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A Phase 3, Multicenter, Randomized, Open-Label Study to Compare the Efficacy and Safety of Pomalidomide, Bortezomib and Low-Dose Dexamethasone Versus Bortezomib and Low-Dose Dexamethasone in Subjects With Relapsed or Refractory Multiple Myeloma


Phase 3
18 Years
N/A
Open (Enrolling)
Both
Multiple Myeloma

Thank you

Trial Information

A Phase 3, Multicenter, Randomized, Open-Label Study to Compare the Efficacy and Safety of Pomalidomide, Bortezomib and Low-Dose Dexamethasone Versus Bortezomib and Low-Dose Dexamethasone in Subjects With Relapsed or Refractory Multiple Myeloma


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.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Progression Free Survival

Outcome Description:

The length of time during and after the treatment that participants in the study live without the disease getting worse

Outcome Time Frame:

Up to 1 year

Safety Issue:

No

Principal Investigator

Ye Hua, MD

Investigator Role:

Study Director

Investigator Affiliation:

Celgene Corporation

Authority:

United States: Food and Drug Administration

Study ID:

CC-4047-MM-007

NCT ID:

NCT01734928

Start Date:

December 2012

Completion Date:

January 2017

Related Keywords:

  • Multiple Myeloma
  • Multiple Myeloma
  • Pomalidomide
  • Multiple Myeloma
  • Neoplasms, Plasma Cell

Name

Location

Celgene Study SiteWest Palm Beach, Florida  33401
Celgene Study SiteMarietta, Georgia  30060
Celgene Study SiteBaltimore, Maryland  21215
Celgene Study SiteSt. Louis, Missouri  63110
Celgene Study SiteOmaha, Nebraska  68198
Celgene Study SiteHackensack, New Jersey  07601
Celgene Study SiteSioux Falls, South Dakota  57105
Celgene Study SiteDallas, Texas  75390
Celgene Study SiteMilwaukee, Wisconsin  53226
Celgene Study SiteWashington, District of Columbia  20037
Celgene Study SiteNew Orleans, Louisiana  70112
Celgene Study SiteBrewer, Maine  04412
Celgene Study SiteBillings, Montana  59102
Celgene Study SiteCanton, Ohio  44718
Celgene Study SiteNashville, Tennessee  37232