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A Multicenter, Single-Arm, Open-Label Study With Pomalidomide in Combination With Low Dose Dexamethasone in Subjects With Refractory or Relapsed and Refractory Multiple Myeloma


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

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Trial Information

A Multicenter, Single-Arm, Open-Label Study With Pomalidomide in Combination With Low Dose Dexamethasone in Subjects With Refractory or Relapsed and Refractory Multiple Myeloma


Inclusion Criteria:



- Patients ≥18 years old, who must understand and voluntarily sign an Informed Consent.

- Patients must have documented diagnosis of Multiple Myeloma and have measurable
disease.

- Patients must have undergone prior treatment with ≥ 2 treatments lines, of
anti-myeloma therapy.

- Patients must have either refractory or relapsed and refractory disease.

- Patients must have received at least 2 consecutive cycles of prior treatment that
include lenalidomide and bortezomib, either alone or in combination regimens.

- Patients must have received adequate alkylator therapy

Exclusion Criteria:

- Prior history of malignancies, other than Multiple Myeloma.

- Previous therapy with Pomalidomide, hypersensitivity to thalidomide and lenalidomide
or dexamethasone.

- Patients who received an allogeneic bone marrow or allogeneic peripheral blood stem
cell transplant.

- Patients who are planning for or who are eligible for stem cell transplant.

- Patients who received major surgery and any anti-myeloma drug therapy within the last
14 days of starting study treatment.

- Patients with a current disease that can interfere with protocol procedures or study
treatment.

- Patients unable or unwilling to undergo antithrombotic prophylactic treatment.

- Pregnant or breastfeeding females.

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Adverse Events

Outcome Description:

Number of participants with adverse events

Outcome Time Frame:

Up to 5 years

Safety Issue:

Yes

Principal Investigator

Nicolas Leupin, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Celgene Corporation

Authority:

United States: Food and Drug Administration

Study ID:

CC-4047-MM-010

NCT ID:

NCT01712789

Start Date:

November 2012

Completion Date:

November 2019

Related Keywords:

  • Multiple Myeloma
  • Multiple Myeloma
  • Relapsed Multiple Myeloma
  • Relapsed and refractory Multiple Myeloma
  • Pomalidomide
  • Dexamethasone
  • Multiple Myeloma
  • Neoplasms, Plasma Cell

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