Newly Diagnosed Multiple MyelomaPhase 2NCT03733691
Ph 2 Maintenance Trial: Ixazomib vs Ixazomib-Lenalidomide for MM Patients
A Phase 2 study testing Ixazomib and Lenalidomide in people with Newly Diagnosed Multiple Myeloma, run by Oncotherapeutics at 1 site in United States.
Trial summary
This is a randomized, Phase 2 study involving two arms evaluating the efficacy and safety of ixazomib alone and the combination of both ixazomib and lenalidomide as maintenance therapy for patients with multiple myeloma who have achieved at least partial response (PR) or better after receiving a bortezomib- and… Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Newly Diagnosed Multiple Myeloma
- What is being tested?
- Ixazomib and Lenalidomide
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2019to 19 Oct 2023
- 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 to 100 years
- 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.
- Patients must be receiving a frontline bortezomib- and lenalidomide-containing regimen for treatment of disease
- Patients must meet the following clinical laboratory criteria:
- Absolute neutrophil count (ANC) grater or equal 1,000/mm3 and platelet count greater or equal 75,000/mm3. Platelet transfusions to help patients meet eligibility criteria are not allowed within 7 days prior to screening platelets or at investigator's discretion.
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- Hemoglobin ≥ 8.0 g/dL. Use of erythropoietic stimulating factors and red blood cell (RBC) transfusions per institutional guidelines is allowed; however, most recent RBC transfusion must have been at least 7 days prior to obtaining screening hemoglobin or at investigator's discretion.
- Total bilirubin less or equal 1.5 times the upper limit of the normal range (ULN).
- Calculated or measured creatinine clearance greater or equal 30 mL/min. Calculation is based on a standard Cockcroft and Gault formula (Section 14.2).
- AST (SGOT) and ALT (SGPT) less or equal 3 x ULN or less or equal 5 x ULN if hepatic metastases are present.
- LVEF ≥ 40%. 2-D transthoracic echocardiogram (ECHO) is the preferred method of evaluation. Mitigated Acquisition Scan (MUGA) is acceptable if ECHO is not available.
- Patients must be transplant ineligible as determined by the treating physician.
- Patients must have a life-expectancy of more than 6 months.
- Patients must have a confirmed diagnosis of MM.
- Patients receiving front-line therapy must have achieved at least PR and have completed at least 6 cycles of treatment.
- The disease must have reached a plateau phase at the end of front-line treatment as demonstrated bythe same response (using IMWG criteria) in three consecutive tests with at least three weeks between each test.
- Patients must have received frontline treatment within 8 weeks of enrollment.
- Patient can adhere to the study visit schedule and other protocol requirements.
- Patient Eastern Cooperative Oncology Group (ECOG) performance status is ≤ 2.
- Patients must voluntarily give written consent before any study related procedure not part of standard medical care is performed, with the understanding that consent may be withdrawn by the patient at any time without prejudice to future medical care.
- Female patients must be postmenopausal for at least 1 year before screening visit OR surgically sterile. If patient is female of childbeating potential (FCBP), patient must agree to practice two 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. FCBP must also adhere to the guidelines of any treatment-specific pregnancy prevention program AND agree to practice true abstinence when this is in line with the preferred and usual lifestyle of the subject. Periodic abstinence (e.g. calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception.
- Male patients, even if surgically sterilized (i.e., status post-vasectomy), must agree to one of the following:
- To practice effective barrier contraception during the entire study treatment period and through 90 days after the last dose of study drug
- To practice true abstinence when this is in line with the preferred and usual lifestyle of the subject. Periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception.
Who cannot join
- Patients meeting any of the following exclusion criteria are not to be enrolled in the study:
- Patient is currently progressing on a bortezomib- and lenalidomide-containing regimen.
- Patients who have received more than 1 line of therapy (thus non-frontline treated patients).
- Patients who were exposed to ixazomib during frontline therapy.
- Patient has ¬> Grade 3 peripheral neuropathy or Grade 2 with pain during the screening period.
- Patient has known gastrointestinal disease or gastrointestinal procedure that could interfere with the oral absorption or tolerance of ixazomib including difficulty swallowing.
