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NCT06577025 | RECRUITING | Multiple Myeloma

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
Sponsor:

Janssen Research & Development, LLC

Brief 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.

Condition or disease

Multiple Myeloma

Intervention/treatment

Cilta-cel

Talquetamab

Daratumumab

Teclistamab

Bortezomib

Lenalidomide

Dexamethasone

Cyclophosphamide

Fludarabine

Phase

PHASE2

Study Type : INTERVENTIONAL
Estimated Enrollment : 40 participants
Masking : NONE
Primary Purpose : TREATMENT
Official Title : A Phase 2, Open-label Study to Evaluate the Efficacy and Safety of Different Sequences of Ciltacabtagene Autoleucel (Cilta-cel), Talquetamab SC in Combination With Daratumumab SC (Tal-D) and Teclistamab SC in Combination With Daratumumab SC (Tec-D) Following Induction With Daratumumab, Bortezomib, Lenalidomide and Dexamethasone (DVRd) in Participants With Standard-risk Newly Diagnosed Multiple Myeloma
Actual Study Start Date : 2024-08-20
Estimated Primary Completion Date : 2030-07-31
Estimated Study Completion Date : 2030-09-02

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years to 70 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
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)
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

Location Details

NCT06577025

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How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

RECRUITING

United States, California

City of Hope

Duarte, California, United States, 91010

RECRUITING

United States, California

University of California San Francisco

San Francisco, California, United States, 94143

RECRUITING

United States, Iowa

University of Iowa Hospital and Clinics

Iowa City, Iowa, United States, 52242

RECRUITING

United States, New York

Memorial Sloan Kettering Cancer Center

New York, New York, United States, 10065

RECRUITING

United States, North Carolina

Levine Cancer Institute

Charlotte, North Carolina, United States, 28204

ACTIVE NOT RECRUITING

Australia,

Peter MacCallum Cancer Centre

Melbourne, Australia, 3000

ACTIVE NOT RECRUITING

Australia,

The Alfred Hospital

Melbourne, Australia, 3004

RECRUITING

Brazil,

Research and Teaching Institute

Salvador, Brazil, 41253 190

RECRUITING

Brazil,

Foundation Antonio Prudente A C CAMARGO CANCER CENTER

São Paulo, Brazil, 01509 900

RECRUITING

Brazil,

Brazilian Israelite Charitable Society Albert Einstein Hospital

São Paulo, Brazil, 05652 900

RECRUITING

Germany,

Universitaetsklinikum Heidelberg

Heidelberg, Germany, 69120

RECRUITING

Germany,

Universitaet clinic tuebing

Tue, Germany, 72076

RECRUITING

Germany,

University Hospital Würzburg

Wuerzburg, Germany, 97080

RECRUITING

Spain,

Hosp. UNIV. October 12

Madrid, Spain, 28041

RECRUITING

Spain,

Hosp Clinico Univ de Salamanca

Salamanca, Spain, 37007

RECRUITING

Spain,

Hosp. Univ. Marques de Valdecilla

Santander, Spain, 39008