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

Study ID
CC-4047-MM-007

Cancer Related
Yes

Healthy Volunteers
No

Study Sites

  • Clements University Hospital
  • UT Southwestern Ambulatory Services
  • Zale Lipshy University Hospital

Contact
James Pond
214/648-7030
blake.pond@utsouthwestern.edu

Principal Investigator
Larry Anderson

Official Title

A Phase 3, Multicenter, Randomized, Open-label Study to Compare the Efficacy and Safety of Pomalidomide (POM), Bortezomib (BTZ) and Low-Dose Dexamethasone (LD-DEX) Versus Bortezomib and Low-Dose Dexamethasone in Subjects With Relapsed or Refractory Multiple Myeloma (MM)

Brief Overview


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

Participant Eligibility


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.