Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Trial Review
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
information for consumers
Download to PDF
Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT04181827
Registration number
NCT04181827
Ethics application status
Date submitted
27/11/2019
Date registered
2/12/2019
Date last updated
20/05/2025
Titles & IDs
Public title
A Study Comparing JNJ-68284528, a CAR-T Therapy Directed Against B-cell Maturation Antigen (BCMA), Versus Pomalidomide, Bortezomib and Dexamethasone (PVd) or Daratumumab, Pomalidomide and Dexamethasone (DPd) in Participants With Relapsed and Lenalidomide-Refractory Multiple Myeloma
Query!
Scientific title
A Phase 3 Randomized Study Comparing JNJ-68284528, a Chimeric Antigen Receptor T Cell (CAR-T) Therapy Directed Against BCMA, Versus Pomalidomide, Bortezomib and Dexamethasone (PVd) or Daratumumab, Pomalidomide and Dexamethasone (DPd) in Subjects With Relapsed and Lenalidomide-Refractory Multiple Myeloma
Query!
Secondary ID [1]
0
0
68284528MMY3002
Query!
Secondary ID [2]
0
0
CR108695
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
CARTITUDE-4
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Multiple Myeloma
0
0
Query!
Condition category
Condition code
Cancer
0
0
0
0
Query!
Other cancer types
Query!
Intervention/exposure
Study type
Interventional(has expanded access)
Query!
Description of intervention(s) / exposure
Treatment: Drugs - Cilta-cel
Treatment: Drugs - Pomalidomide
Treatment: Drugs - Bortezomib
Treatment: Drugs - Dexamethasone
Treatment: Drugs - Daratumumab
Experimental: Arm A: PVd or DPd (Standard Therapy) - Participants will receive either PVd or DPd as a standard therapy. In PVd treatment, participants will receive oral pomalidomide 4 mg on Days 1 to 14 in each cycle; bortezomib 1.3 mg/meter square (m\^2) SC on Days 1, 4, 8 and 11 (Cycles 1 to 8) and on Days 1 and 8 (Cycle 9 onwards) and oral dexamethasone 20 mg on Days 1, 2, 4, 5, 8, 9, 11 and 12 (Cycles 1 to 8) and Days 1, 2, 8 and 9 (Cycle 9 onwards). Each cycle will consist of 21 days. In DPd treatment, participants will receive daratumumab SC 1800 mg weekly on Days 1, 8, 15, and 22 (Cycles 1 and 2), every 2 weeks on Days 1 and 15 (Cycles 3 to 6) and every 4 weeks on Day 1 (Cycle 7 onwards); oral pomalidomide 4 mg on Days 1 to 21 (Cycle 1 onwards); dexamethasone 40 mg oral or IV weekly on Days 1, 8, 15, and 22 (Cycle 1 onwards). Each cycle will consist of 28 days. Participants will continue to receive PVd or DPd until confirmed PD, death, intolerable toxicity, withdrawal of consent, or end of the study, whichever occurs earlier.
Experimental: Arm B: (Ciltacabtagene Autoleucel [Cilta-cel]) - Participants will receive at least one cycle of bridging therapy (PVd or DPd) and additional cycles of bridging therapy may be considered based on participant's clinical status and timing of availability of cilta-cel along with conditioning regimen (cyclophosphamide 300 milligram \[mg\]/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).
Treatment: Drugs: Cilta-cel
Cilta-cel infusion will be administered at a target dose of 0.75 \* 10\^6 CAR-positive viable T cells/kilogram (kg).
Treatment: Drugs: Pomalidomide
Pomalidomide 4 mg will be administered orally.
Treatment: Drugs: Bortezomib
Bortezomib 1.3 milligram per meter square (mg/m\^2) will be administered subcutaneously (SC).
Treatment: Drugs: Dexamethasone
Dexamethasone 20 mg/day (10mg/day for participants \>75 years of age) (on bortezomib treatment days and the days following bortezomib treatment) will be administered orally in PVd treatment; and orally or intravenous (IV) at 40 mg weekly (20mg weekly for participants \>75 years of age) in DPd treatment.
Treatment: Drugs: Daratumumab
Daratumumab 1800 mg will be administered SC.
Query!
Intervention code [1]
0
0
Treatment: Drugs
Query!
