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)
Status and phase
Active, not recruiting
Phase 2
Conditions
Multiple Myeloma
Treatments
Drug: Teclistamab
Drug: Lenalidomide
Drug: Bortezomib
Drug: Talquetamab
Drug: Dexamethasone
Drug: Cyclophosphamide
Drug: Daratumumab
Drug: Fludarabine
Drug: Cilta-cel
Study type
Interventional
Funder types
Industry
Identifiers
Details and patient eligibility
About
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.
Enrollment
43 patients
Sex
All
Ages
18 to 70 years old
Volunteers
No Healthy Volunteers
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)
Trial design
Primary purpose
Treatment
Allocation
Randomized
Interventional model
Parallel Assignment
Masking
None (Open label)
43 participants in 2 patient groups
Cohort A: DVRd Induction + Tal-D Consolidation + Cilta-cel
Experimental group
Description:
Participants will undergo apheresis followed by 4 cycles of DVRd induction (each cycle is of 28 days) and cilta-cel will be generated from the participants' T-cells selected from the apheresis product. Upon completion of cilta-cel production, product release, and completion of induction, participants will begin consolidation with 4 cycles of Tal-D (each cycle is of 28 days), followed by a conditioning regimen (cyclophosphamide and fludarabine daily for 3 days); cilta-cel will be administered 5 to 7 days after the start of the conditioning regimen.
Treatment:
Drug: Cilta-cel
Drug: Fludarabine
Drug: Daratumumab
Drug: Cyclophosphamide
Drug: Dexamethasone
Drug: Talquetamab
Drug: Bortezomib
Drug: Lenalidomide
Cohort B: DVRd Induction + Cilta-cel + Tal-D and Tec-D Consolidation
Experimental group
Description:
Participants will undergo apheresis followed by 4 cycles of DVRd induction and Cilta-cel will be generated from the participants' T-cells selected from the apheresis product. Upon completion of cilta-cel production, product release and completion of induction, participants will begin consolidation with a conditioning regimen (cyclophosphamide and fludarabine daily for 3 days) with infusion of cilta-cel 5 to 7 days after the start of the conditioning regimen. Following cilta-cel infusion, alternating cycles of Tal-D (Cycle 1, 3, 5, and 7) and Tec-D (Cycle 2, 4, 6, and 8) will be started, no earlier than Day 84 and no later than Day 168 post cilta-cel infusion. Each cycle of Tal-D or Tec-D is 84 days which includes an extended treatment-free interval.
Treatment:
Drug: Cilta-cel
Drug: Fludarabine
Drug: Daratumumab
Drug: Cyclophosphamide
Drug: Dexamethasone
Drug: Talquetamab
Drug: Bortezomib
Drug: Lenalidomide
Drug: Teclistamab
Trial contacts and locations
16
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Central trial contact
Study Contact
Data sourced from clinicaltrials.gov
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