Multiple MyelomaPhase 1POM RenalNCT01575925
Study of Pomalidomide to Evaluate the Pharmacokinetics and Safety for Patients With Multiple Myeloma and Impaired Renal Function (POM Renal)
A Phase 1 study testing 4 mg Oral POM + 40 mg Oral DEX and 2 mg Oral POM + 40 mg Oral DEX in people with Multiple Myeloma and Renal Impairment, run by Celgene at 9 sites in 2 countries.
Trial summary
The purpose of this study is to determine the pharmacokinetics (PK) and safety for the combination of pomalidomide (POM) + low-dose dexamethasone (LD- DEX) in subjects with relapsed or refractory Multiple Myeloma (RRMM) and impaired renal function. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Myeloma, Renal Impairment
- What is being tested?
- 4 mg Oral POM + 40 mg Oral DEX and 2 mg Oral POM + 40 mg Oral DEX
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 9 sitesin 2 countries
- Study dates
- 1 Jun 2012to 7 Aug 2018
- Phase
- Phase 1
- 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:
- Must be ≥ 18 years at the time of signing the informed consent form
- Must understand and voluntarily sign an informed consent document prior to any study-related assessments/procedures
- Must be able to adhere to the study visit schedule and other protocol requirements
- Must have documented diagnosis of relapsed or refractory multiple myeloma and have measurable disease (serum M-protein ≥ 0.5 g/dL or urine M-protein ≥ 200 mg/24 hours)
- Must have had at least 1 prior anti-myeloma regimen
Show all 14Show fewer
- Must have documented progression as per the International Myeloma Working Group uniform response criteria (Durie, 2006) during or after the last anti-myeloma regimen
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1, or 2
- Females of childbearing potential (FCBP) must agree to utilize two reliable forms of contraception simultaneously or practice complete abstinence from heterosexual contact for at least 28 days before starting study drug, while participating in the study (including dose interruptions), and for at least 28 days after study treatment discontinuation, and must agree to regular pregnancy testing during this timeframe
- Females must agree to abstain from breastfeeding during study participation and for 28 following discontinuation from study treatment
- Males must agree to use a latex condom during any sexual contact with FCBP while participating in the study and for 28 days following discontinuation from study treatment, even if he has undergone a successful vasectomy
- Males must also agree to refrain from donating semen or sperm while on pomalidomide and for 28 days after discontinuation from study treatment
- All subjects must agree to refrain from donating blood while on study drug and for 28 days after discontinuation from study treatment
- All subjects must agree not to share medication
Who cannot join
- The presence of any of the following will exclude a subject from enrollment:
- Peripheral neuropathy ≥ Grade 2
- Non-secretory multiple myeloma
- Any of the following laboratory abnormalities:
- Absolute neutrophil count (ANC) < 1,000/µL
- Platelet count < 75,000/µL
Show all 35Show fewer
- Corrected serum calcium > 14 mg/dL (> 3.5 mmol/L)
- Hemoglobin < 8 g/dL (< 4.9 mmol/L; prior RBC transfusion or recombinant human erythropoietin use is permitted)
- Serum glutamic oxaloacetic transaminase/aspartate aminotransferase (SGOT/AST) or serum glutamic pyruvic transaminase/alanine aminotransferase (SGPT/ALT) > 3.0 x upper limit of normal (ULN)
- Serum total bilirubin > 2.0 mg/dL
- Prior history of malignancies, other than the disease being studied, unless the subject has been free of the malignancy for ≥ 5 years from initiating study treatment, with the following exceptions:
- Basal cell carcinoma of the skin
- Squamous cell carcinoma of the skin
- Carcinoma in situ of the cervix
- Carcinoma in situ of the breast
- Incidental histologic finding of prostate cancer (T1a or T1b using the TNM [tumor, nodes, metastasis] clinical staging system).
