A Study to Record in an Observational Manner the Treatment of Multiple Myeloma as it is Being Done in Every Day Practice Without Providing Any Investigational Drug or Prescribing Any Procedure

NCT01241396 | Completed

• 1 other identifier: CR017410
• Study Type: observational
• Target: 2,396
• Locations: 20 countries
• Sites: 157

Brief Summary

The primary objective of this observational study is to document and describe current treatment regimens and disease progression of patients with Multiple Myeloma (MMY). The aim of this registry is to provide accurate, descriptive information on the way Multiple Myeloma is treated in routine clinical practice. The registry will collect information related to the treatment received for Multiple Myeloma. About 3000 patients will take part in the study in about 28 countries. The registry will only collect information that is already in medical files regarding treatment. Patients will not be required to actively do anything in addition to what would be done without participating in this registry, nor will there be any procedures or interventions that are not already part of the current treatment.

Conditions

Multiple Myeloma

Keywords

Multiple Myeloma; observational; survey; non-interventional; international; epidemiology; treatment; routine clinical practice; retrospective; prospective

Outcome Measures

Primary Outcomes (1)

• Description of current treatment regimens for MMY.

  Every 3 months from baseline to 3 years after last patient recruited

Secondary Outcomes (4)

• Utilisation of current treatment regimens for MMY

  Every 3 months from baseline to 3 years after last patient recruited

• Quality of life and health economic parameters associated with MMY treatment regimens

  Every 3 months from baseline to 3 years after last patient recruited

• Safety profile of current treatment regimens for MMY

  Every 3 months from baseline to 3 years after last patient recruited

• The effectiveness of current treatment regimens for MMY

  Every 3 months from baseline to 3 years after last patient recruited

Study Arms (1)

001

Any MMY treatment Any line of treatment for MMY

Other: Any MMY treatment

Interventions

Any MMY treatment OTHER

Any line of treatment for MMY

001

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

The study will focus on enrolling consecutively, patients who are initiating any new line of therapy for Multiple Myeloma, regardless of the line of treatment. Because this is a non-interventional study, intended to provide a picture of routine clinical practice, no guidance will be given on any aspect of treatment, patient clinical management or treatment dose selection.

You may qualify if:

• \- Requires commencement of a new line of treatment for MMY at any stage, regardless of type of therapy selected.

You may not qualify if:

• Patients currently participating in another investigational study or clinical trial.

Sponsors & Collaborators

• Janssen Pharmaceutica N.V., Belgium: lead

Study Sites (159)

