[M20-917] Multiple Myeloma: Lemzoparlimab as Monotherapy and in Combination with Anti-Myeloma Regimens in Subjects with Relapsed/Refractory Multiple Myeloma

JRCT ID: jRCT2071220010

Registered date:25/05/2022

Basic Information

• Recruitment status: Suspended
• Health condition(s) or Problem(s) studied: Multiple Myeloma
• Date of first enrollment: 20/06/2022
• Target sample size: 163
• Countries of recruitment: US,Japan,Australia,Japan,France,Japan,Germany,Japan,Israel,Japan,Spain,Japan,United Kingdom,Japan
• Study type: Interventional

Intervention(s)

Dose Escalation: Lemzoparlimab
Participants will receive lemzoparlimab in 28 day cycles.

Dose Escalation: Lemzoparlimab + Pomalidomide + Dexamethasone
Participants will receive lemzoparlimab + pomalidomide + dexamethasone in 28 day cycles.

Experimental: Dose Escalation: Lemzoparlimab + Carfilzomib + Dexamethasone
Participants will receive lemzoparlimab + carfilzomib + dexamethasone in 28 day cycles.

Experimental: Dose Escalation: Lemzoparlimab + Daratumumab + Dexamethasone
Participants will receive lemzoparlimab + daratumumab + dexamethasone in 28 day cycles.

Experimental: Dose Expansion: Lemzoparlimab
Participants will receive lemzoparlimab at recommended dose determined in Dose Escalation portion in 28 day cycles.

Experimental: Dose Expansion: Lemzoparlimab + Dexamethasone
Participants will receive lemzoparlimab at recommended dose determined in Dose Escalation portion + dexamethasone in 28 day cycles.

Experimental: Dose Expansion: Lemzoparlimab + Pomalidomide + Dexamethasone
Participants will receive lemzoparlimab at recommended dose determined in Dose Escalation portion + pomalidomide + dexamethasone in 28 day cycles.

Experimental: Dose Expansion: Lemzoparlimab + Carfilzomib + Dexamethasone
Participants will receive lemzoparlimab at recommended dose determined in Dose Escalation portion + carfilzomib + dexamethasone in 28 day cycles.

Experimental: Dose Expansion: Lemzoparlimab + Daratamumab + Dexamethasone
Participants will receive lemzoparlimab at recommended dose determined in Dose Escalation portion + daratamumab + dexamethasone in 28 day cycles.

Outcome(s)

• Primary Outcome: Dose Limiting Toxicities (DLTs)

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

- Diagnosis of relapsed/refractory (R/R) multiple myeloma (MM) with documented evidence of progression during or after the participant's last treatment regimen based on the investigator's determination of the International Myeloma Working Group (IMWG) criteria.
-- Relapsed defined as previously treated myeloma that progresses and requires initiation of salvage therapy, but does not meet criteria for refractory myeloma.
-- Refractory defined as disease that is nonresponsive (failure to achieve minimal response or development of progressive disease) while on primary or salvage therapy, or progresses within 60 days of last therapy.
- Measurable disease per the protocol within 28 days prior to enrollment.
- Arm A - Lemzoparlimab with or without Dexamethasone
-- For Both Escalation and Expansion Phase, participant must have refractory to 3 prior lines of treatment of anti-myeloma treatments, as outlined in the protocol.
- Arm B - Lemzoparlimab + Pomalidomide-Dexamethasone
-- For Escalation Phase - Participant must have received at least 3 prior lines of therapy, as outlined in the protocol.
-- For Expansion Phase- Participant must have received at least 2 prior line of therapy, as outlined in the protocol.
- Arm C - Lemzoparlimab + Carfilzomib-Dexamethasone
-- For Escalation Phase- Participant must have received at least 3 prior lines of therapy as outlined in the protocol.
-- For Expansion Phase- Participant must have received at least 1 prior line of therapy.
- Arm D - Lemzoparlimab + Daratumumab-Dexamethasone
-- For Both Escalation and Expansion Phase : Participant must:
--- Have received at least 3 prior lines of therapy, as outlined in the protocol.

Exclude criteria

- Arm B - Lemzoparlimab + Pomalidomide-Dexamethasone
-- For Both Escalation and Expansion Phase participant must have had no prior treatment with pomalidomide.
- Arm C - Lemzoparlimab + Carfilzomib-Dexamethasone
-- For Both Escalation and Expansion Phase - prior treatment with carfilzomib.
- Arm D - Lemzoparlimab + Daratumumab-Dexamethasone
-- For Both Escalation and Expansion Phase - prior treatment with daratumumab or other anti-CD38 therapy.

Related Information

• Primary Sponsor: Okubo Sumiko
• Secondary ID(s): NCT04895410