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

NCT ID: NCT02045017

Last Updated: 2021-08-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 81 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-02-28
• Study Completion Date: 2021-07-28

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.

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.

Conditions

Multiple Myeloma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Pomalidomide and low dose Dexamethasone

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

Group Type: EXPERIMENTAL

Pomalidomide and Dexamethasone

Intervention Type: DRUG

Interventions

Pomalidomide and Dexamethasone

Intervention Type: DRUG

Other Intervention Names

Tablet

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Celgene

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Elisabeth Kueenburg, MD

Role: STUDY_DIRECTOR

Celgene

Locations

Krankenhaus der Elisabethinen Linz, I Interne Abteilung

Linz, , Austria

Medizinische Universitat Wien

Vienna, , Austria

Wilhelminenspital der Stadt Wien

Vienna, , Austria

Hopital Dypuytren-CHU de Limoges

Limoges, , France

Hopital Saint Louis

Paris, , France

CHU de Poitiers

Poitiers, , France

Medizinische Klinik und Poliklinik V Hamatologie, Onkologie und Rheumatologie

Neuenheimer Feld 410, , Germany

University Hospital Tubingen

Tübingen, , Germany

Alexandra Hospital, University of Athens

Athens, , Greece

Azienda Ospedaliero Universitaria Ospedali

Ancona, , Italy

S.C. Oncologia Medica

Lecco, , Italy

Ospedale Maggiore Policlinico Mangiagalli Regina Elena

Milan, , Italy

Arcispedale Santa Maria Nuova

Reggio Emilia, , Italy

VU University Medical Center VU Medisch Centrum

Amsterdam, , Netherlands

Daniel den Hoed Kliniek Medical Oncology, Erasmus MC

Rotterdam, , Netherlands

Hospital de La Princesa

Madrid, , Spain

CEIC Hospital Universitario de Salamanca

Salamanca, , Spain

Hospital Universitario Doctor Peset

Valencia, , Spain

Queen Elizabeth Hospital UHB NHS Foundation Trust

Birmingham, , United Kingdom

Ninewells Hospital and Medical School

Dundee, , United Kingdom

Oxford Radcliffe Hospital ICRF Medical Oncology Unit

Headington, , United Kingdom

St Thomas' HospitalGuy's Hospital Dept. of Haematology

London, , United Kingdom

Countries

Austria; France; Germany; Greece; Italy; Netherlands; Spain; United Kingdom

References

Li Y, Wang X, O'Mara E, Dimopoulos MA, Sonneveld P, Weisel KC, Matous J, Siegel DS, Shah JJ, Kueenburg E, Sternas L, Cavanaugh C, Zaki M, Palmisano M, Zhou S. Population pharmacokinetics of pomalidomide in patients with relapsed or refractory multiple myeloma with various degrees of impaired renal function. Clin Pharmacol. 2017 Nov 8;9:133-145. doi: 10.2147/CPAA.S144606. eCollection 2017.

Reference Type: BACKGROUND

PMID: 29184451 (View on PubMed)

Dimopoulos M, Weisel K, van de Donk NWCJ, Ramasamy K, Gamberi B, Streetly M, Offidani M, Bridoux F, de la Rubia J, Mateos MV, Ardizzoia A, Kueenburg E, Collins S, Di Micco A, Rosettani B, Li Y, Bacon P, Sonneveld P. Pomalidomide Plus Low-Dose Dexamethasone in Patients With Relapsed/Refractory Multiple Myeloma and Renal Impairment: Results From a Phase II Trial. J Clin Oncol. 2018 Jul 10;36(20):2035-2043. doi: 10.1200/JCO.2017.76.1742. Epub 2018 Feb 2.

Reference Type: BACKGROUND

PMID: 29394124 (View on PubMed)

Other Identifiers

2013-001903-36

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

CC-4047-MM-013

Identifier Type: -

Identifier Source: org_study_id