Efficacy and Safety of Pomalidomide and Dexamethasone in RRMM Patients With Renal Insufficiency

Sponsor
Celgene (Industry)
Overall Status
Completed
CT.gov ID
NCT02045017
Collaborator
(none)
81
22
1
88.9
3.7
0

Study Details

Study Description

Brief Summary

The primary purpose of the study is to determine the safety and efficacy and to generate PK and biomarker data for the combination of Pomalidomide and low-dose Dexamethasone in patients with relapsed or refractory multiple myeloma, with moderate or severe renal impairment.

Condition or Disease Intervention/Treatment Phase
  • Drug: Pomalidomide and Dexamethasone
Phase 2

Detailed Description

The study will consist of a Screening phase within 28 days prior to cycle 1 day 1. Subjects once enrolled will enter the Treatment phase, in which patients will be treated until progression, or study discontinuation due to other reasons. Subjects will enter the long term Follow-up phase of the study where data will be collected every 3 months for up to 5 years on Secondary primary malignancies, survival, subsequent anti myeloma treatments and date of progression. Subjects will be recruited into one of 3 cohorts depending on the severity of their renal impairment.

Study Design

Study Type:
Interventional
Actual Enrollment :
81 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Phase 2 Multicenter, Open-label Study to Determine the Efficacy and Safety of Pomalidomide (CC-4047) in Combination With Low-Dose Dexamethasone in Subjects With Relapsed or Refractory Multiple Myeloma and Moderate or Severe Renal Impairment Including Subjects Undergoing Hemodialysis
Actual Study Start Date :
Feb 28, 2014
Actual Primary Completion Date :
Jan 27, 2017
Actual Study Completion Date :
Jul 28, 2021

Arms and Interventions

Arm Intervention/Treatment
Experimental: Pomalidomide and low dose Dexamethasone

Pomalidomide 4mg, and low dose Dexamethasone, starting at 40mgs(≤ 75 years old) or 20 mg/day (> 75 years old)

Drug: Pomalidomide and Dexamethasone
Other Names:
  • Tablet
  • Outcome Measures

    Primary Outcome Measures

    1. Evaluate efficacy of the combination of pomalidomide and low-dose dexamethasone in subjects with RRMM and impaired renal function [Approximately 2 years]

      Overall response rate determined by Myeloma responses determined by modified IMWG criteria

    Secondary Outcome Measures

    1. Assessment of renal response according to the criteria defined by Dimopoulos and Ludwig (Dimopoulos, 2009; Dimopoulos, 2010 b,c; Ludwig, 2010). [Approximately 2 years]

      Assessment of renal response according to the criteria defined by Ludwig and Dimopoulos

    2. Time to Myeloma response [Approximately 2 years]

      Evaluated according to the CTCAE grading

    3. Time to renal response [Approximately 2 years]

      Evaluated according to the CTCAE grading

    4. Duration of response [Approximately 2 years]

      Evaluated according to the CTCAE grading

    5. Progression-free survival [Approximately 2 years]

      Evaluated according to the CTCAE grading

    6. Time to progression [Approximately 2 years]

      Evaluated according to the CTCAE grading

    7. Overall Survival [Approximately 2 years]

      Evaluated according to the CTCAE grading

    8. Adverse events (AEs) assessment (type, frequency, seriousness, severity, relationship to pomalidomide and/or dexamethasone and outcomes) including second primary malignancy (SPM). [Approximately 2 years]

      Pharmacokinetics (PK) of pomalidomide in subjects with RRMM and impaired renal function (moderate to severe renal impairment).

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Subjects must satisfy the following criteria to be enrolled in the study.
    1. Subjects must have documented diagnosis of multiple myeloma and have measurable disease (serum M-protein ≥ 0.5 g/dL or urine M-protein ≥ 200 mg/24 hours).

