Ixazomib Rollover Study

NCT02924272 | Completed Phase 2 Results FDA Drug

• 3 other identifiers: C16027U1111-1184-20412016-001681-28
• Study Type: interventional
• Target: 32
• Locations: 11 countries
• Sites: 26

Brief Summary

The purpose of this study is to provide continued access to ixazomib and/or other study drugs from an ixazomib parent study.

Conditions

Multiple Myeloma; Lymphoma; Amyloidosis

Keywords

Drug Therapy

Outcome Measures

Primary Outcomes (6)

• Number of Participants With Serious Adverse Events (SAEs)

  An adverse event (AE) is defined as any untoward medical occurrence in a participant administered a pharmaceutical product; the untoward medical occurrence does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product whether or not it is related to the medicinal product. An SAE is any untoward medical occurrence that at any dose: a) results in death; b) is life-threatening (refers to an 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.

  Up to 7 years

• 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 (e.g., 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. The severity grade was evaluated as per the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0. Grade 3: severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care activities of daily living (ADL), Grade 4: life-threatening consequences; urgent intervention indicated. Grade 5 was: death related to AE.

  Up to 7 years

• Number of Participants With ≥ Grade 2 Peripheral Neuropathy

  Severity grade was evaluated based on CTCAE version 5.0. Grade 2: moderate symptoms; limiting instrumental activities of daily living. Grade 3: severe or medically significant; limiting self-care activities of daily living. Grade 4: life threatening consequences; urgent intervention indicated.

  Up to 7 years

• Number of Participants With New Primary Malignancies

  Up to 7 years

• Number of Participants With Any AE Resulting in Dose Modification or Discontinuation of Any Study Drug

  An AE means any untoward medical occurrence in a participant administered a pharmaceutical product; the untoward medical occurrence does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product whether or not it is related to the medicinal product.

  Up to 7 years

• Number of Participants With Any Other AE That in the Opinion of the Investigator is a Clinically Significant Event

  An AE means any untoward medical occurrence in a participant administered a pharmaceutical product; the untoward medical occurrence does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product whether or not it is related to the medicinal product. Any AE interpreted by the investigator as a clinically significant event was reported.

  Up to 7 years

Study Arms (2)

Ixazomib Monotherapy

EXPERIMENTAL

Participants received ixazomib capsule, orally, at same dose and schedule as they were receiving in the parent study until disease progression, clinical deterioration in the investigator's judgment, experienced an unacceptable toxicity, withdrew consent, pursued an alternative therapy, met other study-specified reasons for discontinuation of study drug, or until the participant was transitioned to ixazomib through commercial channels, including reimbursement for the participant's indication, or up to a maximum of 7 years whichever was sooner.

Drug: Ixazomib

Ixazomib Combination Therapy

EXPERIMENTAL

Participants received combination therapy with ixazomib capsule, orally and another medication(s) (1 or more of the anticancer agents dexamethasone, lenalidomide or cyclophosphamide) at same dose and schedule as they were receiving in the parent study until disease progression, clinical deterioration in the investigator's judgment, experienced an unacceptable toxicity, withdrew consent, pursued an alternative therapy, met other study-specified reasons for discontinuation of study drug, or until the participant was transitioned to ixazomib through commercial channels, including reimbursement for the participant's indication, or up to a maximum of 6.5 years whichever was sooner.

Drug: Ixazomib

Interventions

Ixazomib DRUG

Ixazomib Capsules

Also known as: MLN9708, Ninlaro

Ixazomib Combination Therapy; Ixazomib Monotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Takeda: lead
• Takeda Development Center Americas, Inc.: collaborator

Study Sites (26)

Emory University

Atlanta, Georgia, 30322, United States

Location

Appalachian Regional Healthcare

Hazard, Kentucky, 41701, United States

Location

Dana Farber Cancer Institute

Boston, Massachusetts, 02215, United States

Location

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

UZ Leuven

Leuven, 3000, Belgium

Location

Princess Margaret Cancer Centre

Toronto, Ontario, M5G 1X5, Canada

Location

University Health Network

Toronto, Ontario, M5G 2M9, Canada

Location

Peking University Third Hospital

Beijing, Beijing Municipality, 100191, China

Location

Peking Union Medical College Hospital

Beijing, Beijing Municipality, 100730, China

Location

1st Affiliated Hospital of Zhejiang University

Hangzhou, 310003, China

Location

Shanghai Chang Zheng Hospital

Shanghai, 200003, China

Location

Laiko General Hospital of Athens

Athens, Attica, 115 27, Greece

Location

University of Athens Medical School - Regional General Hospital Alexandra

Athens, 11528, Greece

Location

Tokyo Metropolitan Komagome Hospital

Bunkyo-Ku, Tokyo, 113-8677, Japan

Location

Japanese Red Cross Medical Center

Shibuya-Ku, Tokyo, 150-8935, Japan

Location

Samodzielny Publiczny Zaklad Opieki Zdrowotnej Zespol Szpitali Miejskich

Chorzów, Silesian Voivodeship, 41-500, Poland

Location

Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. M. Kopernika w Lodzi

Lodz, 93-510, Poland

Location

Centrum Onkologii Ziemi Lubelskiej

Lublin, 20-090, Poland

Location

MTZ Clinical Research Sp z o o

Warsaw, 02-106, Poland

Location

National University Hospital

Singapore, 119082, Singapore

Location

Asan Medical Center - PPDS

Seoul, 5505, South Korea

Location

Hospital Universitario de Donostia

Donostia / San Sebastian, 20014, Spain

Location

Complejo Asistencial Universitario de Salamanca H. Clinico

Salamanca, 37007, Spain

Location

Karolinska Universitetssjukhuset Huddinge

Stockholm, Södermanland County, Sweden

Location

Skanes Universitetssjukhus Lund

Lund, 22185, Sweden

Location

Karolinska Universitetssjukhuset Solna

Stockholm, SE-17176, Sweden

Location

MeSH Terms

Conditions

Multiple Myeloma; Lymphoma; Amyloidosis

Interventions

ixazomib

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases; Lymphatic Diseases; Proteostasis Deficiencies; Metabolic Diseases; Nutritional and Metabolic Diseases

Results Point of Contact

• Title: Study Director
• Organization: Takeda

TrialDisclosures@takeda.com

+1-877-825-3327

Study Officials

• Medical Director

  Takeda

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 4, 2016
• First Posted: October 5, 2016
• Study Start: December 16, 2016
• Primary Completion: July 3, 2024
• Study Completion: July 3, 2024
• Last Updated: March 12, 2025
• Results First Posted: March 12, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• 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.

Locations

JP (2); GR (2); CN (4); BE (1); CA (2); SG (1); KR (1); ES (2); PL (4); US (4); SE (3)