Evaluation of Safety of Pomalidomide in Combination With Dexamethasone (Low Dose) in Patients With Refractory or Relapsed and Refractory Multiple Myeloma (STRATUS)

Celgene

Status and phase: Completed; Phase 3

Conditions: Multiple Myeloma

Treatments: Drug: Dexamethasone; Drug: Pomalidomide

Study type: Interventional

Funder types: Industry

Identifiers

NCT01712789

2012-001888-78 (EudraCT Number)

CC-4047-MM-010

Details and patient eligibility

About

The primary purpose of the study is to evaluate the safety and efficacy and to generate PK and biomarker data for the combination of pomalidomide and low-dose dexamethasone in patients with refractory or relapsed and refractory multiple myeloma.

The study consists of a Screening phase within 28 days prior to cycle 1 day 1, a Treatment phase and a Follow-up phase which starts within 28 days of discontinuation from study treatment, every 3 months for up to 5 years.

In addition, the collection of steady-state PK data from a large population will enable robust population PK and assess Pomalidomide exposure response analyses.

The exploratory objectives of the study are to investigate potential markers predictive of POM response or resistance and pharmacodynamic markers.

Enrollment: 682 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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682 participants in 1 patient group

Pomalidomide plus Dexamethasone

Experimental group

Description:

Pomalidomide 4mg by mouth (PO) daily days 1 through 21 of a 28 day cycle and dexamethasone 40mg/day PO for those ≤75 years of age or 20mg/day for those greater than 75 years of age on Days 1, 8, 15 and 22 of a 28 day cycle.

Treatment:

Drug: Pomalidomide

Drug: Dexamethasone