Back to resultsA Study to Compare the Efficacy and Safety of Idecabtagene Vicleucel With Lenalidomide Maintenance Therapy Versus Lenalidomide Maintenance Therapy Alone in Adult Participants With Newly Diagnosed Multiple Myeloma Who Have Suboptimal Response After Autologous Stem Cell Transplantation (KarMMa-9)
Primary Purpose
Multiple Myeloma
Status
Recruiting
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
idecabtagene vicleucel
Lenalidomide
Fludarabine
Cyclophosphamide
Sponsored by
About this trial
This is an interventional treatment trial for Multiple Myeloma focused on measuring CAR-T
Eligibility Criteria
Inclusion Criteria: Participants aged ≥18 with Newly Diagnosed Multiple Myeloma (NDMM) who has received induction therapy followed by high-dose chemotherapy and autologous stem cell transplantation (ASCT), without subsequent consolidation or maintenance. EXCEPTION: Participant received ≤ 7 days of lenalidomide (LEN) maintenance therapy and the investigator documents that there is no impact to the overall benefit/risk assessment due to the temporary interruption of LEN. Participant must have received 4 to 6 cycles of induction therapy, which must contain at a minimum an immunomodulatory drugs (IMiD) and a proteasome inhibitor (PI) (with or without anti-CD38 monoclonal antibody) and must have had a single ASCT 80 to 120 days prior to consent. Note: Participant must not have confirmed progression since commencing induction. Participant must have documented response of PR or VGPR at time of consent. Participant must have Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1 (participants with ECOG 2 due to pain because of underlying myeloma-associated bone lesions are eligible per investigator's discretion). Participant must have recovered to ≤ Grade 1 for any nonhematologic toxicities due to prior treatments, excluding alopecia and Grade 2 neuropathy. Exclusion Criteria: Participant with known central nervous system involvement with myeloma. Participant has non-secretory MM. Participant has systemic and uncontrolled fungal, bacterial, viral, or other infection. Participant has history of primary immunodeficiency. Participant has previous history of an allogeneic hematopoietic stem cell transplantation or treatment with any gene therapy-based therapeutic for cancer or investigational cellular therapy for cancer or B-cell maturation antigen targeted therapy.
Sites / Locations
- Banner MD Anderson Cancer Center
- Mayo Clinic in Arizona - Scottsdale
- University of California, Irvine (UCI) Health - UC Irvine Medical Center
- University of California Davis (UC Davis) Comprehensive Cancer Center
- Colorado Blood Cancer Institute
- Yale University School of Medicine
- Mayo Clinic in Florida
- AdventHealth Orlando
- Moffitt Cancer Center
- Winship Cancer Institute, Emory University
- Northside Hospital
- Massachusetts General Hospital
- Boston Medical Center
- University of Michigan
- Ascension Providence Hospital
- Mayo Clinic in Rochester, Minnesota
- Washington University School of Medicine
- Washington University School of Medicine
- Columbia University Irving Medical Center
- Wake Forest Baptist Health
- University Hospitals Cleveland Medical Center
- The James Cancer Hospital and Solove Research Institute at The Ohio State University Comprehensive Cancer Center
- UT Southwestern Medical Center
- University of Texas MD Anderson Cancer Center
- Local Institution - 0007
- Local Institution - 0005
- Local Institution - 0004
- Local Institution - 0006
- Local Institution - 0008
- Local Institution - 0011
- Local Institution - 0089
- Local Institution - 0090
- Local Institution - 0083
- Local Institution - 0084Recruiting
- Local Institution - 0003
- Local Institution - 0001
- Local Institution - 0036
- Local Institution - 0034
- Local Institution - 0035
- Local Institution - 0033
- Local Institution - 0070
- CHU Bordeaux Haut-Leveque
- Institut Paoli-Calmettes
- Hopital Claude Huriez - CHU de Lille
- Centre Hospitalier Universitaire de Nantes - L' Hopital l'hôtel-Dieu
- Centre Hospitalier Lyon Sud
- Henri Mondor Hospital
- Gustave RoussyRecruiting
- Centre Hospitalier Universitaire de Poitiers
- Hôpital Saint-Louis
- Institut Universitaire du Cancer Toulouse - Oncopole - CHU de TOULOUSE
- Hôpital Saint Antoine
- Local Institution - 0072
- Local Institution - 0078
- Local Institution - 0077
- Local Institution - 0074
- Local Institution - 0073
- Local Institution - 0079
- Local Institution - 0087
- Local Institution - 0075
- Local Institution - 0115
