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

August 25, 2021 updated by: Celgene

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

81

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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).

5. 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.

6. 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.

  1. Impaired renal function must be due to multiple myeloma which needs to be confirmed by kidney biopsy.
  2. 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:

    1. Basal or squamous cell carcinoma of the skin
    2. Carcinoma in situ of the cervix or breast
    3. Incidental histological finding of prostate cancer (Tumour lymphNode Metastasis stage of T1a or T1b)

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

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluate efficacy of the combination of pomalidomide and low-dose dexamethasone in subjects with RRMM and impaired renal function
Time Frame: Approximately 2 years
Overall response rate determined by Myeloma responses determined by modified IMWG criteria
Approximately 2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Assessment of renal response according to the criteria defined by Dimopoulos and Ludwig (Dimopoulos, 2009; Dimopoulos, 2010 b,c; Ludwig, 2010).
Time Frame: Approximately 2 years
Assessment of renal response according to the criteria defined by Ludwig and Dimopoulos
Approximately 2 years
Time to Myeloma response
Time Frame: Approximately 2 years
Evaluated according to the CTCAE grading
Approximately 2 years
Time to renal response
Time Frame: Approximately 2 years
Evaluated according to the CTCAE grading
Approximately 2 years
Duration of response
Time Frame: Approximately 2 years
Evaluated according to the CTCAE grading
Approximately 2 years
Progression-free survival
Time Frame: Approximately 2 years
Evaluated according to the CTCAE grading
Approximately 2 years
Time to progression
Time Frame: Approximately 2 years
Evaluated according to the CTCAE grading
Approximately 2 years
Overall Survival
Time Frame: Approximately 2 years
Evaluated according to the CTCAE grading
Approximately 2 years
Adverse events (AEs) assessment (type, frequency, seriousness, severity, relationship to pomalidomide and/or dexamethasone and outcomes) including second primary malignancy (SPM).
Time Frame: Approximately 2 years
Pharmacokinetics (PK) of pomalidomide in subjects with RRMM and impaired renal function (moderate to severe renal impairment).
Approximately 2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Celgene

Investigators

  • Study Director: Elisabeth Kueenburg, MD, Celgene

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 28, 2014

Primary Completion (Actual)

January 27, 2017

Study Completion (Actual)

July 28, 2021

Study Registration Dates

First Submitted

December 16, 2013

First Submitted That Met QC Criteria

January 23, 2014

First Posted (Estimate)

January 24, 2014

Study Record Updates

Last Update Posted (Actual)

August 27, 2021

Last Update Submitted That Met QC Criteria

August 25, 2021

Last Verified

August 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CC-4047-MM-013
  • 2013-001903-36 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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