This was a multicenter, open-label, single-arm phase 3B study of the combination lenalidomide plus pulse high-dose dexamethasone. This study (CC-5013-MM-019) was set up and executed primarily as an expanded access program in Germany. Screening procedures were to take place within 28 days prior to Cycle 1 Day 1 (baseline) with the exception of hematology assessments that were to be performed within 14 days prior to Cycle 1 Day 1. Randomization, blinding, and stratification were not applied in this open-label single-arm study. Eligible subjects given open-label treatment and received treatment with lenalidomide plus high-dose dexamethasone in 28-day cycles. Lenalidomide (hard capsules) was to be administered orally (PO) at a dose of 25 mg daily (QD) for the first 21 days of each 28-day cycle. According to the protocol, accrual of subjects to the study was to be terminated within 2 months of commercial availability of lenalidomide for this indication in Germany. Upon discontinuation from study, minimal information was collected in order to identify when disease progressed.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
150
Oral lenalidomide at a dose of 25 mg daily for 21 days every 28 days. Treatment as tolerated until disease progression.
Oral pulse dexamethasone at a dose of 40 mg daily on days 1-4, 9-12, and 17-20 for each 28-day-cycle for cycles 1 through 4 (approximately months 1-4). Beginning cycle 5 (approximately month 5) dexamethasone is reduced to 40 mg daily for days 1-4 every 28 days.
Medizinische Klinik und Poliklinik II der Charité Universitätsmedizin Berlin Campus Mitte
Berlin, Germany
Poliklinik I, Hämatologie/ Onkologie, Universitätsklinikum Bonn
Bonn, Germany
Johanniter-Krankenhaus Bonn Friedrich-Wilhelm-Stift gGmbH
Bonn, Germany
Medizinische Klinik Städtisches Klinikum Braunschweig gGmbH
Braunschweig, Germany
Interne Klinik Dr. Argirov, Schön-Kliniken
Burg, Germany
Kaplan Meier Estimate for Time to Disease Progression
Time to disease progression (TTP) was based on the European Group for Blood and Marrow Transplantation (EBMT) myeloma response determination criteria developed by Bladé (Bladé, 1998). TTP is a Kaplan Meier estimate of the time from randomization to the first documentation of progressive disease. Progressive disease based on increasing monoclonal paraprotein levels require a confirmatory value one week apart. Disease progression can also be based on bone marrow findings, worsening lytic bone disease, progressively enlarging extramedullary plasmacytomas, or hypercalcemia.
Time frame: up to 827 days
Participant's Best Overall Response Based on the European Group for Blood and Marrow Transplantation (EBMT) Myeloma Response Criteria
Best overall response was calculated as the best assessment from all cycles (including treatment discontinuation visit) and follow-up. The response rate was summarized as complete response (CR), partial response (PR), stable disease (SD), progression (PD), response not evaluable, and derived categories (PR+CR) and (PR+CR+SD). CR is negative immunofixation on both serum and urine maintained for 6 weeks straight. PR is a 50% decrease in serum paraprotein maintained for 6 weeks straight. SD is serum paraprotein values within 25% of baseline.
Time frame: Up to 827 days
Participants With Treatment-emergent Adverse Experiences (TEAEs)
Counts of study participants who had treatment-emergent adverse events (TEAEs) defined as any reported AE that started on or after the first day of study drug dosing. A participant with multiple occurrences of an adverse event within a category is counted only once in that category. National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE version 3.0) was used by investigators to assess TEAEs. Severity scale ranges from 0 (none) to 5 (death). Grade 3=severe AE; Grade 4=life threatening or disabling AE; Grade 5=death.
Time frame: up to 8 months
Time to Partial Response Based on the European Group for Blood and Marrow Transplantation (EBMT) Myeloma Response Determination Criteria
Time to partial response is the time from randomization to a 50% decrease in serum paraprotein maintained for six weeks straight. This was determined by free light chain concentrations which were taken every two weeks during the treatment phase of the trial.
Time frame: up to 827 days
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Klinik für Innere Medizin III Klinikum Chemnitz gGmbH
Chemnitz, Germany
Ärzte f. Innere Medizin Gemeinschaftspraxis f. Hämatologie u. Onkologie
Cologne, Germany
Klinik f. Innere Medizin, Klinikum der Universität zu Köln
Cologne, Germany
Medizinische Klinik und Poliklinik, Uniklinikum Dresden
Dresden, Germany
Universitaetsklinikum Dusseldorf Klinik fuer Haematologie
Düsseldorf, Germany
...and 38 more locations