Multiple MyelomaPEXIUSNCT01632826
Pomalidomide (POM) in Combination With Low Dose Dexamethasone (LD-Dex) in Patients With Relapsed or Refractory Multiple Myeloma
A study testing Pomalidomide in people with Multiple Myeloma, run by Celgene at 42 sites in 2 countries.
Trial summary
To provide pomalidomide access to relapsed/refractory multiple myeloma subjects with a likelihood of benefit from the pomalidomide treatment while the medication is not commercially available 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
- How many people
- Not given
- Where
- 42 sitesin 2 countries
- Study dates
- Start not givento not given
- Phase
- Expanded access
- 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
- Adult, Older adult
Who may be able to join
- Must have documented diagnosis of relapsed or relapsed/refractory multiple myeloma and have measurable disease (serum or urine M-protein)
- Age ≥ 18 years
- Must have had at least ≥ 2 prior anti-myeloma therapies
- Must have received at least 2 consecutive cycles of both lenalidomide and bortezomib, either alone or in combination
- Must have failed treatment with the last lenalidomide-containing regimen and the last bortezomib-containing regimen
- Must have documented disease progression during or after the last antimyeloma regimen
- 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 drug, while participating in the study and for at least 28 days after study treatment discontinuation.
- Males must agree to use a latex condom during sexual contact with FCBP while participating in the study and for 28 days following discontinuation from study treatment.
Who cannot join
- Peripheral Neuropathy ≥ Grade 2
- Non-secretory multiple myeloma
- Previous therapy with pomalidomide
- 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.
- Hypersensitivity to thalidomide, lenalidomide or dexamethasone
Show all 9Show fewer
- Known Human Immunodeficiency Virus positive, active or chronic Hepatitis A, B or C
- Pregnant or breastfeeding females
- Unacceptable hematological or biochemical laboratory abnormalities
Trial locations and contacts
42 sites in 2 countries.
42 sites in 2 countries
United States25 sites
Celgene Study Site
Baltimore, Maryland, 21215
Celgene Study Site
Dallas, Texas, 75390
Celgene Study Site
Denver, Colorado, 80218
Celgene Study Site
Duarte, California, 91010
Celgene Study Site
Greenbrae, California, 94904
Celgene Study Site
Greenville, South Carolina, 29615
Celgene Study Site
Hackensack, New Jersey, 07601
Celgene Study Site
Houston, Texas, 77030
Celgene Study Site
Hyannis, Massachusetts, 02601
Celgene Study Site
Indianapolis, Indiana, 46202
Celgene Study Site
Iowa City, Iowa, 52242
Celgene Study Site
Los Angeles, California, 90048
Celgene Study Site
Marietta, Georgia, 30060
Celgene Study Site
Milwaukee, Wisconsin, 53226
Celgene Study Site
Morgantown, West Virginia, 26506
Celgene Study Site
New York, New York, 10016
Celgene Study Site
New York, New York, 10029
Celgene Study Site
Omaha, Nebraska, 68198
Celgene Study Site
Peoria, Illinois, 61615
Celgene Study Site
Philadelphia, Pennsylvania, 19107
Celgene Study Site
Salt Lake City, Utah, 84106
Celgene Study Site
Sellersville, Pennsylvania, 18960
Celgene Study Site
Sioux Falls, South Dakota, 57105
Celgene Study Site
St Louis, Missouri, 63110
Celgene Study Site
West Palm Beach, Florida, 33401
Canada17 sites
Celgene Study Site
Calgary, Alberta, T2N 4N2
Celgene Study Site
Edmonton, Alberta, T6G 1Z2
Celgene Study Site
Halifax, Nova Scotia, B3H 1V7
Celgene Study Site
Hamilton, Ontario, L8V 5C2
Celgene Study Site
London, Ontario, N6A 4G5
Celgene Study Site
Montreal, Quebec, H1T 2M4
Celgene Study Site
Montreal, Quebec, H3A 1A1
Celgene Study Site
Montreal, Quebec, H3T 1E2
Celgene Study Site
Ottawa, Ontario, K1H 8L6
Celgene Study Site
Québec, Quebec, G1R 2J6
Celgene Study Site
Saskatoon, Saskatchewan, S7N 4H4
Celgene Study Site
St. John's, Newfoundland and Labrador, A1B3V6
Celgene Study Site
Toronto, Ontario, M5G 2M9
Celgene Study Site
Vancouver, British Columbia, V5Z1M9
Celgene Study Site
Victoria, British Columbia, V8R6V5
Celgene Study Site
Windsor, Ontario, N8W1L9
Celgene Study Site
Winnipeg, Manitoba, R3E 0V9
About this study
Official title: A Multicenter, Single-Arm, Open-Label Treatment Use Protocol for Pomalidomide (POM) in Combination With Low Dose Dexamethasone (LD-Dex) in Patients With Relapsed or Refractory Multiple Myeloma
To provide pomalidomide access to relapsed/refractory multiple myeloma subjects with a likelihood of benefit from the pomalidomide treatment while the medication is not commercially available
Read the detailed description
Several clinical studies indicate that pomalidomide has activity in relapsed and refractory multiple myeloma with response rates ranging between 30% and 60% at pomalidomide doses at 2 mg/day and/or 4 mg/day.
