Ixazomib Rollover Study

Multiple Myeloma Clinical Trial

Official title:

An Open-Label, Rollover Protocol for Patients Previously Enrolled in Millennium-Sponsored Ixazomib Studies

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02924272
• Other study ID #: C16027
• Secondary ID: U1111-1184-20412
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: December 16, 2016
• Est. completion date: February 22, 2027

Study information

• Verified date: June 2024
• Source: Takeda
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 31
• Est. completion date: February 22, 2027
• Est. primary completion date: February 22, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Amyloidosis
• Lymphoma
• Multiple Myeloma

Intervention

Drug:
• Ixazomib
Ixazomib Capsules

Locations

Country	Name	City	State
Belgium	UZ Leuven	Leuven
Canada	Princess Margaret Cancer Centre	Toronto	Ontario
Canada	University Health Network	Toronto	Ontario
China	Peking Union Medical College Hospital	Beijing	Beijing
China	Peking University Third Hospital	Beijing	Beijing
China	1st Affiliated Hospital of Zhejiang University	Hangzhou
China	Shanghai Chang Zheng Hospital	Shanghai
Greece	Laiko General Hospital of Athens	Athens	Attiki
Greece	University of Athens Medical School - Regional General Hospital Alexandra	Athens
Japan	Tokyo Metropolitan Komagome Hospital	Bunkyo-Ku	Tokyo
Japan	Japanese Red Cross Medical Center	Shibuya-Ku	Tokyo
Korea, Republic of	Asan Medical Center - PPDS	Seoul
Poland	Samodzielny Publiczny Zaklad Opieki Zdrowotnej Zespol Szpitali Miejskich	Chorzow	Slaskie
Poland	Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. M. Kopernika w Lodzi	Lodz
Poland	Centrum Onkologii Ziemi Lubelskiej	Lublin
Poland	MTZ Clinical Research Sp z o o	Warszawa
Singapore	National University Hospital	Singapore
Spain	Complejo Asistencial Universitario de Salamanca H. Clinico	Salamanca
Spain	Hospital Universitario de Donostia	San Sebastian
Sweden	Skanes Universitetssjukhus Lund	Lund
Sweden	Karolinska Universitetssjukhuset Huddinge	Stockholm	Sodermanlands Lan
Sweden	Karolinska Universitetssjukhuset Solna	Stockholm
United States	Emory University	Atlanta	Georgia
United States	Dana Farber Cancer Institute	Boston	Massachusetts
United States	Appalachian Regional Healthcare	Hazard	Kentucky
United States	Washington University School of Medicine	Saint Louis	Missouri

Sponsors (2)

Lead Sponsor	Collaborator
Takeda	Takeda Development Center Americas, Inc.

Countries where clinical trial is conducted

United States,  Belgium,  Canada,  China,  Greece,  Japan,  Korea, Republic of,  Poland,  Singapore,  Spain,  Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Up to 5 years
Primary	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.	Up to 5 years
Primary	Number of Participants With = Grade 2 Peripheral Neuropathy		Up to 5 years
Primary	Number of Participants With New Primary Malignancies		Up to 5 years
Primary	Number of Participants With any AE Resulting in Dose Modification or Discontinuation of any Study Drug		Up to 5 years
Primary	Number of Participants With any other AE That in the Opinion of the Investigator is a Clinically Significant Event		Up to 5 years