- Local Institution - 0076
- Local Institution - 0063
- Local Institution - 0061
- Local Institution - 0062
- Local Institution - 0060
- Local Institution - 0055
- Local Institution - 0058
- Local Institution - 0057
- Local Institution - 0088
- Local Institution - 0056
- Local Institution - 0059
- Local Institution - 0064
- Local Institution - 0067
- Local Institution - 0065
- Local Institution - 0066
- Local Institution - 0052
- Local Institution - 0048
- Local Institution - 0086
- Local Institution - 0051
- Local Institution - 0085
- Local Institution - 0049
- Local Institution - 0054
- Local Institution - 0053
- Local Institution - 0071
- Local Institution - 0050
- Local Institution - 0041
- Local Institution - 0039
- Local Institution - 0040
- Local Institution - 0038
- Local Institution - 0043
- Local Institution - 0069Recruiting
- Local Institution - 0027
- Local Institution - 0095
- Local Institution - 0023
- Local Institution - 0026
- Local Institution - 0024
- Local Institution - 0022
- Local Institution - 0091
- Local Institution - 0020
- Local Institution - 0017
- Local Institution - 0016Recruiting
- Local Institution - 0012Recruiting
- Local Institution - 0021Recruiting
- Local Institution - 0013Recruiting
- Local Institution - 0014Recruiting
- Local Institution - 0093
- Local Institution - 0080
- Local Institution - 0094
- Local Institution - 0081
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Arm A
Arm B
Arm Description
Outcomes
Primary Outcome Measures
Progression Free Survival (PFS)
PFS as assessed by Independent Review Committee (IRC)
Secondary Outcome Measures
Overall Survival (OS)
Percentage of Participants with Sustained Minimal Residual Disease Negative (MRDneg) Complete Response (CR) for 12 months
Percentage of Participants with Minimal Residual Disease Negative (MRDneg) Complete Response (CR)
Event-Free Survival (EFS)
Duration of Response (DOR)
Percentage of Participants with Complete Response (CR)
CR as assessed by IRC
Time to Progression (TTP)
Progression as assessed by IRC
Progression post-next line of treatment (PFS2)
Time to Next Treatment (TTNT)
Number of Participants Experiencing Adverse Events (AEs)
Number of Participants Experiencing Adverse Events of Special Interest (AESI)
Maximum Observed Plasma Concentration (Cmax)
Time of Maximum Observed Plasma Concentration (Tmax)
Area Under the Curve (AUC) from time zero to 28 days post infusion (AUC [0- 28D])
Time of Last Measurable Observed Plasma Concentration (Tlast)
Time-to-Definitive Deterioration
Time-to-definitive deterioration based on the European Organization for Research and Treatment of Cancer core quality of life questionnaire EORTC QLQ-C30 global health status/quality of life subscale
Mean Change from Baseline in EORTC QLQ-C30 Selected Subscales
The following subscales on the European Organization for Research and Treatment of Cancer core quality of life questionnaire EORTC QLQ-C30 will be assessed:
Global health status/quality of life
Physical Functioning
Fatigue
Pain
Mean Change from Baseline in EORTC QLQ-MY20 Selected Subscales
The following subscales on the European Organization for Research and Treatment of Cancer core quality of life questionnaire EORTC QLQ-MY20 will be assessed:
Disease symptoms
Side-effects of treatment
Full Information
NCT ID
NCT06045806
First Posted
September 13, 2023
Last Updated
October 19, 2023
Sponsor
Bristol-Myers Squibb
1. Study Identification
Unique Protocol Identification Number
NCT06045806
Brief Title
A Study to Compare the Efficacy and Safety of Idecabtagene Vicleucel With Lenalidomide Maintenance Therapy Versus Lenalidomide Maintenance Therapy Alone in Adult Participants With Newly Diagnosed Multiple Myeloma Who Have Suboptimal Response After Autologous Stem Cell Transplantation
Acronym
KarMMa-9
Official Title
A Randomized, Open-Label, Phase 3 Trial to Compare the Efficacy and Safety of Idecabtagene Vicleucel With Lenalidomide Maintenance Versus Lenalidomide Maintenance Therapy Alone in Adult Participants With Newly Diagnosed Multiple Myeloma Who Have Suboptimal Response After Autologous Stem Cell Transplantation (KarMMa-9)
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 16, 2023 (Actual)
Primary Completion Date
March 27, 2031 (Anticipated)
Study Completion Date
July 4, 2032 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bristol-Myers Squibb