Comparator / control treatment
Query!
Control group
Query!
Outcomes
Primary outcome [1]
0
0
Progression Free Survival (PFS)
Query!
Assessment method [1]
0
0
PFS: defined as time from date of randomization to date of first documented progressed disease (PD) as per International Myeloma Working Group (IMWG) criteria, or death due to any cause, whichever occurred first. PD: increase of 25% from lowest response value: serum and urine M-component (absolute increase must be \>=0.5 grams per deciliter \[g/dL\] and \>=200 milligrams \[mg\] per 24 hours, respectively); only in participants without measurable serum and urine M-protein levels, difference between involved and uninvolved free light chain (FLC) levels (absolute increase of \>10 mg/dL); only in participants without measurable serum and urine M-protein levels and without measurable disease by FLC levels, bone marrow plasma cell (PC)% (absolute increase of \>=10%), appearance of new lesion; definite development of new bone lesions or definite increase in size of existing bone lesions, \>=50% increase in circulating PCs (minimum of 200 cells per microliter \[uL\]) if this was only measure of disease.
Query!
Timepoint [1]
0
0
From randomization (Day 1) to either progressive disease or death, whichever occurred first (up to 3.9 years)
Query!
Secondary outcome [1]
0
0
Percentage of Participants Who Achieved Complete Response (CR) or Stringent Complete Response (sCR)
Query!
Assessment method [1]
0
0
Query!
Timepoint [1]
0
0
From randomization (Day 1) up to 7 years
Query!
Secondary outcome [2]
0
0
Percentage of Participants Who Achieved Overall Minimal Residual Disease (MRD) Negative Status (at 10^-5)
Query!
Assessment method [2]
0
0
Query!
Timepoint [2]
0
0
From randomization (Day 1) up to 7 years
Query!
Secondary outcome [3]
0
0
Percentage of Participants Who Were in CR or sCR and Achieved MRD-negative Status at 12 Months +/-3 Months
Query!
Assessment method [3]
0
0
Query!
Timepoint [3]
0
0
From randomization (Day 1) up to 12 months +/- 3 months
Query!
Secondary outcome [4]
0
0
Percentage of Participants Who Achieved Sustained MRD-negative Status
Query!
Assessment method [4]
0
0
Query!
Timepoint [4]
0
0
From randomization (Day 1) up to 7 years
Query!
Secondary outcome [5]
0
0
Overall Survival (OS)
Query!
Assessment method [5]
0
0
Query!
Timepoint [5]
0
0
From randomization (Day 1) up to 7 years
Query!
Secondary outcome [6]
0
0
Time to Worsening of Symptoms Using the Multiple Myeloma Symptom and Impact Questionnaire (MySIm-Q) Total Symptom Score
Query!
Assessment method [6]
0
0
Query!
Timepoint [6]
0
0
From randomization (Day 1) up to 7 years
Query!
Secondary outcome [7]
0
0
Overall Response Rate (ORR)
Query!
Assessment method [7]
0
0
Query!
Timepoint [7]
0
0
From randomization (Day 1) up to 7 years
Query!
Secondary outcome [8]
0
0
Progression Free Survival on Next-line Therapy (PFS2)
Query!
Assessment method [8]
0
0
Query!
Timepoint [8]
0
0
From randomization (Day 1) up to 7 years
Query!
Secondary outcome [9]
0
0
Number of Participants With Treatment-emergent Adverse Events (AEs)
Query!
Assessment method [9]
0
0
Query!
Timepoint [9]
0
0
From Cycle 1 Day 1 up to 7 years
Query!
Secondary outcome [10]
0
0
Number of Participants With Treatment-emergent Adverse Events (AEs) by Severity
Query!
Assessment method [10]
0
0
Query!
Timepoint [10]
0
0
From Cycle 1 Day 1 up to 7 years
Query!
Secondary outcome [11]
0
0
Change From Baseline in Systemic Cytokine Concentrations on Participants Who Received Cilta-cel as Study Treatment (Arm B)
Query!
Assessment method [11]
0
0
Query!
Timepoint [11]
0
0
From baseline (Cycle 1 Day 1) up to 7 years
Query!
