Safety and Efficacy of Pomalidomide, Bortezomib and Low-dose Dexamethasone in Subjects With Relapsed or Refractory Multiple Myeloma

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Basic Trial Information

PhaseTypeAgeTrial IDs
Phase IIITreatment18 and overCC-4047-MM-007
NCI-2013-00024, NCT01734928

Trial Description


The purpose of this study is to compare the efficacy of the combination of Pomalidomide,

Bortezomib and Dexamethasone to the combination of Bortezomib and Dexamethasone in patients

with relapsed/refractory multiple myeloma. This study will also assess how safe the

combination of Pomalidomide, Bortezomib and Dexamethasone is compared to the combination of

Bortezomib and Dexamethasone

Eligibility Criteria

Inclusion Criteria:

All subjects must have received prior treatment with a lenalidomide containing

regimen for at least 2 consecutive cycles.

Must have documented disease progression during or after their last anti-myeloma


Must have had at least 1 but no greater than 3 prior anti-myeloma regimens.

Must have documented diagnosis of multiple myeloma and have measureable disease by

serum and urine protein electrophoresis.

Must be ≥ 18yrs at the time of signing informed consent.

Exclusion Criteria:

Previous therapy with pomalidomide.

Subjects with severe renal impairment requiring dialysis.

Non-secretory multiple myeloma.

Peripheral neuropathy Grade 3, Grade 4 or Grade 2 with pain within 14 days prior to


Refractory to prior Bortezomib-containing therapy under the 1.3 mg/m2 dose twice

weekly dosing schedule.

Trial Contact Information

Trial Lead Organizations / Sponsors / Collaborators

Celgene Corporation

    Trial Sites


    Los Angeles

    USC / Norris Comprehensive Cancer Center

    Ann Mohrbacher
    Principal Investigator


    University of Colorado Cancer Center - Anschutz Cancer Pavilion

    Clayton Allan Smith
    Principal Investigator


    University of Chicago Comprehensive Cancer Center

    Andrzej J. Jakubowiak
    Principal Investigator


    Beth Israel Deaconess Medical Center

    Jacalyn M. Rosenblatt

    Jacalyn M. Rosenblatt
    Principal Investigator

    Dana-Farber Cancer Institute

    Paul Gerard Guy Richardson
    Principal Investigator


    Massachusetts General Hospital

    Andrew Yee

    Andrew Yee
    Principal Investigator

    New York

    Albert Einstein College of Medicine

    Ramakrishna Battini
    Principal Investigator

    South Carolina

    Medical University of South Carolina

    Luciano Jose Megale Costa
    Principal Investigator


    Vanderbilt University/Ingram Cancer Center

    Madan Harikishin Jagasia
    Principal Investigator


    UT Southwestern/Simmons Cancer Center-Dallas

    Larry D. Anderson
    Principal Investigator

    Link to the current record.
    NLM Identifer NCT01734928

    Note: Information about participating sites on pharmaceutical industry trials may be incomplete. Please visit the record via the link above for more information about participating sites.