Expanded Access Treatment Protocol CA204-143

Sponsor
Bristol-Myers Squibb (Industry)
Overall Status
No longer available
CT.gov ID
NCT02368301
Collaborator
(none)
27

Study Details

Study Description

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 U.S. sites where licensed physicians determine clinical need.

Condition or Disease Intervention/Treatment Phase
  • Drug: Elotuzumab in combination with Lenalidomide and Dexamethasone

Study Design

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

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All

    For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com

    Inclusion Criteria:
    • Men and women 18 years and older

    • Active, relapsed or refractory multiple myeloma by IMWG (International myeloma Working Group) criteria as assessed by the treating physician and have received one prior line of multiple myeloma therapy

    • Prior lenalidomide exposure is permitted only if they fulfill all of the following:

    i)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 enrolment.

    1. Patient did not discontinue lenalidomide due to a Grade ≥ 3 related AE
    Exclusion Criteria:
    • Active plasma cell leukemia (defined as either 20% of peripheral WBC comprised of plasma/CD138+ cells or an absolute count of 2 x 109/L).

    • 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

    • HIV infection or active hepatitis A, B, or C

    • History of participation in elotuzumab studies CA204-004, CA204-006 or CA204-009

    • Inadequate recovery from prior surgery or prior myeloma therapy. If prior allogeneic stem cell transplant, history of moderate to severe chronic graft versus host disease (GvHD)

    • Any medical conditions that, in the attending physician's opinion, would impose excessive risk to the patient

    • Certain abnormal physical or laboratory findings

    • Hypersensitivity to lenalidomide, dexamethasone, any excipients in the elotuzumab formulation, or recombinant protein

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 John Muir Medical Center Concord California United States 94520
    2 Compassionate Cancer Res Grp Corona California United States 92879
    3 City Of Hope National Medical Center Duarte California United States 91010-3000
    4 UC San Diego Moores Cancer Ctr La Jolla California United States 92093-0698
    5 Central Coast Med Oncology Los Angeles California United States 90095
    6 David Geffen School Of Medicine At Ucla Los Angeles California United States 90095
    7 Torrance Health Association Redondo Beach California United States 90277
    8 Sansum Santa Barbara Medical Foundation Clinic Solvang California United States 93463
    9 St. Mary's Hospital Med Ctr Grand Junction Colorado United States 81501
    10 Cancer Specialists Of North Florida Jacksonville Florida United States 32256
    11 The Emory Clinic Atlanta Georgia United States 30322
    12 Center For Cancer And Blood Disorders Bethesda Maryland United States 20817
    13 Beth Israel Deaconess Medical Center (BIDMC) Boston Massachusetts United States 02114
    14 Dana-Farber Cancer Institute Boston Massachusetts United States 02114
    15 Massachusetts General Hospital Boston Massachusetts United States 02114
    16 Karmanos Cancer Institute Detroit Michigan United States 48201
    17 Billings Clinic Billings Montana United States 59101
    18 Southeast Nebraska Cancer Center Lincoln Nebraska United States 68510
    19 Roswell Park Cancer Institute Buffalo New York United States 14263
    20 North Shore Hematology/Oncology Associates, P.C. East Setauket New York United States 11733
    21 New York Presbyterian Hospital-Weill Cornell Med College New York New York United States 10021
    22 Mount Sinai Medical Center New York New York United States 10029
    23 Cone Health Cancer Center Greensboro North Carolina United States 27403
    24 Northern Utah Associates Ogden Utah United States 84403
    25 Huntsman Cancer Institute At The Univ. Of Utah Salt Lake City Utah United States 84112
    26 Wellmont Medical Associates Bristol Virginia United States 24201
    27 Virginia Cancer Institute Richmond Virginia United States 23230

    Sponsors and Collaborators

    • Bristol-Myers Squibb

    Investigators

    • Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Bristol-Myers Squibb
    ClinicalTrials.gov Identifier:
    NCT02368301
    Other Study ID Numbers:
    • CA204-143
    First Posted:
    Feb 23, 2015
    Last Update Posted:
    Mar 21, 2022
    Last Verified:
    Mar 1, 2022

    Study Results

    No Results Posted as of Mar 21, 2022