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Ixazomib Rollover Study

Primary Purpose

Multiple Myeloma, Lymphoma, Amyloidosis

Status
Active
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Ixazomib
Sponsored by
Takeda
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Multiple Myeloma focused on measuring Drug Therapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Voluntary written consent must be given before performance of any study-related procedure not part of standard medical care. Participants should consent and enter the study within a maximum of 8 weeks of their last dose of treatment in the parent study or as agreed by the Takeda clinician/designee.

  2. Previously treated with ixazomib, background therapy, and/or comparator drugs (including placebo) in a Takeda-sponsored ixazomib parent study. Participants will be eligible to enter the rollover study when:

    1. The parent study is closed or planned to be closed; and
    2. The participant is on ixazomib monotherapy, a combination regimen with ixazomib and other study medication(s), on a placebo combination, or on an alternative arm regimen in a designated ixazomib parent study (i.e., Studies C16003 [NCT00932698], C16005 [NCT01217957], C16006 [NCT01335685], C16007 [NCT01318902], C16008 [NCT01383928], C16010 Global [NCT01564537], C16011 [NCT01659658], C16013 [NCT01645930], C16014 Global [NCT01850524] and Korean Continuation, C16017 [NCT01939899], C16020 [NCT02046070], C16029 [NCT03170882], and C16047 [NCT03439293]); and
    3. In the opinion of the investigator and approved by the Takeda medical monitor, the participant may continue to benefit from treatment with ixazomib and/or another study drug/combination regimen (e.g., response to therapy or stable disease without evidence of disease progression) and has no alternate means to access the study drug(s) (e.g., commercial supply).
  3. Agree to continue to practice contraceptive methods as outlined in the parent study.

Exclusion Criteria:

  1. The participant meets any of the criteria for treatment discontinuation in the parent study.
  2. Female patients who are lactating and breastfeeding or have a positive serum pregnancy test during the eligibility period.

Sites / Locations

  • Emory University
  • Appalachian Regional Healthcare
  • Dana Farber Cancer Institute
  • Washington University School of Medicine
  • UZ Leuven
  • Princess Margaret Cancer Centre
  • University Health Network
  • Peking University Third Hospital
  • Peking Union Medical College Hospital
  • 1st Affiliated Hospital of Zhejiang University
  • Shanghai Chang Zheng Hospital
  • Laiko General Hospital of Athens
  • University of Athens Medical School - Regional General Hospital Alexandra
  • Tokyo Metropolitan Komagome Hospital
  • Japanese Red Cross Medical Center
  • Asan Medical Center - PPDS
  • Samodzielny Publiczny Zaklad Opieki Zdrowotnej Zespol Szpitali Miejskich
  • Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. M. Kopernika w Lodzi
  • Centrum Onkologii Ziemi Lubelskiej
  • MTZ Clinical Research Sp z o o
  • National University Hospital
  • Complejo Asistencial Universitario de Salamanca H. Clinico
  • Hospital Universitario de Donostia
  • Karolinska Universitetssjukhuset Huddinge
  • Skanes Universitetssjukhus Lund
  • Karolinska Universitetssjukhuset Solna

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Ixazomib

Arm Description

Ixazomib capsule, orally, at same dose and schedule that participants were receiving in the parent study until disease progression, clinical deterioration in the investigator's judgment, experience an unacceptable toxicity, withdraw consent, pursue an alternative therapy, meet other study-specified reasons for discontinuation of study drug, or until the participant is transitioned to ixazomib through commercial channels, including reimbursement for the participant's indication, whichever is sooner. Participants who were receiving a combination therapy with ixazomib and another medication(s) will continue to receive the combination regimen.

Outcomes

Primary Outcome Measures

Number of Participants With Serious Adverse Events (SAEs)
SAE means any untoward medical occurrence that at any dose: a) results in death; b) is life-threatening (refers to an Adverse Event [AE] in which the participant was at risk of death at the time of the event. It does not refer to an event which hypothetically might have caused death if it were more severe); c) requires inpatient hospitalization or prolongation of an existing hospitalization; d) results in persistent or significant disability or incapacity; e) is a congenital anomaly/birth defect; f) is a medically important event. This refers to an AE that may not result in death, be immediately life threatening, or require hospitalization, but may be considered serious when, based on appropriate medical judgment, may jeopardize the participant, require medical or surgical intervention to prevent 1 of the outcomes listed above, or involves suspected transmission via a medicinal product of an infectious agent.
Number of Participants With ≥ Grade 3 AEs
An AE is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (eg, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug.
Number of Participants With ≥ Grade 2 Peripheral Neuropathy
Number of Participants With New Primary Malignancies
Number of Participants With any AE Resulting in Dose Modification or Discontinuation of any Study Drug
Number of Participants With any other AE That in the Opinion of the Investigator is a Clinically Significant Event

