This trial is active, not recruiting.

Condition multiple myeloma
Treatments pomalidomide, dexamethasone
Phase phase 3
Sponsor Celgene Corporation
Start date November 2012
End date December 2019
Trial size 682 participants
Trial identifier NCT01712789, 2012-001888-78, CC-4047-MM-010


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety study
Intervention model single group assignment
Masking open label
Primary purpose treatment
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.
Oral Pomalidomide at the starting dose of 4 mg on Days 1-21 of a 28-day cycle
Oral Low dose Dexamethasone at the starting dose of 40mg/day (≤ 75 years old) or 20 mg/day (> 75 years old) on Days 1, 8, 15 and 22 of a 28-day cycle.

Primary Outcomes

Adverse Events
time frame: Up to 5 years

Secondary Outcomes

time frame: Up to 5 years
time frame: Up to 5 years
time frame: Up to 5 years
Overall response rate
time frame: Up to 5 years
Time to response
time frame: Up to 5 years
Duration of response
time frame: Up to 5 years
Progression-free survival
time frame: Up to 5 years
Time to progression
time frame: Up to 5 years
Overall survival
time frame: Up to 5 years
POM population pharmacokinetics and exposure-response
time frame: During the first 6 cycles of treatment

Eligibility Criteria

Male or female participants at least 18 years old.

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.

Additional Information

Official title 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
Principal investigator Nicolas Leupin, MD
Trial information was received from ClinicalTrials.gov and was last updated in October 2016.
Information provided to ClinicalTrials.gov by Celgene Corporation.