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

PhaseTypeStatusAgeTrial IDs
Phase IIITreatmentActive18 and overCC-4047-MM-007
NCI-2013-00024, NCT01734928

Trial Description

Summary

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:

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

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

serum and urine protein electrophoresis.

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

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

therapy.

All subjects must have received prior treatment with a lenalidomide containing

regimen for at least 2 consecutive cycles.

Exclusion Criteria:

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

weekly dosing schedule.

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

randomization.

Non-secretory multiple myeloma.

Subjects with severe renal impairment requiring dialysis.

Previous therapy with pomalidomide.

Trial Contact Information

Trial Lead Organizations / Sponsors / Collaborators

Celgene

    Link to the current ClinicalTrials.gov record.
    NLM Identifier NCT01734928

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