Secondary Outcome Measures

Full Information

First Posted
October 4, 2016
Last Updated
January 30, 2023
Sponsor
Takeda
Collaborators
Takeda Development Center Americas, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT02924272
Brief Title
Ixazomib Rollover Study
Official Title
An Open-Label, Rollover Protocol for Patients Previously Enrolled in Millennium-Sponsored Ixazomib Studies
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
December 16, 2016 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Takeda
Collaborators
Takeda Development Center Americas, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to provide continued access to ixazomib and/or other study drugs from an ixazomib parent study.
Detailed Description
The drug being tested in this study is called ixazomib. This study will look at the long term safety profile of ixazomib in participants who have previously received and tolerated ixazomib in a Takeda-sponsored clinical study, and in the investigator's opinion and approved by the Takeda medical monitor, may benefit from continued ixazomib therapy. The study will enroll approximately 250 patients. All participants will receive ixazomib as a single agent or in combination with other study drugs at same dose and schedule that they were receiving in the parent study until they experience disease progression, clinical deterioration in the investigator's judgment, experience an unacceptable toxicity, withdraw consent, pursue an alternative therapy, meet other study-specified reasons for discontinuation of study drug, or until ixazomib is available to the participant is transitioned to ixazomib/other therapy through commercial channels, including reimbursement for the participant's indication, whichever is sooner. This multicenter, rollover study will be conducted worldwide. The overall time to participate in this study is up to 7 years. Participants will make multiple visits to the clinic, and a final visit after 30 days of last dose of study drug for a safety assessment.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Myeloma, Lymphoma, Amyloidosis
Keywords
Drug Therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
31 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Ixazomib
Arm Type
Experimental
Arm Description
Ixazomib capsule, orally, at same dose and schedule that participants were receiving in the parent study until disease progression, clinical deterioration in the investigator's judgment, experience an unacceptable toxicity, withdraw consent, pursue an alternative therapy, meet other study-specified reasons for discontinuation of study drug, or until the participant is transitioned to ixazomib through commercial channels, including reimbursement for the participant's indication, whichever is sooner. Participants who were receiving a combination therapy with ixazomib and another medication(s) will continue to receive the combination regimen.
Intervention Type
Drug
Intervention Name(s)
Ixazomib
Other Intervention Name(s)
MLN9708, Ninlaro
Intervention Description
Ixazomib Capsules
Primary Outcome Measure Information:
Title
Number of Participants With Serious Adverse Events (SAEs)
Description
SAE means any untoward medical occurrence that at any dose: a) results in death; b) is life-threatening (refers to an Adverse Event [AE] in which the participant was at risk of death at the time of the event. It does not refer to an event which hypothetically might have caused death if it were more severe); c) requires inpatient hospitalization or prolongation of an existing hospitalization; d) results in persistent or significant disability or incapacity; e) is a congenital anomaly/birth defect; f) is a medically important event. This refers to an AE that may not result in death, be immediately life threatening, or require hospitalization, but may be considered serious when, based on appropriate medical judgment, may jeopardize the participant, require medical or surgical intervention to prevent 1 of the outcomes listed above, or involves suspected transmission via a medicinal product of an infectious agent.
Time Frame
Up to 5 years
Title
Number of Participants With ≥ Grade 3 AEs
Description
An AE is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (eg, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug.
Time Frame
Up to 5 years
Title
Number of Participants With ≥ Grade 2 Peripheral Neuropathy
Time Frame
Up to 5 years
Title
Number of Participants With New Primary Malignancies
Time Frame
Up to 5 years
Title
Number of Participants With any AE Resulting in Dose Modification or Discontinuation of any Study Drug
Time Frame
Up to 5 years
Title
Number of Participants With any other AE That in the Opinion of the Investigator is a Clinically Significant Event
Time Frame