- Previous therapy with Pomalidomide
- Hypersensitivity to thalidomide, lenalidomide, or dexamethasone
- Rash ≥ Grade 3 during prior thalidomide or lenalidomide therapy
- Incidence of gastrointestinal disease that may significantly alter the absorption of pomalidomide
- Subjects with any one of the following:
- Congestive heart failure (New York Heart Association Class III or IV)
- Myocardial infarction within 12 months prior to starting study treatment
- Unstable or poorly controlled angina pectoris, including Prinzmetal variant angina pectoris
- Subjects who received any of the following within the last 14 days of initiation of study treatment:
- Plasmapheresis
- Major surgery (kyphoplasty is not considered major surgery)
- Radiation therapy (with the exception of radiation therapy to a pathological fracture site to enhance bone healing or to treat post-fracture pain that is refractory to narcotic analgesics)
- Any anti-myeloma drug therapy
- Use of any investigational agents within 28 days or 5 half-lives (whichever is longer) of initiating study treatment
- Subjects with conditions requiring chronic steroid or immunosuppressive treatment, such as rheumatoid arthritis, multiple sclerosis, and lupus, which likely need additional steroid or immunosuppressive treatments in addition to the study treatment. Includes subjects receiving corticosteroids (> 10 mg/day of prednisone or equivalent) within 3 weeks prior to initiating study treatment
- Subjects unable or unwilling to undergo antithrombotic prophylactic treatment will not be eligible to participate in this 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
- Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subjects from signing the informed consent form
- Pregnant or breastfeeding females
Trial locations and contacts
9 sites in 2 countries.
9 sites in 2 countries
United States7 sites
Winship Cancer Institute of Emory University
Atlanta, Georgia, 30322
Cleveland Clinic
Cleveland, Ohio, 44195
Colorado Blood Cancer Institute
Denver, Colorado, 80218
Hackensack University Medical Center
Hackensack, New Jersey, 07601
Ingalls Cancer Research Center
Harvey, Illinois, 60426
MD Anderson Cancer Center
Houston, Texas, 77030
Weill Cornell Medical College
New York, New York, 10065
Canada2 sites
Queen Elizabeth II Health Sciences Centre
Halifax, Nova Scotia, B3H 2Y9
L'Hotel Dieu de Quebec
Québec, G1R 2J6
About this study
Official title: A Phase 1 Multi-Center, Open-Label, Dose-Escalation Study to Determine the Pharmacokinetics and Safety of Pomalidomide When Given in Combination With Low Dose Dexamethasone in Subjects With Relapsed or Refractory Multiple Myeloma and Impaired Renal Function
The purpose of this study is to determine the pharmacokinetics (PK) and safety for the combination of pomalidomide (POM) + low-dose dexamethasone (LD- DEX) in subjects with relapsed or refractory Multiple Myeloma (RRMM) and impaired renal function.
Read the detailed description
The primary objective of the study is to determine the PK and safety for the combination of POM + (LD-DEX) in subjects with RRMM and impaired renal function.
The secondary objective of the study is to evaluate the efficacy of POM + (LD_DEX) in subjects with RRMM and impaired renal function.
This is a 3+3 dose escalation design, with one cohort each for patients with severely impaired renal function patients (CrCl < 30 mL/min) requiring and not requiring dialysis respectively. There will also be one control cohort with normal renal function, these patients will receive 4 mg POM. Dosing will be 21 days out of a 28 day cycle.
- Conditions
- Multiple Myeloma, Renal Impairment
- Being tested
- 4 mg Oral POM + 40 mg Oral DEX, 2 mg Oral POM + 40 mg Oral DEX
- Keywords
- Pomalidomide for multiple myeloma, renal impairment, multiple myeloma patients with renal impairment, Pomalidomide for patients with renal impairment due to multiple myeloma, Pomalidomide, dexamethasone, RRMM, impaired renal function in multiple myeloma, hemodialysis, dialysis, POM, Pomalyst, MM, severe renal impairment, CrCl ≤ 30 mL/min, Creatinine less than 30, clinical trial in subjects with multiple myeloma with renal impairement
- 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.
4 mg Oral POM + 40 mg Oral DEXDrug
Also called Pomalidomide (POM), Dexamethasone
2 mg Oral POM + 40 mg Oral DEXDrug
Also called Pomalidomide (POM), Dexamethasone
| Study group | Role | What they receive |
|---|---|---|
| 4 mg Oral POM + 40 mg Oral DEX | Experimental | Oral POM at 4 mg on days 1-21 of a 28-day cycle, Oral DEX at 40 mg/day (≤ 75 years old) or 20 mg/day (> 75 years old) on days 1, 8, 15 and 22 of a 28-day cycle Receives: Drug: 4 mg Oral POM + 40 mg Oral DEX |
| 2 mg Oral POM + 40 mg Oral DEX | Experimental | Oral POM at 2 mg on days 1-21 of a 28-day cycle, Oral DEX at 40 mg/day (≤ 75 years old) or 20 mg/day (> 75 years old) on days 1, 8, 15 and 22 of a 28-day cycle Receives: Drug: 2 mg Oral POM + 40 mg Oral DEX |
What is being measured
The primary outcome is the main question the study is designed to answer.
