A135 Bortezomib International Observational Study in Multiple Myeloma: Baseline Characteristics

Clinical Studies Including Transplantation analysis, we included patients with follow-up period of q 12 weeks or death. Results: 489 patients (56% male, median age, 64 years) were enrolled as of August 29, 2008. In the year before bortezomib therapy, PN was seen in 127 (26%) patients. At baseline, just before initiation of bortezomib therapy, 110 (22%) patients had PN due to previous MM treatment. Most PN cases at baseline were grade 1. Sixty-seven percent of patients started bortezomib in combination with other therapies such as dexamethasone, thalidomide, lenalidomide, and/or prednisone. Of 253 patients with no PN at baseline and q 12-week follow-up, newonset PN was largely grade 1 (21%) or grade 2 (16%). Grade 3 and 4 PN developed in 24 (9%) and 4 (2%) patients, respectively. Of the 82 patients with PN at baseline and q 12-week follow-up, 42 (51%) had PN improvement or resolution at any time during bortezomib therapy, 15(18%) had PN worsening, and 25 (30%) patients had no change in PN. Conclusion: In this international observational study PN was observed in 1 of 4 patients prior to bortezomib therapy. Consistent with clinical trial data, most cases with new-onset PN during bortezomib therapy were mild or moderate in severity. Despite the presence of baseline PN, more than half of these patients had improvement or stabilization of PN during bortezomib therapy.

A135 Bortezomib International Observational Study in Multiple Myeloma: Baseline Characteristics K Zervas,1 R Dhawan,1 M Delforge,2 H Samblanx,3 D Sargin,4 C Hulin,5 M Linderholm, J De la Rubia,6 K Abdulkadyrov,7 R Ganguly,8 J Diels9

Len/Dex ± Bortezomib for Advanced Myeloma According to Prior Neuropathy: The Impact of Cytogenetics

Theageneion Anticancer Hospital of Thessaloniki, Greece;

2

University Hospital Leuven, Belgium;

3

ZNA Middelheim, Antwerp, Belgium;

4

Istanbul University Istanbul Medical Faculty, Turkey;

5

Centre Hospitalier Universitaire of Nancy-Brabois, France;

MA Dimopoulos, E Kastritis, D Christoulas, M Migkou, M Gavriatopoulou, F Zagouri, M Roussou, E Terpos

5

Dept. of Haematology, Linköping University Hospital, Sweden;

Department of Clinical Therapeutics, University of Athens School of

6

La Fe Hospital in Valencia, Spain;

Medicine

7

Russian Scientific Research Institute of Hematology and

8

Johnson & Johnson Pharmaceutical Services, Raritan NJ;

9

Johnson & Johnson Pharmaceutical Services, Beerse, Belgium

Introduction: Bortezomib is indicated for the treatment of multiple myeloma (MM). The Electronic VELCADE Observational Study (eVOBS) is a non-interventional study evaluating clinical outcomes of bortezomib therapy in actual clinical practice. Enrollment in Belgium, France, Greece, Russia, Spain, Sweden, and Turkey is scheduled for October 2006 to December 2008. This report includes baseline patient characteristics of relapsed/ refractory (R/R) MM patients to date. Materials and Methods: Adults scheduled to initiate bortezomib for R/R MM were eligible for study. Sociodemographics, chronic comorbidities, and patient characteristics were recorded at baseline. Treatment history was documented retrospectively for 1 year before initiation of bortezomib. After enrollment, all bortezomib dosages and concomitant treatments were permitted. Data on efficacy, safety, and concomitant therapy were collected prospectively for 3 years. Disease staging used Durie Salmon (DS) or International Staging

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A136

1

Transfusiology, Saint-Petersburg, Russia;

S22

System (ISS) criteria. Results: 489 patients (56% male) were enrolled as of August 29, 2008. Median age was 64 years (range, 33-95 years), with a median of 2 years (range, 0-21 years) since first MM treatment. MM was stage III (ISS or DS) in 47% of patients. Most patients (77%) had q 1 comorbidity at baseline: 22% had 2 and 28% had q 3 comorbidities. 50%, 28%, and 10% of patients were initiated on bortezomib for 2nd, 3rd, and q 4th-line, respectively. The most common prior MM treatments were melphalan/prednisone combinations (23%), thalidomide/ dexamethasone (13%), vincristine/doxorubicin/dexamethasone o cyclophosphamide (12%) and thalidomide monotherapy (11%); 4% received an autograft and 25% had no MM treatment in the prior year. At baseline, before starting bortezomib, 12%, 8%, and 3% of patients had grade 1, 2, and 3 peripheral neuropathy, respectively. Initial bortezomib therapy for R/R MM included monotherapy (33%), + dexamethasone (45%), + thalidomide (7%; mostly + dexamethasone), + lenalidomide (3%), + prednisone (5%), and + chemotherapy (8%). Most patients (84%) received an initial bortezomib dose of 1.3mg/m2. Conclusion: Baseline demographics of R/R MM patients in eVOBS are similar to those in a pivotal bortezomib clinical trial (APEX, N Eng J Med 2005). Several bortezomib combination regimens were used in q 2nd-line MM therapy. This database closely captures real-life practice and should provide valuable information for clinicians.

Introduction: Lenalidomide + dexamethasone (RD) is effective for patients with advanced MM and adding bortezomib (BRD) might enhance activity. Materials and Methods: In an ongoing study, patients with pre-existing peripheral neuropathy grade < 2 receive BRD (B: 1 mg/m2 on days 1, 4, 8, and 11; R: 15 mg daily for 14 days or at a lower dose if creatinine clearance (CrCl) < 30 mL/min) and D 40 mg orally on days 1-4, repeated every 21 days) and those with grade q 2 receive RD (28-day cycle of R according to CrCl on days 1 to 21 and D 40 mg orally on days 1-4 and 1518 for the first 4 cycles and on days 1-4 thereafter). Results: 58 patients have been included so far regardless of renal function but without prior treatment with lenalidomide. Baseline conventional metaphase cytogenetics and FISH for del13q, del17p, add1q21, t(4;14), t(14;16) is performed in all patients. Prophylaxis consists of aspirin 100 mg unless already on coumadine or LMWH. BRD: 26 patients, RD: 32 patients. Median number of prior treatments: 3 (range, 1-8 treatments). Prior treatment with thal: 85% (63% thal resistant), prior treatment with B: 83% (54% B resistant), presence of at least one adverse cytogenetic abnormality by FISH in 45.5%, non-hyperdiploid karyotype in 21%, baseline CrCl < 50 mL/min in

Clinical Lymphoma & Myeloma Supplement February 2009