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Algiers, Algeria

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Constantine, Algeria

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Oran, Algeria

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Sétif, Algeria

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Tizi Ouzou, Algeria

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Graz, Austria

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Innsbruck, Austria

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Zagreb, Croatia

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Holstebro, Denmark

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Odense, Denmark

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Tallinn, Estonia

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Tartu, Estonia

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Avignon, France

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Blois, France

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Bordeaux, France

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Brest, France

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Clermont-Ferrand, France

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Le Mans, France

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Montpellier, France

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Nantes, France

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Nîmes, France

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Perpignan, France

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Pontoise, France

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Rennes, France

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Saint-Brieuc, France

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Troyes, France

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Amberg, Germany

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Aschaffenburg, Germany

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Augsburg, Germany

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Bad Soden, Germany

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Bamberg, Germany

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Berlin, Germany

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Bielefeld, Germany

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Bonn, Germany

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Borken, Germany

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Bottrop, Germany

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Bremerhaven, Germany

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Coburg, Germany

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Dresden, Germany

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Goslar, Germany

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Hamburg, Germany

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Hamm, Germany

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Hanover, Germany

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Hildesheim, Germany

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Hof, Germany

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Kaiserslautern, Germany

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Lübeck, Germany

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Mainz, Germany

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Mayen, Germany

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Mutlangen, Germany

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München, Germany

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Naunhof, Germany

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Neunkirchen, Germany

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Nuremberg, Germany

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Olpe, Germany

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Ostfildern, Germany

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Rostock, Germany

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Rotenburg (Wümme), Germany

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Saarbrÿcken, Germany

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Stuttgart, Germany

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Weiden, Germany

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Würzburg, Germany

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Athens, Greece

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Larissa, Greece

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Thessalonikis, Greece

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Budapest, Hungary

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Debrecen, Hungary

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Pécs, Hungary

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Szeged, Hungary

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Szombathely, Hungary

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Haifa, Israel

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Kfar Saba, Israel

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Petah Tikva, Israel

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Ramat Gan, Israel

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Riga, Latvia

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Klaipėda, Lithuania

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Vilnius, Lithuania

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Skopje, North Macedonia

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Bialystok, Poland

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Brzozów, Poland

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Bytom, Poland

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Chorzów, Poland

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Gdansk, Poland

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Gorzów Wielkopolski, Poland

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Katowice, Poland

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Legnica, Poland

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Lublin, Poland

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Opole, Poland

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Poznan, Poland

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Rzeszów, Poland

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Słupsk, Poland

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Warsaw, Poland

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Warszawa Poland, Poland

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Wroclaw, Poland

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Zamość, Poland

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Ponta Delgada, Portugal

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Porto, Portugal

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Kolomna, Russia

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Krasnodar, Russia

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Krasnogorsk, Russia

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Moscow, Russia

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Podolsk, Russia

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Saint Petersburg, Russia

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Samara, Russia

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Saransk, Russia

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Tula, Russia

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Ulyanovsk, Russia

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Volgograd, Russia

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Vologda, Russia

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Ljubljana, Slovenia

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Bloemfontein, South Africa

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Cape Town, South Africa

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Durban, South Africa

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Johannesburg, South Africa

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Alicante, Spain

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Barcelona, Spain

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Cadiz, Spain

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Cáceres, Spain

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Ciudad Real, Spain

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Donostia / San Sebastian, Spain

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Guadalajara, Spain

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Jaén, Spain

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León, Spain

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Madrid, Spain

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Marbella, Spain

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Murcia, Spain

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Palma de Mallorca, Spain

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Salamanca, Spain

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Seville, Spain

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Talavera de La Reina, Toledo, Spain

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Tarragona, Spain

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Zaragoza, Spain

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Adana, Turkey (Türkiye)

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Ankara, Turkey (Türkiye)

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Antalya, Turkey (Türkiye)

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Bursa, Turkey (Türkiye)

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Istanbul, Turkey (Türkiye)

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Izmir, Turkey (Türkiye)

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Kayseri, Turkey (Türkiye)

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Samsun, Turkey (Türkiye)

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Cherkassy, Ukraine

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Dnipro, Ukraine

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Donetsk, Ukraine

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Ivano-Frankivsk, Ukraine

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Kharkiv, Ukraine

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Kherson, Ukraine

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Khmelnitskiy, Ukraine

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Kiev, Ukraine

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Lutsk, Ukraine

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Lviv, Ukraine

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Mykolayiv, Ukraine

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Odesa, Ukraine

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Poltava, Ukraine

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Simferopol, Ukraine

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Ternopil, Ukraine

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Uzhhorod, Ukraine

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Vinnitsa, Ukraine

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Zaporizhzhya, Ukraine

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Zhytomyr, Ukraine

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MeSH Terms

Conditions

Multiple Myeloma

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Janssen Pharmaceutica N.V. Clinical Trial

  Janssen Pharmaceutica N.V.

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 12, 2010
• First Posted: November 16, 2010
• Study Start: October 1, 2010
• Primary Completion: November 1, 2014
• Study Completion: November 1, 2014
• Last Updated: June 20, 2016

Record last verified: 2016-06

Locations

TU (8); UA (19); ES (18); CR (1); AL (5); PT (2); PL (17); IL (4); FR (14); DE (36); AU (2); LA (1); LI (2); NO (1); ZA (4); SL (1); HU (5); GR (3); RU (12); DK (2)