Lenalidomide, cyclophosphamide and dexamethasone (CRd) for newly diagnosed multiple myeloma: Results from a phase 2 trial

Shaji K Kumar, Martha Lacy, Suzanne R. Hayman, Alexander Keith Stewart, Francis K. Buadi, Jacob Allred, Kristina Laumann, Philip R. Greipp, John A. Lust, Morie Gertz, Steven R. Zeldenrust, Peter Leif Bergsagel, Craig B. Reeder, Thomas Elmer Witzig, Rafael Fonseca, Stephen J Russell, Joseph R Mikhael, David M Dingli, S Vincent Rajkumar, Angela Dispenzieri

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Abstract

The combination of lenalidomide and low-dose dexamethasone is an effective treatment for multiple myeloma (MM). Addition of alkylating agents to lenalidomide or thalidomide results in increased response rates and deeper responses. We designed this trial to study the combination of cyclophosphamide, lenalidomide, and dexamethasone (CRd) as initial therapy for MM. Fifty-three patients with previously untreated symptomatic MM was enrolled. Patients received 4-week treatment cycles consisting of lenalidomide (25 mg daily for 3 weeks), dexamethasone (40 mg weekly), and cyclophosphamide (300 mg/m2 weekly for 3 weeks). A partial response or better was seen in 85% of patients including 47% with a very good partial response or better. The toxicities were manageable with over 80% of planned doses delivered; six patients went off study for toxicity. The median progression free survival (PFS) for the entire group was 28 months (95% CI: 22.7-32.6) and the overall survival (OS) at 2 years was 87% (95% CI: 78-96). Importantly, 14 patients with high-risk MM had similar PFS and OS as the standard-risk patients (n = 39). CRd is an effective and well-tolerated regimen for upfront therapy of MM with high response rates and excellent 2-year OS, and is suitable for long-term therapy.

Original languageEnglish (US)
Pages (from-to)640-645
Number of pages6
JournalAmerican Journal of Hematology
Volume86
Issue number8
DOIs
StatePublished - Aug 2011

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Multiple Myeloma
Cyclophosphamide
Dexamethasone
Disease-Free Survival
Survival
Therapeutics
Thalidomide
Alkylating Agents
lenalidomide

ASJC Scopus subject areas

  • Hematology

Cite this

Lenalidomide, cyclophosphamide and dexamethasone (CRd) for newly diagnosed multiple myeloma : Results from a phase 2 trial. / Kumar, Shaji K; Lacy, Martha; Hayman, Suzanne R.; Stewart, Alexander Keith; Buadi, Francis K.; Allred, Jacob; Laumann, Kristina; Greipp, Philip R.; Lust, John A.; Gertz, Morie; Zeldenrust, Steven R.; Bergsagel, Peter Leif; Reeder, Craig B.; Witzig, Thomas Elmer; Fonseca, Rafael; Russell, Stephen J; Mikhael, Joseph R; Dingli, David M; Rajkumar, S Vincent; Dispenzieri, Angela.

In: American Journal of Hematology, Vol. 86, No. 8, 08.2011, p. 640-645.

Research output: Contribution to journalArticle

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abstract = "The combination of lenalidomide and low-dose dexamethasone is an effective treatment for multiple myeloma (MM). Addition of alkylating agents to lenalidomide or thalidomide results in increased response rates and deeper responses. We designed this trial to study the combination of cyclophosphamide, lenalidomide, and dexamethasone (CRd) as initial therapy for MM. Fifty-three patients with previously untreated symptomatic MM was enrolled. Patients received 4-week treatment cycles consisting of lenalidomide (25 mg daily for 3 weeks), dexamethasone (40 mg weekly), and cyclophosphamide (300 mg/m2 weekly for 3 weeks). A partial response or better was seen in 85{\%} of patients including 47{\%} with a very good partial response or better. The toxicities were manageable with over 80{\%} of planned doses delivered; six patients went off study for toxicity. The median progression free survival (PFS) for the entire group was 28 months (95{\%} CI: 22.7-32.6) and the overall survival (OS) at 2 years was 87{\%} (95{\%} CI: 78-96). Importantly, 14 patients with high-risk MM had similar PFS and OS as the standard-risk patients (n = 39). CRd is an effective and well-tolerated regimen for upfront therapy of MM with high response rates and excellent 2-year OS, and is suitable for long-term therapy.",
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