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Protein Degradation Enhancer

DVRd + Ciltacabtagene Autoleucel / ASCT for Multiple Myeloma (CARTITUDE-6 Trial)

Phase 3
Recruiting
Research Sponsored by Stichting European Myeloma Network
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
ECOG performance status of grade 0 or 1
Participants with documented NDMM according to IMWG diagnostic criteria, for whom high-dose therapy and ASCT are part of the intended initial treatment plan
Must not have
Known active, or prior history of central nervous system (CNS) involvement or clinical signs of meningeal involvement of MM
Received or plans to receive any live, attenuated vaccine (except for COVID-19 vaccines) within 4 weeks prior to randomization
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 10 years ( or 300 pfs events)
Awards & highlights
All Individual Drugs Already Approved
No Placebo-Only Group
Pivotal Trial
Approved for 60 Other Conditions

Summary

This trial is testing a combination of four drugs followed by either a special cell therapy or a stem cell transplant in newly diagnosed multiple myeloma patients who can have a transplant. The drugs fight cancer and boost immunity, while the cell therapy reprograms immune cells to attack cancer, and the stem cell transplant rebuilds bone marrow.

Who is the study for?
This trial is for newly diagnosed multiple myeloma patients who have measurable disease, are in good physical condition (ECOG grade 0 or 1), and have normal lab values. It's not open to those who've had CAR-T therapy, BCMA target therapy, other MM treatments except corticosteroids, strong CYP3A4 inducers recently, live vaccines within a month (except COVID-19 vaccine), or CNS involvement by MM.
What is being tested?
The study compares two approaches: one group receives Daratumumab with Bortezomib, Lenalidomide and Dexamethasone followed by a cell-based gene therapy called Ciltacabtagene Autoleucel; the other follows the same initial treatment but then has an Autologous Stem Cell Transplant instead.
What are the potential side effects?
Possible side effects include immune system reactions from Daratumumab and Cilta-cel therapies such as infusion reactions and infections. Chemotherapy drugs like Bortezomib may cause nerve damage while Lenalidomide can affect blood counts. Dexamethasone might lead to increased blood sugar levels.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am fully active or restricted in physically strenuous activity but can do light work.
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I have newly diagnosed multiple myeloma and plan to undergo high-dose therapy and stem cell transplant.
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My cancer can be measured by specific protein levels in my blood or urine.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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My cancer has affected or previously affected my brain or spinal cord.
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I have not had any live vaccines (other than COVID-19) in the last 4 weeks.
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I have received treatments targeting BCMA before.
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I have only used corticosteroids briefly for my myeloma.
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I have previously undergone CAR-T cell therapy.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 10 years ( or 300 pfs events)
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 10 years ( or 300 pfs events) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Progression free survival (PFS)
Sustained MRD-negative CR
Secondary study objectives
Change from Baseline in Health-Related Quality of Life (HRQoL) as Assessed by European Organization for Research and Treatment of Cancer Quality-of-life Questionnaire Core 30 (EORTC-QLQ-C30) Scale Score
Change from Baseline in Health-Related Quality of Life as Assessed by European Quality of Life - 5 Dimensions-5 Levels (EQ-5D-5L) Scale Scor
Change from Baseline in Health-Related Quality of Life as Assessed by MySIm-Q Scale Score
+8 more

Awards & Highlights

All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Approved for 60 Other Conditions
This treatment demonstrated efficacy for 60 other conditions.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Arm B: DVRd followed by Ciltacabtagene AutoleucelExperimental Treatment7 Interventions
Participants will receive daratumumab, bortezomib, lenalidomide and dexamethasone (DVRd) for 6 induction cycles. Participants will receive a conditioning regimen (cyclophosphamide 300 mg/m\^2 intravenous \[IV\] and fludarabine 30 mg/m\^2 IV daily for 3 days) and Cilta-cel infusion 0.75\*10\^6 chimeric antigen receptor (CAR)-positive viable T cells/kilogram (kg), followed by lenalidomide post CAR-T cell therapy for 2 years Daratumumab subcutaneously (SC), 1800 mg on days 1, 8, 15 and 22 of cycle 1 and 2, on days 1 and 15 of cycle 3-6. Bortezomib SC 1.3 mg/m\^2 on days 1, 4, 8, and 11 of each cycle 1-6. Lenalidomide orally, 25 mg on days 1 to 21 of each cycle 1-6. Dexamethasone orally, 40 mg once a week on days 1, 8, 15 and 22 of each cycle 1-6. Each cycle will consist of 28 days. Lenalidomide maintenance orally 10 to 15 mg on days 1 to 28 (continuously) until confirmed progressive disease or unacceptable toxicity or for a maximum of 2 years
Group II: Arm A: DVRd + ASCT+DVRd (Standard Therapy)Active Control4 Interventions
Participants will receive daratumumab, bortezomib, lenalidomide and dexamethasone (DVRd) for 4 induction cycles. Followed by ASCT and 2 cycles of DVRd consolidation, and lenalidomide maintenance therapy for 2 years Daratumumab subcutaneously (SC), 1800 mg on days 1, 8, 15 and 22 of cycle 1 and 2, on days 1 and 15 of cycle 3-6. Bortezomib SC 1.3 mg/m\^2 on days 1, 4, 8, and 11 of each cycle 1-6. Lenalidomide orally, 25 mg on days 1 to 21 of each cycle 1-6. Dexamethasone orally, 40 mg once a week on days 1, 8, 15 and 22 of each cycle 1-6. Each cycle will consist 28 days. Lenalidomide maintenance orally 10 to 15 mg on days 1 to 28 (continuously) until confirmed progressive disease or unacceptable toxicity or for a maximum of 2 years
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Lenalidomide
FDA approved
Dexamethasone
FDA approved
Bortezomib
FDA approved
Ciltacabtagene autoleucel
FDA approved
Fludarabine
FDA approved
Daratumumab
FDA approved
Cyclophosphamide
FDA approved

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Multiple Myeloma treatments target the disease through various mechanisms. Daratumumab is a monoclonal antibody that targets CD38 on myeloma cells, leading to cell death. Bortezomib is a proteasome inhibitor that disrupts protein degradation, causing apoptosis in myeloma cells. Lenalidomide is an immunomodulatory drug that enhances immune response against myeloma cells and inhibits their growth. Dexamethasone is a corticosteroid that reduces inflammation and has direct anti-myeloma effects. Ciltacabtagene Autoleucel (CAR-T cell therapy) targets BCMA on myeloma cells, using modified T-cells to recognize and kill these cells. These treatments are crucial as they address different pathways in myeloma cell survival and proliferation, offering a comprehensive approach to managing the disease.

Find a Location

Who is running the clinical trial?

Stichting European Myeloma NetworkLead Sponsor
27 Previous Clinical Trials
17,709 Total Patients Enrolled
21 Trials studying Multiple Myeloma
12,925 Patients Enrolled for Multiple Myeloma
Janssen Research & Development, LLCIndustry Sponsor
993 Previous Clinical Trials
6,386,263 Total Patients Enrolled
76 Trials studying Multiple Myeloma
19,243 Patients Enrolled for Multiple Myeloma
European Myeloma Network B.V.Lead Sponsor
16 Previous Clinical Trials
6,552 Total Patients Enrolled
11 Trials studying Multiple Myeloma
1,813 Patients Enrolled for Multiple Myeloma

Media Library

Bortezomib (Protein Degradation Enhancer) Clinical Trial Eligibility Overview. Trial Name: NCT05257083 — Phase 3
Multiple Myeloma Research Study Groups: Arm B: DVRd followed by Ciltacabtagene Autoleucel, Arm A: DVRd + ASCT+DVRd (Standard Therapy)
Multiple Myeloma Clinical Trial 2023: Bortezomib Highlights & Side Effects. Trial Name: NCT05257083 — Phase 3
Bortezomib (Protein Degradation Enhancer) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05257083 — Phase 3
~500 spots leftby Jun 2033
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