- Conditions
- Multiple Myeloma
- Being tested
- Pomalidomide
- Keywords
- Relapsed, refractory multiple myeloma, pomalidomide
- Medical subject headings
- Multiple Myeloma, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PomalidomideDrug
4 mg daily for 21 days in a 28 day cycle until disease progression or other reasons for treatment discontinuation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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
- Expanded access
Sponsor and investigators
- Lead sponsor
- Celgene
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Lars Sternas, MD, PhD, Study director, Celgene Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01632826
- Sponsor's protocol ID
- CC-4047-MM-009
- Acronym
- PEXIUS
- Status last verified
- Nov 2019
- First submitted
- 29 Jun 2012
- Last updated
- 12 Nov 2019
- Results posted
- No
Publications
Qian X, Dimopoulos MA, Amatangelo M, Bjorklund C, Towfic F, Flynt E, Weisel KC, Ocio EM, Yu X, Peluso T, Sternas L, Zaki M, Moreau P, Thakurta A. Cereblon gene expression and correlation with clinical outcomes in patients with relapsed/refractory multiple myeloma treated with pomalidomide: an analysis of STRATUS. Leuk Lymphoma. 2019 Feb;60(2):462-470. doi: 10.1080/10428194.2018.1485915. Epub 2018 Aug 2.
PubMed 30068263
Study at a glance
From the registry record, last updated by the sponsor on 12 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Single-Arm, Open-Label Treatment Use Protocol for Pomalidomide (POM) in Combination With Low Dose Dexamethasone (LD-Dex) in Patients With Relapsed or Refractory Multiple Myeloma
- ClinicalTrials.gov ID
- NCT01632826
- Acronym / sponsor ID
- PEXIUS / CC-4047-MM-009
- Conditions
- Multiple Myeloma
- Keywords
- Relapsed, refractory multiple myeloma, pomalidomide
- Study type
- Expanded access
- Recruitment status
- Approved For Marketing
- Lead sponsor
- CelgeneIndustry (pharma, biotech, devices)
- First posted
- 3 Jul 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.
To provide pomalidomide access to relapsed/refractory multiple myeloma subjects with a likelihood of benefit from the pomalidomide treatment while the medication is not commercially available
Detailed description
Several clinical studies indicate that pomalidomide has activity in relapsed and refractory multiple myeloma with response rates ranging between 30% and 60% at pomalidomide doses at 2 mg/day and/or 4 mg/day.
Study design
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Must have documented diagnosis of relapsed or relapsed/refractory multiple myeloma and have measurable disease (serum or urine M-protein)
- Age ≥ 18 years
- Must have had at least ≥ 2 prior anti-myeloma therapies
- Must have received at least 2 consecutive cycles of both lenalidomide and bortezomib, either alone or in combination
- Must have failed treatment with the last lenalidomide-containing regimen and the last bortezomib-containing regimen
Key exclusion criteria (9 listed)
- Peripheral Neuropathy ≥ Grade 2
- Non-secretory multiple myeloma
- Previous therapy with pomalidomide
- 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.
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 |
|---|---|---|
| Pomalidomide4 mg daily for 21 days in a 28 day cycle until disease progression or other reasons for treatment discontinuation | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Nov 2019.
- Background: PubMed 30068263Qian X, Dimopoulos MA, Amatangelo M, Bjorklund C, Towfic F, Flynt E, Weisel KC, Ocio EM, Yu X, Peluso T, Sternas L, Zaki M, Moreau P, Thakurta A. Cereblon gene expression and correlation with clinical outcomes in patients with relapsed/refractory multiple myeloma treated with pomalidomide: an analysis of STRATUS. Leuk Lymphoma. 2019 Feb;60(2):462-470. doi: 10.1080/10428194.2018.1485915. Epub 2018 Aug 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.
Lars Sternas, MD, PhD study director
Celgene Corporation
42 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pomalidomide in people with Multiple Myeloma, run by Celgene at 42 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 8 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 12 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 42 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.
Are results available for this study?
Results are not available in the source record.
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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01632826, which also lists 1 linked publication.
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 12 Nov 2019.