Multiple MyelomaPhase 1/2NCT02477215
Study of Bendamustine and IXAZOMIB (MLN9708) Plus Dexamethasone in Relapsed/Refractory Multiple Myeloma
A Phase 1/2 study testing MLN9708, Dexamethasone and Bendamustine (multiple dose levels) in people with Multiple Myeloma, run by Parameswaran Hari at 1 site in United States.
Trial summary
This Phase I/II study is designed to first identify doses of MLN9708 and bendamustine that are associated with an acceptable adverse event profile when delivered together in 28-day cycles. Additionally, the study aims to assess the efficacy of the combination in patients with relapsed/refractory 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?
- MLN9708, Dexamethasone and Bendamustine (multiple dose levels)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Oct 2015to 17 Sep 2020
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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of any study related procedure not part of standard medical care, with the understanding that consent may be withdrawn by the patient at any time without prejudice to future medical care.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 one year before the screening visit, OR
- Are surgically sterile, OR
- If they are of childbearing potential, 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, 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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- 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, postovulation methods] and withdrawal are not acceptable methods of contraception.)
- Patients must have have histologically or cytologically confirmed symptomatic Multiple Myeloma, who are non-responsive to or ineligible for autologous stem cell transplant, and who progress after prior exposure to proteasome inhibitor (bortezomib, carfilzomib) and lenalidomide or pomalidomide or thalidomide (IMID); and refractory/progressing to at least one of these agents and must meet at least one of the following parameters of measurable disease:
- Measurable levels of monoclonal protein (M protein): > 1 g/dL of immunoglobin G (IgG) or immunoglobin M (IgM) M-protein or > 0.5 g/dL immunoglobin A (IgA) or immunoglobin D (IgD) M protein on serum protein electrophoresis OR > 200 mg/24h of free light chain proteinuria on a 24 hour urine protein electrophoresis which must be obtained within 4 weeks prior to registration OR > 10 mg/dL involved free light chain on serum free light chain testing with an abnormal kappa:lambda light chain ratio.
- Patients with lytic bone disease, defined as at least one lytic lesion that can be accurately measured in at least one dimension.
- Eastern Cooperative Oncology Group (ECOG) performance status and/or other performance status 0, 1, or 2.
- Patients are eligible after autologous or allogeneic stem cell transplantation. Allogeneic transplantation can be enrolled only if they have no ongoing transplant related side effects.
- Patients must be at least 2 weeks from major surgery, radiation therapy, participation in other investigational trials and have recovered from clinically significant toxicities of these prior treatments
- Patients must meet the following clinical laboratory criteria:
- Absolute neutrophil count (ANC) ≥ 1,000/mm3 and platelet count ≥ 75,000/mm3. Platelet transfusions or granulocyte-colony stimulating factor (G-CSF) can be used to help patients meet eligibility criteria but are not allowed within 3 days before study enrollment.
- Total bilirubin < 1.5 x the upper limit of the normal range (ULN), , OR, direct bilirubin within normal limits (WNL), when total bilirubin is >>< 1.5 x the ULN.
- Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) < 3 x ULN.
- Calculated creatinine clearance ≥ 30 mL/min.
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 except for peripheral neuropathy, which is addressed in exclusion criteria no. #14.
- Major surgery within 14 days before enrollment.
- Radiotherapy within 14 days before enrollment. If the involved field is limited (single disease focus not involving pelvis and involving <36 Gy radiation), 7 days will be considered a sufficient interval between treatment and administration of Ixazomib provided hematologic inclusion parameters are met.
- 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.
- Systemic treatment, within 14 days before the first dose of IXAZOMIB, with strong inhibitors of cytochrome P1A2 (CYP1A2) (fluvoxamine, enoxacin, ciprofloxacin), strong inhibitors of cytochrome P3A (CYP3A) (clarithromycin, telithromycin, itraconazole, voriconazole, ketoconazole, nefazodone, posaconazole) or strong CYP3A inducers (rifampin, rifapentine, rifabutin, carbamazepine, phenytoin, phenobarbital), or use of Ginkgo biloba or St. John's wort.
- 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 IXAZOMIB including difficulty swallowing.
- Diagnosed or treated for another malignancy where the expected survival is less than two years will be excluded. Patients with nonmelanoma skin cancer or carcinoma in situ of any type are not excluded if they have undergone complete resection.
