Multiple MyelomaPhase 2NCT02578121
UARK 2015-03 A Phase II Trial of a Novel Proteasome/IMiD Combination
A Phase 2 study testing Ixazomib, Pomalidomide and Dexamethasone in people with Multiple Myeloma, run by University of Arkansas at 1 site in United States.
Trial summary
The purpose of this study is to determine the efficacy of Ixazomib when combined with Pomalidomide and Dexamethasone, in terms of overall response rate in subjects with relapsed Multiple Myeloma 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?
- Ixazomib, Pomalidomide and Dexamethasone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2015to Jan 2017
- 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
- Each patient must meet all of the following inclusion criteria to be enrolled in the study:
- Male or female patients 18 years or older.
- Voluntary written consent must be given before performance of any study related procedure not part of standard medical care, with the understanding that consent may be withdrawn by the patient at any time without prejudice to future medical care.
- Female patients who:
- Are postmenopausal for at least 1 year before the screening visit, OR Are surgically sterile, OR If they are of childbearing potential, agree to practice 2 effective methods of contraception, at the same time, from the time of signing the informed consent form through 90 days after the last dose of study drug, AND Agree to practice true abstinence when this is in line with the preferred and usual lifestyle of the subject. (Periodic abstinence [eg, calendar, ovulation, symptothermal, post-ovulation methods] and withdrawal are not acceptable methods of contraception.)
- Male patients, even if surgically sterilized (ie, status post-vasectomy), must agree to one of the following: Agree to practice effective barrier contraception during the entire study treatment period and through 90 days after the last dose of study drug, OR Agree to practice true abstinence when this is in line with the preferred and usual lifestyle of the subject. (Periodic abstinence (eg, calendar, ovulation, symptothermal, post-ovulation methods] and withdrawal are not acceptable methods of contraception.)
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- Patients must have a diagnosis of relapsed and/or refractory multiple myeloma and must have received at least one line of prior therapy. Patients must be at least 14 days beyond the last multiple myeloma therapy and have recovered from acute toxicities of prior therapies measured by CTCAE (Version 4.0)
- Patients must have life expectancy of at least 3 months.
- Eastern Cooperative Oncology Group (ECOG) performance status and/or other performance status 0, 1, or 2.
- Patients must meet the following clinical laboratory criteria:
- Absolute neutrophil count (ANC) > 1,000/mm3 and platelet count> 50,000/mm3. Platelet transfusions to help patients meet eligibility criteria are not allowed within 3 days before study enrollment. Total bilirubin <1.5 x the upper limit of the normal range (ULN). Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) < 3 x ULN. Calculated creatinine clearance > 30 mL/min (see APPENDIX C for the Cockcroft-Gault Equation).,
Who cannot join
- Patients meeting any of the following exclusion criteria are not to be enrolled in the study:
- Female patients who are lactating or have a positive serum pregnancy test during the screening period.
- Failure to have fully recovered (ie, < Grade 1 toxicity) from the reversible effects of prior chemotherapy.
- Major surgery within 14 days before enrollment.
- Radiotherapy within 14 days before enrollment. If the involved field is small, 7 days will be considered a sufficient interval.
- Central nervous system involvement.
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- Infection requiring systemic antibiotic therapy or other serious infection within 14 days before study enrollment.
- Evidence of current uncontrolled cardiovascular conditions, including uncontrolled hypertension, uncontrolled cardiac arrhythmias, symptomatic congestive heart failure, unstable angina, or myocardial infarction within the past 6 months.
- Ongoing or active systemic infection, active hepatitis B or C virus infection, or known human immunodeficiency virus (HIV) positive.
- Any serious medical or psychiatric illness that could, in the investigator's opinion, potentially interfere with the completion of treatment according to this protocol.
- Known allergy to any of the study medications, their analogues, or excipients in the various formulations of any agent.
- Known GI disease or GI procedure that could interfere with the oral absorption or tolerance of oral medications including difficulty swallowing.
- Diagnosed or treated for another malignancy within 2 years before study enrollment or previously diagnosed with another malignancy and have any evidence of residual disease. Patients with non-melanoma skin cancer or carcinoma in situ of any type are not excluded if they have undergone complete resection.
- Patient has > Grade 3 peripheral neuropathy, or Grade 2 with pain on clinical examination during the screening period.
- Participation in other clinical trials, including those with other investigational agents not included in this trial, within 21 days of the start of this trial and throughout the duration of this trial.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Arkansas for Medical Science
Little Rock, Arkansas, 72205
About this study
Official title: A Phase II Trial of a Novel Proteasome/IMiD Combination, Ixazomib, Pomalidomide, and Dexamethasone in Relapsed Multiple Myeloma Patients
The purpose of this study is to determine the efficacy of Ixazomib when combined with Pomalidomide and Dexamethasone, in terms of overall response rate in subjects with relapsed Multiple Myeloma
Read the detailed description
This single arm, Phase II study will examine the efficacy and safety of the novel Proteasome/IMiD combination of Ixazomib 4mg days 1, 8, 15, Pomalidomide 4 mg days 1-21, Dexamethasone 20 mg days 1, 8, 15, and 22 of a 28 day cycle, in relapse patients. The long term aim being to develop a backbone regimen to which future novel targeted treatments may be added as part of a personalized medicine approach.
- Conditions
- Multiple Myeloma
- Being tested
- Ixazomib, Pomalidomide, Dexamethasone
- Keywords
- Relapsed, Response Rate, Progression free
- 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.
