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NCT01335685 · REGISTRY CONDITION SEARCH

Study of Oral Ixazomib in Combination With Melphalan and Prednisone in Participants With Newly Diagnosed 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, PHASE2
Status at capture
COMPLETED
Registry last update
2018-01-23

The purpose of this phase 1/2, open-label study was to evaluate the effect of oral formulation of Ixazomib when added to standard melphalan and prednisone (MP) treatment. Both phases of the study included participants who had newly diagnosed multiple myeloma and were ineligible for high-dose therapy plus stem cell transplantation because of age (≥65 years of age) or coexisting conditions and for whom standard MP treatment was indicated.

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

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baseline

Baseline characteristics

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outcome · POSTED

Maximum Tolerated Dose (MTD) and Recommended Phase 2 Dose (RP2D) of Ixazomib (Phase 1)

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outcome · POSTED

Very Good Partial Response (VGPR) or Better Response Rate (Phase 2)

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outcome · POSTED

Maximum Inhibition Rate (Emax) (Phase 1)

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outcome · POSTED

Time of Occurrence of Emax (TEmax) (Phase 1)

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outcome · POSTED

Cmax: Maximum Observed Plasma Concentration for Ixazomib (Phase 1)

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outcome · POSTED

Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for Ixazomib (Phase 1)

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outcome · POSTED

AUCtau: Area Under the Plasma Concentration-time Curve Over the Dosing Interval for Ixazomib (Phase 1)

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outcome · POSTED

Terminal Elimination Rate Constant (λz) for Ixazomib (Phase 1)

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outcome · POSTED

Terminal Phase Elimination Half-life (T1/2) for Ixazomib (Phase 1)

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outcome · POSTED

Observed Accumulation Ratio for AUCtau (Rac) (Phase 1)

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outcome · POSTED

Overall Response Rate (ORR)

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outcome · POSTED

Time to First Response (Phase 2)

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outcome · POSTED

Duration of Response (DOR) (Phase 2)

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outcome · POSTED

Time to Progression (TTP) (Phase 2)

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outcome · POSTED

Time to Next Therapy (Phase 2)

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outcome · POSTED

Progression Free Survival (Phase 2)

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outcome · POSTED

Overall Survival (Phase 2)

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outcome · POSTED

Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs)

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outcome · POSTED

Assessments of Quality of Life (Phase 2)

