Lenalidomide is safe and active in Waldenström macroglobulinemia.
Lenalidomide is manageable and effective in multiple myeloma, particularly in elderly patients. Surprisingly, the combination of lenalidomide with rituximab produced clinically significant anemia at 25 mg/day for 21/28 days, the highest possible dose, in Waldenström's Macroglobulinemia (WM). We aimed to determine the maximum tolerated dose (MTD) of single agent lenalidomide and determine its impact on WM. RV-WM-0426 is a multicenter dose escalation open label phase 1/2 study of lenalidomide in relapsed/refractory WM (RRWM). Lenalidomide was given orally 21/28 days per cycle for 1 year, at escalated dose of 15 to 20 mg during phase 1 to determine the MTD; the phase 2 part was conducted at the MTD. Seventeen RRWM patients were included. The MTD was established at 15 mg/day 21/28. By ITT analysis, the overall response rate was 29%. With a median follow-up of 36 months, median TTP was 16 months (95% CI 5.5-26), the 5-year OS was 91%. The most frequent adverse events ≥ grade 3 at 15 mg were 14% anemia and 43% neutropenia. The MTD of lenalidomide is 15 mg/day 21/28 days in RRWM. Lenalidomide is active in the treatment of RRWM and the safety profile appears manageable. Future studies may look into combinations of lenalidomide and continuous dosing.
Maladies Du Sang, Hôpital Huriez, CHRU, Lille, France.
Guillemette
G
Fouquet
Maladies Du Sang, Hôpital Huriez, CHRU, Lille, France.
Stéphanie
S
Guidez
Maladies Du Sang, Hôpital Huriez, CHRU, Lille, France.
Marie-Odile
MO
Petillon
Département De Recherche Clinique, CHRU, Lille, France.
Chanaz
C
Louni
Département De Recherche Clinique, CHRU, Lille, France.
Bella
B
Ohyba
Département De Recherche Clinique, CHRU, Lille, France.
Malek
M
Dib
U837 Inserm, IRCL, CHRU, Lille, France.
Stéphanie
S
Poulain
Maladies Du Sang, Hôpital Huriez, CHRU, Lille, France.
Charles
C
Herbaux
Hématologie, Hôpital Côte De Nacre, CHU Caen, France.
Audrey
A
Martin
Central Pharmacy, CHRU, Lille, France.
Béatrice
B
Thielemans
Hématologie, Hôpital Pitié-Salpêtrière, APHP, Paris, France.
Pauline
P
Brice
Institut Universitaire D'hématologie, APHP Saint Louis, Paris, EA3963, France.
Sylvain
S
Choquet
Hématologie, CH, France, Lens.
Jana
J
Bakala
Maladies Du Sang, Hôpital Huriez, CHRU, Lille, France.
Claire
C
Bories
Maladies Du Sang, Hôpital Huriez, CHRU, Lille, France.
Hélène
H
Demarquette
Maladies Du Sang, Hôpital Huriez, CHRU, Lille, France.
Morgane
M
Nudel
Hématologie Clinique Hôpital Estaing, CHU Clermont-Ferrand, France.
Olivier
O
Tournilhac
Hématologie, Hôpital Pitié-Salpêtrière, APHP, Paris, France.
Bertrand
B
Arnulf
Hématologie Clinique, Hôtel-Dieu, CHU, France, Nantes.
Steven
S
LeGouill
Hématologie, CH, France, Lens.
Pierre
P
Morel
Hématologie, CH, France, Bayonne.
Anne
A
Banos
Hématologie, Lyon-Sud, Lyon, CHU, France.
Lionel
L
Karlin
Hématologie, Lyon-Sud, Lyon, CHU, France.
Gilles
G
Salles
Hématologie, Hôpital Pitié-Salpêtrière, APHP, Paris, France.
Véronique
V
Leblond
Maladies Du Sang, Hôpital Huriez, CHRU, Lille, France.|U837 Inserm, IRCL, CHRU, Lille, France.
Xavier
X
Leleu
D000284:Administration, Oral; D000368:Aged; D000369:Aged, 80 and over; D000740:Anemia / Q000139:chemically induced / Q000473:pathology; D000970:Antineoplastic Agents / Q000008:administration & dosage* / Q000009:adverse effects; D004334:Drug Administration Schedule; D054796:Drug Dosage Calculations; D005260:Female; D006801:Humans; D007155:Immunologic Factors / Q000008:administration & dosage* / Q000009:adverse effects; D000077269:Lenalidomide; D008297:Male; D020714:Maximum Tolerated Dose; D008875:Middle Aged; D009503:Neutropenia / Q000139:chemically induced / Q000473:pathology; D012008:Recurrence; D016019:Survival Analysis; D013792:Thalidomide / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives*; D016896:Treatment Outcome; D008258:Waldenstrom Macroglobulinemia / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology
D000970:Antineoplastic Agents; D007155:Immunologic Factors; D013792:Thalidomide; D000077269:Lenalidomide