Secondary outcome [12]
0
0
Change From Baseline in Levels of CAR-T Cell Activation Markers on Participants Who Received Cilta-cel as Study Treatment (Arm B)
Query!
Assessment method [12]
0
0
Query!
Timepoint [12]
0
0
From baseline (Cycle 1 Day 1) up to 7 years (each cycle of 28 days)
Query!
Secondary outcome [13]
0
0
Change From Baseline in Levels of JNJ-68284528 T Cell Expansion (Proliferation), and Persistence on Participants Who Received Cilta-cel as Study Treatment (Arm B)
Query!
Assessment method [13]
0
0
Query!
Timepoint [13]
0
0
From baseline (Cycle 1 Day 1) up to 7 years (each cycle of 28 days)
Query!
Secondary outcome [14]
0
0
Number of Participants With Anti-JNJ-68284528 Antibodies on Participants Who Received Cilta-cel as Study Treatment (Arm B)
Query!
Assessment method [14]
0
0
Query!
Timepoint [14]
0
0
From Cycle 1 Day 1 up to 7 years
Query!
Secondary outcome [15]
0
0
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 Item (EORTC-QLQ-C30) Scale Score
Query!
Assessment method [15]
0
0
Query!
Timepoint [15]
0
0
From baseline (Cycle 1 Day 1) up to 7 years (each cycle of 28 days)
Query!
Secondary outcome [16]
0
0
Change From Baseline in Health-Related Quality of Life as Assessed by MySIm-Q Scale Sore
Query!
Assessment method [16]
0
0
Query!
Timepoint [16]
0
0
From baseline (Cycle 1 Day 1) up to 7 years (each cycle of 28 days)
Query!
Secondary outcome [17]
0
0
Change From Baseline in Health-Related Quality of Life as Assessed by European Quality of Life - 5 Dimensions-5 Levels (EQ-5D-5L) Questionnaire Scale Score
Query!
Assessment method [17]
0
0
Query!
Timepoint [17]
0
0
From baseline (Cycle 1 Day 1) up to 7 years (each cycle of 28 days)
Query!
Secondary outcome [18]
0
0
Change From Baseline in Health-Related Quality of Life as Assessed by Patient Global Impression of Symptom Severity (PGIS) Scale Score
Query!
Assessment method [18]
0
0
Query!
Timepoint [18]
0
0
From baseline (Cycle 1 Day 1) up to 7 years (each cycle of 28 days)
Query!
Secondary outcome [19]
0
0
Number of Participants in Health-Related Quality of Life as Assessed by The Patient-reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) Item
Query!
Assessment method [19]
0
0
Query!
Timepoint [19]
0
0
From randomization (Day 1) up to 7 years
Query!
Eligibility
Key inclusion criteria
* Measurable disease at screening as defined by any of the following: (a) Serum monoclonal paraprotein (M-protein) level greater than or equal to (>=) 0.5 gram per deciliter (g/dL) or urine M-protein level >=200 milligram (mg)/24 hours; or (b) Light chain multiple myeloma without measurable M-protein in the serum or the urine: Serum free light chain >=10 mg/dL and abnormal serum free light chain ratio
* Have received 1 to 3 prior lines of therapy including a proteasome inhibitor (PI) and an immunomodulatory drug (IMiD)
* Have documented evidence of PD by International Myeloma Working Group (IMWG) criteria based on investigator's determination on or within 6 months of their last regimen
* Be refractory to lenalidomide per IMWG consensus guidelines (failure to achieve minimal response or progression on or within 60 days of completing lenalidomide therapy). Progression on or within 60 days of the last dose of lenalidomide given as maintenance will meet this criterion. For participants with more than 1 prior line of therapy, there is no requirement to be lenalidomide refractory to the most recent line of prior therapy. However, participants must be refractory to lenalidomide in at least one prior line
* Have clinical laboratory values meeting the following criteria during the Screening Phase (re testing is allowed but the below criteria must be met in the latest test prior to randomization):
1. Hemoglobin >=8 gram per deciliter (g/dL) (without prior RBC transfusion within 7 days before the laboratory test; recombinant human erythropoietin use is permitted);
2. Absolute neutrophil count (ANC) >=1 * 10^9 per liter (L) (without recombinant human granulocyte colony-stimulating factor [G-CSF] within 7 days and without pegylated G-CSF within 14 days of the laboratory test);
3. Platelet count >=75 * 10^9/L (without prior platelet transfusion within 7 days before the laboratory test) in participants in whom less than (<) 50 percent (%) of bone marrow nucleated cells are plasma cells; platelet count >=50 * 10^9/L (without prior platelet transfusion within 7 days before the laboratory test) in participants in whom >=50% of bone marrow nucleated cells are plasma cells;
4. Lymphocyte count >=0.3 * 10^9/L;
5. Aspartate aminotransferase (AST) less than or equal to (<=)3 * upper limit of normal (ULN);
6. Alanine aminotransferase (ALT) <=3 * ULN;
7. Total bilirubin <=2.0 * ULN; except in participants with congenital bilirubinemia, such as Gilbert syndrome (in which case direct bilirubin <=1.5 * ULN is required);
8. Estimated glomerular filtration rate >=40 milliliter per minute (mL/min) per 1.73 meter square (m^2) (to be calculated using the Modification of Diet in Renal Disease [MDRD] formula)
Query!