Up to 5 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Voluntary written consent must be given before performance of any study-related procedure not part of standard medical care. Participants should consent and enter the study within a maximum of 8 weeks of their last dose of treatment in the parent study or as agreed by the Takeda clinician/designee. Previously treated with ixazomib, background therapy, and/or comparator drugs (including placebo) in a Takeda-sponsored ixazomib parent study. Participants will be eligible to enter the rollover study when: The parent study is closed or planned to be closed; and The participant is on ixazomib monotherapy, a combination regimen with ixazomib and other study medication(s), on a placebo combination, or on an alternative arm regimen in a designated ixazomib parent study (i.e., Studies C16003 [NCT00932698], C16005 [NCT01217957], C16006 [NCT01335685], C16007 [NCT01318902], C16008 [NCT01383928], C16010 Global [NCT01564537], C16011 [NCT01659658], C16013 [NCT01645930], C16014 Global [NCT01850524] and Korean Continuation, C16017 [NCT01939899], C16020 [NCT02046070], C16029 [NCT03170882], and C16047 [NCT03439293]); and In the opinion of the investigator and approved by the Takeda medical monitor, the participant may continue to benefit from treatment with ixazomib and/or another study drug/combination regimen (e.g., response to therapy or stable disease without evidence of disease progression) and has no alternate means to access the study drug(s) (e.g., commercial supply). Agree to continue to practice contraceptive methods as outlined in the parent study. Exclusion Criteria: The participant meets any of the criteria for treatment discontinuation in the parent study. Female patients who are lactating and breastfeeding or have a positive serum pregnancy test during the eligibility period.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Study Director
Organizational Affiliation
Takeda
Official's Role
Study Director
Facility Information:
Facility Name
Emory University
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
Appalachian Regional Healthcare
City
Hazard
State/Province
Kentucky
ZIP/Postal Code
41701
Country
United States
Facility Name
Dana Farber Cancer Institute
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
Washington University School of Medicine
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
UZ Leuven
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
Facility Name
Princess Margaret Cancer Centre
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 1X5
Country
Canada
Facility Name
University Health Network
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2M9
Country
Canada
Facility Name
Peking University Third Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100191
Country
China
Facility Name
Peking Union Medical College Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100730
Country
China
Facility Name
1st Affiliated Hospital of Zhejiang University
City
Hangzhou
ZIP/Postal Code
310003
Country
China
Facility Name
Shanghai Chang Zheng Hospital
City
Shanghai
ZIP/Postal Code
200003
Country
China
Facility Name
Laiko General Hospital of Athens
City
Athens
State/Province
Attiki
ZIP/Postal Code
115 27
Country
Greece
Facility Name
University of Athens Medical School - Regional General Hospital Alexandra
City
Athens
ZIP/Postal Code
11528
Country
Greece
Facility Name
Tokyo Metropolitan Komagome Hospital
City
Bunkyo-Ku
State/Province
Tokyo
ZIP/Postal Code
113-8677
Country
Japan
Facility Name
Japanese Red Cross Medical Center
City
Shibuya-Ku
State/Province
Tokyo
ZIP/Postal Code
150-8935
Country
Japan
Facility Name
Asan Medical Center - PPDS
City
Seoul
ZIP/Postal Code
5505
Country
Korea, Republic of
Facility Name
Samodzielny Publiczny Zaklad Opieki Zdrowotnej Zespol Szpitali Miejskich
City
Chorzow
State/Province
Slaskie
ZIP/Postal Code
41-500
Country
Poland
Facility Name
Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. M. Kopernika w Lodzi
City
Lodz
ZIP/Postal Code
93-510
Country
Poland
Facility Name
Centrum Onkologii Ziemi Lubelskiej
City
Lublin
ZIP/Postal Code
20-090
Country
Poland
Facility Name
MTZ Clinical Research Sp z o o
City
Warszawa
ZIP/Postal Code
02-106
Country
Poland
Facility Name
National University Hospital
City
Singapore
ZIP/Postal Code
119082
Country
Singapore
Facility Name
Complejo Asistencial Universitario de Salamanca H. Clinico
City
Salamanca
ZIP/Postal Code
37007
Country
Spain
Facility Name
Hospital Universitario de Donostia
City
San Sebastian
ZIP/Postal Code
20014
Country
Spain
Facility Name
Karolinska Universitetssjukhuset Huddinge
City
Stockholm
State/Province
Sodermanlands Lan
Country
Sweden
Facility Name
Skanes Universitetssjukhus Lund
City
Lund
ZIP/Postal Code
22185
Country
Sweden
Facility Name
Karolinska Universitetssjukhuset Solna
City
Stockholm
ZIP/Postal Code
SE-17176
Country
Sweden

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.
IPD Sharing Access Criteria
IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.
IPD Sharing URL
https://vivli.org/ourmember/takeda/

Learn more about this trial

Ixazomib Rollover Study

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