Relapsed or refractory multiple myeloma
Conditions
Interventions
Product Name: Sorafenib
Pharmaceutical Form: Tablet
Sponsors
University hospital of Bonn
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - informed consent - histologically or cytologically confirmed Multiple Myeloma in Stage IIA or IIIA (Durie and Salmon). - Measurable disease, definerd by: - Serum M protein at least 1.0 g/dl by protein electrophoreses or free light chain measurement an/or – - quantitative immunoglobulins and/or urinary M protein excretion of at least 200 mg/24 hours. - Relapse following any conventional multiple myeloma therapy (including autologous stem cell transplantation), or refractory to their most recent multiple myeloma therapy (including immunotherapy, radiation therapy, or other investigational agents). Note: Patients need not to have responded to the previous (one) therapeutic regimen. - Male or female patients > 18 years of age. - Life expectancy of at least 12 weeks - Patients must have an ECOG performance status of less or equal 2 - Women of childbearing age with a negative pregnancy test within 7 days prior to enrolment and willing to use adequate contraception during therapy - Men and women: Willing to use adequate contraceptive barrier methods during treatment. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - Patients with non-secretory myeloma and plasma cell leukemia - Patients eligible and willing to undergo second-line high-dose therapy or ABSCT. - Hypercalcaemia >3.0 mmol/l (14 mg/dl) - Insufficient bone marrow, liver, and renal function as assessed by the following laboratory investigations at screening (Note: Values obtained within 7 days prior to the screening visit can be used): (Hemoglobin 1.5 x upper limit normal, ALT and AST > 2.5 x upper limit normal, Amylase and lipase > 1.5 x upper limit normal, Serum creatininie > 2.0 x upper limit normal, PT or INR and PTT > 1.5 x upper limit normal) - Major surgery within 4 weeks of enrolment - Patients with history of other malignancies during the past 5 years with the exception of adequately treated basal or squamous-cell skin cancer or cervical carcinoma or localized prostate carcinoma. - Systemic amyloidosis (except amyloidosis of skin or bone marrow). - Known history of HIV infection or chronic hepatitis B or C infection. - Active clinically serious bacterial or fungal infections (>or equal grade 2 NCI-CTCAE, Version 3.0). - Manifest depression - History of cardiac disease: congestive heart failure >NYHA class 2, active cardiovascular disease (MI more than 6 months prior to study entry is allowed); cardiac arrhythmia requiring antiarrhythmic therapy (beta blockers or digoxin are permitted) or uncontrolled hypertension. - Known neoplastic CNS abnormality - Known or suspected allergy to the investigational agent or any agent given in association with this trial. - Patients with seizure disorder requiring medication. - Substance abuse, medical, psychological or social conditions that may interfere with the patient’s participation in the study. - Pregnant or breast feeding patients. - Concurrent anticancer chemotherapy or immunotherapy. (Note: The administration of bisphosphonates is recommended and not excluded). - Concurrent treatment with systemic corticosteroids. - Prior use of inhibitors of the Ras/Raf-, MEK-, AKT-kinase- and mTOR-signaling pathway or of farnesyl-transferase inhibitors. - Prior use of angiogenesis inhibitors (targeting VEGF/VEGFR, PDGF/PDGFR and other key molecules in angiogenesis). Note: the prior use of thalidmide and its derivatives is no exclusion criterium. - Concomitant Rifampicin and St. John´s Wort (hypericum perforatum). - Receiving immunotherapy, radiation therapy, or other investigational agents within 30 days prior to the first study drug administration.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Primary aim is to demonstrate that Sorafenib is active in patients with multiple myeloma in relapse or recurrent disease as a first evaluation of the effectiveness of this novel agent in the field of multiple myeloma.;Secondary Objective: To evaluate specific toxicity, safety, tolerability and response rates, duration of response as well as accompanying scientific topics like changes in blood vessel density and the prediction of clinical outcome and response to treatment by global gene expression profiling (GEP).;Primary end point(s): Evaluation of progression free survival (PFS) | — |
Countries
Germany
Outcome results
None listed