Minimum age
18
Years
Query!
Query!
Maximum age
No limit
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
No
Query!
Key exclusion criteria
* Prior treatment with chimeric antigen receptor T-cell (CAR-T) therapy directed at any target
* Any previous therapy that is targeted to B-cell maturation antigen (BCMA)
* Ongoing toxicity from previous anticancer therapy that has not resolved to baseline levels or to Grade 1 or less; except for alopecia
* Participants with Grade 1 peripheral neuropathy with pain or Grade 2 or higher peripheral neuropathy will not be permitted to receive pomalidomide, bortezomib, and dexamethasone (PVd) as standard therapy or bridging therapy; however, participants may receive daratumumab, pomalidomide, and dexamethasone (DPd) as standard therapy or bridging therapy
* Received a cumulative dose of corticosteroids equivalent to >=70 mg of prednisone within the 7 days prior to randomization
* Monoclonal antibody treatment within 21 days
* Cytotoxic therapy within 14 days
* Proteasome inhibitor therapy within 14 days
* Immunomodulatory drug (IMiD) therapy within 7 days
Query!
Study design
Purpose of the study
Treatment
Query!
Allocation to intervention
Randomised controlled trial
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Query!
Masking / blinding
Open (masking not used)
Query!
Who is / are masked / blinded?
Query!
Query!
Query!
Query!
Intervention assignment
Parallel
Query!
Other design features
Query!
Phase
Phase 3
Query!
Type of endpoint/s
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Active, not recruiting
Query!
Data analysis
Query!
Reason for early stopping/withdrawal
Query!
Other reasons
Query!
Date of first participant enrolment
Anticipated
Query!
Actual
12/06/2020
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
30/06/2027
Query!
Actual
Query!
Sample size
Target
Query!
Accrual to date
Query!
Final
419
Query!
Recruitment in Australia
Recruitment state(s)
Query!
Recruitment hospital [1]
0
0
Royal Adelaide Hospital - Adelaide
Query!
Recruitment hospital [2]
0
0
Royal Prince Alfred Hospital - Camperdown
Query!
Recruitment hospital [3]
0
0
Royal Brisbane and Womens Hospital - Herston
Query!
Recruitment hospital [4]
0
0
Peter MacCallum Cancer Centre - Melbourne
Query!
Recruitment hospital [5]
0
0
Alfred Health - Melbourne
Query!
Recruitment hospital [6]
0
0
Fiona Stanley Hospital - Murdoch
Query!
Recruitment postcode(s) [1]
0
0
5000 - Adelaide
Query!
Recruitment postcode(s) [2]
0
0
2050 - Camperdown
Query!
Recruitment postcode(s) [3]
0
0
4029 - Herston
Query!
Recruitment postcode(s) [4]
0
0
3000 - Melbourne
Query!
Recruitment postcode(s) [5]
0
0
3004 - Melbourne
Query!
Recruitment postcode(s) [6]
0
0
6150 - Murdoch
Query!
Recruitment outside Australia
Country [1]
0
0
United States of America
Query!
State/province [1]
0
0
Alabama
Query!
Country [2]
0
0
United States of America
Query!
State/province [2]
0
0
Arizona
Query!
