadi,1 VivekRoy,1 Martha Q. Lacy,1 Morie A. Gertz,1 Jacob Allred,1 Kristina M. Laumann,1 Leif P. Bergsagel,1 David Dingli,1 Joseph R. Mikhael,1 Craig B. Reeder,1 A. Keith Stewart,1 Steven R. Zeldenrust,1 Philip R. Greipp,1 John A. Lust,1 Rafael Fonseca,1 Stephen J. Russell,1 S. Vincent Rajkumar,1 and Angela Dispenzieri1
1Division

of Hematology and Internal Medicine, Mayo Clinic, Rochester, MN

Light-chain(AL) amyloidosis remains incurable despite recent therapeutic advances. Given the activity of the lenalidomidealkylating agent combination in myeloma, we designed this phase 2 trial of lenalidomide, cyclophosphamide, and dexamethasone in AL amyloidosis. Thirty-five patients, including 24 previously untreated, were enrolled. Nearly one-half of the patients had cardiac stage III disease and 28% had >3 organs involved. The overall hematologic response (> partial response [PR]) rate was 60%, including 40% with very-good partial response or better. Us-

ing serum-free light chain for assessing response, 77% of patients had a hematologic response. Organ responses were seen in 29% of patients and were limited to those with a hematologic response. The median hematologic progressionfree survivalwas 28.3 months, and the median overall survival was 37.8 months. Hematologic toxicity was the predominant adverse event, followed by fatigue, edema, and gastrointestinal symptoms. A grade 3 or higher toxicity occurred in 26 patients (74%) including > grade 3 hematologic toxicity in 16 patients (46%)

and > grade 3 nonhematologic toxicity in 25 patients (71%). Seven patients (20%) died on study,primarily because of advanced disease. Lenalidomide, cyclophosphamide, and dexamethasone (CRd) is an effective combination for treatment of AL amyloidosis and leads to durable hematologic responses as well as organ responses with manageable toxicity. The trial was registered at www.clinicaltrials. gov (NCT00564889). (Blood. 2012;119(21): 4860-4867)

Introduction
Light-chain (AL) amyloidosis,...