The aim of the study is to provide patients with certain kinds of cancer continued access to the same drug they have received in a previous study, if they have benefited from the use of the drug.

Phase 1

• Conditions: ewly diagnosed multiple myeloma and relapsed and/or refractory multiple myeloma; MedDRA version: 20.0Level: LLTClassification code 10028228Term: Multiple myelomaSystem Organ Class: 100000004864; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2016-001681-28-GR
• Lead Sponsor: Millennium Pharmaceuticals, Inc., a wholly owned subsidiary of Takeda Pharmaceutical Company Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2017-10-30
• Last Update Posted: 22 January 2018

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 48

Inclusion Criteria

Patients previously treated with ixazomib (excluding comparator or placebo patients not on current treatment with ixazomib) in a Millennium-sponsored study. Patients will be eligible to enter the rollover study when:
a.The parent study is closed or planned to be closed; and
b.The patient is on ixazomib monotherapy or on a drug combination with another medication, established while in his/her parent study; and
c.In the opinion of the investigator and confirmed by the Millennium medical monitor, the patient may continue to benefit from treatment with ixazomib (eg, response to therapy or stable disease without evidence of disease progression).

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 10
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 38

Exclusion Criteria

Patients meeting any of the following exclusion criteria are not to be enrolled in the study:
1. The patient 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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified