Multiple MyelomaPhase 2NCT02045017
Efficacy and Safety of Pomalidomide and Dexamethasone in RRMM Patients With Renal Insufficiency
A Phase 2 study testing Pomalidomide and Dexamethasone in people with Multiple Myeloma, run by Celgene at 22 sites in 8 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Myeloma
- What is being tested?
- Pomalidomide and Dexamethasone
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 81 participants
- Where
- 22 sitesin 8 countries
- Study dates
- 28 Feb 2014to 28 Jul 2021
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
- 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.
Who cannot join
- 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
Show all 10Show fewer
- Carcinoma in situ of the cervix or breast
- 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.
Trial locations and contacts
22 sites in 8 countries.
22 sites in 8 countries
Italy4 sites
Azienda Ospedaliero Universitaria Ospedali
Ancona, 60126
S.C. Oncologia Medica
Lecco, 23900
Ospedale Maggiore Policlinico Mangiagalli Regina Elena
Milan, 20122
Arcispedale Santa Maria Nuova
Reggio Emilia, 42100
United Kingdom4 sites
Queen Elizabeth Hospital UHB NHS Foundation Trust
Birmingham, B15 2TH
Ninewells Hospital and Medical School
Dundee, DD1 9SY
Oxford Radcliffe Hospital ICRF Medical Oncology Unit
Headington, OX37LJ
St Thomas' HospitalGuy's Hospital Dept. of Haematology
London, SE1 9RT
Austria3 sites
Krankenhaus der Elisabethinen Linz, I Interne Abteilung
Linz, 4020
Medizinische Universitat Wien
Vienna, 1090
Wilhelminenspital der Stadt Wien
Vienna, 1160
France3 sites
Hopital Dypuytren-CHU de Limoges
Limoges, 87042
Hopital Saint Louis
Paris, 75475
CHU de Poitiers
Poitiers, 86021
Spain3 sites
Hospital de La Princesa
Madrid, 28006
CEIC Hospital Universitario de Salamanca
Salamanca, 37007
Hospital Universitario Doctor Peset
Valencia, 46017
Germany2 sites
Medizinische Klinik und Poliklinik V Hamatologie, Onkologie und Rheumatologie
Neuenheimer Feld 410, 69120
University Hospital Tubingen
Tübingen, 72076
Netherlands2 sites
VU University Medical Center VU Medisch Centrum
Amsterdam, 1081 HV
Daniel den Hoed Kliniek Medical Oncology, Erasmus MC
Rotterdam, 3075 EA
About this study
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
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.
Read the 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
- Being tested
- Pomalidomide and Dexamethasone
- Keywords
- Multiple Myeloma, Relapsed Multiple Myeloma, Refactory Multiple Myeloma, Renal Insufficiency, Pomalidomide, Dexamethasone
- Medical subject headings
- Multiple Myeloma, Renal Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pomalidomide and DexamethasoneDrug
Also called Tablet
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: Drug: Pomalidomide and Dexamethasone |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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).
Assessment of renal response according to the criteria defined by Ludwig and Dimopoulos
Measured: Approximately 2 years
Time to Myeloma response
Evaluated according to the CTCAE grading
Measured: Approximately 2 years
Time to renal response
Evaluated according to the CTCAE grading
Measured: Approximately 2 years
Duration of response
Evaluated according to the CTCAE grading
Measured: Approximately 2 years
Progression-free survival
Evaluated according to the CTCAE grading
Measured: Approximately 2 years
Time to progression
Evaluated according to the CTCAE grading
Measured: Approximately 2 years
Overall Survival
Evaluated according to the CTCAE grading
Measured: 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).
Measured: Approximately 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2014 (estimated)
- Study start28 Feb 2014
- Primary completion27 Jan 2017
- Study completion28 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Multiple MyelomaStudies of the same condition, open and under way.
- More trials run by CelgeneThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 81 participants (actual)
Sponsor and investigators
- Lead sponsor
- Celgene
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Elisabeth Kueenburg, MD, Study director, Celgene
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02045017
- Sponsor's protocol ID
- CC-4047-MM-013
- Other IDs
- 2013-001903-36
- Status last verified
- Aug 2021
- First submitted
- 16 Dec 2013
- Last updated
- 27 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 29184451Dimopoulos 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.
PubMed 29394124
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02045017
- Acronym / sponsor ID
- CC-4047-MM-013
- Conditions
- Multiple Myeloma
- Keywords
- Multiple Myeloma, Relapsed Multiple Myeloma, Refactory Multiple Myeloma, Renal Insufficiency, Pomalidomide, Dexamethasone
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 81 participants (actual)
- Lead sponsor
- CelgeneIndustry (pharma, biotech, devices)
- Study start
- 28 Feb 2014 (actual)
- Primary completion
- 27 Jan 2017 (actual)
- Study completion
- 28 Jul 2021 (actual)
- First posted
- 24 Jan 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pomalidomide and low dose Dexamethasone | Experimental | Drug: Pomalidomide and DexamethasonePomalidomide 4mg, and low dose Dexamethasone, starting at 40mgs(≤ 75 years old) or 20 mg/day (> 75 years old) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
- Impaired renal function must be due to multiple myeloma which needs to be confirmed by kidney biopsy.
Key exclusion criteria (10 listed)
- 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:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pomalidomide and DexamethasoneAlso: Tablet | Drug | Pomalidomide and low dose Dexamethasone |
Primary outcome
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
8 secondary outcomes
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
Time to Myeloma response
Time frame: Approximately 2 years
Time to renal response
Time frame: Approximately 2 years
Duration of response
Time frame: Approximately 2 years
Progression-free survival
Time frame: Approximately 2 years
Time to progression
Time frame: Approximately 2 years
Overall Survival
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2021.
- Background: PubMed 29184451Li 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.
- Background: PubMed 29394124Dimopoulos 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Elisabeth Kueenburg, MD study director
Celgene
22 sites in 8 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Pomalidomide and Dexamethasone in people with Multiple Myeloma, run by Celgene at 22 sites in 8 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 22 sites in Italy, United Kingdom, Austria, France, Spain and 3 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluate efficacy of the combination of pomalidomide and low-dose dexamethasone in subjects with RRMM and impaired renal function (time frame: Approximately 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02045017, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Aug 2021.