Relapsed and Refractory Multiple MyelomaPhase 1NCT00932698

Study of Oral Ixazomib in Adult Participants With Relapsed and/or Refractory (RR) Multiple Myeloma

A Phase 1 study testing Ixazomib in people with Relapsed and Refractory Multiple Myeloma, run by Millennium Pharmaceuticals, Inc. at 5 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

This study will determine the safety profile, tolerability, and maximum tolerated dose (MTD) and disease response of Ixazomib administered orally in participants with relapsed and/or refractory multiple myeloma. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Relapsed and Refractory Multiple Myeloma
What is being tested?: Ixazomib
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 60 participants
Where: 5 sitesUnited States
Study dates: 12 Oct 2009to 23 May 2017
Phase: Phase 1
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

Each participant must meet all of the following inclusion criteria to be enrolled in the study:
Multiple myeloma diagnosed according to the standard criteria.
Participants with multiple myeloma who have relapsed following at least 2 lines of therapy.
Participants must have measurable disease.
Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.
Female participants who are post menopausal, surgically sterile, or agree to practice 2 effective methods of contraception or abstain from heterosexual intercourse.

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Male participants who agree to practice effective barrier contraception or agree to abstain from heterosexual intercourse.
Voluntary written consent.
Suitable venous access for study-required blood sampling.

Who cannot join

Participants meeting any of the following exclusion criteria are not to be enrolled in the study:
Peripheral neuropathy greater than or equal to (>=) Grade 2.
Female participants who are lactating or have a positive serum pregnancy test during the screening period.
Major surgery within 14 days before the first dose of study drug.
Infection requiring systemic antibiotic therapy or other serious infection within 14 days before the first dose of study treatment.
Life-threatening illness unrelated to cancer.

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Diarrhea > Grade 1, based on the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) categorization.
Systemic antineoplastic or radiation therapy within 14 days of cytotoxic agents within 21 days before the first dose of study treatment.
Treatment with any investigational products within 21 days before the first dose of study treatment.
Treatment with any investigational proteasome inhibitor.
Systemic treatment with prohibited medication.
Ongoing therapy with corticosteroids greater than 10mg of prednisone or its equivalent per day. Inhaled and topical steroids are permitted.
Central nervous system involvement.
Evidence of current uncontrolled cardiovascular conditions, including cardiac arrhythmias, congestive heart failure, angina, or myocardial infarction within the past 6 months.
Corrected QT interval (QTc) > 470 milliseconds on a 12-lead electrocardiogram (ECG) obtained during the screening period.
Known human immunodeficiency virus (HIV) positive, hepatitis B surface antigen-positive status, or known or suspected active hepatitis C infection.
Any serious medical or psychiatric illness that could, in the investigator's opinion, potentially interfere with the completion of treatment according to the protocol.
Known gastrointestinal (GI) disease or GI procedure that could interfere with the oral absorption of tolerance of ixazomib including difficulty swallowing.

Trial locations and contacts

5 sites in 1 country.

City, postcode or hospital

5 sites in 1 country

United States5 sites

University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, 48109
Emory University
Atlanta, Georgia, 30322
Dana-Farber Cancer Institute
Boston, Massachusetts, 02115
M.D. Anderson Cancer Center
Houston, Texas, 77030
H. Lee Moffitt Cancer Center
Tampa, Florida, 33617

Other trials in United States

About this study

Official title: An Open-Label, Dose-Escalation, Phase 1 Study of the Oral Form of Ixazomib (MLN9708), a Second-Generation Proteasome Inhibitor, in Adult Patients With Relapsed and/or Refractory Multiple Myeloma

Read the detailed description

The drug being tested in this study is ixazomib. Ixazomib is being tested to treat people who have multiple myeloma. This study will look at the safety and efficacy of ixazomib and will enroll approximately 60 participants.

Participants will receive ixazomib by oral capsule twice weekly on Days 1, 4, 8, and 11 of a 21-day cycle. The study will consist of a dose escalation phase to determine the MTD, followed by an expansion phase in which participants will be treated at the MTD.

This multi-center trial will be conducted in the United States. The overall time to participate in this study is 8 years.

Conditions: Relapsed and Refractory Multiple Myeloma
Being tested: Ixazomib
Keywords: Relapsed multiple myeloma, Refractory multiple myeloma, Ixazomib Proteasome inhibitor
Medical subject headings: Recurrence, Multiple Myeloma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

