Maintenance therapy with thalidomide improves survival in patients with multiple myeloma.
Newer chemotherapeutic protocols as well as high-dose chemotherapy have increased the response rate in myeloma. However, these treatments are not curative. Effective maintenance strategies are now required to prolong the duration of response. We conducted a randomized trial of maintenance treatment with thalidomide and pamidronate. Two months after high-dose therapy, 597 patients younger than age 65 years were randomly assigned to receive no maintenance (arm A), pamidronate (arm B), or pamidronate plus thalidomide (arm C). A complete or very good partial response was achieved by 55% of patients in arm A, 57% in arm B, and 67% in arm C (P = .03). The 3-year postrandomization probability of event-free survival was 36% in arm A, 37% in arm B, and 52% in arm C (P < .009). The 4-year postdiagnosis probability of survival was 77% in arm A, 74% in arm B, and 87% in arm C (P < .04). The proportion of patients who had skeletal events was 24% in arm A, 21% in arm B, and 18% in arm C (P = .4). Thalidomide is an effective maintenance therapy in patients with multiple myeloma. Maintenance treatment with pamidronate does not decrease the incidence of bone events.
Attal
Michel
M
Service d'Hématologie, Hôpital Purpan, Place du Dr Baylac, 31059 Toulouse, France. attal.m@chu-toulouse.fr
Harousseau
Jean-Luc
JL
Leyvraz
Serge
S
Doyen
Chantal
C
Hulin
Cyrille
C
Benboubker
Lofti
L
Yakoub Agha
Ibrahim
I
Bourhis
Jean-Henri
JH
Garderet
Laurent
L
Pegourie
Brigitte
B
Dumontet
Charles
C
Renaud
Marc
M
Voillat
Laurent
L
Berthou
Christian
C
Marit
Gerald
G
Monconduit
Mathieu
M
Caillot
Denis
D
Grobois
Bernard
B
Avet-Loiseau
Herve
H
Moreau
Philippe
P
Facon
Thierry
T
D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use; D001847:Bone Diseases / Q000209:etiology; D004164:Diphosphonates / Q000008:administration & dosage* / Q000633:toxicity; D018572:Disease-Free Survival; D005260:Female; D018380:Hematopoietic Stem Cell Transplantation; D006801:Humans; D008297:Male; D008875:Middle Aged; D009101:Multiple Myeloma / Q000150:complications / Q000401:mortality / Q000628:therapy*; D000077268:Pamidronate; D011379:Prognosis; D012008:Recurrence; D012074:Remission Induction / Q000379:methods; D016879:Salvage Therapy; D016019:Survival Analysis; D015996:Survival Rate; D013792:Thalidomide / Q000008:administration & dosage* / Q000633:toxicity
D004164:Diphosphonates; D013792:Thalidomide; D000077268:Pamidronate