gms | German Medical Science

Objectives: This study was performed to investigate the efficacy and tolerability of VEL under routine conditions in patients (pts.) with MM, who have received at least 1 previous line of therapy and are refractory to or have relapsed after their last therapy.

Methods: Pts. will be treated with VEL or VEL-based combinations for up to 24 weeks. Diagnostic and therapeutic instructions are not provided in the protocol. At baseline, demographical and medical history data are collected, including type and number of prior therapies and concomitant diseases. Adverse events (AEs) will be continuously documented. The baseline data of the pts. as well as initial safety evaluations are presented here.

Results: To date, n=43 pts. (26 female, 17 male) were included in 11 German OBHs. Median age is 68 years (yrs.): 10 pts. ≤ 60 and 14 pts. > 70 yrs. old. A median of 44,6 months (m) (range: 1,6-206,7 m) passed between initial diagnosis and current treatment indication. Pts. received a median of 2 prior treatments. In the age class > 70 yrs., 13/14 pts. were treated with the MP combination therapy, while in the age class ≤ 60 yrs. 3/10 pts. received MP. VAD-like regimens were used in 5/10 pts. ≤ 60 yrs. vs. 2/14 pts. > 70 yrs. of age. Cyclophosphamide-monotherapy or a bendamustin/prednisone combination was given to 3/10 and 2/10 of the younger pts. (≤ 60), respectively, while none of the older pts. underwent these treatments. Most frequent concomitant diseases were hypertension in 27.9% of the pts., renal failure in 20.9% and coronary heart disease in 11.6% of the pts., as well as heart failure in 9.3% of the pts. Overall, 9.3% of the pts. exhibited a peripheral neuropathy at baseline (7.0% grade 1 without pain; 2.3% without indication of the degree of severity).

At time of analysis, a total of 234 AEs were documented (9.4% classified grade 3; 3.4% grade 4). The investigators assessed 119 AEs (50.8%) as related to VEL and most frequently documented: thrombocytopenia (14.3%), leukocytopenia and diarrhea (each 5.9%) as well as anemia, vomiting and nausea (each 4.2 %).

A total of 21/234 AEs (9%) were classified as serious, with 8 (38%) of them related to the VEL therapy according to the investigator´s opinion. Up to now, 2 pts. (4,6%) died in the course of the study (deaths not related to VEL).

Conclusion: The VEL therapy is safe in an unselected, pretreated group of MM pts. Thus the use of VEL is also suitable for office-based hematologists.