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this study is to compare the efficacy, safety, and tolerability of ide-cel with lenalidomide (LEN) maintenance to that of LEN maintenance alone in adult participants with Newly Diagnosed Multiple Myeloma (NDMM) who have achieved a suboptimal response post autologous stem cell transplantation (ASCT).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Myeloma
Keywords
CAR-T
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
618 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Arm A
Arm Type
Experimental
Arm Title
Arm B
Arm Type
Active Comparator
Intervention Type
Biological
Intervention Name(s)
idecabtagene vicleucel
Other Intervention Name(s)
BMS-986395, Abecma, bb2121, ide-cel
Intervention Description
Specified dose on specified days
Intervention Type
Drug
Intervention Name(s)
Lenalidomide
Other Intervention Name(s)
Revlimid, LEN
Intervention Description
Specified dose on specified days
Intervention Type
Drug
Intervention Name(s)
Fludarabine
Other Intervention Name(s)
FLUDARA, BENDARBIN
Intervention Description
Specified dose on specified days
Intervention Type
Drug
Intervention Name(s)
Cyclophosphamide
Other Intervention Name(s)
ENDOXAN, CYTOXAN
Intervention Description
Specified dose on specified days
Primary Outcome Measure Information:
Title
Progression Free Survival (PFS)
Description
PFS as assessed by Independent Review Committee (IRC)
Time Frame
Up to approximately 49 months after the first participant is randomized
Secondary Outcome Measure Information:
Title
Overall Survival (OS)
Time Frame
Up to approximately 60 months after the last participant is randomized
Title
Percentage of Participants with Sustained Minimal Residual Disease Negative (MRDneg) Complete Response (CR) for 12 months
Time Frame
From randomization up to 27 months from randomization
Title
Percentage of Participants with Minimal Residual Disease Negative (MRDneg) Complete Response (CR)
Time Frame
From randomization up to 15 months from randomization
Title
Event-Free Survival (EFS)
Time Frame
Up to approximately 60 months after the last participant is randomized
Title
Duration of Response (DOR)
Time Frame
Up to approximately 60 months after the last participant is randomized
Title
Percentage of Participants with Complete Response (CR)
Description
CR as assessed by IRC
Time Frame
Up to approximately 60 months after the last participant is randomized
Title
Time to Progression (TTP)
Description
Progression as assessed by IRC
Time Frame
Up to approximately 60 months after the last participant is randomized
Title
Progression post-next line of treatment (PFS2)
Time Frame
Up to approximately 60 months after the last participant is randomized
Title
Time to Next Treatment (TTNT)
Time Frame
Up to approximately 60 months after the last participant is randomized
Title
Number of Participants Experiencing Adverse Events (AEs)
Time Frame
Up to approximately 60 months after the last participant is randomized
Title
Number of Participants Experiencing Adverse Events of Special Interest (AESI)
Time Frame
Up to approximately 60 months after the last participant is randomized
Title
Maximum Observed Plasma Concentration (Cmax)
Time Frame
Up to approximately 60 months after the last participant is randomized
Title
Time of Maximum Observed Plasma Concentration (Tmax)
Time Frame
Up to approximately 60 months after the last participant is randomized
Title
Area Under the Curve (AUC) from time zero to 28 days post infusion (AUC [0- 28D])
Time Frame
Up to 28 days post infusion
Title
Time of Last Measurable Observed Plasma Concentration (Tlast)
Time Frame
Up to approximately 60 months after the last participant is randomized
Title
Time-to-Definitive Deterioration
Description
Time-to-definitive deterioration based on the European Organization for Research and Treatment of Cancer core quality of life questionnaire EORTC QLQ-C30 global health status/quality of life subscale
Time Frame
Up to approximately 49 months after the first participant is randomized
Title
Mean Change from Baseline in EORTC QLQ-C30 Selected Subscales
Description
The following subscales on the European Organization for Research and Treatment of Cancer core quality of life questionnaire EORTC QLQ-C30 will be assessed:
Global health status/quality of life
Physical Functioning
Fatigue
Pain
Time Frame
Up to approximately 49 months after the first participant is randomized
Title
Mean Change from Baseline in EORTC QLQ-MY20 Selected Subscales
Description
The following subscales on the European Organization for Research and Treatment of Cancer core quality of life questionnaire EORTC QLQ-MY20 will be assessed:
Disease symptoms
