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Myeloma patients with renal impairment need a rapid and effective reduction of tumor burden to enable renal recovery, which is correlated with prognosis of the patients. However, effective combination regimens are often hampered by necessary dose reductions or increased toxicity in renally impaired patients. The well known positive effects on renal impairment by Bortezomib combined with Daratumumab, which, as all monoclonal Antibody, is not renally excreted or metabolized and as so far known should not add significant toxicity but efficacy, makes the proposed combination of Daratumumab, Bortezomib and Dexamethasone highly attractive for renally impaired MM patients.
In the current clinical trials with Daratumumab patients with renal function impairment (GFR ≤ 20 ml/min) were so far excluded. Consequently questions about efficacy, safety and pharmacokinetics of Daratumumab in combination with Bortezomib and Dexamethasone in patients with relapsed and refractory MM and severe renal impairment are still unanswered. This trial will answer these questions for a patient group, who has still an unmet need for novel and effective treatment options
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Daratumumab, Bortezomib, Dexamethasone
Not yet recruiting
University Hospital Tuebingen
Published on BioPortfolio: 2016-12-01T16:08:22-0500
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This study is a Phase Ib open label, single arm, adaptive multicentre trial. Patients with newly diagnosed Multiple Myeloma (MM) will be treated with Cyclophosphamide-Bortezomib-Dexamethas...
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The MUK five protocol: a phase II randomised, controlled, parallel group, multi-centre trial of carfilzomib, cyclophosphamide and dexamethasone (CCD) vs. cyclophosphamide, bortezomib (Velcade) and dexamethasone (CVD) for first relapse and primary refractory multiple myeloma.
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Filanesib is a kinesin spindle protein inhibitor that has demonstrated encouraging activity in patients with recurrent/refractory multiple myeloma. Preclinical synergy with bortezomib was the rational...
A rare, aggressive variant of MULTIPLE MYELOMA characterized by the circulation of excessive PLASMA CELLS in the peripheral blood. It can be a primary manifestation of multiple myeloma or develop as a terminal complication during the disease.
Abnormal immunoglobulins characteristic of MULTIPLE MYELOMA.
An abnormal protein with unusual thermosolubility characteristics that is found in the urine of patients with MULTIPLE MYELOMA.
Class I human histocompatibility (HLA) antigens encoded by a small cluster of structural genes at the C locus on chromosome 6. They have significantly lower immunogenicity than the HLA-A and -B determinants and are therefore of minor importance in donor/recipient crossmatching. Their primary role is their high-risk association with certain disease manifestations (e.g., spondylarthritis, psoriasis, multiple myeloma).
A malignancy of mature PLASMA CELLS engaging in monoclonal immunoglobulin production. It is characterized by hyperglobulinemia, excess Bence-Jones proteins (free monoclonal IMMUNOGLOBULIN LIGHT CHAINS) in the urine, skeletal destruction, bone pain, and fractures. Other features include ANEMIA; HYPERCALCEMIA; and RENAL INSUFFICIENCY.
Nephrology - kidney function
Nephrology is a specialty of medicine and pediatrics that concerns itself with the study of normal kidney function, kidney problems, the treatment of kidney problems and renal replacement therapy (dialysis and kidney transplantation). Systemic conditions...