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| ID | Type | Description | Link |
|---|---|---|---|
| 2013-001903-36 | EudraCT Number |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pomalidomide and Dexamethasone | Drug |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 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). | Assessment of renal response according to the criteria defined by Ludwig and Dimopoulos | Approximately 2 years |
| Time to Myeloma response |
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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.
Exclusion Criteria:
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:
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.
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| Name | Affiliation | Role |
|---|---|---|
| Elisabeth Kueenburg, MD | Celgene | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Krankenhaus der Elisabethinen Linz, I Interne Abteilung | Linz | 4020 | Austria | |||
| Medizinische Universitat Wien |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29184451 | Background | 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. | |
| 29394124 |
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Evaluated according to the CTCAE grading |
| Approximately 2 years |
| Time to renal response | Evaluated according to the CTCAE grading | Approximately 2 years |
| Duration of response | Evaluated according to the CTCAE grading | Approximately 2 years |
| Progression-free survival | Evaluated according to the CTCAE grading | Approximately 2 years |
| Time to progression | Evaluated according to the CTCAE grading | Approximately 2 years |
| Overall Survival | 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). | Pharmacokinetics (PK) of pomalidomide in subjects with RRMM and impaired renal function (moderate to severe renal impairment). | Approximately 2 years |
| Vienna |
| 1090 |
| Austria |
| Wilhelminenspital der Stadt Wien | Vienna | 1160 | Austria |
| Hopital Dypuytren-CHU de Limoges | Limoges | 87042 | France |
| Hopital Saint Louis | Paris | 75475 | France |
| CHU de Poitiers | Poitiers | 86021 | France |
| Medizinische Klinik und Poliklinik V Hamatologie, Onkologie und Rheumatologie | Neuenheimer Feld 410 | 69120 | Germany |
| University Hospital Tubingen | Tübingen | 72076 | Germany |
| Alexandra Hospital, University of Athens | Athens | 11528 | Greece |
| Azienda Ospedaliero Universitaria Ospedali | Ancona | 60126 | Italy |
| S.C. Oncologia Medica | Lecco | 23900 | Italy |
| Ospedale Maggiore Policlinico Mangiagalli Regina Elena | Milan | 20122 | Italy |
| Arcispedale Santa Maria Nuova | Reggio Emilia | 42100 | Italy |
| VU University Medical Center VU Medisch Centrum | Amsterdam | 1081 HV | Netherlands |
| Daniel den Hoed Kliniek Medical Oncology, Erasmus MC | Rotterdam | 3075 EA | Netherlands |
| Hospital de La Princesa | Madrid | 28006 | Spain |
| CEIC Hospital Universitario de Salamanca | Salamanca | 37007 | Spain |
| Hospital Universitario Doctor Peset | Valencia | 46017 | Spain |
| Queen Elizabeth Hospital UHB NHS Foundation Trust | Birmingham | B15 2TH | United Kingdom |
| Ninewells Hospital and Medical School | Dundee | DD1 9SY | United Kingdom |
| Oxford Radcliffe Hospital ICRF Medical Oncology Unit | Headington | OX37LJ | United Kingdom |
| St Thomas' HospitalGuy's Hospital Dept. of Haematology | London | SE1 9RT | United Kingdom |
| 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. |
| ID | Term |
|---|---|
| D009101 | Multiple Myeloma |
| D051437 | Renal Insufficiency |
| ID | Term |
|---|---|
| D054219 | Neoplasms, Plasma Cell |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D020141 | Hemostatic Disorders |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010265 | Paraproteinemias |
| D001796 | Blood Protein Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D006474 | Hemorrhagic Disorders |
| D008232 | Lymphoproliferative Disorders |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
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| ID | Term |
|---|---|
| C467566 | pomalidomide |
| D003907 | Dexamethasone |
| D013607 | Tablets |
| ID | Term |
|---|---|
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |
| D004304 | Dosage Forms |
| D004364 | Pharmaceutical Preparations |
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