Treatment of bendamustine and prednisone in patients with newly diagnosed multiple myeloma results in superior complete response rate, prolonged time to treatment failure and improved quality of life compared to treatment with melphalan and prednisone--a randomized phase III study of the East German Study Group of Hematology and Oncology (OSHO).
OBJECTIVE
This randomized phase III study compared bendamustine and prednisone (BP) to standard melphalan and prednisone (MP) treatment in previously untreated patients with multiple Myeloma (MM).


METHODS
To be included, patients had to have histologically and cytologically proven stage II with progressive diseases or stage III MM. They were randomly assigned to receive BP (n=68) or MP (n=63). The primary endpoint was the time to treatment failure (TTF). Secondary endpoints included survival, remission rate, toxicity and quality of life.


RESULTS
The overall response rate was 75% in the BP and 70% in the MP group. A significantly higher number of patients treated with BP achieved a complete remission than did patients receiving MP (32 vs. 13%; P=0.007), and the maximum response was achieved more rapidly in patients treated with BP compared to those receiving MP (6.8 vs. 8.7 cycles; P<0.02). TTF and remission duration were significantly longer in the BP group. Patients receiving BP had higher QoL scores and reported pain less frequently than patients receiving MP.


CONCLUSIONS
BP is superior to MP with respect to complete remission rate, TTF, cycles needed to achieve maximum remission and quality of life and should be considered the new standard in first-line treatment of MM patients not eligible for transplantation.
Pönisch
W
W
Department of Hematology and Oncology, University of Leipzig, Johannisallee 32A, 04103, Leipzig, and Hospital Riesa, Germany.
Mitrou
P S
PS
Merkle
K
K
Herold
M
M
Assmann
M
M
Wilhelm
G
G
Dachselt
K
K
Richter
P
P
Schirmer
V
V
Schulze
A
A
Subert
R
R
Harksel
B
B
Grobe
N
N
Stelzer
E
E
Schulze
M
M
Bittrich
A
A
Freund
M
M
Pasold
R
R
Friedrich
Th
T
Helbig
W
W
Niederwieser
D
D
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D000069461:Bendamustine Hydrochloride; D018572:Disease-Free Survival; D005260:Female; D005859:Germany, East; D006801:Humans; D008297:Male; D008558:Melphalan / Q000008:administration & dosage* / Q000009:adverse effects; D008875:Middle Aged; D009101:Multiple Myeloma / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology; D009588:Nitrogen Mustard Compounds / Q000008:administration & dosage* / Q000009:adverse effects; D011241:Prednisone / Q000008:administration & dosage* / Q000009:adverse effects; D011788:Quality of Life; D012074:Remission Induction; D016019:Survival Analysis; D013997:Time Factors; D017211:Treatment Failure
D009588:Nitrogen Mustard Compounds; D000069461:Bendamustine Hydrochloride; D008558:Melphalan; D011241:Prednisone