Side-effects of treatment
Time Frame
Up to approximately 49 months after the first participant is randomized
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Participants aged ≥18 with Newly Diagnosed Multiple Myeloma (NDMM) who has received induction therapy followed by high-dose chemotherapy and autologous stem cell transplantation (ASCT), without subsequent consolidation or maintenance. EXCEPTION: Participant received ≤ 7 days of lenalidomide (LEN) maintenance therapy and the investigator documents that there is no impact to the overall benefit/risk assessment due to the temporary interruption of LEN.
Participant must have received 4 to 6 cycles of induction therapy, which must contain at a minimum an immunomodulatory drugs (IMiD) and a proteasome inhibitor (PI) (with or without anti-CD38 monoclonal antibody) and must have had a single ASCT 80 to 120 days prior to consent. Note: Participant must not have confirmed progression since commencing induction.
Participant must have documented response of PR or VGPR at time of consent.
Participant must have Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1 (participants with ECOG 2 due to pain because of underlying myeloma-associated bone lesions are eligible per investigator's discretion).
Participant must have recovered to ≤ Grade 1 for any nonhematologic toxicities due to prior treatments, excluding alopecia and Grade 2 neuropathy.
Exclusion Criteria:
Participant with known central nervous system involvement with myeloma.
Participant has non-secretory MM.
Participant has systemic and uncontrolled fungal, bacterial, viral, or other infection.
Participant has history of primary immunodeficiency.
Participant has previous history of an allogeneic hematopoietic stem cell transplantation or treatment with any gene therapy-based therapeutic for cancer or investigational cellular therapy for cancer or B-cell maturation antigen targeted therapy.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
BMS Study Connect Contact Center www.BMSStudyConnect.com
Phone
855-907-3286
Email
Clinical.Trials@bms.com
First Name & Middle Initial & Last Name or Official Title & Degree
First line of the email MUST contain the NCT# and Site #.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bristol-Myers Squibb
Organizational Affiliation
Bristol-Myers Squibb
Official's Role
Study Director
Facility Information:
Facility Name
Banner MD Anderson Cancer Center
City
Gilbert
State/Province
Arizona
ZIP/Postal Code
85234
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rajneesh Nath, Site 0096
Phone
480-256-3223
Facility Name
Mayo Clinic in Arizona - Scottsdale
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85259
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Peter Bergsagel, Site 0097
Phone
480-342-4800
Facility Name
University of California, Irvine (UCI) Health - UC Irvine Medical Center
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Stefan Ciurea, Site 0126
Phone
714-509-2290
Facility Name
University of California Davis (UC Davis) Comprehensive Cancer Center
City
Sacramento
State/Province
California
ZIP/Postal Code
95817
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mehrdad Abedi, Site 0113
Phone
916-734-3772
Facility Name
Colorado Blood Cancer Institute
City
Denver
State/Province
Colorado
ZIP/Postal Code
80218
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tara Gregory, Site 0101
Phone
720-754-4800
Facility Name
Yale University School of Medicine
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06510
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Noffar Bar, Site 0111
Phone
000-000-0000
Facility Name
Mayo Clinic in Florida
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32224
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sikander Ailawadhi, Site 0098
Phone
904-953-2000
Facility Name
AdventHealth Orlando
City
Orlando
State/Province
Florida
ZIP/Postal Code
32804
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rushang Patel, Site 0127
Phone
407-303-2070
Facility Name
Moffitt Cancer Center
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Omar Castaneda Puglianini, Site 0129
Phone
813-745-0365
Facility Name
Winship Cancer Institute, Emory University
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nisha Joseph, Site 0121
Phone
502-608-5503
Facility Name
Northside Hospital
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30342
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Scott Solomon, Site 0104
Phone
404-255-1930
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Diana Cirstea, Site 0102