IxazomibDrug
4.0 mg will be given on days 1, 8 and 15 of a 28 day cycle
PomalidomideDrug
4.0 mg will be given on days 1-21 of a 28 day cycle
DexamethasoneDrug
20 mg will be given on days 1, 8, 15 and 22 of a 28 day cycle
| Study group | Role | What they receive |
|---|---|---|
| Ixazomib, Pomalidomide, Dexamethasone | Experimental | Protasome/IMiD combination of Ixazomib 4mg days 1, 8, and 15, Pomalidomide 4mg days 1-21 amd Dexamethasone 20 mg days 1, 8, 15 and 22 of a 28 day cycle Receives: Drug: Ixazomib; Drug: Pomalidomide; Drug: Dexamethasone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Response rate after combination of Ixazomib, Pomalidomide and Dexamethasone therapy
Response rate will be assessed at baseline, with each scheduled study visit , including the exit visit.
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2015 (estimated)
- Study startDec 2015
- Primary completionJan 2017
- Study completionJan 2017
Why it stopped: Investigator decided to close study without enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple MyelomaStudies of the same condition, open and under way.
- More trials run by University of ArkansasThe 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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Arkansas
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Faith Davies, MD, Principal investigator, University of Arkansas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02578121
- Sponsor's protocol ID
- 0203974
- Status last verified
- Jan 2017
- First submitted
- 14 Oct 2015
- Last updated
- 23 Jan 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Trial of a Novel Proteasome/IMiD Combination, Ixazomib, Pomalidomide, and Dexamethasone in Relapsed Multiple Myeloma Patients
- ClinicalTrials.gov ID
- NCT02578121
- Acronym / sponsor ID
- 0203974
- Conditions
- Multiple Myeloma
- Keywords
- Relapsed, Response Rate, Progression free
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Investigator decided to close study without enrollment
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of ArkansasUniversity, hospital or other
- Study start
- Dec 2015
- Primary completion
- Jan 2017 (actual)
- Study completion
- Jan 2017 (actual)
- First posted
- 16 Oct 2015 (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 efficacy of Ixazomib when combined with Pomalidomide and Dexamethasone, in terms of overall response rate in subjects with relapsed Multiple Myeloma
Detailed description
This single arm, Phase II study will examine the efficacy and safety of the novel Proteasome/IMiD combination of Ixazomib 4mg days 1, 8, 15, Pomalidomide 4 mg days 1-21, Dexamethasone 20 mg days 1, 8, 15, and 22 of a 28 day cycle, in relapse patients. The long term aim being to develop a backbone regimen to which future novel targeted treatments may be added as part of a personalized medicine approach.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ixazomib, Pomalidomide, Dexamethasone | Experimental | Drug: Ixazomib, Drug: Pomalidomide, Drug: DexamethasoneProtasome/IMiD combination of Ixazomib 4mg days 1, 8, and 15, Pomalidomide 4mg days 1-21 amd Dexamethasone 20 mg 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 (11 listed)
- Each patient must meet all of the following inclusion criteria to be enrolled in the study:
- Are postmenopausal for at least 1 year before the screening visit, OR Are surgically sterile, OR If they are of childbearing potential, agree to practice 2 effective methods of contraception, at the same time, from the time of signing the informed consent form through 90 days after the last dose of study drug, AND Agree to practice true abstinence when this is in line with the preferred and usual lifestyle of the subject. (Periodic abstinence [eg, calendar, ovulation, symptothermal, post-ovulation methods] and withdrawal are not acceptable methods of contraception.)
- Male patients, even if surgically sterilized (ie, status post-vasectomy), must agree to one of the following: Agree to practice effective barrier contraception during the entire study treatment period and through 90 days after the last dose of study drug, OR Agree to practice true abstinence when this is in line with the preferred and usual lifestyle of the subject. (Periodic abstinence (eg, calendar, ovulation, symptothermal, post-ovulation methods] and withdrawal are not acceptable methods of contraception.)
- Patients must have a diagnosis of relapsed and/or refractory multiple myeloma and must have received at least one line of prior therapy. Patients must be at least 14 days beyond the last multiple myeloma therapy and have recovered from acute toxicities of prior therapies measured by CTCAE (Version 4.0)
- Patients must have life expectancy of at least 3 months.
Key exclusion criteria (15 listed)
- Patients meeting any of the following exclusion criteria are not to be enrolled in the study:
- Female patients who are lactating or have a positive serum pregnancy test during the screening period.
- Failure to have fully recovered (ie, < Grade 1 toxicity) from the reversible effects of prior chemotherapy.
- Major surgery within 14 days before enrollment.
- Radiotherapy within 14 days before enrollment. If the involved field is small, 7 days will be considered a sufficient interval.
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 |
|---|---|---|
| Ixazomib4.0 mg will be given on days 1, 8 and 15 of a 28 day cycle | Drug | Ixazomib, Pomalidomide, Dexamethasone |
| Pomalidomide4.0 mg will be given on days 1-21 of a 28 day cycle | Drug | Ixazomib, Pomalidomide, Dexamethasone |
| Dexamethasone20 mg will be given on days 1, 8, 15 and 22 of a 28 day cycle | Drug | Ixazomib, Pomalidomide, Dexamethasone |
Primary outcome
Response rate after combination of Ixazomib, Pomalidomide and Dexamethasone therapy
Time frame: 28 days
Response rate will be assessed at baseline, with each scheduled study visit , including the exit visit.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2017.
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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.
Faith Davies, MD principal investigator
University of Arkansas
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Ixazomib, Pomalidomide and Dexamethasone in people with Multiple Myeloma, run by University of Arkansas at 1 site in United States.
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 11 inclusion and 15 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: withdrawn, as of the sponsor's last update on 23 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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 was withdrawn before enrolling participants, so there are no results.
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?
Response rate after combination of Ixazomib, Pomalidomide and Dexamethasone therapy (time frame: 28 days). 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 23 Jan 2017.