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

NCT02045017 | Completed Phase 2

• 2 other identifiers: CC-4047-MM-0132013-001903-36
• Study Type: interventional
• Target: 81
• Locations: 8 countries
• Sites: 22

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.

Conditions

Multiple Myeloma

Keywords

Multiple Myeloma; Relapsed Multiple Myeloma; Refactory Multiple Myeloma; Renal Insufficiency; Pomalidomide; Dexamethasone

Outcome Measures

Primary Outcomes (1)

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

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

  Approximately 2 years

Secondary Outcomes (8)

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

  Approximately 2 years

• Time to Myeloma response

  Approximately 2 years

• Time to renal response

  Approximately 2 years

• Duration of response

  Approximately 2 years

• Progression-free survival

  Approximately 2 years

Study Arms (1)

Pomalidomide and low dose Dexamethasone

EXPERIMENTAL

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

Drug: Pomalidomide and Dexamethasone

Interventions

Pomalidomide and Dexamethasone DRUG

Also known as: Tablet

Pomalidomide and low dose Dexamethasone

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- Subjects must satisfy the following criteria to be enrolled in the study.
• \. 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).
• \. 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.
• \. 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.
• Impaired renal function must be due to multiple myeloma which needs to be confirmed by kidney biopsy.
• 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.

You may not qualify if:

• The presence of any of the following will exclude a subject from enrollment
• Any significant medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from participating in the study.
• Any condition including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study.
• Renal insufficiency due to other reasons than multiple myeloma or due to hypocalcaemia only.
• Prior history of malignancies, other than MM, unless the subject has been free of the disease for ≥ 5 years; exceptions include the following:
• Basal or squamous cell carcinoma of the skin
• Carcinoma in situ of the cervix or breast
• Incidental histological finding of prostate cancer (Tumour lymphNode Metastasis stage of T1a or T1b)
• \. Previous therapy with pomalidomide. 7. Hypersensitivity to thalidomide, lenalidomide, or dexamethasone (this includes ≥ Grade 3 rash during prior thalidomide or lenalidomide therapy).
• \. Subjects who are planning for or who are eligible for stem cell transplant.

Sponsors & Collaborators

• Celgene: lead

Study Sites (22)

Krankenhaus der Elisabethinen Linz, I Interne Abteilung

Linz, 4020, Austria

Location

Medizinische Universitat Wien

Vienna, 1090, Austria

Location

Wilhelminenspital der Stadt Wien

Vienna, 1160, Austria

Location

Hopital Dypuytren-CHU de Limoges

Limoges, 87042, France

Location

Hopital Saint Louis

Paris, 75475, France

Location

CHU de Poitiers

Poitiers, 86021, France

Location

Medizinische Klinik und Poliklinik V Hamatologie, Onkologie und Rheumatologie

Neuenheimer Feld 410, 69120, Germany

Location

University Hospital Tubingen

Tübingen, 72076, Germany

Location

Alexandra Hospital, University of Athens

Athens, 11528, Greece

Location

Azienda Ospedaliero Universitaria Ospedali

Ancona, 60126, Italy

Location

S.C. Oncologia Medica

Lecco, 23900, Italy

Location

Ospedale Maggiore Policlinico Mangiagalli Regina Elena

Milan, 20122, Italy

Location

Arcispedale Santa Maria Nuova

Reggio Emilia, 42100, Italy

Location

VU University Medical Center VU Medisch Centrum

Amsterdam, 1081 HV, Netherlands

Location

Daniel den Hoed Kliniek Medical Oncology, Erasmus MC

Rotterdam, 3075 EA, Netherlands

Location

Hospital de La Princesa

Madrid, 28006, Spain

Location

CEIC Hospital Universitario de Salamanca

Salamanca, 37007, Spain

Location

Hospital Universitario Doctor Peset

Valencia, 46017, Spain

Location

Queen Elizabeth Hospital UHB NHS Foundation Trust

Birmingham, B15 2TH, United Kingdom

Location

Ninewells Hospital and Medical School

Dundee, DD1 9SY, United Kingdom

Location

Oxford Radcliffe Hospital ICRF Medical Oncology Unit

Headington, OX37LJ, United Kingdom

Location

St Thomas' HospitalGuy's Hospital Dept. of Haematology

London, SE1 9RT, United Kingdom

Location

Related Publications (2)

• 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.

  PMID: 29184451 BACKGROUND

• 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.

  PMID: 29394124 BACKGROUND

MeSH Terms

Conditions

Multiple Myeloma; Renal Insufficiency

Interventions

pomalidomide; Dexamethasone; Tablets

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Dosage Forms; Pharmaceutical Preparations

Study Officials

• Elisabeth Kueenburg, MD

  Celgene

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 16, 2013
• First Posted: January 24, 2014
• Study Start: February 28, 2014
• Primary Completion: January 27, 2017
• Study Completion: July 28, 2021
• Last Updated: August 27, 2021

Record last verified: 2021-08

Locations

AU (3); DE (2); GR (1); NL (2); GB (4); FR (3); ES (3); IT (4)