臨床研究等提出・公開システム

Scientific Title	A Phase 3, Two-stage, Randomized, Multicenter, Open-label Study Comparing Mezigdomide (CC-92480/BMS-986348), Carfilzomib, and Dexamethasone (MeziKd) Versus Carfilzomib and Dexamethasone (Kd) in Participants with Relapsed or Refractory Multiple Myeloma (RRMM): SUCCESSOR-2
Public Title	Phase 3 Study to Evaluate Mezigdomide (CC-92480/BMS-986348) in Combination with Carfilzomib and Dexamethasone in Relapsed or Refractory Multiple Myeloma: SUCCESSOR-2 (CA057008)

Contact for Scientific Queries	Name	Engelhardt Brian
	Affiliation	Bristol-Myers Squibb
	Address	1-2-1 Otemachi, Chiyoda-ku, Tokyo
	Telephone	+81-120-093-507
	E-mail	mg-jp-clinical_trial@bms.com
Contact for Public Queries	Name	Engelhardt Brian
	Affiliation	Bristol-Myers Squibb
	Address	1-2-1 Otemachi, Chiyoda-ku, Tokyo
	Telephone	+81-120-093-507
	E-mail	MG-JP-RCO-JRCT@bms.com

Recruitment status	Recruiting

Anticipated date of first enrollment		Jan. 04, 2024
Actual date of first enrollment		Feb. 06, 2024
Target sample size		41
Study Type		Interventional
Study Design	allocation	randomized controlled trial
	masking	open(masking not used)
	control	active control
	assignment	single assignment
	purpose	treatment purpose
Key inclusion & exclusion criteria	Inclusion Criteria	Participant has documented diagnosis of Multiple Myeloma and measurable disease. Participant has received at least 1 prior line of anti-myeloma therapy. Participant must have received prior treatment with lenalidomide and at least 2 cycles of an anti-CD38 monoclonal antibody.
	Exclusion Criteria	Participant who has had prior treatment with mezigdomide or carfilzomib. Participant has previously received allogeneic stem cell transplantation at any time during prior therapy or received autologous stem cell transplantation within 12 weeks of initiating study intervention.
	Age Minimum	18age old over
	Age Maximum	No limit
	Gender	Both
Health Condition(s) or Problem(s) Studied		Multiple Myeloma
Intervention(s)		Arm A: Mezigdomide, Carfilzomib and Dexamethasone Arm B: Carfilzomib and Dexamethasone
Health Condition(s) Keyword
Intervention(s) Keyword
Health Condition(s) Code
Intervention(s) Code
Primary Outcome(s)		progression-free survival
Secondary Outcome(s)		Overall Survival, Overall Response, Very good partial response, Complete response, Time to Response, Duration of Response, Time to Progression, Time to Next Treatment, Progression-free Survival 2, adverse events

Primary Sponsor	Bristol-Myers Squibb

Source of Monetary Support / Secondary Sponsor
Secondary Sponsor

Source of Monetary Support
Secondary Sponsor

Name of Certified Review Board	Japan Community Healthcare Organization Kyushu Hospital IRB
Address	1-8-1,Kishinoura,yahatanishi-ku, Fukuoka, Fukuoka
Telephone	+81-93-641-5111
E-Mail
Approval Status	Approval
Date of approval	Nov. 20, 2023

Plan to share IPD	Yes
Plan description	BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. Additional information regarding Bristol Myers Squibb's data sharing policy and process can be found at: https://www.bms.com/researchers-and-partners/clinical-trials-and-research/disclosurecommitment.html

Secondary ID(s)	NCT05552976
Issuing Authority

Countries of Recruitment（Except Japan）	USA/Argentina/UK/Israel/Italy/India/Australia/Austria/Netherlands/Canada/Korea/Greece/Colombia/Spain/Singapore/Taiwan/China/Denmark/Germany/Norway/Hungary/Hong Kong/Brazil

History of Changes

List of change history