IxazomibDrug
Also called MLN9708
Ixazomib capsules

Study groups in NCT00932698
Study group	Role	What they receive
Dose Escalation Cohort 1: Ixazomib 0.24 mg/m^2	Experimental	Ixazomib 0.24 mg/m^2, capsule, orally, on Days 1, 4, 8 and 11 during a 21-day treatment cycle until progressive disease (PD) or unacceptable toxicity up to 12 months unless the investigator and sponsor determined the participant would benefit from therapy beyond 12 months (Up to 220 days). Receives: Drug: Ixazomib
Dose Escalation Cohort 2: Ixazomib 0.48 mg/m^2	Experimental	Ixazomib 0.48 mg/m^2, capsule, orally, on Days 1, 4, 8 and 11 during a 21-day treatment cycle until progressive disease (PD) or unacceptable toxicity up to 12 months unless the investigator and sponsor determined the participant would benefit from therapy beyond 12 months (Up to 270 days). Receives: Drug: Ixazomib
Dose Escalation Cohort 3: Ixazomib 0.8 mg/m^2	Experimental	Ixazomib 0.8 mg/m^2, capsule, orally, on Days 1, 4, 8 and 11 during a 21-day treatment cycle until progressive disease (PD) or unacceptable toxicity up to 12 months unless the investigator and sponsor determined the participant would benefit from therapy beyond 12 months (Up to 137 days). Receives: Drug: Ixazomib
Dose Escalation Cohort 4: Ixazomib 1.2 mg/m^2	Experimental	Ixazomib 1.2 mg/m^2, capsule, orally, on Days 1, 4, 8 and 11 during a 21-day treatment cycle until progressive disease (PD) or unacceptable toxicity up to 12 months unless the investigator and sponsor determined the participant would benefit from therapy beyond 12 months (Up to 1436 days). Receives: Drug: Ixazomib
Dose Escalation Cohort 5: Ixazomib 1.68 mg/m^2	Experimental	Ixazomib 1.68 mg/m^2, capsule, orally, on Days 1, 4, 8 and 11 during a 21-day treatment cycle until progressive disease (PD) or unacceptable toxicity up to 12 months unless the investigator and sponsor determined the participant would benefit from therapy beyond 12 months (Up to 456 days). Receives: Drug: Ixazomib
Dose Escalation Cohort 6: Ixazomib 2.0 mg/m^2	Experimental	Ixazomib 2.0 mg/m^2, capsule, orally, on Days 1, 4, 8 and 11 during a 21-day treatment cycle until progressive disease (PD) or unacceptable toxicity up to 12 months unless the investigator and sponsor determined the participant would benefit from therapy beyond 12 months (Up to 1621 days). Receives: Drug: Ixazomib
Dose Escalation Cohort 7: Ixazomib 2.23 mg/m^2	Experimental	Ixazomib 2.23 mg/m^2, capsule, orally, on Days 1, 4, 8 and 11 during a 21-day treatment cycle until progressive disease (PD) or unacceptable toxicity up to 12 months unless the investigator and sponsor determined the participant would benefit from therapy beyond 12 months (Up to 2434 days). Receives: Drug: Ixazomib
Relapsed and Refractory Expansion Cohort: Ixazomib 2 mg/m^2	Experimental	Ixazomib 2.0 mg/m^2, capsule, orally, on Days 1, 4, 8 and 11 during a 21-day treatment cycle until progressive disease (PD) or unacceptable toxicity up to 12 months unless the investigator and sponsor determined the participant would benefit from therapy beyond 12 months, Participants must also be refractory to their most recent therapy as evidenced by PD while on therapy or within 60 days after their last dose of therapy (Up to 1621 days). Receives: Drug: Ixazomib
Velcade-Relapsed (VR) Expansion Cohort: Ixazomib 2.0 mg/m^2	Experimental	Ixazomib 2.0 mg/m^2, capsule, orally, on Days 1, 4, 8 and 11 during a 21-day treatment cycle until progressive disease (PD) or unacceptable toxicity up to 12 months unless the investigator and sponsor determined the participant would benefit from therapy beyond 12 months. Participants with relapsed or refractory disease after >=1 prior therapy but have relapsed after previous Velcade exposure and were not treated with any other proteasome inhibitors (Up to 1573 days). Receives: Drug: Ixazomib
Proteasome Inhibitor-Naive Expansion Cohort: Ixazomib 2 mg/m^2	Experimental	Ixazomib 2.0 mg/m^2, capsule, orally, on Days 1, 4, 8 and 11 during a 21-day treatment cycle until progressive disease (PD) or unacceptable toxicity up to 12 months unless the investigator and sponsor determined the participant would benefit from therapy beyond 12 months. Participants with relapsed or refractory disease after >=1 prior therapy which must include thalidomide (or lenalidomide) and corticosteroid, but who never received a proteasome inhibitor (Up to 550 days). Receives: Drug: Ixazomib
Carfilzomib Expansion Cohort: Ixazomib 2.0 mg/m^2	Experimental	Ixazomib 2.0 mg/m^2, capsule, orally, on Days 1, 4, 8 and 11 during a 21-day treatment cycle until progressive disease (PD) or unacceptable toxicity up to 12 months unless the investigator and sponsor determined the participant would benefit from therapy beyond 12 months. Participants who previously received carfilzomib and had relapsed or refractory disease (Up to 123 days). Receives: Drug: Ixazomib

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Participants With One or More Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
An AE is any untoward medical occurrence in a participant administered a medicinal investigational drug. The untoward medical occurrence does not necessarily have to have a causal relationship with treatment. An SAE is any untoward medical occurrence that results in death;is life-threatening;requires inpatient hospitalization or prolongation of present hospitalization;results in persistent or significant disability/incapacity;is a congenital anomaly/birth defect;or is a medically important event that may not be immediately life-threatening or result in death or hospitalization, but may jeopardize the participant or may require intervention to prevent one of other outcomes listed in definition above, or involves suspected transmission via a medicinal product of an infectious agent. A TEAE is defined as an AE that occurs after administration of first dose of study drug and through 30 days after last dose of study drug or until start of subsequent antineoplastic therapy.
Measured: From first dose of the study drug through 30 days after the last dose of study drug or start of subsequent antineoplastic therapy (Up to 81.1 months)
Number of Participants With Clinically Significant Abnormalities Reported as TEAEs
The number of participants with any clinically significant abnormal standard safety laboratory values collected throughout the study reported as TEAEs. Parameters assessed were hematology, serum chemistry and urinalysis.
Measured: From first dose of the study drug through 30 days after the last dose of study drug or start of subsequent antineoplastic therapy (Up to 81.1 months)
Number of Participants With a TEAE of Peripheral Neuropathy
Neurotoxicity was assessed as the number of participants with the TEAE of peripheral neuropathy.
Measured: From first dose of the study drug through 30 days after the last dose of study drug or start of subsequent antineoplastic therapy (Up to 81.1 months)
Number of Participants With Clinically Significant Changes in Vital Signs Reported as TEAEs
The number of participants with any clinically significant changes in vital signs collected throughout the study that were reported as TEAEs. Measurement of vital signs, included oral temperature, blood pressure, and heart rate.
Measured: From first dose of the study drug through 30 days after the last dose of study drug or start of subsequent antineoplastic therapy (Up to 81.1 months)
Maximum Tolerated Dose (MTD) of Ixazomib
MTD was highest dose of Ixazomib, at which <=1 of 6 participants experienced dose-limiting toxicity (DLT) during Cycle 1 of Phase 1. DLT was defined as any of following considered possibly related to therapy: Grade 4 neutropenia (absolute neutrophil count [ANC] <500 cell per cubic millimeter [cells/mm^3]) for >7 days;Grade 3 neutropenia with fever or infection; Grade 4 thrombocytopenia (platelets < 25,000/mm^3) for >7 days;Grade 3 thrombocytopenia with clinically significant bleeding; platelet count <10,000/mm^3; Grade 2 peripheral neuropathy with pain or >=Grade 3 peripheral neuropathy; >=Grade 3 nausea/emesis, diarrhea controlled by supportive therapy; Grade 3 QTc prolongation (QTc >500 millisecond [msec]);any >=Grade 3 nonhematologic toxicity except Grade 3 arthralgia/myalgia; or <1 week Grade 3 fatigue; delay in initiation of the subsequent therapy cycle by >2 weeks; other >=Grade 2 study drug-related nonhematologic toxicities requiring therapy discontinuation.
Measured: Cycle 1 (21 days)
Recommended Phase 2 Dose (RP2D) of Ixazomib
The RP2D of Ixazomib was determined in Part 1 (dose escalation) on the basis of the totality of safety, tolerability, pharmacokinetics (PK) and pharmacodynamic data observed in Cycle 1 and beyond.
Measured: Cycle 1 through Cycle 39 (Up to 28.3 months)

Secondary outcomes (10)

Cmax: Maximum Observed Plasma Concentration for Ixazomib
Measured: Cycle 1, Days 1 and 11: Predose and at multiple time points (up to 264 hours) postdose
Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for Ixazomib
Measured: Cycle 1, Days 1 and 11: Predose and at multiple time points (Up to 264 hours) postdose
AUC(0-last): Area Under the Plasma Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration for Ixazomib
Measured: Cycle 1, Days 1 and 11: Predose and at multiple time points (Up to 264 hours) postdose
AUC(0-72): Area Under the Plasma Concentration-Time Curve From Time 0 to 72 Hours Postdose for Ixazomib
Measured: Cycle 1, Days 1 and 11: Predose and at multiple time points (Up to 72 hours) postdose
λz: Terminal Disposition Phase Rate Constant for Ixazomib
Measured: Cycle 1, Day 11: predose and at multiple time points (Up to 264 hours) postdose
T1/2: Terminal Disposition Phase Elimination Half-life for Ixazomib
Measured: Cycle 1, Day 11: predose and at multiple time points (up to 264 hours) postdose
CL/F: Blood Clearance Calculated Using the Observed Value of the Last Quantifiable Concentration for Ixazomib
CL/F is apparent clearance of the drug from the plasma.
Measured: Cycle 1, Days 1 and 11: Predose and at multiple time points (Up to 264 hours) postdose
Emax: Maximum Observed Effect for Ixazomib
Emax was determined to characterize the whole blood 20S proteasome inhibition parameters.
Measured: Cycle 1, Days 1 and 11: Predose and at multiple time points (Up to 264 hours) postdose
TEmax: Time to Maximum Observed Effect (Emax) for Ixazomib
TEmax was determined to characterize the whole blood 20S proteasome inhibition parameters.
Measured: Cycle 1, Days 1 and 11: Predose and at multiple time points (Up to 264 hours) postdose
Overall Response Rate (ORR)
ORR is defined as percentage of participants with complete response (CR) or partial response (PR) or minimal response (MR) as assessed by the investigator using International Myeloma Working Group Uniform Response criteria. CR=Negative immunofixation on the serum and urine and disappearance of any soft tissue plasmacytomas and <5% plasma cells in bone marrow. PR=≥50% reduction of serum M-protein and reduction in 24-h urinary M-protein by ≥90% or to <200 mg /24 h. MR=25-49% reduction in the serum monoclonal paraprotein maintained for a minimum of 6 weeks; 50-89% reduction in 24-h urinary light chain excretion, which still exceeds 200 mg/24 h, maintained for a minimum of 6 weeks; for participants with non-secretory myeloma only, 25-49% reduction in plasma cells in a bone marrow aspirate and on trephine biopsy, if biopsy is performed, maintained for a minimum of 6 weeks; 25-49% reduction in the size of soft tissue plasmacytomas; no increase in the size or number of lytic bone lesions.
Measured: Cycle 1 through Cycle 115 (Up to 80.1 months)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

