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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 10 years ( or 300 pfs events)
Awards & highlights
CARTITUDE-6 Trial Summary
This trial compares two treatments for people newly diagnosed with multiple myeloma.
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.Check my eligibility
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.See study design
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.
CARTITUDE-6 Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am fully active or restricted in physically strenuous activity but can do light work.
Select...
I have newly diagnosed multiple myeloma and plan to undergo high-dose therapy and stem cell transplant.
Select...
My cancer can be measured by specific protein levels in my blood or urine.
CARTITUDE-6 Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 10 years ( or 300 pfs events)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 10 years ( or 300 pfs events)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Progression free survival (PFS)
Sustained MRD-negative CR
Secondary outcome measures
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 moreCARTITUDE-6 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
Ciltacabtagene autoleucel
FDA approved
Bortezomib
FDA approved
Fludarabine
FDA approved
Daratumumab
FDA approved
Cyclophosphamide
FDA approved
Find a Location
Who is running the clinical trial?
Stichting European Myeloma NetworkLead Sponsor
27 Previous Clinical Trials
17,822 Total Patients Enrolled
21 Trials studying Multiple Myeloma
13,038 Patients Enrolled for Multiple Myeloma
Janssen Research & Development, LLCIndustry Sponsor
976 Previous Clinical Trials
6,383,942 Total Patients Enrolled
70 Trials studying Multiple Myeloma
18,712 Patients Enrolled for Multiple Myeloma
European Myeloma NetworkLead Sponsor
26 Previous Clinical Trials
11,822 Total Patients Enrolled
20 Trials studying Multiple Myeloma
7,038 Patients Enrolled for Multiple Myeloma
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am fully active or restricted in physically strenuous activity but can do light work.Your test results need to be within a certain range.My cancer has affected or previously affected my brain or spinal cord.I have not had any live vaccines (other than COVID-19) in the last 4 weeks.I have not taken strong CYP3A4 inducers recently.I have not had a stroke or seizure in the last 6 months.I have received treatments targeting BCMA before.I have only used corticosteroids briefly for my myeloma.I have newly diagnosed multiple myeloma and plan to undergo high-dose therapy and stem cell transplant.My cancer can be measured by specific protein levels in my blood or urine.I have previously undergone CAR-T cell therapy.
Research Study Groups:
This trial has the following groups:- Group 1: Arm B: DVRd followed by Ciltacabtagene Autoleucel
- Group 2: Arm A: DVRd + ASCT+DVRd (Standard Therapy)
Awards:
This trial has 4 awards, including:- Approved for 60 Other Conditions - This treatment demonstrated efficacy for 60 other conditions.
- 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.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is enrolling in this clinical trial a viable option for potential participants at present?
"Per the information provided on clinicaltrials.gov, this trial has ceased recruitment; it was originally posted on October 1st 2023 and last updated August 14th 2023. Although no longer accepting applicants for this particular study, there are 819 other medical trials now seeking candidates."
Answered by AI
Which locations are undertaking the clinical experiment in this city?
"This experiment is actively recruiting 113 participants, with ASST Grande Ospedale Metropolitano Niguarda in Milan, Fondazione Policlinico Universitario Agostino Gemelli in Roma, and Juntendo University Hospital in Bunkyō-Ku being three of the many possible locations."
Answered by AI
What risks are associated with the Arm B: DVRd followed by Ciltacabtagene Autoleucel treatment protocol?
"Due to the existence of multiple clinical trials that have established efficacy and safety, Arm B: DVRd followed by Ciltacabtagene Autoleucel was given a rating of 3 on our scale."
Answered by AI
What is the primary aim of this clinical experiment?
"The prime outcome evaluated in this trial, which will be tracked over a decade or 300 progression-free survival events, is Sustained MRD-negative Complete Response. Further objectives include assessing the change from baseline of health-related quality of life with the EORTC QLQ-C30 scale score and overall minimal residual disease negative complete response obtained by NGS before beginning additional myeloma treatments."
Answered by AI
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