Skip to content
Triangle logo TriangleGet started
← Study library

NCT00932698 · REGISTRY CONDITION SEARCH

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

Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.

Phase
PHASE1
Status at capture
COMPLETED
Registry last update
2019-08-07

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.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

→

baseline

Baseline characteristics

→

outcome · POSTED

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

→

outcome · POSTED

Number of Participants With Clinically Significant Abnormalities Reported as TEAEs

→

outcome · POSTED

Number of Participants With a TEAE of Peripheral Neuropathy

→

outcome · POSTED

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

→

outcome · POSTED

Maximum Tolerated Dose (MTD) of Ixazomib

→

outcome · POSTED

Recommended Phase 2 Dose (RP2D) of Ixazomib

→

outcome · POSTED

Cmax: Maximum Observed Plasma Concentration for Ixazomib

→

outcome · POSTED

Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for Ixazomib

→

outcome · POSTED

AUC(0-last): Area Under the Plasma Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration for Ixazomib

→

outcome · POSTED

AUC(0-72): Area Under the Plasma Concentration-Time Curve From Time 0 to 72 Hours Postdose for Ixazomib

→

outcome · POSTED

λz: Terminal Disposition Phase Rate Constant for Ixazomib

→

outcome · POSTED

T1/2: Terminal Disposition Phase Elimination Half-life for Ixazomib

→

outcome · POSTED

CL/F: Blood Clearance Calculated Using the Observed Value of the Last Quantifiable Concentration for Ixazomib

→

outcome · POSTED

Emax: Maximum Observed Effect for Ixazomib

→

outcome · POSTED

TEmax: Time to Maximum Observed Effect (Emax) for Ixazomib

→

outcome · POSTED

Overall Response Rate (ORR)

→

adverse events

Adverse events

→

more info

Limitations, agreements, and source contact

→
Who could take part
eligibility Criteria
Inclusion Criteria: 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. * 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. Exclusion Criteria: 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. * 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.
healthy Volunteers
false
minimum Age
18 Years
sex
ALL
std Ages
  1. ADULT
  2. OLDER_ADULT
Treatment arms and interventions
arm Groups
  1. description
    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).
    intervention Names
    1. Drug: Ixazomib
    label
    Dose Escalation Cohort 1: Ixazomib 0.24 mg/m^2
    type
    EXPERIMENTAL
  2. description
    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).
    intervention Names
    1. Drug: Ixazomib
    label
    Dose Escalation Cohort 2: Ixazomib 0.48 mg/m^2
    type
    EXPERIMENTAL
  3. description
    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).
    intervention Names
    1. Drug: Ixazomib
    label
    Dose Escalation Cohort 3: Ixazomib 0.8 mg/m^2
    type
    EXPERIMENTAL
  4. description
    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).
    intervention Names
    1. Drug: Ixazomib
    label
    Dose Escalation Cohort 4: Ixazomib 1.2 mg/m^2
    type
    EXPERIMENTAL
  5. description
    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).
    intervention Names
    1. Drug: Ixazomib
    label
    Dose Escalation Cohort 5: Ixazomib 1.68 mg/m^2
    type
    EXPERIMENTAL
  6. description
    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).
    intervention Names
    1. Drug: Ixazomib
    label
    Dose Escalation Cohort 6: Ixazomib 2.0 mg/m^2
    type
    EXPERIMENTAL
  7. description
    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).
    intervention Names
    1. Drug: Ixazomib
    label
    Dose Escalation Cohort 7: Ixazomib 2.23 mg/m^2
    type
    EXPERIMENTAL
  8. description
    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).
    intervention Names
    1. Drug: Ixazomib
    label
    Relapsed and Refractory Expansion Cohort: Ixazomib 2 mg/m^2
    type
    EXPERIMENTAL
  9. description
    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).
    intervention Names
    1. Drug: Ixazomib
    label
    Velcade-Relapsed (VR) Expansion Cohort: Ixazomib 2.0 mg/m^2
    type
    EXPERIMENTAL
  10. description
    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).
    intervention Names
    1. Drug: Ixazomib
    label
    Proteasome Inhibitor-Naive Expansion Cohort: Ixazomib 2 mg/m^2
    type
    EXPERIMENTAL
  11. description
    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).
    intervention Names
    1. Drug: Ixazomib
    label
    Carfilzomib Expansion Cohort: Ixazomib 2.0 mg/m^2
    type
    EXPERIMENTAL
interventions
  1. arm Group Labels
    1. Carfilzomib Expansion Cohort: Ixazomib 2.0 mg/m^2
    2. Dose Escalation Cohort 1: Ixazomib 0.24 mg/m^2
    3. Dose Escalation Cohort 2: Ixazomib 0.48 mg/m^2
    4. Dose Escalation Cohort 3: Ixazomib 0.8 mg/m^2
    5. Dose Escalation Cohort 4: Ixazomib 1.2 mg/m^2
    6. Dose Escalation Cohort 5: Ixazomib 1.68 mg/m^2
    7. Dose Escalation Cohort 6: Ixazomib 2.0 mg/m^2
    8. Dose Escalation Cohort 7: Ixazomib 2.23 mg/m^2
    9. Proteasome Inhibitor-Naive Expansion Cohort: Ixazomib 2 mg/m^2
    10. Relapsed and Refractory Expansion Cohort: Ixazomib 2 mg/m^2
    11. Velcade-Relapsed (VR) Expansion Cohort: Ixazomib 2.0 mg/m^2
    description
    Ixazomib capsules
    name
    Ixazomib
    other Names
    1. MLN9708
    type
    DRUG
Study design
allocation
NA
intervention Model
SINGLE_GROUP
masking Info
masking
NONE
primary Purpose
TREATMENT
Enrollment
count
60
type
ACTUAL
Registered outcome plans (not posted results)
primary Outcomes
  1. description
    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.
    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)
  2. description
    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.
    measure
    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)
  3. description
    Neurotoxicity was assessed as the number of participants with the TEAE of peripheral neuropathy.
    measure
    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)
  4. description
    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.
    measure
    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)
  5. description
    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.
    measure
    Maximum Tolerated Dose (MTD) of Ixazomib
    time Frame
    Cycle 1 (21 days)
  6. description
    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.
    measure
    Recommended Phase 2 Dose (RP2D) of Ixazomib
    time Frame
    Cycle 1 through Cycle 39 (Up to 28.3 months)
secondary Outcomes
  1. measure
    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
  2. measure
    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
  3. measure
    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
  4. measure
    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
  5. measure
    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
  6. measure
    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
  7. description
    CL/F is apparent clearance of the drug from the plasma.
    measure
    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
  8. description
    Emax was determined to characterize the whole blood 20S proteasome inhibition parameters.
    measure
    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
  9. description
    TEmax was determined to characterize the whole blood 20S proteasome inhibition parameters.
    measure
    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
  10. description
    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.
    measure
    Overall Response Rate (ORR)
    time Frame
    Cycle 1 through Cycle 115 (Up to 80.1 months)
Full study description
brief 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.
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.
Source references
references
  1. citation
    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.
    pmid
    28803351
    type
    DERIVED
  2. citation
    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.
    pmid
    24920586
    type
    DERIVED
Source notices and limitations
    Discovery and provenance
    1. release id
      ctgov-registry-1336d216cbd1bbff780dac70
      edge id
      nct-edge-4ae57b94986f1b04b31c
      requested nct id
      NCT00932698
      primary nct id
      NCT00932698
      source kind
      ctgov_condition_query
      source record id
      Source null
      source file sha256
      2314ce01316b2d7044d298c6d25eda12e99cc5f44273bc75efed6cd5e03a8c14
      payload sha256
      8919f877182f95d31c706ded1d2903a661d818abcc5a5b1de29f814962a59cff
      payload
      clinical indication matching status
      condition_index_match_asserted_by_registry_not_reviewed
      end exclusive
      true
      id
      nct-edge-4ae57b94986f1b04b31c
      link basis
      returned_by_explicit_condition_and_posted_results_filter_query
      nct id
      NCT00932698
      occurrences
      1. context exact
        NCT00932698
        end
        11
        exact text
        NCT00932698
        start
        0
      offset unit
      unicode_code_points
      query cond
      Plasma Cell Neoplasms
      query disease state id
      ds-plasma-cell-neoplasms
      source file
      /Users/arunverma/Documents/ChatGPT/Cancer Statistics Website/research-data/2026-09-10/clinicaltrials-condition/round-0000/raw/cond-plasma-cell-neoplasms-000.json
      source file sha256
      2314ce01316b2d7044d298c6d25eda12e99cc5f44273bc75efed6cd5e03a8c14
      source json pointer
      /studies/74/protocolSection/identificationModule/nctId
      source kind
      ctgov_condition_query
      source record id
      Source null
      source string basis
      parsed_JSON_string_unmodified
      source string sha256
      2aef3225f998d90cfae89b9c048824919e04133ea43a9bd923dc7d88668f0087

    Preserved source evidence · Not medical advice