Country [3]
0
0
United States of America
Query!
State/province [3]
0
0
California
Query!
Country [4]
0
0
United States of America
Query!
State/province [4]
0
0
Colorado
Query!
Country [5]
0
0
United States of America
Query!
State/province [5]
0
0
Connecticut
Query!
Country [6]
0
0
United States of America
Query!
State/province [6]
0
0
Florida
Query!
Country [7]
0
0
United States of America
Query!
State/province [7]
0
0
Iowa
Query!
Country [8]
0
0
United States of America
Query!
State/province [8]
0
0
Kansas
Query!
Country [9]
0
0
United States of America
Query!
State/province [9]
0
0
Maryland
Query!
Country [10]
0
0
United States of America
Query!
State/province [10]
0
0
Minnesota
Query!
Country [11]
0
0
United States of America
Query!
State/province [11]
0
0
Missouri
Query!
Country [12]
0
0
United States of America
Query!
State/province [12]
0
0
New Jersey
Query!
Country [13]
0
0
United States of America
Query!
State/province [13]
0
0
New York
Query!
Country [14]
0
0
United States of America
Query!
State/province [14]
0
0
North Carolina
Query!
Country [15]
0
0
United States of America
Query!
State/province [15]
0
0
Ohio
Query!
Country [16]
0
0
United States of America
Query!
State/province [16]
0
0
Utah
Query!
Country [17]
0
0
United States of America
Query!
State/province [17]
0
0
Wisconsin
Query!
Country [18]
0
0
Belgium
Query!
State/province [18]
0
0
Antwerp
Query!
Country [19]
0
0
Belgium
Query!
State/province [19]
0
0
Gent
Query!
Country [20]
0
0
Belgium
Query!
State/province [20]
0
0
Leuven
Query!
Country [21]
0
0
Belgium
Query!
State/province [21]
0
0
Liege
Query!
Country [22]
0
0
Denmark
Query!
State/province [22]
0
0
Copenhagen
Query!
Country [23]
0
0
France
Query!
State/province [23]
0
0
LILLE Cedex
Query!
Country [24]
0
0
France
Query!
State/province [24]
0
0
Montpellier
Query!
Country [25]
0
0
France
Query!
State/province [25]
0
0
Nantes
Query!
Country [26]
0
0
France
Query!
State/province [26]
0
0
Paris cedex 10
Query!
Country [27]
0
0
France
Query!
State/province [27]
0
0
Pierre Benite cedex
Query!
Country [28]
0
0
France
Query!
State/province [28]
0
0
Poitiers
Query!
Country [29]
0
0
France
Query!
State/province [29]
0
0
Toulouse cedex 9
Query!
Country [30]
0
0
Germany
Query!
State/province [30]
0
0
Dresden
Query!
Country [31]
0
0
Germany
Query!
State/province [31]
0
0
Hamburg
Query!
Country [32]
0
0
Germany
Query!
State/province [32]
0
0
Koeln
Query!
Country [33]
0
0
Germany
Query!
State/province [33]
0
0
Leipzig
Query!
Country [34]
0
0
Germany
Query!
State/province [34]
0
0
Tubingen
Query!
Country [35]
0
0
Germany
Query!
State/province [35]
0
0
Wuerzburg
Query!
Country [36]
0
0
Greece
Query!
State/province [36]
0
0
Athens
Query!
Country [37]
0
0
Israel
Query!
State/province [37]
0
0
Jerusalem
Query!
Country [38]
0
0
Israel
Query!
State/province [38]
0
0
Ramat Gan
Query!
Country [39]
0
0
Israel
Query!
State/province [39]
0
0
Tel Aviv
Query!
Country [40]
0
0
Italy
Query!
State/province [40]
0
0
Bologna
Query!
Country [41]
0
0
Italy
Query!
State/province [41]
0
0
Milano
Query!
Country [42]
0
0
Italy
Query!
State/province [42]
0
0
Roma
Query!
Country [43]
0
0
Italy
Query!
State/province [43]
0
0
Turin
Query!
Country [44]
0
0
Japan
Query!
State/province [44]
0
0
Fukuoka
Query!
Country [45]
0
0
Japan
Query!
State/province [45]
0
0
Kanazawa
Query!