Phone
617-724-4000
Facility Name
Boston Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02118
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fabio Petrocca, Site 0125
Phone
617-638-7541
Facility Name
University of Michigan
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
ATTAPHOL PAWARODE, Site 0123
Phone
734-763-4695
Facility Name
Ascension Providence Hospital
City
Southfield
State/Province
Michigan
ZIP/Postal Code
48075
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Howard Terebelo, Site 0105
Phone
248-552-0620
Facility Name
Mayo Clinic in Rochester, Minnesota
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shaji Kumar, Site 0100
Phone
507-202-8384
Facility Name
Washington University School of Medicine
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
RAVI VIJ, Site 0103
Phone
314-409-4144
Facility Name
Washington University School of Medicine
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michael Slade, Site 0120
Phone
314-454-8304
Facility Name
Columbia University Irving Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ran Reshef, Site 0117
Phone
212-342-0530
Facility Name
Wake Forest Baptist Health
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
John McKay, Site 0107
Phone
336-716-7972
Facility Name
University Hospitals Cleveland Medical Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Koen van Besien, Site 0116
Phone
216-844-0139
Facility Name
The James Cancer Hospital and Solove Research Institute at The Ohio State University Comprehensive Cancer Center
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Srinivas Devarakonda, Site 0106
Phone
570-423-0522
Facility Name
UT Southwestern Medical Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390-88520
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gurbakhash Kaur, Site 0114
Phone
214-648-5364
Facility Name
University of Texas MD Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Krina Patel, Site 0112
Phone
713-792-6662
Facility Name
Local Institution - 0007
City
Camperdown
State/Province
New South Wales
ZIP/Postal Code
2050
Country
Australia
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0007
Facility Name
Local Institution - 0005
City
Brisbane
State/Province
Queensland
ZIP/Postal Code
4029
Country
Australia
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0005
Facility Name
Local Institution - 0004
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3000
Country
Australia
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0004
Facility Name
Local Institution - 0006
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3004
Country
Australia
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0006
Facility Name
Local Institution - 0008
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3065
Country
Australia
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0008
Facility Name
Local Institution - 0011
City
Murdoch
State/Province
Western Australia
ZIP/Postal Code
6150
Country
Australia
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0011
Facility Name
Local Institution - 0089
City
Salzburg
ZIP/Postal Code
5020
Country
Austria
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0089
Facility Name
Local Institution - 0090
City
Wien
ZIP/Postal Code
1090
Country
Austria
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0090
Facility Name
Local Institution - 0083
City
Anderlecht
State/Province
Bruxelles-Capitale, Région De
ZIP/Postal Code
1070
Country
Belgium
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0083
Facility Name
Local Institution - 0084
City
Brussels
State/Province
Bruxelles-Capitale, Région De
ZIP/Postal Code
1090
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0084
Facility Name
Local Institution - 0003
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2N 4N2
Country
Canada
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0003
Facility Name
Local Institution - 0001
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8V5C2
Country
Canada
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0001
Facility Name
Local Institution - 0036
City
Brno
State/Province
Brno-město
ZIP/Postal Code
625 00
Country
Czechia
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0036
Facility Name
Local Institution - 0034
City
Hradec Kralove
State/Province
Hradec Králové
ZIP/Postal Code
500 05
Country
Czechia
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0034
Facility Name
Local Institution - 0035
City
Olomouc
State/Province
Olomoucký Kraj
ZIP/Postal Code