PK-Area under the plasma concentration time curve (AUC)
PK-Area under the plasma concentration time curve (AUC)
Measured: Up to 24 times over 7 months
PK-Time to maximum plasma concentration (Cmax)
PK-Time to maximum plasma concentration (Cmax)
Measured: 24 times over 7 months
PK-Apparent total body clearance (CL/F)
PK-Apparent total body clearance (CL/F)
Measured: 24 times up to 7 months
PK-Renal clearance (CLr)
PK-Renal clearance (CLr)
Measured: 24 times over 7 months
PK-Apparent volume of distribution (V/F)
PK-Apparent volume of distribution (V/F)
Measured: 24 times over 7 months
PK-Effective terminal half-life (T1/2)
PK-Effective terminal half-life (T1/2)
Measured: 24 times over 7 months
Secondary outcomes (4)
Number of participants with adverse events (AEs)
Number of participants with adverse events (AEs)
Measured: Up to 5 years
Number of participants alive
Number of participants alive
Measured: Up to 5 years
Time to response
Time to response
Measured: Up to 5 years
Duration of response
Duration of response
Measured: Up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2012 (estimated)
- Study start1 Jun 2012
- Primary completion7 Aug 2018
- Study completion7 Aug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)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 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Celgene
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bristol Myers-Squibb, Study director, Bristol-Myers Squibb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01575925
- Sponsor's protocol ID
- CC-4047-MM-008
- Acronym
- POM Renal
- Status last verified
- Nov 2022
- First submitted
- 10 Apr 2012
- Last updated
- 4 Nov 2022
- 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 29184451Kavanaugh A, Gladman DD, Edwards CJ, Schett G, Guerette B, Delev N, Teng L, Paris M, Mease PJ. Long-term experience with apremilast in patients with psoriatic arthritis: 5-year results from a PALACE 1-3 pooled analysis. Arthritis Res Ther. 2019 May 10;21(1):118. doi: 10.1186/s13075-019-1901-3.
PubMed 31077258Matous J, et al. MM-008 trial: Pharmacokinetics (PK) and tolerability of pomalidomide plus low-dose dexamethasone (POM plus LoDEX) in relapsed/refractory multiple myeloma (RRMM) patients with renal impairment (RI). Presented at: American Society of Clinical Oncology ASCO 2013, May 31-June 4, 2013, Chicago, IL. Abstract No. 8585. JClinOncol 2013;31(suppl 15):8585-8585.
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Multi-Center, Open-Label, Dose-Escalation Study to Determine the Pharmacokinetics and Safety of Pomalidomide When Given in Combination With Low Dose Dexamethasone in Subjects With Relapsed or Refractory Multiple Myeloma and Impaired Renal Function
- ClinicalTrials.gov ID
- NCT01575925
- Acronym / sponsor ID
- POM Renal / CC-4047-MM-008
- Conditions
- Multiple Myeloma, Renal Impairment
- Keywords
- Pomalidomide for multiple myeloma, renal impairment, multiple myeloma patients with renal impairment, Pomalidomide for patients with renal impairment due to multiple myeloma, Pomalidomide, dexamethasone, RRMM, impaired renal function in multiple myeloma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- CelgeneIndustry (pharma, biotech, devices)
- Study start
- 1 Jun 2012 (actual)
- Primary completion
- 7 Aug 2018 (actual)
- Study completion
- 7 Aug 2018 (actual)
- First posted
- 12 Apr 2012 (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 purpose of this study is to determine the pharmacokinetics (PK) and safety for the combination of pomalidomide (POM) + low-dose dexamethasone (LD- DEX) in subjects with relapsed or refractory Multiple Myeloma (RRMM) and impaired renal function.
Detailed description
The primary objective of the study is to determine the PK and safety for the combination of POM + (LD-DEX) in subjects with RRMM and impaired renal function.
The secondary objective of the study is to evaluate the efficacy of POM + (LD_DEX) in subjects with RRMM and impaired renal function.