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- Female patients who are lactating or have a positive serum pregnancy test during the screening period.
- Major surgery within 14 days before enrollment or at investigator's discretion.
- Patients undergoing stem cell therapy (SCT) or those who are planned for SCT.
- Radiotherapy within 14 days before enrollment or investigator's discretion. If the involved field is small, 7 days or investigator's discretion will be considered a sufficient interval between treatment and administration of the study drugs. Receipt of localized radiation therapy does not preclude enrollment.
- Infection requiring systemic antibiotic therapy or other serious infection such as known active hepatitis B or C virus infection, known human immunodeficiency virus (HIV) positive within 14 days before of study enrollment or at investigator's discretion.
- Evidence of current uncontrolled cardiovascular conditions, including uncontrolled hypertension, uncontrolled cardiac arrhythmias, symptomatic congestive heart failure, NYHA Class III or IV heart failure, unstable angina, clinically significant pericardial disease or myocardial infarction within the past 6 months, unless subject has a pacemaker. Prior to study entry, any ECG abnormality at Screening must be documented by the investigator as not medically relevant.
- Frontline therapy within 14 days or at investigator's discretion of the first dose of study drugs.
- Systemic treatment, within 14 days before or at investigator's discretion of the first dose of study drugs, with strong CYP3A inducers (rifampin, rifapentine, rifabutin, carbamazepine, phenytoin, phenobarbital), or use of St. John's wort or Ginkgo biloba.
- 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.
- 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.
- Participation in other clinical trials throughout the duration of this trial.
- Patient has been diagnosed with:
- Plasma cell dyscrasia with polyneuropathy, organomegaly, endocrinopathy, monoclonal protein (M protein) and skin changes (POEMS) syndrome3.
- Primary amyloidosis
- Plasma cell leukemia.
- Severe hypercalcemia, i.e., serum calcium ≥ 12 mg/dL (3.0 mmol/L) corrected for albumin.
Trial locations and contacts
1 site in 1 country.
United States1 site
James R Berenson, MD, Inc.
West Hollywood, California, 90069
About this study
Official title: A Phase 2, Open Label, Randomized Trial Evaluating Ixazomib Compared to Ixazomib-Lenalidomide Combination Maintenance Therapy for Frontline Multiple Myeloma Patients
This is a randomized, Phase 2 study involving two arms evaluating the efficacy and safety of ixazomib alone and the combination of both ixazomib and lenalidomide as maintenance therapy for patients with multiple myeloma who have achieved at least partial response (PR) or better after receiving a bortezomib- and lenalidomide-containing combination front-line therapy.
Read the detailed description
Patients who have achieved PR or better on a bortezomib- and lenalidomide-containing combination therapy will be randomized to receive maintenance therapy with 28-day cycles of either ixazomib alone or the combination of ixazomib and lenalidomide. If steroids were part of the patient's qualifying regimen, steroids will be administered using the same drug(s), schedule(s) and dose(s) as those of the last treatment cycle of the bortezomib-, lenalidomide- and steroid-containing regimen. Ixazomib will be administered per orem (PO) at 3 mg on days 1, 8 and 15 of 28-day cycles. Lenalidomide will be taken PO, once daily at the same dose as the last treatment on days 1 through 28 of the 28-day cycles. Patients will start the randomized maintenance therapy after receiving a minimum of 6 cycles of a bortezomib- and lenalidomide-containing combination treatment but may have received up to 8 cycles if they continued to show improvement in their response after the first 6 cycles. During cycle 1, patients will have clinical laboratory tests weekly (days 1, 8, 15 and 22) and MM disease assessments on day 22 to monitor for efficacy and potential toxicity. Beginning with cycle 2, patients will have clinical laboratory tests performed twice a month and MM disease assessments once a month. Patients will be treated until documentation of PD or if subject meets any of the treatment discontinuation criteria.
