Abstract
Lenalidomide and dexamethasone are an effective treatment for naïve and relapsed multiple myeloma (MM) patients. Bendamustine is a good option for B-cell malignancies showing only partial cross resistance with alkylating agents used in MM patients. Based on these considerations, we proposed a phase I/II study testing escalating doses of bendamustine and lenalidomide and fixed low doses of dexamethasone (BdL). Fifteen patients were enrolled in phase I study. Maximum tolerated dose was established at dose “level 0”: bendamustine 40 mg/m2 days 1,2; lenalidomide 10 mg days 1–21; d 40 mg days 1,8,15,22 every 28-day cycle, for six cycles. We enrolled 23 patients in the phase II study. BdL combination showed mainly hematological toxicities, fever and infections. Overall response rate was 47%. After median follow up of 22 months, median PFS was 10 months. Two-years OS rate was 65%. BdL combination confirmed to be a promising treatment for patients with relapsed/refractory MM.
| Original language | English |
|---|---|
| Pages (from-to) | 552-559 |
| Number of pages | 8 |
| Journal | Leukemia and Lymphoma |
| Volume | 58 |
| Issue number | 3 |
| DOIs | |
| Publication status | Accepted/In press - Jul 12 2016 |
Fingerprint
Keywords
- bendamustine
- clinical trial
- lenalidomide
- Multiple myeloma
ASJC Scopus subject areas
- Hematology
- Oncology
- Cancer Research
Cite this
Bendamustine, Low-dose dexamethasone, and lenalidomide (BdL) for the treatment of patients with relapsed/refractory multiple myeloma confirms very promising results in a phase I/II study. / Pozzi, Sacchi Samantha; Gentile, Massimo; Sacchi, Stefano; Marcheselli, Raffaella; Corso, Alessandro; Cocito, Federica; Musto, Pellegrino; Guarini, Attilio; Minoia, Carla; Vincelli, Iolanda; Ria, R.; Rivolti, Elena; Mele, G.; Bari, Alessia; Mazzone, C.; Badiali, Stefania; Marcheselli, Luigi; Palumbo, A.; Morabito, Fortunato.
In: Leukemia and Lymphoma, Vol. 58, No. 3, 12.07.2016, p. 552-559.Research output: Contribution to journal › Article
}
TY - JOUR
T1 - Bendamustine, Low-dose dexamethasone, and lenalidomide (BdL) for the treatment of patients with relapsed/refractory multiple myeloma confirms very promising results in a phase I/II study
AU - Pozzi, Sacchi Samantha
AU - Gentile, Massimo
AU - Sacchi, Stefano
AU - Marcheselli, Raffaella
AU - Corso, Alessandro
AU - Cocito, Federica
AU - Musto, Pellegrino
AU - Guarini, Attilio
AU - Minoia, Carla
AU - Vincelli, Iolanda
AU - Ria, R.
AU - Rivolti, Elena
AU - Mele, G.
AU - Bari, Alessia
AU - Mazzone, C.
AU - Badiali, Stefania
AU - Marcheselli, Luigi
AU - Palumbo, A.
AU - Morabito, Fortunato
PY - 2016/7/12
Y1 - 2016/7/12
N2 - Lenalidomide and dexamethasone are an effective treatment for naïve and relapsed multiple myeloma (MM) patients. Bendamustine is a good option for B-cell malignancies showing only partial cross resistance with alkylating agents used in MM patients. Based on these considerations, we proposed a phase I/II study testing escalating doses of bendamustine and lenalidomide and fixed low doses of dexamethasone (BdL). Fifteen patients were enrolled in phase I study. Maximum tolerated dose was established at dose “level 0”: bendamustine 40 mg/m2 days 1,2; lenalidomide 10 mg days 1–21; d 40 mg days 1,8,15,22 every 28-day cycle, for six cycles. We enrolled 23 patients in the phase II study. BdL combination showed mainly hematological toxicities, fever and infections. Overall response rate was 47%. After median follow up of 22 months, median PFS was 10 months. Two-years OS rate was 65%. BdL combination confirmed to be a promising treatment for patients with relapsed/refractory MM.
AB - Lenalidomide and dexamethasone are an effective treatment for naïve and relapsed multiple myeloma (MM) patients. Bendamustine is a good option for B-cell malignancies showing only partial cross resistance with alkylating agents used in MM patients. Based on these considerations, we proposed a phase I/II study testing escalating doses of bendamustine and lenalidomide and fixed low doses of dexamethasone (BdL). Fifteen patients were enrolled in phase I study. Maximum tolerated dose was established at dose “level 0”: bendamustine 40 mg/m2 days 1,2; lenalidomide 10 mg days 1–21; d 40 mg days 1,8,15,22 every 28-day cycle, for six cycles. We enrolled 23 patients in the phase II study. BdL combination showed mainly hematological toxicities, fever and infections. Overall response rate was 47%. After median follow up of 22 months, median PFS was 10 months. Two-years OS rate was 65%. BdL combination confirmed to be a promising treatment for patients with relapsed/refractory MM.
KW - bendamustine
KW - clinical trial
KW - lenalidomide
KW - Multiple myeloma
UR - http://www.scopus.com/inward/record.url?scp=84978952295&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=84978952295&partnerID=8YFLogxK
U2 - 10.1080/10428194.2016.1205741
DO - 10.1080/10428194.2016.1205741
M3 - Article
VL - 58
SP - 552
EP - 559
JO - Leukemia and Lymphoma
JF - Leukemia and Lymphoma
SN - 1042-8194
IS - 3
ER -