Continuing Treatment for Subjects Who Have Participated in a Prior Protocol Investigating Elotuzumab

JRCT ID: jRCT2031210116

Registered date:27/05/2021

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: Multiple myeloma
• Date of first enrollment: 02/07/2021
• Target sample size: 7
• Countries of recruitment: USA,Japan,Canada,Japan,Italy,Japan,Belgium,Japan,Greece,Japan,Poland,Japan,Romania,Japan,Spain,Japan,Turkey,Japan,UK,Japan,Australia,Japan,Hungary,Japan
• Study type: Other

Intervention(s)

Study drug will be administered at the last dose and schedule received on the previous study.
Subjects will receive treatment with study drugs and pre-medications according to the previous
study requirements.
IMP: Elotuzumab
Non-IMP: Dexamethasone (Tablets, Solution), Lenalidomide (Revlimid) Capsules

Outcome(s)

• Primary Outcome: The number of subjects who received at least one dose of elotuzumab or backbone therapy (other study drugs) and the duration of treatment will be collected.
• Secondary Outcome: In this study, all SAEs, Grade 5 AEs, AEs previously not reported, AEs leading to discontinuation will be collected. Adverse events and other symptoms will be graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE).

Key inclusion & exclusion criteria

• Age minimum: Not applicable
• Age maximum: Not applicable
• Gender: Both

Include criteria

Participated in a previous elotuzumab protocol and is deemed by the investigator to be deriving benefit from elotuzumab and/or other study drugs as defined by the previous protocol.
Subjects must be able to tolerate study therapy.
Receiving elotuzumab and/or other study drugs at the time of signature of informed consent.

Exclude criteria

All subjects previously discontinued from an elotuzumab study for any reason.
Subjects not receiving clinical benefit from previous study therapy.
Subjects who are not medically well enough to receive study therapy as determined by the investigator.

Related Information

• Primary Sponsor: Mckiver A Popa Mihaela
• Secondary ID(s): NCT02719613