- Patient has ≥ Grade 2 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 30 days of the start of this trial and throughout the duration of this trial.
- Patients that have previously been treated with IXAZOMIB, or participated in a study with IXAZOMIB whether treated with IXAZOMIB or not.
- Patients with a history of severe chronic obstructive pulmonary disease requiring ongoing oxygen support or those with a resting oxygen saturation <92% on room air irrespective of the cause.
Trial locations and contacts
1 site in 1 country.
United States1 site
Froedtert Hospital and the Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
About this study
Official title: Phase I/II Study of Bendamustine and IXAZOMIB (MLN9708) Plus Dexamethasone in Relapsed/Refractory Multiple Myeloma
This Phase I/II study is designed to first identify doses of MLN9708 and bendamustine that are associated with an acceptable adverse event profile when delivered together in 28-day cycles. Additionally, the study aims to assess the efficacy of the combination in patients with relapsed/refractory multiple myeloma. Responders (stable disease or more), will continue to receive up to eight cycles total in the absence of further progressive disease.
Read the detailed description
OVERVIEW: This Phase I/II study is designed to first identify doses of MLN9708 and bendamustine that are associated with an acceptable adverse event profile when delivered together in 28-day cycles. Additionally, the study aims to assess the efficacy of the combination in patients with relapsed/refractory multiple myeloma. Responders (stable disease or more),will continue to receive up to eight cycles total in the absence of further progressive disease.
OVERVIEW OF THE DOSE ESCALATION/DE-ESCALATION: This study aims to assess the combination's efficacy in patients with relapsed/refractory multiple myeloma. Responders (stable disease or more) will continue to receive up to eight cycles total in the absence of further progressive disease. The dose of MLN9708 will be fixed at 4 mg given on days 1, 8 and 15. Dexamethasone will be administered at 40 mg (oral) on Days 1, 8, 15 of each 28 day cycle. Dexamethasone administered as 40 mg oral on Days 1, 8, 15 of each 28 day cycle. Three doses of bendamustine will be evaluated (Dose 1: 70 mg/m^2, days 1 and 2; Dose 2: 80 mg/m^2. days 1 and 2; and Dose 3: 90 mg/m^2, days 1 and 2).
PHASE 1 DESIGN: A 3+3 design was employed. At each dose, three patients were initially evaluated. When no dose limiting toxicities were observed, the bendamustine dose will be increased.
PHASE 2 DESIGN: Design for Phase II portion of study: The MTD or a recommended phase 2 dose (RP2D) for the combination. The plan is to treat additional patients at that dose to assess efficacy and response to treatment. The investigators plan to enroll 19 patients (including those treated at the MTD in Phase I).
- Conditions
- Multiple Myeloma
- Being tested
- MLN9708, Dexamethasone, Bendamustine (multiple dose levels), Bendamustine (MTD)
- Keywords
- Multiple Myeloma
- Medical subject headings
- Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MLN9708Drug
Also called Ixazomib
4 mg of MLN9708 delivered on days 1, 8 and 15 of a 28 day cycle.
DexamethasoneDrug
Also called Decadron
40 mg oral on Days 1, 8, 15 of each 28 day cycle.
Bendamustine (multiple dose levels)Drug
Also called Treanda, Treakisym, Ribomustin
70 mg/m^2, 80 mg/m^2, or 90 mg/m^2 on days 1 and 2
Bendamustine (MTD)Drug
Also called Treanda, Treakisym, Ribomustin
80 mg/m^2 on days 1 and 2
| Study group | Role | What they receive |
|---|---|---|
| MLN9708, Bendamustine and Dexamethasone Dose Escalation | Experimental | Ixazomib 4 mg, days 1, 8, 15.
Dexamethasone 40 mg oral weekly.
Bendamustine dose levels: 70 mg/m^2, 80mg/m^2, or 90 mg/m^2 given on days 1 and 2 Receives: Drug: MLN9708; Drug: Dexamethasone; Drug: Bendamustine (multiple dose levels) |
| MLN9708, Bendamustine and Dexamethasone MTD | Experimental | Ixazomib 4 mg, days 1, 8, 15.
Dexamethasone 40 mg oral weekly.
Bendamustine dose levels: MTD given on days 1 and 2 Receives: Drug: MLN9708; Drug: Dexamethasone; Drug: Bendamustine (MTD) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Tolerated Dose of Bendamustine
Maximum tolerated dose of bendamustine in combination with fixed doses of ixazomib (MLN9708) and dexamethasone will be determined from the incidence of dose limiting toxicities at each dosage.
Measured: Six months for each dosing cohort
Objective Response Rate
Objective response rate was defined as the number of subjects achieving a complete response (CR) or partial response (PR) after at least four cycles of ixazomib (MLN9708) and bendamustine plus dexamethasone.
Measured: 18 months
Secondary outcomes (5)
Overall Survival (OS)
Overall survival was determined as the average number of months subjects survived following enrollment.
Measured: 36 months
Progression Free Survival (PFS)
This measure is the number of months participants remain free from evidence of disease.
Measured: 18 months
Cumulative Response Rates in Patients After Eight Cycles.
Percentage of subject response rates at any point during the eight cycles.
Measured: 18 months
Duration of Response (DoR)
Median time in months participants maintain CR, PR or stable disease.
Measured: 36 months
Number of Participants Experiencing Dose-Limiting Toxicity (DLT)
A 3+3 design was employed. At each dose, three patients were initially evaluated. If no dose limiting toxicities were observed, the bendamustine dose was increased; if one dose limiting toxicity is observed, three additional patients were treated at that dose. A dose at which 2 DLTs were observed in 3 or 6 patients were judged to be too toxic and the lower dose was defined as the maximally tolerated dose (MTD).
Measured: Six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2015 (estimated)
- Study start9 Oct 2015
- Primary completion2 May 2018
- Study completion17 Sep 2020
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
- Single group
- Masking
- None (open label)
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Parameswaran Hari
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Parameswaran Hari, Medical College of Wisconsin
- Investigators
- Parameswaran Hari, MD, MRCP, MS, Principal investigator, Medical College of Wisconsin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02477215
- Sponsor's protocol ID
- PRO00024991
- Status last verified
- Sep 2020
- First submitted
- 12 Jun 2015
- Last updated
- 22 Oct 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- 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 22 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I/II Study of Bendamustine and IXAZOMIB (MLN9708) Plus Dexamethasone in Relapsed/Refractory Multiple Myeloma
- ClinicalTrials.gov ID
- NCT02477215
- Acronym / sponsor ID
- PRO00024991
- Conditions
- Multiple Myeloma
- Keywords
- Multiple Myeloma
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Parameswaran HariUniversity, hospital or other
- Study start
- 9 Oct 2015 (actual)
- Primary completion
- 2 May 2018 (actual)
- Study completion
- 17 Sep 2020 (actual)
- First posted
- 22 Jun 2015 (estimated)
- Results
- Posted 27 Jan 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This Phase I/II study is designed to first identify doses of MLN9708 and bendamustine that are associated with an acceptable adverse event profile when delivered together in 28-day cycles. Additionally, the study aims to assess the efficacy of the combination in patients with relapsed/refractory multiple myeloma. Responders (stable disease or more), will continue to receive up to eight cycles total in the absence of further progressive disease.
Detailed description
OVERVIEW: This Phase I/II study is designed to first identify doses of MLN9708 and bendamustine that are associated with an acceptable adverse event profile when delivered together in 28-day cycles. Additionally, the study aims to assess the efficacy of the combination in patients with relapsed/refractory multiple myeloma. Responders (stable disease or more),will continue to receive up to eight cycles total in the absence of further progressive disease.
OVERVIEW OF THE DOSE ESCALATION/DE-ESCALATION: This study aims to assess the combination's efficacy in patients with relapsed/refractory multiple myeloma. Responders (stable disease or more) will continue to receive up to eight cycles total in the absence of further progressive disease. The dose of MLN9708 will be fixed at 4 mg given on days 1, 8 and 15. Dexamethasone will be administered at 40 mg (oral) on Days 1, 8, 15 of each 28 day cycle. Dexamethasone administered as 40 mg oral on Days 1, 8, 15 of each 28 day cycle. Three doses of bendamustine will be evaluated (Dose 1: 70 mg/m^2, days 1 and 2; Dose 2: 80 mg/m^2. days 1 and 2; and Dose 3: 90 mg/m^2, days 1 and 2).
PHASE 1 DESIGN: A 3+3 design was employed. At each dose, three patients were initially evaluated. When no dose limiting toxicities were observed, the bendamustine dose will be increased.
PHASE 2 DESIGN: Design for Phase II portion of study: The MTD or a recommended phase 2 dose (RP2D) for the combination. The plan is to treat additional patients at that dose to assess efficacy and response to treatment. The investigators plan to enroll 19 patients (including those treated at the MTD in Phase I).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MLN9708, Bendamustine and Dexamethasone Dose Escalation | Experimental | Drug: MLN9708, Drug: Dexamethasone, Drug: Bendamustine (multiple dose levels)Ixazomib 4 mg, days 1, 8, 15. Dexamethasone 40 mg oral weekly. Bendamustine dose levels: 70 mg/m^2, 80mg/m^2, or 90 mg/m^2 given on days 1 and 2 |
| MLN9708, Bendamustine and Dexamethasone MTD | Experimental | Drug: MLN9708, Drug: Dexamethasone, Drug: Bendamustine (MTD)Ixazomib 4 mg, days 1, 8, 15. Dexamethasone 40 mg oral weekly. Bendamustine dose levels: MTD given on days 1 and 2 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (20 listed)
- 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:
- Male patients, even if surgically sterilized (ie, status post-vasectomy), must agree to one of the following:
- Patients must have have histologically or cytologically confirmed symptomatic Multiple Myeloma, who are non-responsive to or ineligible for autologous stem cell transplant, and who progress after prior exposure to proteasome inhibitor (bortezomib, carfilzomib) and lenalidomide or pomalidomide or thalidomide (IMID); and refractory/progressing to at least one of these agents and must meet at least one of the following parameters of measurable disease:
Key exclusion criteria (18 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 except for peripheral neuropathy, which is addressed in exclusion criteria no. #14.
- Major surgery within 14 days before enrollment.
- Radiotherapy within 14 days before enrollment. If the involved field is limited (single disease focus not involving pelvis and involving <36 Gy radiation), 7 days will be considered a sufficient interval between treatment and administration of Ixazomib provided hematologic inclusion parameters are met.
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 |
|---|---|---|
| MLN9708Also: Ixazomib4 mg of MLN9708 delivered on days 1, 8 and 15 of a 28 day cycle. | Drug | MLN9708, Bendamustine and Dexamethasone Dose Escalation, MLN9708, Bendamustine and Dexamethasone MTD |
| DexamethasoneAlso: Decadron40 mg oral on Days 1, 8, 15 of each 28 day cycle. | Drug | MLN9708, Bendamustine and Dexamethasone Dose Escalation, MLN9708, Bendamustine and Dexamethasone MTD |
| Bendamustine (multiple dose levels)Also: Treanda, Treakisym, Ribomustin70 mg/m^2, 80 mg/m^2, or 90 mg/m^2 on days 1 and 2 | Drug | MLN9708, Bendamustine and Dexamethasone Dose Escalation |
| Bendamustine (MTD)Also: Treanda, Treakisym, Ribomustin80 mg/m^2 on days 1 and 2 | Drug | MLN9708, Bendamustine and Dexamethasone MTD |
Primary outcome
Maximum Tolerated Dose of Bendamustine
Time frame: Six months for each dosing cohort
Maximum tolerated dose of bendamustine in combination with fixed doses of ixazomib (MLN9708) and dexamethasone will be determined from the incidence of dose limiting toxicities at each dosage.
Objective Response Rate
Time frame: 18 months
Objective response rate was defined as the number of subjects achieving a complete response (CR) or partial response (PR) after at least four cycles of ixazomib (MLN9708) and bendamustine plus dexamethasone.
5 secondary outcomes
Overall Survival (OS)
Time frame: 36 months
Progression Free Survival (PFS)
Time frame: 18 months
Cumulative Response Rates in Patients After Eight Cycles.
Time frame: 18 months
Duration of Response (DoR)
Time frame: 36 months
Number of Participants Experiencing Dose-Limiting Toxicity (DLT)
Time frame: Six months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
Parameswaran Hari, MD, MRCP, MS principal investigator
Medical College of Wisconsin
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing MLN9708, Dexamethasone and Bendamustine (multiple dose levels) in people with Multiple Myeloma, run by Parameswaran Hari 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 20 inclusion and 18 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 22 Oct 2020. 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 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 27 Jan 2020). 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?
Maximum Tolerated Dose of Bendamustine (time frame: Six months for each dosing cohort). 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 22 Oct 2020.