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

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ClinicalTrials.gov Identifier: NCT02976493
Recruitment Status : Recruiting
First Posted : November 29, 2016
Last Update Posted : December 13, 2017
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb

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

Condition or disease Intervention/treatment
Multiple Myeloma Other: No Intervention

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Study Type : Observational
Estimated Enrollment : 330 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Elotuzumab Safety Surveillance In Japanese Patients With Relapse Or Refractory Multiple Myeloma
Actual Study Start Date : September 28, 2016
Estimated Primary Completion Date : August 19, 2019
Estimated Study Completion Date : August 19, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Multiple Myeloma
Drug Information available for: Elotuzumab

Group/Cohort Intervention/treatment
MM patients receiving elotuzumab
Non-Interventional Study of all patients with relapsed or refractory multiple myeloma (MM) who are beginning to receive elotuzumab at the selected sites.
Other: No Intervention



Primary Outcome Measures :
  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 ]


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with relapsed or refractory multiple myeloma who are beginning to receive elotuzumab at healthcare facilities in Japan.
Criteria

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:


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02976493


Contacts
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Contact: Recruiting sites have contact information. Please contact the sites directly. If there is no contact information, please email: Clinical.Trials@bms.com
Contact: First line of the email MUST contain NCT # and Site #.

Locations
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Japan
Local Institution Recruiting
Shinjuku-ku, Tokyo, Japan, 162-0822
Contact: Site 0001         
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
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Study Director: Bristol-Myers Squibb Bristol-Myers Squibb

Additional Information:
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Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT02976493     History of Changes
Other Study ID Numbers: CA204-179
First Posted: November 29, 2016    Key Record Dates
Last Update Posted: December 13, 2017
Last Verified: December 2017

Additional relevant MeSH terms:
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Elotuzumab
Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Antineoplastic Agents