12 Oct 200923 May 2017

First posted3 Jul 2009 (estimated)
Study start12 Oct 2009
Primary completion20 Jun 2013
Study completion23 May 2017

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.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Relapsed and Refractory 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
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 60 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00932698
Sponsor's protocol ID: C16003
Other IDs: U1111-1177-7936
Status last verified: Jun 2019
First submitted: 1 Jul 2009
Last updated: 7 Aug 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: Yes: Takeda makes patient-level, de-identified data sets and associated documents available after applicable marketing approvals and commercial availability have been received, an opportunity for the primary publication of the research has been allowed, and other criteria have been met as set forth in Takeda's Data Sharing Policy (see www.TakedaClinicalTrials.com/Approach for details). To obtain access, researchers must submit a legitimate academic research proposal for adjudication by an independent review panel, who will review the scientific merit of the research and the requestor's qualifications and conflict of interest that can result in potential bias. Once approved, qualified researchers who sign a data sharing agreement are provided access to these data in a secure research environment.

Publications

Gupta N, Yang H, Hanley MJ, Zhang S, Liu R, Kumar S, Richardson PG, Skacel T, Venkatakrishnan K. Dose and Schedule Selection of the Oral Proteasome Inhibitor Ixazomib in Relapsed/Refractory Multiple Myeloma: Clinical and Model-Based Analyses. Target Oncol. 2017 Oct;12(5):643-654. doi: 10.1007/s11523-017-0524-3.
PubMed 28803351
Richardson PG, Baz R, Wang M, Jakubowiak AJ, Laubach JP, Harvey RD, Talpaz M, Berg D, Liu G, Yu J, Gupta N, Di Bacco A, Hui AM, Lonial S. Phase 1 study of twice-weekly ixazomib, an oral proteasome inhibitor, in relapsed/refractory multiple myeloma patients. Blood. 2014 Aug 14;124(7):1038-46. doi: 10.1182/blood-2014-01-548826. Epub 2014 Jun 11.
PubMed 24920586

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Relapsed or Refractory Multiple Myeloma

All Relapsed and Refractory Multiple Myeloma trials

Study at a glance

From the registry record, last updated by the sponsor on 7 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An Open-Label, Dose-Escalation, Phase 1 Study of the Oral Form of Ixazomib (MLN9708), a Second-Generation Proteasome Inhibitor, in Adult Patients With Relapsed and/or Refractory Multiple Myeloma
ClinicalTrials.gov ID: NCT00932698
Acronym / sponsor ID: C16003
Conditions: Relapsed and Refractory Multiple Myeloma
Keywords: Relapsed multiple myeloma, Refractory multiple myeloma, Ixazomib Proteasome inhibitor
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 60 participants (actual)
Lead sponsor: Millennium Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
Study start: 12 Oct 2009 (actual)
Primary completion: 20 Jun 2013 (actual)
Study completion: 23 May 2017 (actual)
First posted: 3 Jul 2009 (estimated)
Results: Posted 7 Aug 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

This multi-center trial will be conducted in the United States. The overall time to participate in this study is 8 years.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 11

