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OpenTrials
Completed

NCT Number: NCT00911105

Non -Interventional Study-Palliative Therapy of Multiple Myeloma With a Combination of Lenalidomide and Dexamethasone

Purpose of this non-interventional study is the documentation of efficacy and safety data of multiple myeloma therapy with a combined treatment of Lenalidomide and Dexamethasone in daily routine practice.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Onkologische Schwerpunktpraxis, Bad Homburg, Germany

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients with multiple myeloma with at least one previous therapy.
  • 18 years or older
  • Signed, written informed consent

Exclusion criteria

  • Pregnancy or nursing
  • All other exclusion criteria listed in SmPC (summary of product characteristics)

Treatment and study plan

Primary outcomes

  1. Time to progression (TTP)

    Time frame: maximum 3 years per Patient

Secondary outcomes

  1. Overall Response Rate

    Time frame: maximum 3 years per Patient

  2. Time to Treatment Discontinuation (TTD)

    Time frame: maximum 3 years per Patient

  3. Overall Survival (OS)

    Time frame: maximum 3 years per Patient

  4. Safety Profile

    Time frame: maximum 3 years per Patient

  5. Dosage of Lenalidomide and Dexamethasone

    Time frame: maximum 3 years per Patient

  6. Kidney Function

    Time frame: maximum 3 years per Patient

  7. Neutropenia / Infection (Concomitant Medication)

    Time frame: maximum 3 years per Patient

  8. Thrombosis Prophylaxis

    Time frame: maximum 3 years per Patient

Sponsors and collaborators

Lead sponsor

iOMEDICO AG

Industry

Registry information

Official study title

Combined Application of Lenalidomide and Desamethasone in the Palliative Therapy of Patients With Multiple Myeloma

Acronym: REVLIMID-NIS

Important dates

Study start
2009
Primary completion
2012
Study completion
2015
First posted
Jun 1, 2009
Registry last updated
Jun 6, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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