This is a 3+3 dose escalation design, with one cohort each for patients with severely impaired renal function patients (CrCl < 30 mL/min) requiring and not requiring dialysis respectively. There will also be one control cohort with normal renal function, these patients will receive 4 mg POM. Dosing will be 21 days out of a 28 day cycle.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 4 mg Oral POM + 40 mg Oral DEX | Experimental | Drug: 4 mg Oral POM + 40 mg Oral DEXOral POM at 4 mg on days 1-21 of a 28-day cycle, Oral DEX at 40 mg/day (≤ 75 years old) or 20 mg/day (> 75 years old) on days 1, 8, 15 and 22 of a 28-day cycle |
| 2 mg Oral POM + 40 mg Oral DEX | Experimental | Drug: 2 mg Oral POM + 40 mg Oral DEXOral POM at 2 mg on days 1-21 of a 28-day cycle, Oral DEX at 40 mg/day (≤ 75 years old) or 20 mg/day (> 75 years old) on days 1, 8, 15 and 22 of a 28-day cycle |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Must be ≥ 18 years at the time of signing the informed consent form
- Must understand and voluntarily sign an informed consent document prior to any study-related assessments/procedures
- Must be able to adhere to the study visit schedule and other protocol requirements
- Must have documented diagnosis of relapsed or refractory multiple myeloma and have measurable disease (serum M-protein ≥ 0.5 g/dL or urine M-protein ≥ 200 mg/24 hours)
- Must have had at least 1 prior anti-myeloma regimen
Key exclusion criteria (35 listed)
- Peripheral neuropathy ≥ Grade 2
- Non-secretory multiple myeloma
- Any of the following laboratory abnormalities:
- Prior history of malignancies, other than the disease being studied, unless the subject has been free of the malignancy for ≥ 5 years from initiating study treatment, with the following exceptions:
- Previous therapy with Pomalidomide
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 |
|---|---|---|
| 4 mg Oral POM + 40 mg Oral DEXAlso: Pomalidomide (POM), Dexamethasone | Drug | 4 mg Oral POM + 40 mg Oral DEX |
| 2 mg Oral POM + 40 mg Oral DEXAlso: Pomalidomide (POM), Dexamethasone | Drug | 2 mg Oral POM + 40 mg Oral DEX |
Primary outcome
PK-Area under the plasma concentration time curve (AUC)
Time frame: Up to 24 times over 7 months
PK-Area under the plasma concentration time curve (AUC)
PK-Time to maximum plasma concentration (Cmax)
Time frame: 24 times over 7 months
PK-Time to maximum plasma concentration (Cmax)
PK-Apparent total body clearance (CL/F)
Time frame: 24 times up to 7 months
PK-Apparent total body clearance (CL/F)
PK-Renal clearance (CLr)
Time frame: 24 times over 7 months
PK-Renal clearance (CLr)
PK-Apparent volume of distribution (V/F)
Time frame: 24 times over 7 months
PK-Apparent volume of distribution (V/F)
PK-Effective terminal half-life (T1/2)
Time frame: 24 times over 7 months
PK-Effective terminal half-life (T1/2)
4 secondary outcomes
Number of participants with adverse events (AEs)
Time frame: Up to 5 years
Number of participants alive
Time frame: Up to 5 years
Time to response
Time frame: Up to 5 years
Duration of response
Time frame: Up to 5 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 4 Nov 2022.
- 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 31077258Kavanaugh A, Gladman DD, Edwards CJ, Schett G, Guerette B, Delev N, Teng L, Paris M, Mease PJ. Long-term experience with apremilast in patients with psoriatic arthritis: 5-year results from a PALACE 1-3 pooled analysis. Arthritis Res Ther. 2019 May 10;21(1):118. doi: 10.1186/s13075-019-1901-3.
- BackgroundMatous J, et al. MM-008 trial: Pharmacokinetics (PK) and tolerability of pomalidomide plus low-dose dexamethasone (POM plus LoDEX) in relapsed/refractory multiple myeloma (RRMM) patients with renal impairment (RI). Presented at: American Society of Clinical Oncology ASCO 2013, May 31-June 4, 2013, Chicago, IL. Abstract No. 8585. JClinOncol 2013;31(suppl 15):8585-8585.
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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.
Bristol Myers-Squibb study director
Bristol-Myers Squibb
9 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing 4 mg Oral POM + 40 mg Oral DEX and 2 mg Oral POM + 40 mg Oral DEX in people with Multiple Myeloma and Renal Impairment, run by Celgene at 9 sites in 2 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 14 inclusion and 35 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 4 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in United States, Canada. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
PK-Area under the plasma concentration time curve (AUC) (time frame: Up to 24 times over 7 months). The study lists 6 primary outcomes in all. 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 NCT01575925, which also lists 3 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 4 Nov 2022.