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31 juli 2014: Klik hier voor artikel: Genentest blijkt voorspellende waarde te hebben bij het verloop van Multiple Myeloma - ziekte van Kahler bij nieuw gediagnosteerde patiënten en wel of niet aanslaan van Bortezomib - Velcade.

VELCADE™ (bortezomib) is vanaf mei 2004 officieel geregistreerd medicijn tegen Kahler - Multiple Myeloma in Europa waaronder Nederland. Hier meer informatie over wat Velcade - Bortezomib is en waarvoor het wordt gebruikt.

Bron: Website over Website over Kahler - Multi Myeloma.. VELCADE™ (bortezomib) als medicijn tegen Kahler - Multi Myeloma - nu ook in Nederland en andere Europese landen officieel geregistreerd en met toestemming te gebruiken. Weliswaar alleen nog voor patiënten waarbij twee andere chemokuren niet hebben gewerkt mag pas Velcade (bortezomib) worden toegepast, maar er lopen nu ook fase II studies op kleine schaal voor Kahlerpatiënten die nog geen enkele andere behandeling hebben gehad. Velcade (bortezomib) had vorig jaar al approval gekregen van de FDA voor gebruik van Velcade (MLN-341) bij vergevorderde Kahler - Multiple Myeloma. Het bedrijf Jansen-Gilag is producent van Velcade. Een behandeling met Velcade kost per patiënt € 20.000,-- per half jaar. Misschien ook goed te lezen wat aanvullende goede voeding en suppletie kan doen bij Kahler - Multiple Myeloma, eventueel als aanvulling op Velcade. Consulteer wel a.u.b. hierover een arts en goed gekwalificeerd orthomoleculair arts want we weten uiteraard niet - wij zijn geen arts of medisch deskundigen, lees ook onze disclaimer - of deze aanvulling ook echt een aanvulling is of dat bepaalde vitamines/mineralen de werking van Velcade tegengaan. Lijkt ons wel een interessante optie voor onderzoekers om bij onderzoek naar werking van Velcade ook deze optie mee te nemen in hun onderzoek.

Hier enkele citaten van MM-website gekopieerd waar nog veel en veel meer te lezen is over Velcade (bortezomib) en hoe het werkt en wat de bijwerkingen zijn enz. Velcade wordt ook getest bij andere kankersoorten waaronder mantelcelcarcinoom.

Full Name: Velcade® (bortezomib) for Injection Other Names: PS-341, MLN341, and LDP-341 Description: Proteasome inhibitor (intravenous) Phase: APPROVED, US, EU Company: Millennium Pharmaceuticals, Inc.

Citaat 1: Overview Velcade is a potent, specific, and reversible proteasome inhibitor and the first drug of this type to enter clinical trials. Proteasomes are present in all cells and function to help regulate cell growth. In nonclinical studies, normal cells appear to be able to recover from intermittent proteasome inhibition, but many types of cancer cells undergo apoptosis (programmed cell death) when proteasomes are inhibited, even for a short time. Details on Velcade's Mechanism of Action The proteasome is an enzyme complex that exists in all cells and plays an important role in degrading proteins involved in the cell cycle, growth of new blood vessels (angiogenesis), cell adhesion, cytokine production, apoptosis, and other important cellular processes. Many of the processes that rely on proteasome function can contribute to the growth and survival of cancer cells. Velcade is a potent but reversible inhibitor of the proteasome. By disrupting normal cellular processes, proteasome inhibition promotes apoptosis. Non-clinical data has demonstrated that cancer cells are more susceptible to the effects of proteasome inhibition than normal cells. Due to the reversibility of proteasome inhibition with Velcade, normal cells can recover from its effects, whereas cancer cells are more likely to undergo apoptosis. In addition to its potential use as a single agent, non-clinical research suggests that when Velcade is combined with other chemotherapy treatments or radiation, there is an additive or even synergistic effect.

Citaat 2: Details on Velcade's Mechanism of Action in Myeloma Many of Velcade's anti-myeloma effects are thought to be due to its ability to block a key survival protein known as nuclear factor κB (NF-κB). NF-κB is found within the cell and acts as a transcription factor, turning on genes that cause production of proteins that stimulate cell growth.

Citaat 3: Dosage and Administration The recommended dose of Velcade is 1.3 mg/m2/dose administered as an intravenous injection twice weekly for 2 weeks (days 1, 4, 8, and 11), followed by a 10-day rest period (days 12-21). Doses are typically given on Monday and Thursday or Tuesday and Friday. This 3-week period is considered a treatment cycle. The length of treatment is determined on an individual basis, depending on a patient's response and tolerability. In clinical trials, patients were able to receive Velcade for up to 8 cycles, but patients who were still benefiting were allowed to continue for additional cycles. If a patient experiences any severe side effects (Grade 3 non-hematological or Grade 4 hematological toxicities, excluding neuropathy as discussed below), Velcade therapy should be stopped until the symptoms resolve. Velcade can then be started again at a 25% reduced dose. Patients who experience neuropathic pain (pain associated with neuropathy) and/or peripheral neuropathy (abnormal or decreased sensation, or burning/tingling) on Velcade therapy should have their dose and/or schedule adjusted as indicated in the table below.

Citaat 4: The most commonly seen severe adverse events (Grade 3 and 4) in these trials were: Thrombocytopenia (a decrease in the number of platelets; 30%) Asthenic conditions (fatigue, malaise, or weakness; 18%) Neutropenia (16%) Peripheral neuropathy (14%)

Citaat 5: Clinical Trials On May 13, 2003, Velcade received accelerated approval in the United States for the treatment of multiple myeloma patients who have received at least two prior therapies and have demonstrated disease progression on the last therapy.The approval was based on the data from the Phase II SUMMIT registration trial and the Phase II CREST trial (see below). At that time, the recently ended confirmatory Phase III APEX (Assessment of Proteasome Inhibition for Extending Remissions) trial of Velcade in relapsed and refractory myeloma was underway. As part of the accelerated approval, Millennium will be completing preclinical and phase IV clinical studies. On April 24, 2004, the European Commission also approved Velcade for use in the same myeloma patient population—those who have received at least two prior therapies and have progressed on their most recent therapy. Velcade is now marketed in the 15 member states of the European Union, the 10 accession member countries, plus Norway and Iceland.

Citaat 6: Ongoing Velcade Clinical Trials in Myeloma as of April 2004. Phase II Phase II study of Velcade +/- dexamethasone in previously untreated myeloma patients

View trial information
Phase II study of Velcade, adriamycin and dexamethasone as primary therapy for myeloma
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UARK 2003-33, Total Therapy III: A Phase 2 Study Incorporating Bone Marrow Microenvironment (ME) - Co-Targeting Bortezomib into Tandem Melphalan-Based Autotransplants with DT PACE for Induction/Consolidation and Thalidomide + Dexamethasone for Maintenance
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Phase I
Studying the Pharmacokinetics and Pharmacodynamics of Velcade (bortezomib) in Patients with Relapsed Multiple Myeloma
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A Pilot Study of VDT (Velcade, Doxil® and Thalidomide) as Salvage Therapy for Patients with Relapsed or Refractory Multiple Myeloma (MM)
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Phase I study of Velcade and thalidomide in patients with refractory disease (University of Arkansas)
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Reviewed by: Kenneth C. Anderson, MD Professor of Medicine Dana-Farber Cancer Institute 3/26/04

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