Melphalan, prednisone, and lenalidomide treatment for newly diagnosed myeloma: A report from the GIMEMA - Italian Multiple Myeloma Network

Antonio Palumbo, Patrizia Falco, Paolo Corradini, Antonietta Falcone, Francesco Di Raimondo, Nicola Giuliani, Claudia Crippa, Giovannino Ciccone, Paola Omedè, Maria Teresa Ambrosini, Francesca Gay, Sara Bringhen, Pellegrino Musto, Robin Foà, Robert Knight, Jerome B. Zeldis, Mario Boccadoro, Maria Teresa Petrucci

Research output: Contribution to journalArticle

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Abstract

Purpose: Lenalidomide has shown significant antimyeloma activity in clinical studies. Oral melphalan, prednisone, and thalidomide have been regarded as the standard of care in elderly multiple myeloma patients. We assessed dosing, efficacy, and safety of melphalan, prednisone, and lenalidomide (MPR) in newly diagnosed elderly myeloma patients. Patients and Methods: Oral melphalan was administered in doses ranging from 0.18 to 0.25 mg/kg on days 1 to 4, prednisone at a 2-mg/kg dose on days 1 to 4, and lenalidomide at doses ranging from 5 to 10 mg on days 1 to 21, every 28 days for nine cycles, followed by maintenance therapy with lenalidomide alone. Aspirin was given as a prophylaxis for thrombosis. Results: Fifty-four patients were enrolled and evaluated after completing the assigned treatment schedule. The maximum tolerated dose was defined as 0.18 mg/kg melphalan and 10 mg lenalidomide. With these doses, 81% of patients achieved at least a partial response, 47.6% achieved a very good partial response, and 23.8% achieved a complete immunofixation-negative response. In all patients, 1-year event-free and overall survival rates were 92% and 100%, respectively. At the maximum tolerated dose, grade 3 adverse events included neutropenia (38.1%), thrombocytopenia (14.2%), febrile neutropenia (9.5%), vasculitis (9.5%), and thromboembolism (4.8%); grade 4 adverse events were neutropenia (14.2%) and thrombocytopenia (9.5%). Conclusion: Oral MPR therapy is a promising first-line treatment for elderly myeloma patients. Hematologic adverse events were frequent but manageable. A low incidence of nonhematologic adverse events was noted. Aspirin appears to provide adequate antithrombosis prophylaxis.

Original languageEnglish
Pages (from-to)4459-4465
Number of pages7
JournalJournal of Clinical Oncology
Volume25
Issue number28
DOIs
Publication statusPublished - Oct 1 2007

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Melphalan
Prednisone
Multiple Myeloma
Maximum Tolerated Dose
Neutropenia
Thrombocytopenia
Therapeutics
Aspirin
Febrile Neutropenia
Thalidomide
Thromboembolism
Standard of Care
Vasculitis
lenalidomide
Disease-Free Survival
Appointments and Schedules
Thrombosis
Survival Rate
Safety
Incidence

ASJC Scopus subject areas

  • Cancer Research
  • Oncology
  • Medicine(all)

Cite this

Melphalan, prednisone, and lenalidomide treatment for newly diagnosed myeloma : A report from the GIMEMA - Italian Multiple Myeloma Network. / Palumbo, Antonio; Falco, Patrizia; Corradini, Paolo; Falcone, Antonietta; Di Raimondo, Francesco; Giuliani, Nicola; Crippa, Claudia; Ciccone, Giovannino; Omedè, Paola; Ambrosini, Maria Teresa; Gay, Francesca; Bringhen, Sara; Musto, Pellegrino; Foà, Robin; Knight, Robert; Zeldis, Jerome B.; Boccadoro, Mario; Petrucci, Maria Teresa.

In: Journal of Clinical Oncology, Vol. 25, No. 28, 01.10.2007, p. 4459-4465.