    2. Subjects must have had at least 1 prior antimyeloma regimen including lenalidomide and documented progression as per the International Myeloma Working Group uniform response criteria (Durie, 2006) during or after the last antimyeloma regimen. Induction therapy followed by Autologous Stem Cell Transplant and consolidation/ maintenance will be considered as one regimen.

    3. Subjects must have an impaired renal function with an estimated Glomerular Filtrate Rate of < 45 mL/min/1.73 m2 according to the modification of diet in renal disease equation.

    4. Impaired renal function must be due to multiple myeloma which needs to be confirmed by kidney biopsy.

    5. Subjects may have acute myeloma related renal failure or chronic myeloma related renal failure; they may also have been treated with dialysis before, including dialysis with high cut off membranes.

    Exclusion Criteria:

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

    1. Any significant medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from participating in the study.

    2. Any condition including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study.

    3. Renal insufficiency due to other reasons than multiple myeloma or due to hypocalcaemia only.

    4. Prior history of malignancies, other than MM, unless the subject has been free of the disease for ≥ 5 years; exceptions include the following:

    5. Basal or squamous cell carcinoma of the skin

    6. Carcinoma in situ of the cervix or breast

    7. Incidental histological finding of prostate cancer (Tumour lymphNode Metastasis stage of T1a or T1b)

    8. Previous therapy with pomalidomide. 7. Hypersensitivity to thalidomide, lenalidomide, or dexamethasone (this includes ≥ Grade 3 rash during prior thalidomide or lenalidomide therapy).

    9. Subjects who are planning for or who are eligible for stem cell transplant.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Krankenhaus der Elisabethinen Linz, I Interne Abteilung Linz Austria 4020
    2 Medizinische Universitat Wien Wien Austria 1090
    3 Wilhelminenspital der Stadt Wien Wien Austria 1160
    4 Hopital Dypuytren-CHU de Limoges Limoges cedex France 87042
    5 Hopital Saint Louis Paris France 75475
    6 CHU de Poitiers Poitiers France 86021
    7 Medizinische Klinik und Poliklinik V Hamatologie, Onkologie und Rheumatologie Neuenheimer Feld 410 Germany 69120
    8 University Hospital Tubingen Tubingen Germany 72076
    9 Alexandra Hospital, University of Athens Athens Greece 11528
    10 Azienda Ospedaliero Universitaria Ospedali Ancona Italy 60126
    11 S.C. Oncologia Medica Lecco Italy 23900
    12 Ospedale Maggiore Policlinico Mangiagalli Regina Elena Milano Italy 20122
    13 Arcispedale Santa Maria Nuova Reggio Emilia Italy 42100
    14 VU University Medical Center VU Medisch Centrum Amsterdam Netherlands 1081 HV
    15 Daniel den Hoed Kliniek Medical Oncology, Erasmus MC Rotterdam Netherlands 3075 EA
    16 Hospital de La Princesa Madrid Spain 28006
    17 CEIC Hospital Universitario de Salamanca Salamanca Spain 37007
    18 Hospital Universitario Doctor Peset Valencia Spain 46017
    19 Queen Elizabeth Hospital UHB NHS Foundation Trust Birmingham United Kingdom B15 2TH
    20 Ninewells Hospital and Medical School Dundee United Kingdom DD1 9SY
    21 Oxford Radcliffe Hospital ICRF Medical Oncology Unit Headington United Kingdom OX37LJ
    22 St Thomas' HospitalGuy's Hospital Dept. of Haematology London United Kingdom SE1 9RT

    Sponsors and Collaborators

    • Celgene

    Investigators

    • Study Director: Elisabeth Kueenburg, MD, Celgene

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Celgene
    ClinicalTrials.gov Identifier:
    NCT02045017
    Other Study ID Numbers:
    • CC-4047-MM-013
    • 2013-001903-36
    First Posted:
    Jan 24, 2014
    Last Update Posted:
    Aug 27, 2021
    Last Verified:
    Aug 1, 2021

    Study Results

    No Results Posted as of Aug 27, 2021