Country [46]
0
0
Japan
Query!
State/province [46]
0
0
Kyoto
Query!
Country [47]
0
0
Japan
Query!
State/province [47]
0
0
Nagoya
Query!
Country [48]
0
0
Japan
Query!
State/province [48]
0
0
Okayama
Query!
Country [49]
0
0
Japan
Query!
State/province [49]
0
0
Sapporo
Query!
Country [50]
0
0
Japan
Query!
State/province [50]
0
0
Sendai
Query!
Country [51]
0
0
Japan
Query!
State/province [51]
0
0
Shibuya
Query!
Country [52]
0
0
Korea, Republic of
Query!
State/province [52]
0
0
Seoul
Query!
Country [53]
0
0
Netherlands
Query!
State/province [53]
0
0
Amsterdam
Query!
Country [54]
0
0
Netherlands
Query!
State/province [54]
0
0
Groningen
Query!
Country [55]
0
0
Netherlands
Query!
State/province [55]
0
0
Rotterdam
Query!
Country [56]
0
0
Netherlands
Query!
State/province [56]
0
0
Utrecht
Query!
Country [57]
0
0
Poland
Query!
State/province [57]
0
0
Gdansk
Query!
Country [58]
0
0
Poland
Query!
State/province [58]
0
0
Gliwice
Query!
Country [59]
0
0
Poland
Query!
State/province [59]
0
0
Poznan
Query!
Country [60]
0
0
Poland
Query!
State/province [60]
0
0
Warszawa
Query!
Country [61]
0
0
Spain
Query!
State/province [61]
0
0
Badalona
Query!
Country [62]
0
0
Spain
Query!
State/province [62]
0
0
Barcelona
Query!
Country [63]
0
0
Spain
Query!
State/province [63]
0
0
Madrid
Query!
Country [64]
0
0
Spain
Query!
State/province [64]
0
0
Pamplona
Query!
Country [65]
0
0
Spain
Query!
State/province [65]
0
0
Salamanca
Query!
Country [66]
0
0
Spain
Query!
State/province [66]
0
0
Sevilla
Query!
Country [67]
0
0
Sweden
Query!
State/province [67]
0
0
Lund
Query!
Country [68]
0
0
Sweden
Query!
State/province [68]
0
0
Stockholm
Query!
Country [69]
0
0
Sweden
Query!
State/province [69]
0
0
Uppsala
Query!
Country [70]
0
0
United Kingdom
Query!
State/province [70]
0
0
Birmingham
Query!
Country [71]
0
0
United Kingdom
Query!
State/province [71]
0
0
Bristol
Query!
Country [72]
0
0
United Kingdom
Query!
State/province [72]
0
0
Cardiff
Query!
Country [73]
0
0
United Kingdom
Query!
State/province [73]
0
0
London
Query!
Country [74]
0
0
United Kingdom
Query!
State/province [74]
0
0
Manchester
Query!
Country [75]
0
0
United Kingdom
Query!
State/province [75]
0
0
Newcastle Upon Tyne
Query!
Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Query!
Name
Janssen Research & Development, LLC
Query!
Address
Query!
Country
Query!
Ethics approval
Ethics application status
Query!
Summary
Brief summary
The purpose of this study is to compare the efficacy of ciltacabtagene autoleucel (cilta-cel) with standard therapy, either Pomalidomide, Bortezomib and Dexamethasone (PVd) or Daratumumab, Pomalidomide and Dexamethasone (DPd).
Query!
Trial website
https://clinicaltrials.gov/study/NCT04181827
Query!
Trial related presentations / publications
Query!
Public notes
Query!
Contacts
Principal investigator
Name
0
0
Janssen Research & Development, LLC Clinical Trial
Query!
Address
0
0
Janssen Research & Development, LLC
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for public queries
Name
0
0
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for scientific queries
Data sharing statement
What supporting documents are/will be available?
No Supporting Document Provided
Type
Other Details
Attachment
Study protocol
https://cdn.clinicaltrials.gov/large-docs/27/NCT04181827/Prot_000.pdf
Statistical analysis plan
https://cdn.clinicaltrials.gov/large-docs/27/NCT04181827/SAP_001.pdf
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results are available at
https://clinicaltrials.gov/study/NCT04181827
Download to PDF