Research output: Contribution to journalArticle

Palumbo, A, Falco, P, Corradini, P, Falcone, A, Di Raimondo, F, Giuliani, N, Crippa, C, Ciccone, G, Omedè, P, Ambrosini, MT, Gay, F, Bringhen, S, Musto, P, Foà, R, Knight, R, Zeldis, JB, Boccadoro, M & Petrucci, MT 2007, 'Melphalan, prednisone, and lenalidomide treatment for newly diagnosed myeloma: A report from the GIMEMA - Italian Multiple Myeloma Network', Journal of Clinical Oncology, vol. 25, no. 28, pp. 4459-4465. https://doi.org/10.1200/JCO.2007.12.3463
Palumbo, Antonio ; Falco, Patrizia ; Corradini, Paolo ; Falcone, Antonietta ; Di Raimondo, Francesco ; Giuliani, Nicola ; Crippa, Claudia ; Ciccone, Giovannino ; Omedè, Paola ; Ambrosini, Maria Teresa ; Gay, Francesca ; Bringhen, Sara ; Musto, Pellegrino ; Foà, Robin ; Knight, Robert ; Zeldis, Jerome B. ; Boccadoro, Mario ; Petrucci, Maria Teresa. / Melphalan, prednisone, and lenalidomide treatment for newly diagnosed myeloma : A report from the GIMEMA - Italian Multiple Myeloma Network. In: Journal of Clinical Oncology. 2007 ; Vol. 25, No. 28. pp. 4459-4465.
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abstract = "Purpose: Lenalidomide has shown significant antimyeloma activity in clinical studies. Oral melphalan, prednisone, and thalidomide have been regarded as the standard of care in elderly multiple myeloma patients. We assessed dosing, efficacy, and safety of melphalan, prednisone, and lenalidomide (MPR) in newly diagnosed elderly myeloma patients. Patients and Methods: Oral melphalan was administered in doses ranging from 0.18 to 0.25 mg/kg on days 1 to 4, prednisone at a 2-mg/kg dose on days 1 to 4, and lenalidomide at doses ranging from 5 to 10 mg on days 1 to 21, every 28 days for nine cycles, followed by maintenance therapy with lenalidomide alone. Aspirin was given as a prophylaxis for thrombosis. Results: Fifty-four patients were enrolled and evaluated after completing the assigned treatment schedule. The maximum tolerated dose was defined as 0.18 mg/kg melphalan and 10 mg lenalidomide. With these doses, 81{\%} of patients achieved at least a partial response, 47.6{\%} achieved a very good partial response, and 23.8{\%} achieved a complete immunofixation-negative response. In all patients, 1-year event-free and overall survival rates were 92{\%} and 100{\%}, respectively. At the maximum tolerated dose, grade 3 adverse events included neutropenia (38.1{\%}), thrombocytopenia (14.2{\%}), febrile neutropenia (9.5{\%}), vasculitis (9.5{\%}), and thromboembolism (4.8{\%}); grade 4 adverse events were neutropenia (14.2{\%}) and thrombocytopenia (9.5{\%}). Conclusion: Oral MPR therapy is a promising first-line treatment for elderly myeloma patients. Hematologic adverse events were frequent but manageable. A low incidence of nonhematologic adverse events was noted. Aspirin appears to provide adequate antithrombosis prophylaxis.",
author = "Antonio Palumbo and Patrizia Falco and Paolo Corradini and Antonietta Falcone and {Di Raimondo}, Francesco and Nicola Giuliani and Claudia Crippa and Giovannino Ciccone and Paola Omed{\`e} and Ambrosini, {Maria Teresa} and Francesca Gay and Sara Bringhen and Pellegrino Musto and Robin Fo{\`a} and Robert Knight and Zeldis, {Jerome B.} and Mario Boccadoro and Petrucci, {Maria Teresa}",
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T1 - Melphalan, prednisone, and lenalidomide treatment for newly diagnosed myeloma

T2 - A report from the GIMEMA - Italian Multiple Myeloma Network

AU - Palumbo, Antonio

AU - Falco, Patrizia

AU - Corradini, Paolo

AU - Falcone, Antonietta

AU - Di Raimondo, Francesco

AU - Giuliani, Nicola

AU - Crippa, Claudia

AU - Ciccone, Giovannino

AU - Omedè, Paola

AU - Ambrosini, Maria Teresa

AU - Gay, Francesca

AU - Bringhen, Sara

AU - Musto, Pellegrino

AU - Foà, Robin

AU - Knight, Robert

AU - Zeldis, Jerome B.

AU - Boccadoro, Mario

AU - Petrucci, Maria Teresa

PY - 2007/10/1

Y1 - 2007/10/1

N2 - Purpose: Lenalidomide has shown significant antimyeloma activity in clinical studies. Oral melphalan, prednisone, and thalidomide have been regarded as the standard of care in elderly multiple myeloma patients. We assessed dosing, efficacy, and safety of melphalan, prednisone, and lenalidomide (MPR) in newly diagnosed elderly myeloma patients. Patients and Methods: Oral melphalan was administered in doses ranging from 0.18 to 0.25 mg/kg on days 1 to 4, prednisone at a 2-mg/kg dose on days 1 to 4, and lenalidomide at doses ranging from 5 to 10 mg on days 1 to 21, every 28 days for nine cycles, followed by maintenance therapy with lenalidomide alone. Aspirin was given as a prophylaxis for thrombosis. Results: Fifty-four patients were enrolled and evaluated after completing the assigned treatment schedule. The maximum tolerated dose was defined as 0.18 mg/kg melphalan and 10 mg lenalidomide. With these doses, 81% of patients achieved at least a partial response, 47.6% achieved a very good partial response, and 23.8% achieved a complete immunofixation-negative response. In all patients, 1-year event-free and overall survival rates were 92% and 100%, respectively. At the maximum tolerated dose, grade 3 adverse events included neutropenia (38.1%), thrombocytopenia (14.2%), febrile neutropenia (9.5%), vasculitis (9.5%), and thromboembolism (4.8%); grade 4 adverse events were neutropenia (14.2%) and thrombocytopenia (9.5%). Conclusion: Oral MPR therapy is a promising first-line treatment for elderly myeloma patients. Hematologic adverse events were frequent but manageable. A low incidence of nonhematologic adverse events was noted. Aspirin appears to provide adequate antithrombosis prophylaxis.

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