Arm	Type	Receives
Dose Escalation Cohort 1: Ixazomib 0.24 mg/m^2	Experimental	Drug: IxazomibIxazomib 0.24 mg/m^2, capsule, orally, on Days 1, 4, 8 and 11 during a 21-day treatment cycle until progressive disease (PD) or unacceptable toxicity up to 12 months unless the investigator and sponsor determined the participant would benefit from therapy beyond 12 months (Up to 220 days).
Dose Escalation Cohort 2: Ixazomib 0.48 mg/m^2	Experimental	Drug: IxazomibIxazomib 0.48 mg/m^2, capsule, orally, on Days 1, 4, 8 and 11 during a 21-day treatment cycle until progressive disease (PD) or unacceptable toxicity up to 12 months unless the investigator and sponsor determined the participant would benefit from therapy beyond 12 months (Up to 270 days).
Dose Escalation Cohort 3: Ixazomib 0.8 mg/m^2	Experimental	Drug: IxazomibIxazomib 0.8 mg/m^2, capsule, orally, on Days 1, 4, 8 and 11 during a 21-day treatment cycle until progressive disease (PD) or unacceptable toxicity up to 12 months unless the investigator and sponsor determined the participant would benefit from therapy beyond 12 months (Up to 137 days).
Dose Escalation Cohort 4: Ixazomib 1.2 mg/m^2	Experimental	Drug: IxazomibIxazomib 1.2 mg/m^2, capsule, orally, on Days 1, 4, 8 and 11 during a 21-day treatment cycle until progressive disease (PD) or unacceptable toxicity up to 12 months unless the investigator and sponsor determined the participant would benefit from therapy beyond 12 months (Up to 1436 days).
Dose Escalation Cohort 5: Ixazomib 1.68 mg/m^2	Experimental	Drug: IxazomibIxazomib 1.68 mg/m^2, capsule, orally, on Days 1, 4, 8 and 11 during a 21-day treatment cycle until progressive disease (PD) or unacceptable toxicity up to 12 months unless the investigator and sponsor determined the participant would benefit from therapy beyond 12 months (Up to 456 days).
Dose Escalation Cohort 6: Ixazomib 2.0 mg/m^2	Experimental	Drug: IxazomibIxazomib 2.0 mg/m^2, capsule, orally, on Days 1, 4, 8 and 11 during a 21-day treatment cycle until progressive disease (PD) or unacceptable toxicity up to 12 months unless the investigator and sponsor determined the participant would benefit from therapy beyond 12 months (Up to 1621 days).
Dose Escalation Cohort 7: Ixazomib 2.23 mg/m^2	Experimental	Drug: IxazomibIxazomib 2.23 mg/m^2, capsule, orally, on Days 1, 4, 8 and 11 during a 21-day treatment cycle until progressive disease (PD) or unacceptable toxicity up to 12 months unless the investigator and sponsor determined the participant would benefit from therapy beyond 12 months (Up to 2434 days).
Relapsed and Refractory Expansion Cohort: Ixazomib 2 mg/m^2	Experimental	Drug: IxazomibIxazomib 2.0 mg/m^2, capsule, orally, on Days 1, 4, 8 and 11 during a 21-day treatment cycle until progressive disease (PD) or unacceptable toxicity up to 12 months unless the investigator and sponsor determined the participant would benefit from therapy beyond 12 months, Participants must also be refractory to their most recent therapy as evidenced by PD while on therapy or within 60 days after their last dose of therapy (Up to 1621 days).
Velcade-Relapsed (VR) Expansion Cohort: Ixazomib 2.0 mg/m^2	Experimental	Drug: IxazomibIxazomib 2.0 mg/m^2, capsule, orally, on Days 1, 4, 8 and 11 during a 21-day treatment cycle until progressive disease (PD) or unacceptable toxicity up to 12 months unless the investigator and sponsor determined the participant would benefit from therapy beyond 12 months. Participants with relapsed or refractory disease after >=1 prior therapy but have relapsed after previous Velcade exposure and were not treated with any other proteasome inhibitors (Up to 1573 days).
Proteasome Inhibitor-Naive Expansion Cohort: Ixazomib 2 mg/m^2	Experimental	Drug: IxazomibIxazomib 2.0 mg/m^2, capsule, orally, on Days 1, 4, 8 and 11 during a 21-day treatment cycle until progressive disease (PD) or unacceptable toxicity up to 12 months unless the investigator and sponsor determined the participant would benefit from therapy beyond 12 months. Participants with relapsed or refractory disease after >=1 prior therapy which must include thalidomide (or lenalidomide) and corticosteroid, but who never received a proteasome inhibitor (Up to 550 days).
Carfilzomib Expansion Cohort: Ixazomib 2.0 mg/m^2	Experimental	Drug: IxazomibIxazomib 2.0 mg/m^2, capsule, orally, on Days 1, 4, 8 and 11 during a 21-day treatment cycle until progressive disease (PD) or unacceptable toxicity up to 12 months unless the investigator and sponsor determined the participant would benefit from therapy beyond 12 months. Participants who previously received carfilzomib and had relapsed or refractory disease (Up to 123 days).

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (9 listed)

Each participant must meet all of the following inclusion criteria to be enrolled in the study:
Multiple myeloma diagnosed according to the standard criteria.
Participants with multiple myeloma who have relapsed following at least 2 lines of therapy.
Participants must have measurable disease.
Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.

Key exclusion criteria (18 listed)

Participants meeting any of the following exclusion criteria are not to be enrolled in the study:
Peripheral neuropathy greater than or equal to (>=) Grade 2.
Female participants who are lactating or have a positive serum pregnancy test during the screening period.
Major surgery within 14 days before the first dose of study drug.
Infection requiring systemic antibiotic therapy or other serious infection within 14 days before the first dose of study 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
IxazomibAlso: MLN9708Ixazomib capsules	Drug	Carfilzomib Expansion Cohort: Ixazomib 2.0 mg/m^2, Dose Escalation Cohort 1: Ixazomib 0.24 mg/m^2, Dose Escalation Cohort 2: Ixazomib 0.48 mg/m^2, Dose Escalation Cohort 3: Ixazomib 0.8 mg/m^2, Dose Escalation Cohort 4: Ixazomib 1.2 mg/m^2, Dose Escalation Cohort 5: Ixazomib 1.68 mg/m^2, Dose Escalation Cohort 6: Ixazomib 2.0 mg/m^2, Dose Escalation Cohort 7: Ixazomib 2.23 mg/m^2, Proteasome Inhibitor-Naive Expansion Cohort: Ixazomib 2 mg/m^2, Relapsed and Refractory Expansion Cohort: Ixazomib 2 mg/m^2, Velcade-Relapsed (VR) Expansion Cohort: Ixazomib 2.0 mg/m^2

Primary outcome

Number of Participants With One or More Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Time frame: From first dose of the study drug through 30 days after the last dose of study drug or start of subsequent antineoplastic therapy (Up to 81.1 months)
An AE is any untoward medical occurrence in a participant administered a medicinal investigational drug. The untoward medical occurrence does not necessarily have to have a causal relationship with treatment. An SAE is any untoward medical occurrence that results in death;is life-threatening;requires inpatient hospitalization or prolongation of present hospitalization;results in persistent or significant disability/incapacity;is a congenital anomaly/birth defect;or is a medically important event that may not be immediately life-threatening or result in death or hospitalization, but may jeopardize the participant or may require intervention to prevent one of other outcomes listed in definition above, or involves suspected transmission via a medicinal product of an infectious agent. A TEAE is defined as an AE that occurs after administration of first dose of study drug and through 30 days after last dose of study drug or until start of subsequent antineoplastic therapy.
Number of Participants With Clinically Significant Abnormalities Reported as TEAEs
Time frame: From first dose of the study drug through 30 days after the last dose of study drug or start of subsequent antineoplastic therapy (Up to 81.1 months)
The number of participants with any clinically significant abnormal standard safety laboratory values collected throughout the study reported as TEAEs. Parameters assessed were hematology, serum chemistry and urinalysis.
Number of Participants With a TEAE of Peripheral Neuropathy
Time frame: From first dose of the study drug through 30 days after the last dose of study drug or start of subsequent antineoplastic therapy (Up to 81.1 months)
Neurotoxicity was assessed as the number of participants with the TEAE of peripheral neuropathy.
Number of Participants With Clinically Significant Changes in Vital Signs Reported as TEAEs
Time frame: From first dose of the study drug through 30 days after the last dose of study drug or start of subsequent antineoplastic therapy (Up to 81.1 months)
The number of participants with any clinically significant changes in vital signs collected throughout the study that were reported as TEAEs. Measurement of vital signs, included oral temperature, blood pressure, and heart rate.
Maximum Tolerated Dose (MTD) of Ixazomib
Time frame: Cycle 1 (21 days)
MTD was highest dose of Ixazomib, at which <=1 of 6 participants experienced dose-limiting toxicity (DLT) during Cycle 1 of Phase 1. DLT was defined as any of following considered possibly related to therapy: Grade 4 neutropenia (absolute neutrophil count [ANC] <500 cell per cubic millimeter [cells/mm^3]) for >7 days;Grade 3 neutropenia with fever or infection; Grade 4 thrombocytopenia (platelets < 25,000/mm^3) for >7 days;Grade 3 thrombocytopenia with clinically significant bleeding; platelet count <10,000/mm^3; Grade 2 peripheral neuropathy with pain or >=Grade 3 peripheral neuropathy; >=Grade 3 nausea/emesis, diarrhea controlled by supportive therapy; Grade 3 QTc prolongation (QTc >500 millisecond [msec]);any >=Grade 3 nonhematologic toxicity except Grade 3 arthralgia/myalgia; or <1 week Grade 3 fatigue; delay in initiation of the subsequent therapy cycle by >2 weeks; other >=Grade 2 study drug-related nonhematologic toxicities requiring therapy discontinuation.
Recommended Phase 2 Dose (RP2D) of Ixazomib
Time frame: Cycle 1 through Cycle 39 (Up to 28.3 months)
The RP2D of Ixazomib was determined in Part 1 (dose escalation) on the basis of the totality of safety, tolerability, pharmacokinetics (PK) and pharmacodynamic data observed in Cycle 1 and beyond.

10 secondary outcomes

Cmax: Maximum Observed Plasma Concentration for Ixazomib
Time frame: Cycle 1, Days 1 and 11: Predose and at multiple time points (up to 264 hours) postdose
Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for Ixazomib
Time frame: Cycle 1, Days 1 and 11: Predose and at multiple time points (Up to 264 hours) postdose
AUC(0-last): Area Under the Plasma Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration for Ixazomib
Time frame: Cycle 1, Days 1 and 11: Predose and at multiple time points (Up to 264 hours) postdose
AUC(0-72): Area Under the Plasma Concentration-Time Curve From Time 0 to 72 Hours Postdose for Ixazomib
Time frame: Cycle 1, Days 1 and 11: Predose and at multiple time points (Up to 72 hours) postdose
λz: Terminal Disposition Phase Rate Constant for Ixazomib
Time frame: Cycle 1, Day 11: predose and at multiple time points (Up to 264 hours) postdose
T1/2: Terminal Disposition Phase Elimination Half-life for Ixazomib
Time frame: Cycle 1, Day 11: predose and at multiple time points (up to 264 hours) postdose
CL/F: Blood Clearance Calculated Using the Observed Value of the Last Quantifiable Concentration for Ixazomib
Time frame: Cycle 1, Days 1 and 11: Predose and at multiple time points (Up to 264 hours) postdose
Emax: Maximum Observed Effect for Ixazomib
Time frame: Cycle 1, Days 1 and 11: Predose and at multiple time points (Up to 264 hours) postdose
TEmax: Time to Maximum Observed Effect (Emax) for Ixazomib
Time frame: Cycle 1, Days 1 and 11: Predose and at multiple time points (Up to 264 hours) postdose
Overall Response Rate (ORR)
Time frame: Cycle 1 through Cycle 115 (Up to 80.1 months)

Results and safety

Results posted to the registry on 7 Aug 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Dose Escalation Cohort 1: Ixazomib 0.24 mg/m^2	3	0
Dose Escalation Cohort 2: Ixazomib 0.48 mg/m^2	3	0
Dose Escalation Cohort 3: Ixazomib 0.8 mg/m^2	3	0
Dose Escalation Cohort 4: Ixazomib 1.2 mg/m^2	3	0
Dose Escalation Cohort 5: Ixazomib 1.68 mg/m^2	3	0
Dose Escalation Cohort 6: Ixazomib 2.0 mg/m^2	7	0
Dose Escalation Cohort 7: Ixazomib 2.23 mg/m^2	4	0
Relapsed and Refractory Expansion Cohort: Ixazomib 2.0 mg/m^2	0	0
Velcade-Relapsed (VR) Expansion Cohort: Ixazomib 2.0 mg/m^2	0	0
Proteasome Inhibitor-Naive Expansion Cohort: Ixazomib 2 mg/m^2	0	0
Carfilzomib Expansion Cohort: Ixazomib 2.0 mg/m^2	0	0

Primary outcome: Number of Participants With One or More Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)

Time frame: From first dose of the study drug through 30 days after the last dose of study drug or start of subsequent antineoplastic therapy (Up to 81.1 months). Count of participants. Unit: Participants

Measure	Dose Escalation Cohort 1: Ixazomib 0.24 mg/m^2 n = 3	Dose Escalation Cohort 2: Ixazomib 0.48 mg/m^2 n = 3	Dose Escalation Cohort 3: Ixazomib 0.8 mg/m^2 n = 3	Dose Escalation Cohort 4: Ixazomib 1.2 mg/m^2 n = 3	Dose Escalation Cohort 5: Ixazomib 1.68 mg/m^2 n = 3	Dose Escalation Cohort 6: Ixazomib 2.0 mg/m^2 n = 7	Dose Escalation Cohort 7: Ixazomib 2.23 mg/m^2 n = 4	Relapsed and Refractory Expansion Cohort: Ixazomib 2.0 mg/m^2 n = 20	Velcade-Relapsed (VR) Expansion Cohort: Ixazomib 2.0 mg/m^2 n = 12	Proteasome Inhibitor-Naive Expansion Cohort: Ixazomib 2 mg/m^2 n = 6	Carfilzomib Expansion Cohort: Ixazomib 2.0 mg/m^2 n = 2
AEs	3	3	3	3	3	7	4	20	12	6	2
SAEs	0	0	2	2	0	5	3	14	6	3	2

Population analysed: Safety population included all participants who received at least 1 dose of ixazomib.

Primary outcome: Number of Participants With Clinically Significant Abnormalities Reported as TEAEs

Measure	Dose Escalation Cohort 1: Ixazomib 0.24 mg/m^2 n = 3	Dose Escalation Cohort 2: Ixazomib 0.48 mg/m^2 n = 3	Dose Escalation Cohort 3: Ixazomib 0.8 mg/m^2 n = 3	Dose Escalation Cohort 4: Ixazomib 1.2 mg/m^2 n = 3	Dose Escalation Cohort 5: Ixazomib 1.68 mg/m^2 n = 3	Dose Escalation Cohort 6: Ixazomib 2.0 mg/m^2 n = 7	Dose Escalation Cohort 7: Ixazomib 2.23 mg/m^2 n = 4	Relapsed and Refractory Expansion Cohort: Ixazomib 2.0 mg/m^2 n = 20	Velcade-Relapsed (VR) Expansion Cohort: Ixazomib 2.0 mg/m^2 n = 12	Proteasome Inhibitor-Naive Expansion Cohort: Ixazomib 2 mg/m^2 n = 6	Carfilzomib Expansion Cohort: Ixazomib 2.0 mg/m^2 n = 2
Blood Creatinine Increased	1	1	1	0	0	1	1	2	2	0	0
Blood Urea Increased	0	0	0	0	0	0	0	0	1	1	0
White Blood Cell Count Decreased	0	0	0	0	1	0	1	0	0	0	0
Neutrophil Count Decreased	0	0	0	0	0	0	1	0	1	0	0
Alanine Aminotransferase Increased	0	0	0	0	0	0	0	1	0	0	0
Liver Function Test Increased

Primary outcome: Number of Participants With a TEAE of Peripheral Neuropathy

Measure	Dose Escalation Cohort 1: Ixazomib 0.24 mg/m^2 n = 3	Dose Escalation Cohort 2: Ixazomib 0.48 mg/m^2 n = 3	Dose Escalation Cohort 3: Ixazomib 0.8 mg/m^2 n = 3	Dose Escalation Cohort 4: Ixazomib 1.2 mg/m^2 n = 3	Dose Escalation Cohort 5: Ixazomib 1.68 mg/m^2 n = 3	Dose Escalation Cohort 6: Ixazomib 2.0 mg/m^2 n = 7	Dose Escalation Cohort 7: Ixazomib 2.23 mg/m^2 n = 4	Relapsed and Refractory Expansion Cohort: Ixazomib 2.0 mg/m^2 n = 20	Velcade-Relapsed (VR) Expansion Cohort: Ixazomib 2.0 mg/m^2 n = 12	Proteasome Inhibitor-Naive Expansion Cohort: Ixazomib 2 mg/m^2 n = 6	Carfilzomib Expansion Cohort: Ixazomib 2.0 mg/m^2 n = 2
Neuropathy Peripheral	0	1	1	0	0	1	0	3	3	1	0
Peripheral Sensory Neuropathy	0	0	0	0	1	0	0	0	0	0	0

Population analysed: Safety population included all participants who received at least 1 dose of ixazomib.

Primary outcome: Number of Participants With Clinically Significant Changes in Vital Signs Reported as TEAEs

Measure	Dose Escalation Cohort 1: Ixazomib 0.24 mg/m^2 n = 3	Dose Escalation Cohort 2: Ixazomib 0.48 mg/m^2 n = 3	Dose Escalation Cohort 3: Ixazomib 0.8 mg/m^2 n = 3	Dose Escalation Cohort 4: Ixazomib 1.2 mg/m^2 n = 3	Dose Escalation Cohort 5: Ixazomib 1.68 mg/m^2 n = 3	Dose Escalation Cohort 6: Ixazomib 2.0 mg/m^2 n = 7	Dose Escalation Cohort 7: Ixazomib 2.23 mg/m^2 n = 4	Relapsed and Refractory Expansion Cohort: Ixazomib 2.0 mg/m^2 n = 20	Velcade-Relapsed (VR) Expansion Cohort: Ixazomib 2.0 mg/m^2 n = 12	Proteasome Inhibitor-Naive Expansion Cohort: Ixazomib 2 mg/m^2 n = 6	Carfilzomib Expansion Cohort: Ixazomib 2.0 mg/m^2 n = 2
Value	0	0	0	0	0	0	1	0	0	0	0

Population analysed: Safety population included all participants who received at least 1 dose of ixazomib.

10 secondary outcomes are reported in the full results.

Adverse events

Time frame: From first dose of the study drug through 30 days after the last dose of study drug or start of subsequent antineoplastic therapy (Up to 81.1 months). Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Dose Escalation Cohort 1: Ixazomib 0.24 mg/m^2	0 of 3 (0%)	3 of 3 (100%)	0 of 3
Dose Escalation Cohort 2: Ixazomib 0.48 mg/m^2	0 of 3 (0%)	3 of 3 (100%)	0 of 3
Dose Escalation Cohort 3: Ixazomib 0.8 mg/m^2	2 of 3 (66.7%)	3 of 3 (100%)	1 of 3
Dose Escalation Cohort 4: Ixazomib 1.2 mg/m^2	2 of 3 (66.7%)	3 of 3 (100%)	0 of 3
Dose Escalation Cohort 5: Ixazomib 1.68 mg/m^2	0 of 3 (0%)	3 of 3 (100%)	0 of 3
Dose Escalation Cohort 6: Ixazomib 2.0 mg/m^2	5 of 7 (71.4%)	7 of 7 (100%)	0 of 7
Dose Escalation Cohort 7: Ixazomib 2.23 mg/m^2	3 of 4 (75%)	4 of 4 (100%)	0 of 4
Relapsed and Refractory Expansion Cohort: Ixazomib 2.0 mg/m^2	14 of 20 (70%)	20 of 20 (100%)	1 of 20
Velcade-Relapsed (VR) Expansion Cohort: Ixazomib 2.0 mg/m^2	6 of 12 (50%)	12 of 12 (100%)	0 of 12
Proteasome Inhibitor-Naive Expansion Cohort: Ixazomib 2 mg/m^2	3 of 6 (50%)	6 of 6 (100%)	0 of 6
Carfilzomib Expansion Cohort: Ixazomib 2.0 mg/m^2	2 of 2 (100%)	2 of 2 (100%)	0 of 2

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 28803351Gupta N, Yang H, Hanley MJ, Zhang S, Liu R, Kumar S, Richardson PG, Skacel T, Venkatakrishnan K. Dose and Schedule Selection of the Oral Proteasome Inhibitor Ixazomib in Relapsed/Refractory Multiple Myeloma: Clinical and Model-Based Analyses. Target Oncol. 2017 Oct;12(5):643-654. doi: 10.1007/s11523-017-0524-3.
Derived from this study: PubMed 24920586Richardson PG, Baz R, Wang M, Jakubowiak AJ, Laubach JP, Harvey RD, Talpaz M, Berg D, Liu G, Yu J, Gupta N, Di Bacco A, Hui AM, Lonial S. Phase 1 study of twice-weekly ixazomib, an oral proteasome inhibitor, in relapsed/refractory multiple myeloma patients. Blood. 2014 Aug 14;124(7):1038-46. doi: 10.1182/blood-2014-01-548826. Epub 2014 Jun 11.
Individual participant dataSharing planned: Yes. Takeda makes patient-level, de-identified data sets and associated documents available after applicable marketing approvals and commercial availability have been received, an opportunity for the primary publication of the research has been allowed, and other criteria have been met as set forth in Takeda's Data Sharing Policy (see www.TakedaClinicalTrials.com/Approach for details). To obtain access, researchers must submit a legitimate academic research proposal for adjudication by an independent review panel, who will review the scientific merit of the research and the requestor's qualifications and conflict of interest that can result in potential bias. Once approved, qualified researchers who sign a data sharing agreement are provided access to these data in a secure research environment.

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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.

Medical Monitor study director

Millennium Pharmaceuticals, Inc.

5 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Ixazomib in people with Relapsed and Refractory Multiple Myeloma, run by Millennium Pharmaceuticals, Inc. at 5 sites 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 9 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 7 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites 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 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.

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 7 Aug 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?

Number of Participants With One or More Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) (time frame: From first dose of the study drug through 30 days after the last dose of study drug or start of subsequent antineoplastic therapy (Up to 81.1 months)). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00932698, which also lists 2 linked publications.

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 7 Aug 2019.