Melphalan, prednisone, and lenalidomide for newly diagnosed myeloma: kinetics of neutropenia and thrombocytopenia and time-to-event results.
BACKGROUND
Initial analysis of the combination melphalan, prednisone, plus lenalidomide (MPR) showed significant antimyeloma activity in patients with untreated multiple myeloma, with neutropenia and thrombocytopenia as the most frequent side effects. This updated analysis reassessed the kinetics of neutropenia and thrombocytopenia as well as the safety and efficacy of MPR.


METHODS
A total of 21 patients with newly diagnosed myeloma received melphalan 0.18 mg/kg on days 1-4, prednisone 2 mg/kg on days 1-4, and lenalidomide 10 mg daily on days 1-21 for nine 28-day cycles, followed by maintenance therapy with lenalidomide 10 mg daily on days 1-21.


RESULTS
Grade 3/4 neutropenia occurred in 52% of the patients, and granulocyte colonystimulating factor was administered in 43%. The mean neutrophil counts at the start of each MPR cycle, during nadir, and after 6 months of maintenance were 2.69 x 109/L, 1.43 x 109/L, and 2.11 x 109/L, respectively. Grade 3/4 thrombocytopenia occurred in 24% of the patients. Platelet transfusions were required by 1 patient (5%) with a platelet count of 16 x 109/L; however, no thrombocytopenia-associated bleeding was reported. The mean platelet counts at the start of each cycle, during nadir, and after 6 months of maintenance were 174 x 109/L, 121 x 109/L, and 158 x 109/L, respectively. Median follow-up was 29.6 months, median progression-free survival was 28.5 months, and 2-year overall survival was 91%.


CONCLUSIONS
MPR is a promising regimen with manageable hematologic toxicity.
Palumbo
Antonio
A
Divisione di Ematologia dell'Università di Torino, Azienda Ospedaliera S. Giovanni Battista, Torino, Italy. appalumbo@yahoo.com
Falco
Patrizia
P
Falcone
Antonietta
A
Benevolo
Giulia
G
Canepa
Letizia
L
Gay
Francesca
F
Larocca
Alessandra
A
Magarotto
Valeria
V
Gozzetti
Alessandro
A
Luraschi
Annalisa
A
Morabito
Fortunato
F
Nozza
Andrea
A
Knight
Robert D
RD
Zeldis
Jerome B
JB
Boccadoro
Mario
M
Petrucci
Maria Teresa
MT
D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects* / Q000493:pharmacokinetics / Q000627:therapeutic use; D018572:Disease-Free Survival; D004305:Dose-Response Relationship, Drug; D016179:Granulocyte Colony-Stimulating Factor / Q000627:therapeutic use; D006801:Humans; D000077269:Lenalidomide; D008558:Melphalan / Q000008:administration & dosage / Q000009:adverse effects / Q000493:pharmacokinetics; D008875:Middle Aged; D009101:Multiple Myeloma / Q000097:blood / Q000188:drug therapy*; D009503:Neutropenia / Q000097:blood / Q000139:chemically induced* / Q000188:drug therapy; D011241:Prednisone / Q000008:administration & dosage / Q000009:adverse effects / Q000493:pharmacokinetics; D013792:Thalidomide / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives / Q000493:pharmacokinetics; D013921:Thrombocytopenia / Q000097:blood / Q000139:chemically induced* / Q000188:drug therapy
D016179:Granulocyte Colony-Stimulating Factor; D013792:Thalidomide; D000077269:Lenalidomide; D008558:Melphalan; D011241:Prednisone