A Study of Different Sequences of Cilta-cel, Talquetamab in Combination With Daratumumab and Teclist

A Study of Different Sequences of Cilta-cel, Talquetamab in Combination With Daratumumab and Teclistamab in Combination With Daratumumab Following Induction With Daratumumab, Bortezomib, Lenalidomide and Dexamethasone in Participants With Standard-risk Newly Diagnosed Multiple Myeloma (aMMbition)

Last Updated March 8, 2025

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54767414MMY2093

OVERVIEW

Sexes Eligible for Study
all
Age
18+ years
Phase
phase 2

2
Sites
9 Sites
Status

Recruiting

SUMMARY

The purpose of this study is to evaluate the rate of response (how effectively treatment is working) with signs of potential cure at 5 years after the start of induction treatment. This is defined as a composite of sustained (at least 2 years) minimal residual disease (MRD) negativity with complete response/stringent complete response (CR/sCR) and a positron emission tomography/computed tomography (PET/CT) scan that does not show any signs of cancer at 5 years. MRD negativity and CR/sCR is defined as no detectable signs of remaining cancer cells after the treatment. This study will also characterize how well the treatments administered work in the study through progression-free survival (PFS). PFS is defined as the length of time during and after the treatment of a disease, that a participant lives with the disease, but it does not get worse.

CONDITIONS

Multiple Myeloma

ELIGIBILITY

Inclusion Criteria:

* Participants with documented new diagnosis of multiple myeloma (MM) according to international myeloma working group (IMWG) diagnostic criteria and with no prior myeloma-directed therapy
* Participants must have standard-risk MM (stage I and II) based on revised International Staging System (R-ISS)
* Participants must be considered fit (score equals to [=] 0) or intermediate-fit (score=1) according to IMWG Frailty Index assessment (based on the Charlson Comorbidity Index, the Katz Activity of Daily Living and the Lawson Instrumental Activities of Daily Living)
* Measurable disease defined as: Serum monoclonal paraprotein (M-protein) level greater than or equal to (>=) 1.0 gram per deciliter (g/dL) (>=10 gram per liter [g/L] for institutions using alternative units) or urine M-protein level >= 200 milligrams per 24 hours (mg/24 hours); Light chain MM without measurable disease in the serum or the urine: Serum immunoglobulin free light chain >=10 milligrams per deciliter (mg/dL) (>=100 mg/L for institutions using alternative units) and abnormal serum immunoglobulin kappa lambda free light chain ratio
* Eastern Cooperative Oncology Group (ECOG) performance status grade of 0 or 1

Exclusion Criteria:

* Any ongoing myelodysplastic syndrome or B-cell malignancy (other than MM). Any history of malignancy, other than MM, which is considered at high risk of recurrence requiring systemic therapy
* Peripheral neuropathy or neuropathic pain of Grade >= 2, as defined by National Cancer Institute (NCI)-Common Terminology Criteria for Adverse Events (CTCAE) version 5.0
* Known active or prior history of central nervous system (CNS) involvement or exhibits clinical signs of meningeal involvement of MM
* Stroke or seizure within 6 months of signing the informed consent form (ICF)
* Plasma cell leukemia at the time of diagnosis or any time thereafter through apheresis (>= 5 percent [%] circulating plasma cells in peripheral blood smears), Waldenstrom macroglobulinemia, polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes(POEMS) syndrome, or primary amyloid light chain amyloidosis with associated organ dysfunction
* Presence of high-risk disease features: (a) Cytogenetic high risk lesions by MM fluorescence in situ hybridization (FISH) including deletion 17p (del[17p])/, t(4;14), t(14;16), amplification 1q (amp[1q21]) (>= 4 copies); (b) Presence of 1 or more extramedullary plasmacytomas
* Seropositive for human immunodeficiency virus (HIV)

Inclusion Criteria:

More...

DETAILS

LOCATIONS

Locations in:

United States, Australia, Brazil, Spain

Country (4)	City or Province (9)	Status
United States	Duarte City of Hope	RECRUITING
United States	San Francisco University of California San Francisco	RECRUITING
United States	Iowa City University of Iowa Hospital and Clinics	RECRUITING
Australia	Melbourne Peter MacCallum Cancer Centre	RECRUITING
Australia	Melbourne The Alfred Hospital	RECRUITING
Brazil	Sao Paulo Fundacao Antonio Prudente A C Camargo Cancer Center	RECRUITING
Brazil	Sao Paulo Sociedade Beneficente Israelita Brasileira Hospital Albert Einstein	RECRUITING
Spain	Salamanca Hosp Clinico Univ de Salamanca	RECRUITING
Spain	Santander Hosp. Univ. Marques de Valdecilla	RECRUITING

Geo Locations

34.13945, -117.97729

37.77493, -122.41942

41.66113, -91.53017

-37.814, 144.96332

-23.5475, -46.63611

40.96882, -5.66388

43.46472, -3.80444

Indicates 50+ sites in this region: click to zoom in.

Indicates 10+ sites in this region: click to zoom in.

Indicates < 10 sites in this region: click to zoom in.

Corresponds to individual site.

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