Multiple MyelomaPhase 1/2NCT02548962
Study of Ibrutinib in Combination With Pomalidomide and Dexamethasone in Subjects With Relapsed/Refractory Multiple Myeloma
A Phase 1/2 study testing Ibrutinib, Pomalidomide and Dexamethasone in people with Multiple Myeloma, run by Pharmacyclics LLC. at 16 sites in 6 countries.
Trial summary
Phase 1 is an open-label, dose finding, multicenter study of ibrutinib in combination with pomalidomide and dexamethasone in subjects with relapsed/refractory multiple myeloma. Phase 2b is a randomized, double-blind, multicenter study of ibrutinib or placebo, in combination with pomalidomide and dexamethasone in… Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Multiple Myeloma
- What is being tested?
- Ibrutinib, Pomalidomide and Dexamethasone
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 11 participants
- Where
- 16 sitesin 6 countries
- Study dates
- Mar 2016to 13 Jun 2018
- Phase
- Phase 1/2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects with relapsed/refractory MM who have received at least two prior lines of therapy including lenalidomide and either bortezomib or carfilzomib and have demonstrated disease progression on or within 60 days of the completion of the most recent treatment regimen.
- Measurable disease defined by at least ONE of the following:
- Serum monoclonal protein (SPEP) ≥1 g/dL.
- Urine monoclonal protein (UPEP) ≥200 mg by 24 hour urine.
- Adequate hematologic, hepatic, and renal function
- ECOG performance status of ≤ 2
Who cannot join
- Subject must not have primary refractory disease
- Plasma cell leukemia, primary amyloidosis or POEMS syndrome
- Unable to swallow capsules or disease significantly affecting gastrointestinal function
- Requires treatment with strong CYP3A inhibitors
- Women who are pregnant or breast feeding.
Trial locations and contacts
16 sites in 6 countries.
16 sites in 6 countries
United States5 sites
Dana-Farber Cancer Institute
Boston, Massachusetts, 02215
Medical University of South Carolina
Charleston, South Carolina, 29425
Cleveland Clinic
Cleveland, Ohio, 44195
City of Hope
Duarte, California, 91010
Virginia Commonwealth University
Richmond, Virginia, 23298
Spain4 sites
Hospital de La Santa Creu i Sant Pau
Barcelona, 08025
Clinica Universidad de Navarra
Pamplona, Navarre, 31008
Hospital Universitario de Salamanca
Salamanca, 37007
Hospital Universitario Doctor Peset
Valencia, 46017
Czechia3 sites
Fakultni nemocnice Brno
Brno, 625 00
Fakultni nemocnice Ostrava
Ostrava, 708 52
Vseobecna fakultni nemocnice v Praze
Prague, 128 08
Australia2 sites
Concord Repatriation General Hospital
Concord, New South Wales, 2139
Princess Alexandra Hospital
Woolloongabba, Queensland, 4102
About this study
Official title: A Randomized Multicenter Study of Ibrutinib in Combination With Pomalidomide and Dexamethasone in Subjects With Relapsed/Refractory Multiple Myeloma
Phase 1 is an open-label, dose finding, multicenter study of ibrutinib in combination with pomalidomide and dexamethasone in subjects with relapsed/refractory multiple myeloma.
Phase 2b is a randomized, double-blind, multicenter study of ibrutinib or placebo, in combination with pomalidomide and dexamethasone in subjects with relapsed/refractory multiple myeloma.
Read the detailed description
Bruton's tyrosine kinase (Btk) is an enzyme that is present in hematopoietic cells other than T cells and is necessary for downstream signal transduction from various hematopoietic receptors including the B cell receptor as well as some Fc, chemokine, and adhesion receptors, and is crucial for both B cell development and osteoclastogenesis. Although down-regulated in normal plasma cells, Btk is highly expressed in the malignant cells from many myeloma patients and some cell lines. Ibrutinib is a potent and specific inhibitor of Btk currently in Phase 2 and 3 clinical trials. The current study is designed and intended to determine the safety and efficacy of ibrutinib in combination with pomalidomide and dexamethasone in subjects with relapsed/refractory multiple myeloma.
- Conditions
- Multiple Myeloma
- Being tested
- Ibrutinib, Pomalidomide, Dexamethasone, Placebo
- Keywords
- Multiple Myeloma, Bruton's Tyrosine Kinase, PCI-32765, Pomalidomide, Dexamethasone, Relapsed Refractory Multiple Myeloma, Ibrutinib
- Medical subject headings
- Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IbrutinibDrug
PomalidomideDrug
DexamethasoneDrug
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| Phase 1: Dose Finding | Experimental | Ibrutinib PO+ Pomalidomide PO+ Dexamethasone PO Receives: Drug: Ibrutinib; Drug: Pomalidomide; Drug: Dexamethasone |
| Phase 2: Treatment Arm A | Experimental | Ibrutinib PO+ Pomalidomide PO+ Dexamethasone PO Receives: Drug: Ibrutinib; Drug: Pomalidomide; Drug: Dexamethasone |
| Phase 2: Treatment Arm B | Experimental | Placebo PO+ Pomalidomide PO+ Dexamethasone PO Receives: Drug: Pomalidomide; Drug: Dexamethasone; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Response Rate (ORR) According to the IMWG Response Criteria Per Investigator Assessment
The overall response rate, defined as the proportion of subjects achieving a best overall response of PR or better per investigator assessment per IMWG at or prior to initiation of subsequent anticancer therapy
Measured: 14 Months
Secondary outcomes (2)
Clinical Benefit Response (CBR)
The clinical benefit response, defined as the proportion of subjects achieving a best overall response of MR or better per investigator assessment per IMWG at or prior to initiation of subsequent anticancer therapy.
Measured: 14 Months
Duration of Response (DOR)
The time interval between the date of initial documentation of a response and the date of first documented evidence of progressive disease, death, or date of censoring for the subjects not progressed/died. The censoring date is the last adequate tumor assessment date.
Measured: 14 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2015 (estimated)
- Study startMar 2016
- Primary completion13 Jun 2018
- Study completion13 Jun 2018
Why it stopped: After completing Phase 1, the Sponsor elected not to move forward with Phase 2.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Multiple MyelomaStudies of the same condition, open and under way.
- 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 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pharmacyclics LLC.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Celgene Corporation
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02548962
- Sponsor's protocol ID
- PCYC-1138-CA
- Other IDs
- PCI-32765
- Status last verified
- Nov 2019
- First submitted
- 3 Sep 2015
- Last updated
- 21 Nov 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Multicenter Study of Ibrutinib in Combination With Pomalidomide and Dexamethasone in Subjects With Relapsed/Refractory Multiple Myeloma
- ClinicalTrials.gov ID
- NCT02548962
- Acronym / sponsor ID
- PCYC-1138-CA
- Conditions
- Multiple Myeloma
- Keywords
- Multiple Myeloma, Bruton's Tyrosine Kinase, PCI-32765, Pomalidomide, Dexamethasone, Relapsed Refractory Multiple Myeloma, Ibrutinib
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: After completing Phase 1, the Sponsor elected not to move forward with Phase 2.
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Pharmacyclics LLC.Industry (pharma, biotech, devices)
- Collaborators
- Celgene Corporation
- Study start
- Mar 2016
- Primary completion
- 13 Jun 2018 (actual)
- Study completion
- 13 Jun 2018 (actual)
- First posted
- 14 Sep 2015 (estimated)
- Results
- Posted 23 Apr 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Phase 1 is an open-label, dose finding, multicenter study of ibrutinib in combination with pomalidomide and dexamethasone in subjects with relapsed/refractory multiple myeloma.
Phase 2b is a randomized, double-blind, multicenter study of ibrutinib or placebo, in combination with pomalidomide and dexamethasone in subjects with relapsed/refractory multiple myeloma.
Detailed description
Bruton's tyrosine kinase (Btk) is an enzyme that is present in hematopoietic cells other than T cells and is necessary for downstream signal transduction from various hematopoietic receptors including the B cell receptor as well as some Fc, chemokine, and adhesion receptors, and is crucial for both B cell development and osteoclastogenesis. Although down-regulated in normal plasma cells, Btk is highly expressed in the malignant cells from many myeloma patients and some cell lines. Ibrutinib is a potent and specific inhibitor of Btk currently in Phase 2 and 3 clinical trials. The current study is designed and intended to determine the safety and efficacy of ibrutinib in combination with pomalidomide and dexamethasone in subjects with relapsed/refractory multiple myeloma.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Phase 1: Dose Finding | Experimental | Drug: Ibrutinib, Drug: Pomalidomide, Drug: DexamethasoneIbrutinib PO+ Pomalidomide PO+ Dexamethasone PO |
| Phase 2: Treatment Arm A | Experimental | Drug: Ibrutinib, Drug: Pomalidomide, Drug: DexamethasoneIbrutinib PO+ Pomalidomide PO+ Dexamethasone PO |
| Phase 2: Treatment Arm B | Experimental | Drug: Pomalidomide, Drug: Dexamethasone, Drug: PlaceboPlacebo PO+ Pomalidomide PO+ Dexamethasone PO |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Subjects with relapsed/refractory MM who have received at least two prior lines of therapy including lenalidomide and either bortezomib or carfilzomib and have demonstrated disease progression on or within 60 days of the completion of the most recent treatment regimen.
- Measurable disease defined by at least ONE of the following:
- Adequate hematologic, hepatic, and renal function
- ECOG performance status of ≤ 2
Key exclusion criteria (5 listed)
- Subject must not have primary refractory disease
- Plasma cell leukemia, primary amyloidosis or POEMS syndrome
- Unable to swallow capsules or disease significantly affecting gastrointestinal function
- Requires treatment with strong CYP3A inhibitors
- Women who are pregnant or breast feeding.
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 |
|---|---|---|
| Ibrutinib | Drug | Phase 1: Dose Finding, Phase 2: Treatment Arm A |
| Pomalidomide | Drug | Phase 1: Dose Finding, Phase 2: Treatment Arm A, Phase 2: Treatment Arm B |
| Dexamethasone | Drug | Phase 1: Dose Finding, Phase 2: Treatment Arm A, Phase 2: Treatment Arm B |
| Placebo | Drug | Phase 2: Treatment Arm B |
Primary outcome
Overall Response Rate (ORR) According to the IMWG Response Criteria Per Investigator Assessment
Time frame: 14 Months
The overall response rate, defined as the proportion of subjects achieving a best overall response of PR or better per investigator assessment per IMWG at or prior to initiation of subsequent anticancer therapy
2 secondary outcomes
Clinical Benefit Response (CBR)
Time frame: 14 Months
Duration of Response (DOR)
Time frame: 14 Months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
The record lists no contact. Use the official record to reach the sponsor.
16 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Ibrutinib, Pomalidomide and Dexamethasone in people with Multiple Myeloma, run by Pharmacyclics LLC. at 16 sites in 6 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 5 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: stopped early, as of the sponsor's last update on 21 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 16 sites in United States, Spain, Czechia, Australia, Germany and 1 more country. 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 combined 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.
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?
Yes. Results are posted in the registry (first posted 23 Apr 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Overall Response Rate (ORR) According to the IMWG Response Criteria Per Investigator Assessment (time frame: 14 Months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 Nov 2019.