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Bortezomib Regimen clinical trials

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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NCT ID: NCT02976272 Recruiting - Multiple Myeloma Clinical Trials

Neurotoxic Effect of Bortezomib Treatment in Patient With Myeloma Multiple

SENSIB

Start date: June 7, 2016
Phase:
Study type: Observational

Chemotherapy-induced peripheral neuropathies (CIPN) remain a problem in oncology because no "gold standard" treatment exists to prevent or treat the CIPN. Therefore, oncologists reduce or stop the chemotherapy doses to limit degradation of the quality of life of patients with CIPN. Bortezomib is relatively understudied while neurotoxicity remains a limiting factor for treatment. Since 2012, the FDA and the EMA validated by the administration of bortezomib subcutaneously (SC) instead of intravenous (IV) in order to limit neurotoxicity. However, a retrospective study reported that the prevalence of neuropathy induced by bortezomib after SC administration remains high and equivalent to IV route. No studies have quantitatively and qualitatively evaluated the sensory disorders in peripheral neuropathies induced by bortezomib after SC administration. On the other hand, the QLQ-CIPN20 questionnaire (EORTC) evaluating the intensity of sensory, motor and autonomic disorders associated with CIPN has never been tested in this population. The objective of this study is twofold: (i) psychophysical evaluation of neuropathic disorders by studying the thermal and vibratory detection thresholds and thermal nociceptive thresholds and (ii) quantitative and qualitative assessment of neuropathic disorders by the QLQ-CIPN20 and related comorbidities in a population of neuropathic patients treated with bortezomib (n = 15), compared to control patients treated with bortezomib but non-neuropathic (n = 45).