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OpenTrials
Completed

NCT Number: NCT02976493

Elotuzumab Safety Surveillance In Japanese Patients With Relapse Or Refractory Multiple Myeloma

BMS will conduct a regulatory postmarketing surveillance (PMS) to evaluate the safety of elotuzumab in clinical practice in Japan.

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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 Vascular Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

Local Institution

Shinjuku-ku, Tokyo, 162-0822, Japan

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • All patients with relapsed or refractory multiple myeloma who are beginning to receive elotuzumab at the selected sites will be included in this surveillance study

Exclusion criteria

  • Not Applicable

Treatment and study plan

No intervention

Other

No Intervention

Primary outcomes

  1. Incidence of all adverse events(AE) to elotuzumab in real-world practice in Japan

    Time frame: Up to 72 weeks

  2. Incidence of immune-related (IR) adverse events to elotuzumab in real-world practice in Japan

    Time frame: Up to 72 weeks

    immune-related (IR) adverse events are defined as: 1) AEs that are related to elotuzumab per investigator and 2) are consistent with an inflammatory process.

  3. Number of patients who achieve a Stringent complete response (sCR) as measured by International Myeloma Working Group (IMWG) criteria

    Time frame: Up to 72 weeks

  4. Number of patients who achieve a Complete response (CR) as measured by International Myeloma Working Group (IMWG) criteria

    Time frame: Up to 72 weeks

  5. Number of patients who achieve a Very good partial response (VGPR) as measured by International Myeloma Working Group (IMWG) criteria

    Time frame: Up to 72 weeks

  6. Number of patients who achieve a Partial response (PR) as measured by International Myeloma Working Group (IMWG) criteria

    Time frame: Up to 72 weeks

  7. Number of patients who achieve a Progressive Disease (PD) as measured by International Myeloma Working Group (IMWG) criteria

    Time frame: Up to 72 weeks

  8. Number of patients who achieve a Relapse from complete response as measured by International Myeloma Working Group (IMWG) criteria

    Time frame: Up to 72 weeks

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Nov 29, 2016
Registry last updated
Aug 20, 2019

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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