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adverse events

Adverse events

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more info

Limitations, agreements, and source contact

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Who could take part
eligibility Criteria
Inclusion Criteria: * Is indicated with standard melphalan prednisone (MP) treatment and is not a candidate for high-dose therapy plus stem cell transplantation (HDT-SCT) for 1 of the following reasons: the participant is 65 years of age or older OR the participant is less than 65 years of age but has significant comorbid condition(s) that are likely to have a negative impact on tolerability of HDT-SCT * Is diagnosed with symptomatic multiple myeloma or asymptomatic myeloma with myeloma-related organ damage according to standard criteria * Has measurable disease as specified in study protocol * Has Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2 * Has adequate hematologic, liver, and renal function Exclusion Criteria * Has peripheral neuropathy that is greater or equal to Grade 2 * Has major surgery or radiotherapy within 14 days before the first dose of study drug * Has uncontrolled infection requiring systematic antibiotics * Has diarrhea (\> Grade 1) * Has prior systemic therapy for multiple myeloma, including investigational drugs (prior treatment with corticosteroids or localized radiation therapy dose not disqualify the participantt) * Has central nervous system involvement * Has cardiac status as described in protocol * Has known gastrointestinal condition or procedure that could interfere with swallowing or the oral absorption of tolerance of IXAZOMIB - Diagnosis of smoldering multiple myeloma, Waldenstrom's macroglobulinemia, POEMS syndrome, plasma cell leukemia, primary amyloidosis, myelodysplastic syndrome, or myeloproliferative syndrome * Has Known human immunodeficiency virus (HIV) positive, hepatitis B surface antigen-positive status, or known or suspected active hepatitis C infection * Is diagnosed or treated for another malignancy within 2 years before the first dose or previously diagnosed with another malignancy and have any evidence of residual disease with the exception of nonmelanoma skin cancer or any completely resected carcinoma in situ * Has serious medical or psychiatric illness that could, in the investigator's opinion, potentially interfere with the completion of treatment according to the protocol
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 3.0 mg, capsules, orally, on Days 1, 4, 8, 11, 22, 25, 29, 32 plus melphalan 9 mg/m\^2, tablets, orally on Days 1 to 4 and prednisone 60 mg/m\^2, tablets, orally on Days 1 to 4 in 42-day cycle for up to 9 cycles in induction phase followed by ixazomib at dose last tolerated in induction, orally, on Days 1, 8, 15 in 28-day cycle for up to 12 cycles or until disease progression or unacceptable toxicity if deriving benefit in maintenance phase (up to 23 maintenance cycles; overall up to 32 cycles \[34 months\]).
    intervention Names
    1. Drug: Ixazomib
    2. Drug: Melphalan
    3. Drug: Prednisone
    label
    Arm A: Ixazomib 3.0 mg
    type
    EXPERIMENTAL
  2. description
    Ixazomib 3.7 mg, capsules, orally, on Days 1, 4, 8, 11, 22, 25, 29, 32 plus melphalan 9 mg/m\^2, tablets, orally on Days 1 to 4 and prednisone 60 mg/m\^2, tablets, orally on Days 1 to 4 in 42-day cycle for up 9 cycles in induction phase followed by ixazomib at dose last tolerated in induction, orally, on Days 1, 8, 15 in 28-day cycle up to 12 cycles or until disease progression or unacceptable toxicity if deriving benefit in maintenance phase (up to 10 maintenance cycles; overall up to 19 cycles \[21 months\]).
    intervention Names
    1. Drug: Ixazomib
    2. Drug: Melphalan
    3. Drug: Prednisone
    label
    Arm A: Ixazomib 3.7 mg
    type
    EXPERIMENTAL
  3. description
    Ixazomib 3.0 mg, capsules, orally, on Days 1, 8, 15 plus melphalan 6 mg/m\^2, tablets, orally on Days 1 to 4 and prednisone 60 mg/m\^2, tablets, orally on Days 1-4 in 28-day cycle for up to 13 cycles in induction phase followed by ixazomib at dose last tolerated in induction, orally, on Days 1, 8, 15 in 28-day cycle up to 12 cycles or until disease progression or unacceptable toxicity if deriving benefit in maintenance phase (up to 15 maintenance cycles; overall up to 27 cycles \[25 months\]).
    intervention Names
    1. Drug: Ixazomib
    2. Drug: Melphalan
    3. Drug: Prednisone
    label
    Arm B: Ixazomib 3.0 mg
    type
    EXPERIMENTAL
  4. description
    Ixazomib 4.0 mg, capsules, orally, on Days 1, 8, 15 cycle plus melphalan 6 mg/m\^2, tablets, orally on Days 1 to 4 and prednisone 60 mg/m\^2, tablets, orally on Days 1-4 in 28-day cycle for up to 13 cycles in induction phase followed by ixazomib at dose last tolerated in induction, orally, on Days 1, 8, 15 in 28-day cycle up to 12 cycles or until disease progression or unacceptable toxicity if deriving benefit in maintenance phase (up to 49 maintenance cycles; overall up to 61 cycles \[58 months\]).
    intervention Names
    1. Drug: Ixazomib
    2. Drug: Melphalan
    3. Drug: Prednisone
    label
    Arm B: Ixazomib 4.0 mg
    type
    EXPERIMENTAL
  5. description
    Ixazomib 5.5 mg, capsules, orally, on Days 1, 8, 15 plus melphalan 6 mg/m\^2, tablets orally on Days 1 to 4 and prednisone 60 mg/m\^2, tablets, orally on Days 1-4 in 28-day cycle for up to 13 cycles in induction phase followed by ixazomib at dose last tolerated in induction, orally, on Days 1, 8, 15 in 28-day cycle up to 12 cycles or until disease progression or unacceptable toxicity if deriving benefit in maintenance phase (up to 12 maintenance cycles; overall up to 24 cycles \[24 months\]).
    intervention Names
    1. Drug: Ixazomib
    2. Drug: Melphalan
    3. Drug: Prednisone
    label
    Arm B: Ixazomib 5.5 mg
    type
    EXPERIMENTAL
  6. description
    Ixazomib 3.0 mg, capsules, orally, on Days 1, 8, 15, 22, and 29 plus melphalan 9 mg/m\^2, tablets orally on Days 1 to 4 and prednisone 60 mg/m\^2, tablets, orally on Days 1 to 4 in 42-day cycle for up to 9 cycles in induction phase followed by ixazomib at dose last tolerated in induction, orally, on Days 1, 8, 15 in 28-day cycle up to 12 cycles or until disease progression or unacceptable toxicity if deriving benefit in maintenance phase (up to 30 maintenance cycles; overall up to 39 cycles \[40 months\]).
    intervention Names
    1. Drug: Ixazomib
    2. Drug: Melphalan
    3. Drug: Prednisone
    label
    Arm C: Ixazomib 3.0 mg
    type
    EXPERIMENTAL
  7. description
    Ixazomib 4.0 mg, capsules, orally, on Days 1, 8, 15, 22, and 29 plus melphalan 9 mg/m\^2, tablets, orally on Days 1 to 4 and prednisone 60 mg/m\^2, tablets, orally on Days 1 to 4 in 42-day cycle for up to 9 cycles in induction phase followed by ixazomib at dose last tolerated in induction, orally, on Days 1, 8, 15 in 28-day cycle up to 12 cycles or until disease progression or unacceptable toxicity if deriving benefit in maintenance phase (up to 12 maintenance cycles; overall up to 21 cycles \[24 months\]).
    intervention Names
    1. Drug: Ixazomib
    2. Drug: Melphalan
    3. Drug: Prednisone
    label
    Arm C: Ixazomib 4.0 mg
    type
    EXPERIMENTAL
  8. description
    Ixazomib 4.0 mg, capsules, orally, on Days 1, 8, 22, and 29 plus melphalan 9 mg/m\^2, tablets, orally on Days 1 to 4 and prednisone 60 mg/m\^2, tablets, orally, on Days 1 to 4 in 42-day cycle for up to 9 cycles in induction phase followed by ixazomib at dose last tolerated in induction, orally, on Days 1, 8, 15 in 28-day cycle up to 12 cycles or until disease progression or unacceptable toxicity if deriving benefit in maintenance phase (up to 28 maintenance cycles; overall up to 37 cycles \[38 months\]).
    intervention Names
    1. Drug: Ixazomib
    2. Drug: Melphalan
    3. Drug: Prednisone
    label
    Arm D: Ixazomib 4.0 mg
    type
    EXPERIMENTAL
interventions
  1. arm Group Labels
    1. Arm A: Ixazomib 3.0 mg
    2. Arm A: Ixazomib 3.7 mg
    3. Arm B: Ixazomib 3.0 mg
    4. Arm B: Ixazomib 4.0 mg
    5. Arm B: Ixazomib 5.5 mg
    6. Arm C: Ixazomib 3.0 mg
    7. Arm C: Ixazomib 4.0 mg
    8. Arm D: Ixazomib 4.0 mg
    description
    Ixazomib capsules
    name
    Ixazomib
    type
    DRUG
  2. arm Group Labels
    1. Arm A: Ixazomib 3.0 mg
    2. Arm A: Ixazomib 3.7 mg
    3. Arm B: Ixazomib 3.0 mg
    4. Arm B: Ixazomib 4.0 mg
    5. Arm B: Ixazomib 5.5 mg
    6. Arm C: Ixazomib 3.0 mg
    7. Arm C: Ixazomib 4.0 mg
    8. Arm D: Ixazomib 4.0 mg
    description
    Melphalan tablets
    name
    Melphalan
    type
    DRUG
  3. arm Group Labels
    1. Arm A: Ixazomib 3.0 mg
    2. Arm A: Ixazomib 3.7 mg
    3. Arm B: Ixazomib 3.0 mg
    4. Arm B: Ixazomib 4.0 mg
    5. Arm B: Ixazomib 5.5 mg
    6. Arm C: Ixazomib 3.0 mg
    7. Arm C: Ixazomib 4.0 mg
    8. Arm D: Ixazomib 4.0 mg
    description
    Prednisone tablets
    name
    Prednisone
    type
    DRUG
Study design
intervention Model
PARALLEL
masking Info
masking
NONE
primary Purpose
TREATMENT
Enrollment
count
61
type
ACTUAL
Registered outcome plans (not posted results)
primary Outcomes
  1. description
    The RP2D is the maximum tolerated dose (MTD) or less. The MTD is defined as the dose range at which ≤ 1 of 6 evaluable participants experience dose limiting toxicities (DLT) within the first 28 days of treatment (end of Cycle 1).
    measure
    Maximum Tolerated Dose (MTD) and Recommended Phase 2 Dose (RP2D) of Ixazomib (Phase 1)
    time Frame
    Cycle 1, phase 1 (Up to 42 days)
  2. description
    VGPR or better response rate is defined as percentage of participants with a complete response (CR) and very good partial response (VGPR). Per International Myeloma Working Group Uniform Response Criteria (IMWG), CR: 1) Negative immunofixation on the serum and urine, 2) Disappearance of any soft tissue plasmacytomas and 3) \< 5% plasma cells in bone marrow. VGPR: Serum and urine M-protein detectable by immunofixation but not on electrophoresis or 90% or greater reduction in serum M-protein plus urine M-protein level \< 100 mg per 24 hour.
    measure
    Very Good Partial Response (VGPR) or Better Response Rate (Phase 2)
    time Frame
    Day 1 of every other cycle from Day 1 of Cycle 2 (each cycle of 28 days) until death (Up to 5.5 years)
secondary Outcomes
  1. description
    Whole blood 20S proteasome inhibition parameters
    measure
    Maximum Inhibition Rate (Emax) (Phase 1)
    time Frame
    At multiple time points during Cycles 1-3 of each phase and arm of the study, throughout approximately 84-126 days depending on the arm of the study
  2. description
    Whole blood 20S proteasome inhibition parameters
    measure
    Time of Occurrence of Emax (TEmax) (Phase 1)
    time Frame
    At multiple time points during Cycles 1-3 of each phase and arm of the study, throughout approximately 84-126 days depending on the arm of the study
  3. measure
    Cmax: Maximum Observed Plasma Concentration for Ixazomib (Phase 1)
    time Frame
    Pre-dose on Day 1 and at multiple timepoints (up to 8 hours) on Day 11 for Arm A, Day 15 for Arm B and Day 29 for Arms C and D
  4. measure
    Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for Ixazomib (Phase 1)
    time Frame
    Pre-dose on Day 1 and at multiple timepoints (up to 8 hours) on Day 11 for Arm A, Day 15 for Arm B and Day 29 for Arms C and D
  5. measure
    AUCtau: Area Under the Plasma Concentration-time Curve Over the Dosing Interval for Ixazomib (Phase 1)
    time Frame
    Pre-dose on Day 1 and at multiple timepoints (up to 8 hours) on Day 11 for Arm A, Day 15 for Arm B and Day 29 for Arms C and D
  6. description
    Terminal elimination rate constant, calculated as the negative of the slope of the log-linear regression of the natural logarithm concentration-time curve during the terminal phase.
    measure
    Terminal Elimination Rate Constant (λz) for Ixazomib (Phase 1)
    time Frame
    Pre-dose on Day 1 and at multiple timepoints (up to 8 hours) on Day 11 for Arm A, Day 15 for Arm B and Day 29 for Arms C and D
  7. description
    Terminal phase elimination half-life (T1/2) is the time required for half of the drug to be eliminated from the plasma.
    measure
    Terminal Phase Elimination Half-life (T1/2) for Ixazomib (Phase 1)
    time Frame
    Pre-dose on Day 1 and at multiple timepoints (up to 8 hours) on Day 11 for Arm A, Day 15 for Arm B and Day 29 for Arms C and D
  8. description
    Accumulation ratio for AUCtau (Rac) was calculated as area under the curve from time zero to end of dosing interval (AUCtau) on Day 14 divided by area under the curve from time zero to end of dosing interval (AUCtau) on Day 1.
    measure
    Observed Accumulation Ratio for AUCtau (Rac) (Phase 1)
    time Frame
    Pre-dose on Day 1 and at multiple timepoints (up to 8 hours) on Day 11 for Arm A, Day 15 for Arm B and Day 29 for Arms C and D
  9. description
    ORR is defined as percentage of participants with overall response including CR, VGPR, and partial response (PR). Per IMWG criteria, CR:1)Negative immunofixation on serum and urine, 2)Disappearance of any soft tissue plasmacytomas, 3)\< 5% plasma cells in bone marrow. VGPR: Serum+urine M-protein detectable by immunofixation but not on electrophoresis/ 90% or \>reduction in serum M-protein + urine M-protein level \< 100 mg/ 24-hour. PR:1)≥50% reduction of serum M-protein and reduction in 24-hour urinary M-protein by ≥90% or to \<200 mg/24-hour. If serum+urine M-protein are unmeasurable, ≥50% decrease in difference between involved and uninvolved FLC levels is required. If serum+urine M-protein are unmeasurable and serum free light assay is also unmeasurable, ≥50% reduction in plasma cells is required in place of M-protein, provided baseline bone marrow plasma cell percentage was ≥30%. In addition, if present at baseline, a ≥50% reduction in size of soft tissue plasmacytomas is required.
    measure
    Overall Response Rate (ORR)
    time Frame
    Day 1 of every other cycle from Day 1 of Cycle 2 (each cycle of 28 days) up to 61 cycles, at end of treatment (Up to 5.5 years)
  10. description
    Response is defined as CR, VGPR and PR. Per IMWG criteria, CR:1)Negative immunofixation on serum+urine, 2)Disappearance of any soft tissue plasmacytomas, 3)\< 5% plasma cells in bone marrow. VGPR: Serum+urine M-protein detectable by immunofixation but not on electrophoresis/ 90% or \>reduction in serum M-protein + urine M-protein level \< 100 mg/ 24-hour. PR:1)≥50% reduction of serum M-protein and reduction in 24-hour urinary M-protein by ≥90% or to \<200 mg/24-hour. If serum+urine M-protein are unmeasurable, ≥50% decrease in difference between involved and uninvolved FLC levels is required. Else, ≥50% reduction in plasma cells is required in place of M-protein, provided baseline bone marrow plasma cell percentage was ≥30%. In addition, if present at baseline, a ≥50% reduction in size of soft tissue plasmacytomas is required.
    measure
    Time to First Response (Phase 2)
    time Frame
    From the date of enrollment to the date of the first documented response for up to 5.5 years
  11. description
    DOR is defined as time of first documentation of a confirmed PR or better response to first documented PD or start of alternative therapy. DOR was presented for those achieving CR+VGPR+PR. Per IMWG criteria, CR:1)Negative immunofixation on serum+urine, 2)Disappearance of any soft tissue plasmacytomas, 3)\< 5% plasma cells in bone marrow. VGPR: Serum+urine M-protein detectable by immunofixation but not on electrophoresis/ 90% or \>reduction in serum M-protein + urine M-protein level \< 100 mg/ 24-hour. PR:1)≥50% reduction of serum M-protein and reduction in 24-hour urinary M-protein by ≥90% or to \<200 mg/24-hour. If serum+urine M-protein are unmeasurable, ≥50% decrease in difference between involved and uninvolved FLC levels is required. Else, ≥50% reduction in plasma cells is required in place of M-protein, provided baseline bone marrow plasma cell percentage was ≥30%. In addition, if present at baseline, a ≥50% reduction in size of soft tissue plasmacytomas is required.
    measure
    Duration of Response (DOR) (Phase 2)
    time Frame
    From the time from the date of first documentation of PR or better to the date of first documented disease progression for up to 5.5 years
  12. description
    TTP is defined as time from date of enrollment to date of first documented disease progression (PD). Per IMWG criteria, progressive disease requires any 1 or more of following: Increase of ≥25% from nadir in serum M-component and/or (absolute increase must be ≥0.5 g/dL), urine M-component and/or (absolute increase must be ≥200 mg/24 hour. Participants without measurable serum+urine M-protein levels: difference between involved and uninvolved FLC levels. The absolute increase must be \>10 mg/dL. Bone marrow plasma cell percentage: absolute % must be ≥10%. Definite development of new bone lesions or soft tissue plasmacytomas or definite increase in size of existing bone lesions or soft tissue plasmacytomas. Development of hypercalcemia (corrected serum calcium \>11.5 mg/dL or 2.85 mmol/L) that can be attributed solely to plasma cell proliferative disorder.
    measure
    Time to Progression (TTP) (Phase 2)
    time Frame
    From the date of enrollment to the date of the first documented disease progression for up to 5.5 years
Full study description
brief Summary
The purpose of this phase 1/2, open-label study was to evaluate the effect of oral formulation of Ixazomib when added to standard melphalan and prednisone (MP) treatment. Both phases of the study included participants who had newly diagnosed multiple myeloma and were ineligible for high-dose therapy plus stem cell transplantation because of age (≥65 years of age) or coexisting conditions and for whom standard MP treatment was indicated.
detailed Description
The drug tested in this study was called ixazomib (MLN9708). Ixazomib was tested to treat the people with newly diagnosed multiple myeloma requiring systemic treatment who were not eligible for stem cell transplantation. This study determined the safety, tolerability, efficacy, quality of life (QOL), and pharmacokinetics (PK)/pharmacodynamics (PD) of ixazomib. The study enrolled 61 patients. The study was conducted in 2 parts: 1) phase 1 dose escalation and 2) phase 2 expansion at maximum tolerated dose. Participants were enrolled to receive: * Ixazomib 3.0 mg, 3.7 mg, 4.0 mg, or 5.5. mg depending on the treatment assignment This multicenter trial was conducted in the Unites states, Canada, United Kingdom, Spain and Czech Republic. The overall time to participate in this study is 5.5 years. Participants made multiple visits to the clinic and were followed up every 16 weeks after end of treatment until disease progression if stopped treatment before disease progression and then every 16 weeks up to start of next therapy or death whichever occurs first.
Source references
references
  1. citation
    San-Miguel JF, Echeveste Gutierrez MA, Spicka I, Mateos MV, Song K, Craig MD, Blade J, Hajek R, Chen C, Di Bacco A, Estevam J, Gupta N, Byrne C, Lu V, van de Velde H, Lonial S. A phase I/II dose-escalation study investigating all-oral ixazomib-melphalan-prednisone induction followed by single-agent ixazomib maintenance in transplant-ineligible newly diagnosed multiple myeloma. Haematologica. 2018 Sep;103(9):1518-1526. doi: 10.3324/haematol.2017.185991. Epub 2018 Jun 28.
    pmid
    29954932
    type
    DERIVED
Source notices and limitations
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    Preserved source evidence · Not medical advice