- Conditions
- Newly Diagnosed Multiple Myeloma
- Being tested
- Ixazomib, Lenalidomide
- Keywords
- Multiple Myeloma, Front-line, Maintenance therapy
- Medical subject headings
- Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IxazomibDrug
Also called Ninlaro
3 mg oral capsule, Days 1, 8 and 15 of 28-day cycles
LenalidomideDrug
Also called Revlimid
Same dose as in the front-line treatment in the last treatment cycle, taken orally, on days 1-28 of a 28-day cycle.
| Study group | Role | What they receive |
|---|---|---|
| Ixazomib Only | Experimental | The prescribed dose administration of ixazomib in this study is 3mg orally on Days 1, 8, and 15 of a 28-day cycle. Receives: Drug: Ixazomib |
| Ixazomib + Lenalidomide | Experimental | The prescribed dose administration of ixazomib in this study is 3mg orally on Days 1, 8, and 15 of a 28-day cycle.
The prescribed dose administration of lenalidomide in this study is the same as the dose of the patient's front-line treatment taken in the last treatment cycle unless otherwise clinically indicated per investigator's discretion, taken orally on days 1-28 of a 28-day cycle. If patient was receiving lenalidomide at a higher dose than 10 mg, then the dose of lenalidomide on this study will be adjusted to 10 mg daily on days 1-28 of a 28-day cycle Receives: Drug: Ixazomib; Drug: Lenalidomide |
What is being measured
The primary outcome is the main question the study is designed to answer.
PFS
Progression Free Survival
Measured: Through study completion, approximately 5 years
Adverse events (AEs)
Monitoring safety and tolerability via monitoring adverse events graded by CTCAE v5
Measured: throughout the study completion, approximately 5 years
Secondary outcomes (2)
OS
Overall survival
Measured: from time of initiation of maintenance therapy to death from any cause or last follow-up visit, up to 60 months
Deepening of the response
define as the percentage of patients who improved their response during maintenance therapy.
Measured: throughout the study, up to 60 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2018
- Study start1 Mar 2019
- Primary completion19 Oct 2023
- Study completion19 Oct 2023
Why it stopped: Insufficient enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Newly Diagnosed 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A randomized, open label, Phase 2 study involving two arms evaluating the efficacy and safety of ixazomib monotherapy (with steroids if applicable) and the combination of ixazomib and lenalidomide (with steroids if applicable) as maintenance therapy for patients with MM who have achieved at least PR after receiving a bortezomib and lenalidomide (with steroids if applicable)-containing combination frontline therapy.
- Masking
- None (open label)
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oncotherapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Takeda
- Responsible party
- Sponsor
- Investigators
- James R. Berenson M Inc., MD, Principal investigator, Oncotherapeutics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03733691
- Sponsor's protocol ID
- X16108
- Status last verified
- Oct 2023
- First submitted
- 2 Nov 2018
- Last updated
- 25 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Open Label, Randomized Trial Evaluating Ixazomib Compared to Ixazomib-Lenalidomide Combination Maintenance Therapy for Frontline Multiple Myeloma Patients
- ClinicalTrials.gov ID
- NCT03733691
- Acronym / sponsor ID
- X16108
- Conditions
- Newly Diagnosed Multiple Myeloma
- Keywords
- Multiple Myeloma, Front-line, Maintenance therapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Insufficient enrollment
- Enrolment
- 19 participants (actual)
- Lead sponsor
- OncotherapeuticsIndustry (pharma, biotech, devices)
- Collaborators
- Takeda
- Study start
- 1 Mar 2019 (actual)
- Primary completion
- 19 Oct 2023 (actual)
- Study completion
- 19 Oct 2023 (actual)
- First posted
- 7 Nov 2018 (actual)
- 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.
This is a randomized, Phase 2 study involving two arms evaluating the efficacy and safety of ixazomib alone and the combination of both ixazomib and lenalidomide as maintenance therapy for patients with multiple myeloma who have achieved at least partial response (PR) or better after receiving a bortezomib- and lenalidomide-containing combination front-line therapy.
