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Spots Global Cancer Trial Database for A Study of Bortezomib as Consolidation Therapy in Patients With Multiple Myeloma

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Trial Identification

Brief Title: A Study of Bortezomib as Consolidation Therapy in Patients With Multiple Myeloma

Official Title: Consolidation Therapy With Bortezomib <= 60 Year Old Patients With Multiple Myeloma

Study ID: NCT00416273

Study Description

Brief Summary: The purpose of this study is determination of the event-free survival with and without Bortezomib consolidation therapy from the day of the first chemotherapeutic, myeloma-specific therapy measure, up to the occurrence of progression/recurrence or up to the occurrence of death.

Detailed Description: This is a two-arm (group), open-label (all people know the identity of the intervention), prospective (a study in which the patients are identified and then followed forward in time for the outcome of the study) randomized (the study medication is assigned by chance), multi-center study. Approximately 385 patients will be enrolled in this study. Patients will be randomly assigned to treatment or observation group in a ratio of 1:1. The study duration from screening up to the study end is up to 27 weeks. Then the patients will be observed until the last included patient has completed a 30 month post observational phase. The patients in the treatment arm will receive 4 cycles of a therapy. Each cycle lasts for a 35 days. Safety evaluations will include assessment of adverse events, vital signs, physical examination, electrocardiograms, and clinical laboratory tests.

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT

Sex: ALL

Healthy Volunteers: No

Locations

, Augsburg, , Germany

, Bamberg, , Germany

, Berg, , Germany

, Berlin, , Germany

, Bremen, , Germany

, Dresden, , Germany

, Duisburg, , Germany

, Erlangen, , Germany

, Eschweiler, , Germany

, Frankfurt / Main, , Germany

, Freiburg, , Germany

, Goch, , Germany

, Greifswald, , Germany

, Göttingen, , Germany

, Halle, , Germany

, Hamburg, , Germany

, Hamm, , Germany

, Hannover, , Germany

, Homburg, , Germany

, Jena, , Germany

, Karlsruhe, , Germany

, Kempten, , Germany

, Kiel, , Germany

, Köln, , Germany

, Magdeburg, , Germany

, Mainz, , Germany

, Mutlangen, , Germany

, München, , Germany

, Münster, , Germany

, Nürnberg, , Germany

, Oldenburg, , Germany

, Regensburg, , Germany

, Rostock, , Germany

, Stuttgart, , Germany

, Ulm, , Germany

, Villingen-Schwenningen, , Germany

, Wiesbaden, , Germany

, Würzburg, , Germany

Contact Details

Name: Janssen-Cilag G.m.b.H, Germany Clinical Trial

Affiliation: Janssen-Cilag G.m.b.H

Role: STUDY_DIRECTOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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