Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Study of Pomalidomide to Evaluate the Pharmacokinetics and Safety for Patients With Multiple Myeloma and Impaired Renal Function (POM Renal) (POM Renal)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01575925
Recruitment Status : Active, not recruiting
First Posted : April 12, 2012
Last Update Posted : May 6, 2021
Sponsor:
Information provided by (Responsible Party):
Celgene

Brief Summary:
The purpose of this study is to determine the pharmacokinetics (PK) and safety for the combination of pomalidomide (POM) + low-dose dexamethasone (LD- DEX) in subjects with relapsed or refractory Multiple Myeloma (RRMM) and impaired renal function.

Condition or disease Intervention/treatment Phase
Multiple Myeloma Renal Impairment Drug: 4 mg Oral POM + 40 mg Oral DEX Drug: 2 mg Oral POM + 40 mg Oral DEX Phase 1

Detailed Description:

The primary objective of the study is to determine the PK and safety for the combination of POM + (LD-DEX) in subjects with RRMM and impaired renal function.

The secondary objective of the study is to evaluate the efficacy of POM + (LD_DEX) in subjects with RRMM and impaired renal function.

This is a 3+3 dose escalation design, with one cohort each for patients with severely impaired renal function patients (CrCl < 30 mL/min) requiring and not requiring dialysis respectively. There will also be one control cohort with normal renal function, these patients will receive 4 mg POM. Dosing will be 21 days out of a 28 day cycle.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 25 participants
Allocation: Non-Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1 Multi-Center, Open-Label, Dose-Escalation Study to Determine the Pharmacokinetics and Safety of Pomalidomide When Given in Combination With Low Dose Dexamethasone in Subjects With Relapsed or Refractory Multiple Myeloma and Impaired Renal Function
Actual Study Start Date : June 1, 2012
Estimated Primary Completion Date : June 11, 2021
Estimated Study Completion Date : June 11, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 4 mg Oral POM + 40 mg Oral DEX
Oral POM at 4 mg on days 1-21 of a 28-day cycle, Oral DEX at 40 mg/day (≤ 75 years old) or 20 mg/day (> 75 years old) on days 1, 8, 15 and 22 of a 28-day cycle
Drug: 4 mg Oral POM + 40 mg Oral DEX
Other Names:
  • Pomalidomide (POM)
  • Dexamethasone

Experimental: 2 mg Oral POM + 40 mg Oral DEX
Oral POM at 2 mg on days 1-21 of a 28-day cycle, Oral DEX at 40 mg/day (≤ 75 years old) or 20 mg/day (> 75 years old) on days 1, 8, 15 and 22 of a 28-day cycle
Drug: 2 mg Oral POM + 40 mg Oral DEX
Other Names:
  • Pomalidomide (POM)
  • Dexamethasone




Primary Outcome Measures :
  1. PK-Area under the plasma concentration time curve (AUC) [ Time Frame: Up to 24 times over 7 months ]
    PK-Area under the plasma concentration time curve (AUC)

  2. PK-Time to maximum plasma concentration (Cmax) [ Time Frame: 24 times over 7 months ]
    PK-Time to maximum plasma concentration (Cmax)

  3. PK-Apparent total body clearance (CL/F) [ Time Frame: 24 times up to 7 months ]
    PK-Apparent total body clearance (CL/F)

  4. PK-Renal clearance (CLr) [ Time Frame: 24 times over 7 months ]
    PK-Renal clearance (CLr)

  5. PK-Apparent volume of distribution (V/F) [ Time Frame: 24 times over 7 months ]
    PK-Apparent volume of distribution (V/F)

  6. PK-Effective terminal half-life (T1/2) [ Time Frame: 24 times over 7 months ]
    PK-Effective terminal half-life (T1/2)


Secondary Outcome Measures :
  1. Number of participants with adverse events (AEs) [ Time Frame: Up to 5 years ]
    Number of participants with adverse events (AEs)

  2. Number of participants alive [ Time Frame: Up to 5 years ]
    Number of participants alive

  3. Time to response [ Time Frame: Up to 5 years ]
    Time to response

  4. Duration of response [ Time Frame: Up to 5 years ]
    Duration of response



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Subjects must satisfy the following criteria to be enrolled in the study:

  1. Must be ≥ 18 years at the time of signing the informed consent form
  2. Must understand and voluntarily sign an informed consent document prior to any study-related assessments/procedures
  3. Must be able to adhere to the study visit schedule and other protocol requirements
  4. Must have documented diagnosis of relapsed or refractory multiple myeloma and have measurable disease (serum M-protein ≥ 0.5 g/dL or urine M-protein ≥ 200 mg/24 hours)
  5. Must have had at least 1 prior anti-myeloma regimen
  6. Must have documented progression as per the International Myeloma Working Group uniform response criteria (Durie, 2006) during or after the last anti-myeloma regimen
  7. Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1, or 2
  8. Females of childbearing potential (FCBP) must agree to utilize two 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 dose interruptions), and for at least 28 days after study treatment discontinuation, and must agree to regular pregnancy testing during this timeframe
  9. Females must agree to abstain from breastfeeding during study participation and for 28 following discontinuation from study treatment
  10. Males must agree to use a latex condom during any sexual contact with FCBP while participating in the study and for 28 days following discontinuation from study treatment, even if he has undergone a successful vasectomy
  11. Males must also agree to refrain from donating semen or sperm while on pomalidomide and for 28 days after discontinuation from study treatment
  12. All subjects must agree to refrain from donating blood while on study drug and for 28 days after discontinuation from study treatment
  13. All subjects must agree not to share medication

