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Early Patient Access Treatment Use Protocol CA204-220

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ClinicalTrials.gov Identifier: NCT02856438
Expanded Access Status : Available
First Posted : August 4, 2016
Last Update Posted : December 13, 2017
Sponsor:
Collaborator:
AbbVie
Information provided by (Responsible Party):
Bristol-Myers Squibb

Brief Summary:
The objective of this expanded access program is to provide treatment with elotuzumab in combination with lenalidomide and dexamethasone for patients with relapsed or refractory multiple myeloma at Japanese sites where licensed physicians determine clinical need.

Condition or disease Intervention/treatment
Multiple Myeloma Drug: Elotuzumab Drug: Lenalidomide Drug: Dexamethasone

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Study Type : Expanded Access
Official Title: An Expanded Access Program for Elotuzumab in Combination With Lenalidomide Plus Dexamethasone in Patients With Relapsed or Refractory Multiple Myeloma in Japan



Intervention Details:
  • Drug: Elotuzumab
    Specified dose on specified days
    Other Name: BMS-901608
  • Drug: Lenalidomide
    Specified dose on specified days
  • Drug: Dexamethasone
    Specified dose on specified days

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Criteria

For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

  • Men and women 20 years and older
  • Active, relapsed or refractory multiple myeloma by International Myeloma Working Group (IMWG) criteria as assessed by the treating physician and have received at least 1 prior line of multiple myeloma therapy.
  • Progression from a most recent line of therapy
  • Prior lenalidomide exposure is permitted only if they fulfill all of the following:

    1. Were not refractory to prior lenalidomide, defined as no progression while receiving lenalidomide (induction dose) or within 60 days of last dose of lenalidomide. Patients progressing on lenalidomide maintenance dose are eligible for enrollment.
    2. Patient did not discontinue lenalidomide due to a Grade ≥ 3 related AE.

Exclusion Criteria:

  • All Adverse Events of any prior chemotherapy, surgery, or radiotherapy not resolved to NCI CTCAE (v. 3.0) Grade ≤ 2
  • Significant cardiac disease as determined by the treating physician including cardiac amyloidosis
  • Known HIV infection or active hepatitis A, B, or C
  • Any medical conditions that, in the attending physician's opinion, would impose excessive risk to the patient.

Other protocol defined inclusion/exclusion criteria could apply


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): NCT02856438


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
Nagoya-shi, Aichi, Japan, 4600001
Contact: Site 0002         
Local Institution
Nagoya-shi, Aichi, Japan, 4678602
Contact: Site 0003         
Local Institution
Shibukawa-shi, Gunma, Japan, 3770280
Contact: Site 0001         
Local Institution
Osaka-shi, Osaka, Japan, 5438555
Contact: Site 0004         
Sponsors and Collaborators
Bristol-Myers Squibb
AbbVie
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: NCT02856438     History of Changes
Other Study ID Numbers: CA204-220
First Posted: August 4, 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
Dexamethasone
Dexamethasone acetate
Lenalidomide
BB 1101
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents