Pomalidomide in Combination With Low Dose Dexamethasone in Subjects With Relapsed and Refractory Multiple Myeloma Following Lenalidomide Plus Low Dose Dexamethasone as Second Line Treatment.
Conditions
Multiple Myeloma
Conditions: official terms
Multiple Myeloma - Neoplasms, Plasma Cell
Conditions: Keywords
Multiple Myeloma, MM, cancer, oncology, hematology, plasma, neoplasm, plasmacytoma
Study Type
Interventional
Study Phase
Phase 2
Study Design
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: Pomalidomide Type: Drug
Name: Dexamethasone Type: Drug
Overall Status
Recruiting
Summary
This trial will evaluate the efficacy and safety of combination third-line treatment of pomalidomide (POM) and low-dose dexamethasone (LD-Dex) in subjects with relapsed or refractory multiple myeloma who have received a second line treatment of lenalidomide-based therapy.

This trial will test the hypothesis that the proportion of patients will have an Overall Response Rate (ORR) of > 30 % to reveal that Pomalidomide is efficacious in pre-treated patients who are refractory to lenalidomide.
Detailed Description
This is a multi-center, single-arm, open-label, phase 2 trial designed to further evaluate the efficacy and safety of combination pomalidomide and low-dose dexamethasone in subjects with relapsed or refractory multiple myeloma who received a lenalidomide-based regimen in the second line.

This trial will assess, Overall Response Rate (ORR), Overall Survival (OS), Progression-Free Survival (PFS), Duration of Response (DoR), Time to Response (TTR), Time to Progression(TTP) and safety.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Both
Criteria: Inclusion Criteria:

- 1. Adults ( age ≥ 18 years at the time of signing the informed consent document) with documented diagnosis of multiple myeloma and measurable disease (serum M-protein ≥ 0.5 dL or urine M-protein ≥ 200 mg/24 hours).

2. Subjects must have received 2 prior treatment lines of anti-myeloma therapy. 3. All subjects must have received prior treatment with LEN or a LEN-containing regimen for at least 2 consecutive cycles as the second-line treatment regimen.

4. All subjects must have documented disease progression during or after their last anti-myeloma therapy.

5. Subjects must have an Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1, or 2.

6. Subjects must understand and voluntarily sign an informed consent prior to any study related assessments/procedures being conducted.

7. Subjects must be able to adhere to the study visit schedule and other protocol requirements.

8. All subjects must provide an adequate bone marrow sample at screening that definitively evaluates the presence or absence of myelodysplastic changes.

9. Females with child-bearing potential (FCBP† ) must agree to use 2 reliable forms of contraception simultaneously or practice complete abstinence from heterosexual contact for at least 28 days before starting study drug, while participating in the study (including during dose interruptions), and for at least 28 days after study treatment discontinuation and must agree to regular pregnancy testing during this timeframe.

10. Females must agree to abstain from breastfeeding during study participation and 28 days after study drug discontinuation.

11. Males must agree to use a latex condom during any sexual contact with female of childbearing potential (FCBP) while participating in the study and for 28 days following discontinuation from this study, even if he has undergone a successful vasectomy.

12. Males must also agree to refrain from donating semen or sperm during the treatment phase and for 28 days after discontinuation from this study treatment.

13. All subjects must agree to refrain from donating blood while on study therapy and for 28 days after discontinuation from this study treatment.

14. All subjects must agree not to share medication.

Exclusion Criteria:

- 1. Any of the following laboratory abnormalities:

- Absolute neutrophil count < 1,000/μL

- Platelet count < 75,000/µL for subjects in whom < 50% of bone marrow nucleated cells are plasma cells; or a platelet count < 30,000/µL for subjects in whom ≥ 50% of bone marrow nucleated cells are plasma cells.

- Severe renal impairment (Creatinine Clearance < 30 mL/min) requiring dialysis.

- Corrected serum calcium > 11.5 mdL (> 2.8 mmol/L)

- Hemoglobin < 8 dL (< 4.9 mmol/L; prior red blood cell transfusion or recombinant human erythropoietin use is permitted)

- Serum glutamic-oxaloacetic transaminase(SGOT)/ aspartate aminotransferase or glutamic-pyruvic transaminase (SGPT)/alanine aminotransferase (ALT) > 3.0 x ULN

- Serum total bilirubin > 2.0 mdL (34.2 μmol/L); or > 3.0 x ULN for subjects with hereditary benign hyperbilirubinemia 2. Prior history of malignancies, other than multiple myeloma, unless the subject has been free of the disease for ≥ 5 years. Allowed exceptions include the following:

- Basal or squamous cell carcinoma of the skin

- Carcinoma in situ of the cervix or breast

- Incidental histological finding of prostate cancer (TNM [tumor, nodes, metastasis] stage of T1a or T1b) 3. Previous therapy with Pomalidomide 4. Hypersensitivity to thalidomide, lenalidomide, or dexamethasone (this includes ≥ Grade 3 rash during prior thalidomide or lenalidomide therapy) 5. Subjects who received an allogeneic bone marrow or allogeneic peripheral blood stem cell transplant less than 12 months prior to initiation of study treatment and who have not discontinued immunosuppressive treatment for at least 4 weeks prior to initiation of study treatment and are currently dependent on such treatment.

6. Subjects with any one of the following:

- Congestive heart failure (New York Heart Association Class III or IV)

- Myocardial infarction within 12 months prior to starting study treatment

- Unstable or poorly controlled angina pectoris, including Prinzmetal's variant angina pectoris 7. Subjects who received any of the following within 14 days of initiation of study treatment:

- Major surgery (kyphoplasty is not considered major surgery)

- Use of any anti-myeloma drug therapy 8. Use of any investigational agents within 28 days or 5 half-lives (whichever is longer) of treatment, unless approved by the sponsor.

9. Incidence of gastrointestinal disease that may significantly alter the absorption of Pomalidomide.

10. Subjects unable or unwilling to undergo antithrombotic prophylactic treatment 11. Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent document.

12. Pregnant or breastfeeding females 13. Known Human immunodeficiency virus positivity; active infectious hepatitis A, B, or C; or chronic hepatitis B or C
Locations
UCLA Medical Center
Los Angeles, California, United States
Status: Recruiting
Bay Area Cancer Research Group, LLC
Pleasant Hill, California, United States
Status: Recruiting
Innovative Clinical Research Institute
Whittier, California, United States
Status: Recruiting
Carroll Regional Cancer Center
Westminster, Maryland, United States
Status: Recruiting
St. Luke's Hospital
Kansas City, Missouri, United States
Status: Recruiting
Washington University
St. Louis, Missouri, United States
Status: Recruiting
Veterans Administration New Jersey Health Care System
East Orange, New Jersey, United States
Status: Not yet recruiting
Hackensack University Medical Center
Hackensack, New Jersey, United States
Status: Recruiting
Cleveland Clinic
Cleveland, Ohio, United States
Status: Not yet recruiting
Penn State Hershey Medical Center
Hershey, Pennsylvania, United States
Status: Recruiting
Cancer Care Northwest
Spokane, Washington, United States
Status: Recruiting
Tom Baker Cancer Center University of Calgary
Calgary, Alberta, Canada
Status: Recruiting
Vancouver General Hospital
Vancouver, British Columbia, Canada
Status: Recruiting
Princess Margaret Cancer Centre
Toronto, Ontario, Canada
Status: Recruiting
Royal Victoria Hospital
Montreal, Quebec, Canada
Status: Not yet recruiting
Fundacion de Investigacion
San Juan, Puerto Rico
Status: Not yet recruiting
Start Date
September 2013
Completion Date
December 2020
Sponsors
Celgene Corporation
Source
Celgene Corporation
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page