Exclusion Criteria:

The presence of any of the following will exclude a subject from enrollment:

  1. Peripheral neuropathy ≥ Grade 2
  2. Non-secretory multiple myeloma
  3. Any of the following laboratory abnormalities:

    • Absolute neutrophil count (ANC) < 1,000/µL
    • Platelet count < 75,000/µL
    • Corrected serum calcium > 14 mg/dL (> 3.5 mmol/L)
    • Hemoglobin < 8 g/dL (< 4.9 mmol/L; prior RBC transfusion or recombinant human erythropoietin use is permitted)
    • Serum glutamic oxaloacetic transaminase/aspartate aminotransferase (SGOT/AST) or serum glutamic pyruvic transaminase/alanine aminotransferase (SGPT/ALT) > 3.0 x upper limit of normal (ULN)
    • Serum total bilirubin > 2.0 mg/dL
  4. Prior history of malignancies, other than the disease being studied, unless the subject has been free of the malignancy for ≥ 5 years from initiating study treatment, with the following exceptions:

    • Basal cell carcinoma of the skin
    • Squamous cell carcinoma of the skin
    • Carcinoma in situ of the cervix
    • Carcinoma in situ of the breast
    • Incidental histologic finding of prostate cancer (T1a or T1b using the TNM [tumor, nodes, metastasis] clinical staging system).
  5. Previous therapy with Pomalidomide
  6. Hypersensitivity to thalidomide, lenalidomide, or dexamethasone
  7. Rash ≥ Grade 3 during prior thalidomide or lenalidomide therapy
  8. Incidence of gastrointestinal disease that may significantly alter the absorption of pomalidomide
  9. 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 variant angina pectoris
  10. Subjects who received any of the following within the last 14 days of initiation of study treatment:

    • Plasmapheresis
    • Major surgery (kyphoplasty is not considered major surgery)
    • Radiation therapy (with the exception of radiation therapy to a pathological fracture site to enhance bone healing or to treat post-fracture pain that is refractory to narcotic analgesics)
    • Any anti-myeloma drug therapy
  11. Use of any investigational agents within 28 days or 5 half-lives (whichever is longer) of initiating study treatment
  12. Subjects with conditions requiring chronic steroid or immunosuppressive treatment, such as rheumatoid arthritis, multiple sclerosis, and lupus, which likely need additional steroid or immunosuppressive treatments in addition to the study treatment. Includes subjects receiving corticosteroids (> 10 mg/day of prednisone or equivalent) within 3 weeks prior to initiating study treatment
  13. Subjects unable or unwilling to undergo antithrombotic prophylactic treatment will not be eligible to participate in this study
  14. Any condition, including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study
  15. Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subjects from signing the informed consent form
  16. Pregnant or breastfeeding females

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01575925


Locations
Layout table for location information
United States, Colorado
Colorado Blood Cancer Institute
Denver, Colorado, United States, 80218
United States, Georgia
Winship Cancer Institute of Emory University
Atlanta, Georgia, United States, 30322
United States, Illinois
Ingalls Cancer Research Center
Harvey, Illinois, United States, 60426
United States, New Jersey
Hackensack University Medical Center
Hackensack, New Jersey, United States, 07601
United States, New York
Weill Cornell Medical College
New York, New York, United States, 10065
United States, Ohio
Cleveland Clinic
Cleveland, Ohio, United States, 44195
United States, Texas
MD Anderson Cancer Center
Houston, Texas, United States, 77030
Canada, Nova Scotia
Queen Elizabeth II Health Sciences Centre
Halifax, Nova Scotia, Canada, B3H 2Y9
Canada
L'Hotel Dieu de Quebec
Quebec, Canada, G1R 2J6
Sponsors and Collaborators
Celgene
Investigators
Layout table for investigator information
Study Director: Lars Sternas, MD Celgene Corporation
Publications:
Layout table for additonal information
Responsible Party: Celgene
ClinicalTrials.gov Identifier: NCT01575925    
Other Study ID Numbers: CC-4047-MM-008
First Posted: April 12, 2012    Key Record Dates
Last Update Posted: May 6, 2021
Last Verified: May 2021
Keywords provided by Celgene:
Pomalidomide for multiple myeloma
renal impairment
multiple myeloma patients with renal impairment
Pomalidomide for patients with renal impairment due to multiple myeloma
Pomalidomide
dexamethasone
RRMM
impaired renal function in multiple myeloma
hemodialysis
dialysis
POM
Pomalyst
MM
severe renal impairment
CrCl ≤ 30 mL/min
Creatinine less than 30
clinical trial in subjects with multiple myeloma with renal impairement
Additional relevant MeSH terms:
Layout table for MeSH terms
Multiple Myeloma
Neoplasms, Plasma Cell
Renal Insufficiency
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Kidney Diseases
Urologic Diseases
Thalidomide
Dexamethasone
Dexamethasone acetate
Pomalidomide
BB 1101
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones