A Study of Oral Ixazomib Citrate (MLN9708) Maintenance Therapy in Participa... | Not Recruiting
A Study of Oral Ixazomib Citrate (M... | Not Recruiting
A Study of Oral Ixazomib Citrate (MLN9708) Maintenance Therapy in Participants With Multiple Myeloma Following Autologous Stem Cell Transplant

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Medical Conditions
  • Multiple Myeloma
  • Autologous Stem Cell Transplant
Primary Contact Details
Unfortunately contact details are not available for this trial.
Recruitment Status
Not Recruiting
Trial source and source ID number
NCT02181413
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Summary
The purpose of this study is to determine the effect of ixazomib citrate maintenance therapy on progression-free survival (PFS), compared to placebo, in participants with newly diagnosed multiple myeloma (NDMM) who have had a response (complete response [CR], very good partial response [VGPR], or partial response [PR]) to induction therapy followed by high-dose therapy (HDT) and autologous stem cell transplant (ASCT).
Research Details
  • The investigational drug being tested in this study is called ixazomib citrate. Ixazomib citrate is being tested to slow disease progression and improve overall survival in people who have NDMM who have had any type of positive response to induction therapy followed by HDT and ASCT. This study will look at the effect of ixazomib citrate has on the length of time that participants are free of disease progression and their overall survival.

    The study will enroll approximately 652 participants. Participants will be randomly assigned (by chance, like flipping a coin) to one of the two treatment groups—which will remain undisclosed to the patient and study doctor during the study (unless there is an urgent medical need):

    - Ixazomib citrate 3 mg

    - Placebo (dummy inactive pill) - this is a capsule that looks like the study drug but has no active ingredient All participants will be asked to take one capsule on Days 1, 8 and 15 of each 28-day cycle, for up to 26 cycles (approximately 24 months).

    This multi-center trial will be conducted globally. The overall time to participate in this study is up to 107 months. Participants will make 28 visits to the clinic during the treatment period and will continue to make visits in the 4 follow-up periods (PFS, PD, PFS2, and OS). Participants will be assessed for disease response and PD during the PFS Follow-up period and undergo follow up every 4 weeks until the next line of therapy begins. Participants who start the next line of therapy will enter the PFS2 Follow-up period. During the PFS2 Follow-up period, follow-up will occur every 12 weeks until PD2 occurs. After participants in the PFS2 Follow-up period have PD2 on next-line therapy, they enter the OS Follow-up period. During the OS Follow-up period, follow-up will occur every 12 weeks until death or termination of the study.
Phase
Phase 3
Study Design
Sorry, this information is not available
Study Type
Interventional
Intervention
Drug : Ixazomib Citrate, Drug : Placebo

Study Arm Groups : Ixazomib Citrate, Placebo

Intervention Type
See Interventions above
Primary Outcome Measures
    Progression Free Survival (PFS); Baseline up to End of treatment (24 months); thereafter followed up every 4 weeks until progression of disease or death (up to Month 107)
Secondary Outcome Measures
    Overall Survival (OS); Baseline up to Follow up period (107 months); Percentage of Participants With Any Best Response Category Before PD or Subsequent Therapy; Baseline up to EOT (24 months) and thereafter every 4 week until initiation of the next line of therapy (up to 107 months); Time to Progression (TTP); Baseline until PD (Month 107); Second Progression-Free Survival (PFS2); Baseline up to End of treatment (24 months); thereafter followed up every 4 weeks until initiation of next-line therapy and then every 12 weeks until second progressive disease (PD2) or death (up to Month 107); Time to Start of the Next Line of Therapy; Baseline up to start of next line of therapy (after 24 months treatment period followed by every 4 weeks PFS and PD follow up period); Time to End of the Next Line of Therapy; Baseline up to end of next line of therapy (Month 107); Duration of the Next Line of Therapy; From the start of next line therapy after PD to the last dose of next line therapy (up to Month 107 ); Percentage of Participants Who Develop A New Primary Malignancy; Baseline until death or termination of the study (up to Month 107 ); Percentage of Participants with Conversion from Minimal Residual Disease (MRD) Positive to MRD Negative, and Maintenance of MRD Negativity; Baseline up to EOT (24 months); Correlation between MRD Status and Progression Free Survival (PFS) and Overall Survival (OS); Baseline up to Month 107; OS Benefits in a High-Risk Population; Randomization up to Month 107; PFS Benefits in a High-Risk Population; Randomization up to Month 107; Eastern Cooperative Oncology Group (ECOG) Performance Score; Baseline up to EOT(24 months), thereafter every 4 weeks until initiation of next line therapy; Percentage of Participants who Experience at least one Treatment Emergent Adverse Event (TEAE) or Serious Adverse Events (SAEs); First dose of study drug through 30 days after last dose of study drug (up to 24 months); Number of Participants With Markedly Abnormal Clinical Laboratory Values; Baseline through 30 days after the last dose of study drug (up to 24 months); Health-related quality of life (HRQL) Score Based on The European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Global Quality of Life Domain; Baseline up to PD (up to Month 107); Plasma Concentration of Ixazomib; Day 1 of Cycle 1 at multiple time points (up to 4 hours) post-dose; Days 8 and 15 of Cycle 1, Days 1 and 8 of Cycle 2, Day 1 of Cycles 3 through 10 (each cycle of 28 days): predose; Time to Resolution of Peripheral Neuropathy (PN) Events; From randomization date through 30 days after the last dose of drug (up to 24 months); Time to Improvement of PN Events; From randomization date through 30 days after the last dose of drug (up to 24 months)
Publication(s)
Sorry, this information is not available
Result Reports
Check availability of results on the Clinicaltrials.gov website
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Gender
All
Age Range
18 Years - N/A
Who Can Participate
Patients
Number of Participants
652
Participant Inclusion Criteria
    Inclusion Criteria:

    1. Adult male or female participants 18 years or older with a confirmed diagnosis of symptomatic multiple myeloma according to standard criteria.

    2. Documented results of cytogenetics/ fluorescence in situ hybridization (FISH) obtained at any time before transplant, and International Staging System (ISS) staging at the time of diagnosis available.

    3. Underwent standard of care induction therapy (induction therapy must include proteasome inhibitor (PI) and/or immunomodulating drugs (IMiD)-based regimens as primary therapy for multiple myeloma), followed by a single autologous stem cell transplant (ASCT) with a high-dose melphalan (200 mg/m^2) conditioning regimen, within 12 months of diagnosis. Vincristine, Adriamycin [doxorubicin], and dexamethasone (VAD) is not an acceptable induction therapy for this trial.

    4. Started screening no earlier than 75 days after transplant, completed screening within 15 days, and randomized no later than 115 days after transplant.

    5. Must have not received post-ASCT consolidation therapy.

    6. Documented response to ASCT (PR, VGPR, CR/stringent complete response [sCR]) according to IMWG criteria.

    7. ECOG performance status of 0 to 2.

    8. Female participants who:

    - If they are of childbearing potential, agree to practice 2 effective methods of contraception, at the same time, from the time of signing the informed consent through 90 days after the last dose of study drug, AND

    - Must also adhere to the guidelines of any treatment-specific pregnancy prevention program, if applicable, OR

    - Agree to practice true abstinence, when this is in line with the preferred and usual lifestyle of the participant. (Periodic abstinence [eg, calendar, ovulation, symptothermal, postovulation methods for the female partner] and withdrawal are not acceptable methods of contraception.)

    Male participants, even if surgically sterilized (ie, status postvasectomy), who:

    - Agree to practice effective barrier contraception during the entire study treatment period and through 90 days after the last dose of study drug, AND

    - Must also adhere to the guidelines of any treatment-specific pregnancy prevention program, if applicable, OR

    - Agree to practice true abstinence, when this is in line with the preferred and usual lifestyle of the participant. (Periodic abstinence [eg, calendar, ovulation, symptothermal, postovulation methods for the female partner] and withdrawal are not acceptable methods of contraception.)

    9. Voluntary written consent must be given before performance of any study-related procedure not part of standard medical care, with the understanding that consent may be withdrawn by the participant at any time without prejudice to future medical care.

    10. Suitable venous access for the study-required blood sampling.

    11. Is willing and able to adhere to the study visit schedule and other protocol requirements.

    12. Must meet the following clinical laboratory criteria at study entry:

    - Absolute neutrophil count (ANC) ≥ 1,000 per cubic milliliter (/mm^3) and platelet count ≥ 75,000/mm^3. Platelet transfusions to help patients meet eligibility criteria are not allowed within 3 days before randomization.

    - Total bilirubin ≤ 1.5 * the upper limit of the normal range (ULN).

    - Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 3 * ULN.

    - Calculated creatinine clearance ≥ 30 milliliter per minute (mL/min).

    Exclusion Criteria:

    1. Multiple myeloma which has relapsed following primary therapy or is not responsive to primary therapy. For this study, stable disease following ASCT will be considered nonresponsive to primary therapy.

    2. Double (tandem) ASCT.

    3. Radiotherapy within 14 days before the first dose of study drug.

    4. Diagnosed or treated for another malignancy within 5 years before randomization or previously diagnosed with another malignancy with evidence of residual disease. Participants with nonmelanoma skin cancer or carcinoma in situ of any type are not excluded if they have undergone complete resection.

    5. Female participants who are lactating and breastfeeding or have a positive serum pregnancy test during the Screening period.

    6. Major surgery within 14 days before randomization.

    7. Central nervous system involvement.

    8. Infection requiring intravenous (IV) antibiotic therapy or other serious infection within 14 days before randomization.

    9. Diagnosis of Waldenstrom's macroglobulinemia, POEMS (polyneuropathy, organomegaly, endocrinopathy, monoclonal gammopathy, and skin changes) syndrome, plasma cell leukemia, primary amyloidosis, myelodysplastic syndrome, or myeloproliferative syndrome.

    10. Evidence of current uncontrolled cardiovascular conditions, including uncontrolled hypertension, uncontrolled cardiac arrhythmias, symptomatic congestive heart failure, unstable angina, or myocardial infarction within the past 6 months.

    11. Systemic treatment with strong inhibitors of cytochrome P450s (CYP)1A2 (fluvoxamine, enoxacin, ciprofloxacin), strong inhibitors of CYP3A (clarithromycin, telithromycin, itraconazole, voriconazole, ketoconazole, nefazodone, posaconazole) or strong CYP3A inducers (rifampin, rifapentine, rifabutin, carbamazepine, phenytoin, phenobarbital), or use of Ginkgo biloba or St. John's wort within 14 days before randomization in the study.

    12. Active hepatitis B or C virus infection, or known human immunodeficiency virus (HIV) positive.

    13. Comorbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the participant inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens (eg, peripheral neuropathy that is Grade 1 with pain or Grade 2 or higher of any cause).

    14. Psychiatric illness/social situation that would limit compliance with study requirements.

    15. Known allergy to any of the study medications, their analogues, or excipients in the various formulations of any agent.

    16. Inability to swallow oral medication, inability or unwillingness to comply with the drug administration requirements, or gastrointestinal (GI) procedure that could interfere with the oral absorption or tolerance of treatment.

    17. Treatment with any investigational products within 60 days before the first dose of the study drug regimen.
Participant Exclusion Criteria
This is in the inclusion criteria above
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Trial Location(s)
Local Institution
London
Greater London
Local Institution
Oxford
Oxfordshire
Sheffield
Brook Lane Surgery
Southampton
Leeds
Sutton
Uni Hospital Leicester
Leicester
Swansea
Trial Contact(s)
Primary Trial Contact
Sorry, this information is not available
Other Trial Contacts
Sorry, this information is not available
Countries Recruiting
Argentina, Australia, Austria, Belgium, Brazil, Canada, Colombia, Czech Republic, Denmark, France, Germany, Greece, Hungary, Israel, Italy, Japan, Korea, Republic of, Mexico, Netherlands, Norway, Poland, Portugal, Singapore, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, Ukraine, United Kingdom, United States
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Scientific Title
A Phase 3, Randomized, Placebo-Controlled, Double-Blind Study of Oral Ixazomib Citrate (MLN9708) Maintenance Therapy in Patients With Multiple Myeloma Following Autologous Stem Cell Transplant
EudraCT Number
Not available for this trial
Funder(s)
    Sorry, this information is not available
Other Study ID Numbers
C16019
Sponsor(s)
Millennium Pharmaceuticals, Inc.
Key Dates

Recruitment Start Date

Jun 2014

Recruitment End Date

Mar 2018

Trial Start Date
Date Not Available
Trial End Date
Date Not Available
Date added to source

27 Jun 2014

Date updated in source

30 Mar 2017