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Early Patient Access Treatment Use Protocol CA204-220

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT02856438
Expanded Access Status : Available
First Posted : August 4, 2016
Last Update Posted : December 13, 2017
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

For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit

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 identifier (NCT number): NCT02856438

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

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Local Institution Available
Nagoya-shi, Aichi, Japan, 4600001
Contact: Site 0002         
Local Institution Available
Nagoya-shi, Aichi, Japan, 4678602
Contact: Site 0003         
Local Institution Available
Shibukawa-shi, Gunma, Japan, 3770280
Contact: Site 0001         
Local Institution Available
Osaka-shi, Osaka, Japan, 5438555
Contact: Site 0004         
Sponsors and Collaborators
Bristol-Myers Squibb
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Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
Additional Information:
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Responsible Party: Bristol-Myers Squibb Identifier: NCT02856438    
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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Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Anti-Inflammatory Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Immunologic Factors
Angiogenesis Inhibitors