ClinTrial Refer

Trial Acronym
CA088-1007

Registration Number
NCT06615479

Scientific Title
A Phase 3, Randomized, Open-Label, Multicenter Study to Compare the Efficacy and Safety of BMS-986393, a GPRC5D-directed CAR-T Cell Therapy, Versus Standard Regimens in Adult Participants With Relapsed or Refractory and Lenalidomide-refractory Multiple Myeloma

The purpose of this study is to compare the efficacy and safety of arlo-cel (BMS-986393) versus standard regimens in adult participants with Relapsed or Refractory and Lenalidomide-exposed Multiple Myeloma.

Participants must have relapsed or refractory multiple myeloma (RRMM).
Participants must have received at least 1 but no greater than 3 prior multiple myeloma (MM) regimens which may include a proteasome inhibitor (PI), an immunomodulatory drug (IMiD), and an anti-CD38 monoclonal antibody and have prior exposure to lenalidomide.
Participants must have a documented diagnosis of MM as per International Myeloma Working Group Criteria.
Participants must have measurable disease during screening.
Participants must have adequate organ function.
Participants must have an Eastern Cooperative Oncology group performance status 0 or 1.

Participants must not have known active or history of central nervous system (CNS) involvement of Multiple Myeloma (MM).
Participants must not have solitary plasmacytomas or non-secretory myeloma without other evidence of measurable disease.
Participants must not need urgent treatment due to rapidly progressing MM.
Other protocol-defined Inclusion/Exclusion criteria apply.

Trial Location Name

Address

Status

Fiona Stanley Hospital (Haematology)

11 Robin Warren Dr, Murdoch WA 6150, Australia

Recruiting

Primary Contact : Wendy Angelatos, wendy.angelatos@health.wa.gov.au , 08 6152 6540

Liverpool Hospital (Haematology)

1 Campbell St, Liverpool NSW 2170, Australia

Recruiting

Primary Contact : Pinky Patel, pinky.patel@health.nsw.gov.au , 0474 279 274

Secondary Contact : Sharon Young, Sharon.young@health.nsw.gov.au

Princess Alexandra Hospital (Haematology)

199 Ipswich Rd, Woolloongabba QLD 4102, Australia

Recruiting

Primary Contact : David Barnes, david.barnes2@health.qld.gov.au , +617 3176 6827

Secondary Contact : Steven Ivanhoe, steven.ivanhoe@health.qld.gov.au , (07) 3176 6826

Royal Adelaide Hospital (Haematology)

Port Rd, Adelaide SA 5000, Australia

Recruiting

Primary Contact : Chris Hoare, christine.hoare@sa.gov.au , 08 7074 3290

Royal Prince Alfred Hospital (Haematology)

50 Missenden Rd, Camperdown NSW 2050, Australia

Recruiting

Primary Contact : Hayati Vyas, hayati.vyas@health.nsw.gov.au , 02 9515 2492

Secondary Contact : Dr Jessica Ling, jessica.ling5@health.nsw.gov.au , 9515 7563

Juno Therapeutics, Inc., a Bristol-Myers Squibb Company

Website URL

Link Name

Link URL

ANZCTR

http://www.anzctr.org.au/TrialSearch.aspx?searchTxt=NCT06615479

Clinicaltrials.gov

https://clinicaltrials.gov/ct2/show/NCT06615479

Secondary IDs
CA088-1007

Study Type
Interventional

Intervention Code
Treatment - Drugs

Phase
Phase 3

Minimum Age
18

Maximum Age
100

Date Registered
24/09/2024

Date Closed
N/A

Status
Open

Enrolment Type
By Specialist and/or Surgeon Referral

Mutation Status and Biomarker
Any or not stated

Is it a Cohort Trial?
No

Is this a Tele-Trial?
No

Can healthy volunteer participate?
No

Discipline

Health Condition

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