779 00
Country
Czechia
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0035
Facility Name
Local Institution - 0033
City
Praha 2
ZIP/Postal Code
12808
Country
Czechia
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0033
Facility Name
Local Institution - 0070
City
Odense
State/Province
Syddanmark
ZIP/Postal Code
5000
Country
Denmark
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0070
Facility Name
CHU Bordeaux Haut-Leveque
City
Pessac
State/Province
Aquitaine
ZIP/Postal Code
33600
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cyrille Hulin, Site 0047
Phone
33557656511
Facility Name
Institut Paoli-Calmettes
City
Marseille
State/Province
Bouches-du-Rhône
ZIP/Postal Code
13273
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gabriel Brisou, Site 0045
Phone
+33647880806
Facility Name
Hopital Claude Huriez - CHU de Lille
City
Lille
State/Province
Nord
ZIP/Postal Code
59000
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Salomon Manier, Site 0030
Phone
33320444292
Facility Name
Centre Hospitalier Universitaire de Nantes - L' Hopital l'hôtel-Dieu
City
Nantes
State/Province
Pays-de-la-Loire
ZIP/Postal Code
44000
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cyrille Touzeau, Site 0042
Phone
33240083271
Facility Name
Centre Hospitalier Lyon Sud
City
Pierre-Bénite
State/Province
Rhône
ZIP/Postal Code
69310
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lionel Karlin, Site 0046
Phone
33478864309
Facility Name
Henri Mondor Hospital
City
Créteil
State/Province
Val-de-Marne
ZIP/Postal Code
94010
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Karim Balhadj-Merzoug, Site 0068
Phone
33149812798
Facility Name
Gustave Roussy
City
Villejuif
State/Province
Val-de-Marne
ZIP/Postal Code
94800
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alina Danu, Site 0028
Phone
33142114229
Facility Name
Centre Hospitalier Universitaire de Poitiers
City
Poitiers
State/Province
Vienne
ZIP/Postal Code
86021
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
xavier leleu, Site 0029
Phone
+33 982602178
Facility Name
Hôpital Saint-Louis
City
Paris
ZIP/Postal Code
75010
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bertrand Arnulf, Site 0082
Phone
33142499472
Facility Name
Institut Universitaire du Cancer Toulouse - Oncopole - CHU de TOULOUSE
City
Toulouse
ZIP/Postal Code
31100
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Aurore Perrot, Site 0092
Phone
0531156184
Facility Name
Hôpital Saint Antoine
City
Paris
State/Province
Île-de-France
ZIP/Postal Code
75571
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mohamad Mohty, Site 0031
Phone
33149282620
Facility Name
Local Institution - 0072
City
Heidelberg
State/Province
Baden-Württemberg
ZIP/Postal Code
69120
Country
Germany
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0072
Facility Name
Local Institution - 0078
City
Ulm
State/Province
Baden-Württemberg
ZIP/Postal Code
89081
Country
Germany
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0078
Facility Name
Local Institution - 0077
City
Nuremberg
State/Province
Bayern
ZIP/Postal Code
90419
Country
Germany
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0077
Facility Name
Local Institution - 0074
City
Wuerzburg
State/Province
Bayern
ZIP/Postal Code
97080
Country
Germany
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0074
Facility Name
Local Institution - 0073
City
Köln
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
50937
Country
Germany
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0073
Facility Name
Local Institution - 0079
City
Dresden
State/Province
Sachsen
ZIP/Postal Code
01307
Country
Germany
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0079
Facility Name
Local Institution - 0087
City
Leipzig
State/Province
Sachsen
ZIP/Postal Code
04103
Country
Germany
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0087
Facility Name
Local Institution - 0075
City
Kiel
State/Province
Schleswig-Holstein
ZIP/Postal Code
24105
Country
Germany
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0075
Facility Name
Local Institution - 0115
City
Essen
ZIP/Postal Code
45122
Country
Germany
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0115
Facility Name
Local Institution - 0076
City
Hamburg
ZIP/Postal Code
20246
Country
Germany
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0076
Facility Name
Local Institution - 0063
City
Patras
State/Province
Achaḯa
ZIP/Postal Code
26504
Country
Greece
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0063
Facility Name
Local Institution - 0061
City
Athens
State/Province
Attikí
ZIP/Postal Code
106 76
Country
Greece
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0061
Facility Name
Local Institution - 0062
City
Chaidari
State/Province
Attikí
ZIP/Postal Code
12462
Country
Greece
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0062
Facility Name
Local Institution - 0060
City
Thessaloniki
State/Province
Thessaloníki
ZIP/Postal Code
570 10
Country
Greece
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0060
Facility Name
Local Institution - 0055
City
Be'er Sheva
State/Province
HaDarom
ZIP/Postal Code
8410101
Country
Israel
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0055
Facility Name
Local Institution - 0058
City
Petah-Tikva
State/Province
HaMerkaz
ZIP/Postal Code
4910021
Country
Israel
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0058
Facility Name
Local Institution - 0057
City
Ramat Gan
State/Province
HaMerkaz
ZIP/Postal Code
5262100
Country
Israel
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0057
Facility Name
Local Institution - 0088
City
Tel Aviv
State/Province
Tell Abīb
ZIP/Postal Code
6423906
Country
Israel
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0088
Facility Name
Local Institution - 0056
City
Haifa
ZIP/Postal Code
31096
Country
Israel
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0056
Facility Name
Local Institution - 0059
City
Jerusalem
ZIP/Postal Code
9112001
Country
Israel
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0059
Facility Name
Local Institution - 0064
City
Rozzano
State/Province
Milano
ZIP/Postal Code
20089
Country
Italy
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0064
Facility Name
Local Institution - 0067
City
Torino
State/Province
Piemonte
ZIP/Postal Code
10126
Country
Italy
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0067
Facility Name
Local Institution - 0065
City
Bologna
ZIP/Postal Code
40138
Country
Italy
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0065
Facility Name
Local Institution - 0066
City
Roma
ZIP/Postal Code
00161
Country
Italy
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0066
Facility Name
Local Institution - 0052
City
Nagoya
State/Province
Aichi
ZIP/Postal Code
467-8602
Country
Japan
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0052
Facility Name
Local Institution - 0048
City
Sapporo
State/Province
Hokkaido
ZIP/Postal Code
060-8648
Country
Japan
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0048
Facility Name
Local Institution - 0086
City
Nishinomiya
State/Province
Hyogo
ZIP/Postal Code
663-8501
Country
Japan
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0086
Facility Name
Local Institution - 0051
City
Kanazawa
State/Province
Ishikawa
ZIP/Postal Code
920-8641
Country
Japan
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0051
Facility Name
Local Institution - 0085
City
Isehara
State/Province
Kanagawa
ZIP/Postal Code
259-1193
Country
Japan
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0085
Facility Name
Local Institution - 0049
City
Chiba
ZIP/Postal Code
260-8677
Country
Japan
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0049
Facility Name
Local Institution - 0054
City
Fukuoka
ZIP/Postal Code
812-8582
Country
Japan
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0054
Facility Name
Local Institution - 0053
City
Okayama
ZIP/Postal Code
700-8558
Country
Japan
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0053
Facility Name
Local Institution - 0071
City
Shimotsuke
ZIP/Postal Code
329-0498
Country
Japan
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0071
Facility Name
Local Institution - 0050
City
Tokyo
ZIP/Postal Code
150-8935
Country
Japan
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0050
Facility Name
Local Institution - 0041
City
Hwasun Gun
State/Province
Jeonranamdo
ZIP/Postal Code
58128
Country
Korea, Republic of
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0041
Facility Name
Local Institution - 0039
City
Seoul
State/Province
Seoul-teukbyeolsi [Seoul]
ZIP/Postal Code
03080
Country
Korea, Republic of
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0039
Facility Name
Local Institution - 0040
City
Seoul
State/Province
Seoul-teukbyeolsi [Seoul]
ZIP/Postal Code
05505
Country
Korea, Republic of
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0040
Facility Name
Local Institution - 0038
City
Seoul
State/Province
Seoul-teukbyeolsi [Seoul]
ZIP/Postal Code
06351
Country
Korea, Republic of
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0038
Facility Name