Detailed description
Patients who have achieved PR or better on a bortezomib- and lenalidomide-containing combination therapy will be randomized to receive maintenance therapy with 28-day cycles of either ixazomib alone or the combination of ixazomib and lenalidomide. If steroids were part of the patient's qualifying regimen, steroids will be administered using the same drug(s), schedule(s) and dose(s) as those of the last treatment cycle of the bortezomib-, lenalidomide- and steroid-containing regimen. Ixazomib will be administered per orem (PO) at 3 mg on days 1, 8 and 15 of 28-day cycles. Lenalidomide will be taken PO, once daily at the same dose as the last treatment on days 1 through 28 of the 28-day cycles. Patients will start the randomized maintenance therapy after receiving a minimum of 6 cycles of a bortezomib- and lenalidomide-containing combination treatment but may have received up to 8 cycles if they continued to show improvement in their response after the first 6 cycles. During cycle 1, patients will have clinical laboratory tests weekly (days 1, 8, 15 and 22) and MM disease assessments on day 22 to monitor for efficacy and potential toxicity. Beginning with cycle 2, patients will have clinical laboratory tests performed twice a month and MM disease assessments once a month. Patients will be treated until documentation of PD or if subject meets any of the treatment discontinuation criteria.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- A randomized, open label, Phase 2 study involving two arms evaluating the efficacy and safety of ixazomib monotherapy (with steroids if applicable) and the combination of ixazomib and lenalidomide (with steroids if applicable) as maintenance therapy for patients with MM who have achieved at least PR after receiving a bortezomib and lenalidomide (with steroids if applicable)-containing combination frontline therapy.
| Arm | Type | Receives |
|---|---|---|
| Ixazomib Only | Experimental | Drug: IxazomibThe prescribed dose administration of ixazomib in this study is 3mg orally on Days 1, 8, and 15 of a 28-day cycle. |
| Ixazomib + Lenalidomide | Experimental | Drug: Ixazomib, Drug: LenalidomideThe prescribed dose administration of ixazomib in this study is 3mg orally on Days 1, 8, and 15 of a 28-day cycle. The prescribed dose administration of lenalidomide in this study is the same as the dose of the patient's front-line treatment taken in the last treatment cycle unless otherwise clinically indicated per investigator's discretion, taken orally on days 1-28 of a 28-day cycle. If patient was receiving lenalidomide at a higher dose than 10 mg, then the dose of lenalidomide on this study will be adjusted to 10 mg daily on days 1-28 of a 28-day cycle |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (24 listed)
- -
- Each patient must meet all of the following inclusion criteria to be enrolled in the study:
- Male or female patients 18 years or older.
- Patients must be receiving a frontline bortezomib- and lenalidomide-containing regimen for treatment of disease
- Patients must meet the following clinical laboratory criteria:
Key exclusion criteria (24 listed)
- Patients meeting any of the following exclusion criteria are not to be enrolled in the study:
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 |
|---|---|---|
| IxazomibAlso: Ninlaro3 mg oral capsule, Days 1, 8 and 15 of 28-day cycles | Drug | Ixazomib + Lenalidomide, Ixazomib Only |
| LenalidomideAlso: RevlimidSame dose as in the front-line treatment in the last treatment cycle, taken orally, on days 1-28 of a 28-day cycle. | Drug | Ixazomib + Lenalidomide |
Primary outcome
PFS
Time frame: Through study completion, approximately 5 years
Progression Free Survival
Adverse events (AEs)
Time frame: throughout the study completion, approximately 5 years
Monitoring safety and tolerability via monitoring adverse events graded by CTCAE v5
2 secondary outcomes
OS
Time frame: from time of initiation of maintenance therapy to death from any cause or last follow-up visit, up to 60 months
Deepening of the response
Time frame: throughout the study, up to 60 months
Results and safety
The study was stopped early (reason given: Insufficient enrollment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Oct 2023.
- Individual participant dataSharing planned: No
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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.
James R. Berenson M Inc., MD principal investigator
Oncotherapeutics
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 and Lenalidomide in people with Newly Diagnosed Multiple Myeloma, run by Oncotherapeutics 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 24 inclusion and 24 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 25 Oct 2023. 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 stopped early (reason given: Insufficient enrollment). 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.
What does the primary outcome measure?
PFS (time frame: Through study completion, approximately 5 years). The study lists 2 primary outcomes in all. 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 25 Oct 2023.