Study of Intravenously (IV) Infused Etentamig in Combination With an Oral Cereblon E3 Ligase Modulatory Drug (CELMoD) Agent Assessing Adverse Events and Change in Disease Activity in Adult Participants With Relapsed or Refractory Multiple Myeloma
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Etentamig, Iberdomide.
- Who it may be relevant to
- Registry conditions: Multiple Myeloma. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States, Australia, Canada, France, Japan +2
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Phase 1/2 Study of Etentamig in Combination With a CELMoD Agent for the Treatment of Patients With Relapsed/Refractory Multiple Myeloma
Overview
Multiple myeloma (MM) is a plasma cell disease characterized by the growth of clonal plasma cells in the bone marrow. The purpose of this study is to assess the adverse events and change in disease activity of etentamig in combination with a cereblon E3 ligase modulatory drug (CELMoD) agent in adult participants with relapsed/refractory (R/R) multiple myeloma (MM). Adverse events and change in disease state will be assessed. Etentamig is an investigational drug being developed for the treatment of R/R MM. Study doctors put the participants in groups called treatment arms. Multiple doses of etentamig in combination with iberdomide will be explored. Each treatment arm receives a different dose of etentamig and iberdomide to determine a tolerable dose. Approximately 135 adult participants with R/R MM will be enrolled in the study in approximately 50 sites worldwide. In phase 1 participants will receive escalating intravenous (IV) etentamig in combination with oral iberdomide. In phase 2 participants will receive IV etentamig at one of two doses in combination with oral iberdomide, as part of the approximately 129 month study duration. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at an approved institution (hospital or clinic). The effect of the treatment will be frequently checked by medical assessments, blood tests, questionnaires and and monitoring of side effects.
Detailed description
B-cell maturation antigen (BCMA) chimeric antigen receptor T-cell (CAR-T) or BCMA antibody-drug conjugate (ADC) are allowed.
Interventions
- Drug Etentamig
Intravenous (IV) Infusion - Drug Iberdomide
Oral Capsule
Primary outcome measures
- Phase 1: Dose-Limiting Toxicities (DLT)s of Etentamig when given in Combination with Iberdomide in Participants with Relapsed/Refractory Multiple Myeloma (RRMM) [Time frame: Up to Approximately 56 Days]
- Number of Participants with Adverse Events (AE)s [Time frame: Up to Approximately 129 Months]
Secondary outcome measures (9)
- Partial Response (PR) Response Rate (RR) [Time frame: Up to 3 Years]
- Very Good Partial Response (VGPR) RR [Time frame: Up to 3 Years]
- Complete Response (CR) RR [Time frame: Up to 3 Years]
- Stringent Complete Response (sCR) RR [Time frame: Up to 3 Years]
- Overall Response Rate (ORR) [Time frame: Up to 3 Years]
- Progression-Free Survival (PFS) [Time frame: Up to 3 Years]
- Duration of Response (DOR) [Time frame: Up to 3 Years]
- Time-to-Progression (TTP) [Time frame: Up to 3 Years]
- Minimal Residual Disease (MRD) negativity [Time frame: Up to 3 Years]
Eligibility criteria
Inclusion criteria
- Eastern Cooperative Oncology Group (ECOG) performance of 0 or 1.
- Must have confirmed diagnosis of Relapsed/Refractory Multiple Myeloma (RRMM) after the participant's last treatment, as outlined in the protocol.
- All participants must have measurable diseases per central laboratory as outlined in protocol
Exclusion criteria
- Has received prior etentamig treatment.
- Prior exposure to BCMA-targeted therapy as noted in the protocol.
- Has received prior cereblon E3 ligase modulatory drug (CELMoD) (iberdomide or mezigdomide).
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Sequential
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 7 centers
- Beverly Hills Cancer Center /ID# 266921 — Beverly Hills
- Colorado Blood Cancer Institute /ID# 273751 — Denver
- Washington University /ID# 266972 — St Louis
- Rutgers Cancer Institute of New Jersey /ID# 266833 — New Brunswick
- Memorial Sloan Kettering Cancer Center - New York - York Avenue /ID# 270282 — New York
- University Of North Carolina Health Care - Hillsborough Campus /ID# 278230 — Hillsborough
- Swedish Medical Center - Seattle /ID# 268052 — Seattle
Australia · 5 centers
- Blacktown Hospital /ID# 265983 — Blacktown
- Wollongong Hospital /ID# 265625 — Wollongong
- The Alfred Hospital /ID# 265981 — Melbourne
- Austin Hospital /ID# 265984 — Melbourne
- Sir Charles Gairdner Hospital /ID# 265985 — Nedlands
France · 5 centers
- Chu de Nice-Hopital Larchet Ii /Id# 266845 — Nice
- Hôpital La Timone /ID# 267053 — Marseille
- Chu De Lille - Hopital Claude Huriez /ID# 270193 — Lille
- Centre Hospitalier Régional Universitaire de Tours - Hôpital Bretonneau /ID# 267694 — Tours
- IUCT Oncopole /ID# 266391 — Toulouse
Japan · 5 centers
- National Cancer Center Hospital East /ID# 268343 — Kashiwa-shi
- Kumamoto University Hospital /ID# 270530 — Kumamoto
- Dokkyo Medical University Hospital /ID# 271648 — Mibu
- Nippon Medical School Hospital /ID# 270254 — Bunkyo-ku
- The Cancer Institute Hospital Of JFCR /ID# 268342 — Koto-ku
Canada · 2 centers
- University Health Network_Princess Margaret Cancer Centre /ID# 275636 — Toronto
- Jewish General Hospital /ID# 267574 — Montreal
Netherlands · 2 centers
- Amsterdam UMC, Location VUmc /ID# 267670 — Amsterdam
- Universitair Medisch Centrum Utrecht /ID# 267660 — Utrecht
Norway · 1 center
- Oslo Universitetssykehus Ulleval /ID# 275433 — Oslo
Identifiers
NCT: NCT06896916 · M24-555 · 2024-512146-41-00