Local Institution - 0043
City
Seoul
State/Province
Seoul-teukbyeolsi [Seoul]
ZIP/Postal Code
06591
Country
Korea, Republic of
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0043
Facility Name
Local Institution - 0069
City
Oslo
ZIP/Postal Code
0372
Country
Norway
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0069
Facility Name
Local Institution - 0027
City
Lublin
State/Province
Lubelskie
ZIP/Postal Code
20-090
Country
Poland
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0027
Facility Name
Local Institution - 0095
City
Warsaw
State/Province
Mazowieckie
ZIP/Postal Code
02-097
Country
Poland
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0095
Facility Name
Local Institution - 0023
City
Warsaw
State/Province
Mazowieckie
ZIP/Postal Code
02-776
Country
Poland
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0023
Facility Name
Local Institution - 0026
City
Gdańsk
State/Province
Pomorskie
ZIP/Postal Code
80-952
Country
Poland
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0026
Facility Name
Local Institution - 0024
City
Poznań
State/Province
Wielkopolskie
ZIP/Postal Code
60-569
Country
Poland
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0024
Facility Name
Local Institution - 0022
City
Gliwice
State/Province
Śląskie
ZIP/Postal Code
44-101
Country
Poland
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0022
Facility Name
Local Institution - 0091
City
Bucuresti
State/Province
București
ZIP/Postal Code
022328
Country
Romania
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0091
Facility Name
Local Institution - 0020
City
Badalona
State/Province
Barcelona [Barcelona]
ZIP/Postal Code
08916
Country
Spain
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0020
Facility Name
Local Institution - 0017
City
L'Hospitalet Del Llobregat
State/Province
Barcelona [Barcelona]
ZIP/Postal Code
08908
Country
Spain
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0017
Facility Name
Local Institution - 0016
City
Barcelona
State/Province
Catalunya [Cataluña]
ZIP/Postal Code
08036
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0016
Facility Name
Local Institution - 0012
City
Pamplona
State/Province
Navarra
ZIP/Postal Code
31008
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0012
Facility Name
Local Institution - 0021
City
Madrid
ZIP/Postal Code
28041
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0021
Facility Name
Local Institution - 0013
City
Salamanca
ZIP/Postal Code
37007
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0013
Facility Name
Local Institution - 0014
City
València
ZIP/Postal Code
46026
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0014
Facility Name
Local Institution - 0093
City
Birmingham
State/Province
England
ZIP/Postal Code
B15 2TH
Country
United Kingdom
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0093
Facility Name
Local Institution - 0080
City
London
State/Province
London, City Of
ZIP/Postal Code
SE5 9RS
Country
United Kingdom
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0080
Facility Name
Local Institution - 0094
City
London
State/Province
London, City Of
ZIP/Postal Code
W12 0HS
Country
United Kingdom
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0094
Facility Name
Local Institution - 0081
City
Glasgow
ZIP/Postal Code
G12 0YN
Country
United Kingdom
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0081
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. Additional information regarding Bristol Myer Squibb's data sharing policy and process can be found at: https://www.bms.com/researchers-and-partners/clinical-trials-and-research/disclosure-commitment.html
IPD Sharing Time Frame
See plan description
IPD Sharing Access Criteria
See plan description
IPD Sharing URL
https://www.bms.com/researchers-and-partners/clinical-trials-and-research/disclosure-commitment.html
Links:
URL
https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html
Description
BMS Clinical Trial Information
URL
https://www.bmsstudyconnect.com/s/US/English/USenHome
Description
BMS Clinical Trial Patient Recruiting
URL
https://www.fda.gov/Safety/MedWatch/SafetyInformation/default.htm
Description
FDA Safety Alerts and Recalls
Learn more about this trial
A Study to Compare the Efficacy and Safety of Idecabtagene Vicleucel With Lenalidomide Maintenance Therapy Versus Lenalidomide Maintenance Therapy Alone in Adult Participants With Newly Diagnosed Multiple Myeloma Who Have Suboptimal Response After Autologous Stem Cell Transplantation
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