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

Information source: Celgene Corporation
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Multiple Myeloma

Intervention: Pomalidomide and Dexamethasone (Drug)

Phase: Phase 2

Status: Active, not recruiting

Sponsored by: Celgene Corporation

Official(s) and/or principal investigator(s):
Elisabeth Kueenburg, MD, Study Director, Affiliation: Celgene Corporation

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.

Clinical Details

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

Study design: Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Evaluate efficacy of the combination of pomalidomide and low-dose dexamethasone in subjects with RRMM and impaired renal function

Secondary outcome:

Assessment of renal response according to the criteria defined by Dimopoulos and Ludwig (Dimopoulos, 2009; Dimopoulos, 2010 b,c; Ludwig, 2010).

Time to Myeloma response

Time to renal response

Duration of response

Progression-free survival

Time to progression

Overall Survival

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

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.

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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.

Locations and Contacts

Hôpital Dupuytren, Limoges 87042, France

Hôpital Saint Louis, Paris 75010, France

CHU de Poitiers, Poitiers 86021, France

Universitätsklinikum Heidelberg, Heidelberg 69120, Germany

Universitätsklinikum Tübingen, Tübingen 72076, Germany

Alexandras Hospital, Athens 11528, Greece

Ospedali Riuniti di Ancona Umberto I,, Ancona 60126, Italy

Ospedale "Alessandro Manzoni", Lecco 23900, Italy

Arcispedale S. Maria Nuova, Reggio Emilia 42100, Italy

Erasmus MC, Rotterdam 3015CE, Netherlands

Hospital de la Princesa, Madrid 28006, Spain

Hospital Universitario Salamanca, Salamanca 33007, Spain

Queen Elizabeth Hospital, Birmingham B152TG, United Kingdom

Guys and St. Thomas NHS Trust, London SE19RT, United Kingdom

Oxford Univesity Hospital, Oxford OX37LE, United Kingdom

Additional Information

Starting date: October 2013
Last updated: January 23, 2014

Page last updated: August 23, 2015

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