Trial Title:
A Study to Compare the Efficacy and Safety of BMS-986393 Versus Standard Regimens in Adult Participants With Relapsed or Refractory and Lenalidomide-refractory Multiple Myeloma (QUINTESSENTIAL-2)
NCT ID:
NCT06615479
Condition:
Relapsed or Refractory Multiple Myeloma (RRMM)
Conditions: Official terms:
Multiple Myeloma
Neoplasms, Plasma Cell
Dexamethasone
Cyclophosphamide
Fludarabine
Daratumumab
Pomalidomide
Conditions: Keywords:
Relapsed or Refractory Multiple Myeloma
Multiple Myeloma
BMS-986393
Chimeric Antigen Receptor T-cell (CAR T-cell)
CAR T-cell Therapy
Study type:
Interventional
Study phase:
Phase 3
Overall status:
Not yet recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
BMS-986393
Description:
Specified dose on specified days
Arm group label:
Arm A
Intervention type:
Drug
Intervention name:
Cyclophosphamide
Description:
Specified dose on specified days
Arm group label:
Arm A
Intervention type:
Drug
Intervention name:
Fludarabine
Description:
Specified dose on specified days
Arm group label:
Arm A
Intervention type:
Drug
Intervention name:
Daratumumab
Description:
Specified dose on specified days
Arm group label:
Arm A
Arm group label:
Arm B
Intervention type:
Drug
Intervention name:
Pomalidomide
Description:
Specified dose on specified days
Arm group label:
Arm A
Arm group label:
Arm B
Intervention type:
Drug
Intervention name:
Dexamethasone
Description:
Specified dose on specified days
Arm group label:
Arm A
Arm group label:
Arm B
Intervention type:
Drug
Intervention name:
Carfilzomib
Description:
Specified dose on specified days
Arm group label:
Arm A
Arm group label:
Arm B
Summary:
The purpose of this study is to compare the efficacy and safety of BMS-986393 versus
standard regimens in adult participants with Relapsed or Refractory and
Lanalidomide-refractory Multiple Myeloma.
Criteria for eligibility:
Criteria:
Inclusion Criteria
- Participants must have relapsed or refractory multiple myeloma (RRMM).
- Participants must have received at least 1 but no greater than 3 prior multiple
myeloma (MM) regimens which may include a proteasome inhibitor (PI), an
immunomodulatory drug (IMiD), and an anti-CD38 monoclonal antibody, and be
refractory to lenalidomide (LEN) (progression on or within 60 days of completing LEN
therapy).
- Participants must have a documented diagnosis of MM as per International Myeloma
Working Group Criteria.
- Participants must have measurable disease during screening.
- Participants must have adequate organ function.
- Participants must have an Eastern Cooperative Oncology group performance status 0 or
1.
Exclusion Criteria
- Participants must not have known active or history of central nervous system (CNS)
involvement of Multiple Myeloma (MM).
- Participants must not have solitary plasmacytomas or non-secretory myeloma without
other evidence of measurable disease.
- Participants must not need urgent treatment due to rapidly progressing MM.
- Other protocol-defined Inclusion/Exclusion criteria apply.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Local Institution - 0071
Address:
City:
Birmingham
Zip:
35205
Country:
United States
Contact:
Last name:
Site 0071
Facility:
Name:
Local Institution - 0032
Address:
City:
Los Angeles
Zip:
90404
Country:
United States
Contact:
Last name:
Site 0032
Facility:
Name:
Local Institution - 0130
Address:
City:
Miami
Zip:
33136
Country:
United States
Contact:
Last name:
Site 0130
Facility:
Name:
Local Institution - 0058
Address:
City:
Atlanta
Zip:
30322
Country:
United States
Contact:
Last name:
Site 0058
Facility:
Name:
Local Institution - 0077
Address:
City:
Westwood
Zip:
66205
Country:
United States
Contact:
Last name:
Site 0077
Facility:
Name:
Local Institution - 0133
Address:
City:
Baltimore
Zip:
21218
Country:
United States
Facility:
Name:
Local Institution - 0042
Address:
City:
New York
Zip:
10065
Country:
United States
Facility:
Name:
Local Institution - 0131
Address:
City:
Durham
Zip:
27710
Country:
United States
Contact:
Last name:
Site 0131
Facility:
Name:
Local Institution - 0097
Address:
City:
Philadelphia
Zip:
19111
Country:
United States
Contact:
Last name:
Site 0097
Facility:
Name:
Local Institution - 0044
Address:
City:
Salt Lake City
Zip:
84112
Country:
United States
Contact:
Last name:
Site 0044
Facility:
Name:
Local Institution - 0068
Address:
City:
Madison
Zip:
53792
Country:
United States
Facility:
Name:
Local Institution - 0122
Address:
City:
ABB
Zip:
C1199ABB
Country:
Argentina
Contact:
Last name:
Site 0122
Facility:
Name:
Local Institution - 0121
Address:
City:
Buenos Aires
Zip:
C1118AAT
Country:
Argentina
Contact:
Last name:
Site 0121
Facility:
Name:
Local Institution - 0142
Address:
City:
Camperdown
Zip:
2050
Country:
Australia
Contact:
Last name:
Site 0142
Facility:
Name:
Local Institution - 0140
Address:
City:
Brisbane
Zip:
4102
Country:
Australia
Contact:
Last name:
Site 0140
Facility:
Name:
Local Institution - 0139
Address:
City:
Adelaide
Zip:
5000
Country:
Australia
Contact:
Last name:
Site 0139
Facility:
Name:
Local Institution - 0143
Address:
City:
Clayton
Zip:
3168
Country:
Australia
Contact:
Last name:
Site 0143
Facility:
Name:
Local Institution - 0138
Address:
City:
Melbourne
Zip:
3000
Country:
Australia
Contact:
Last name:
Site 0138
Facility:
Name:
Local Institution - 0141
Address:
City:
Murdoch
Zip:
6150
Country:
Australia
Contact:
Last name:
Site 0141
Facility:
Name:
Local Institution - 0167
Address:
City:
Linz
Zip:
4020
Country:
Austria
Contact:
Last name:
Site 0167
Facility:
Name:
Local Institution - 0166
Address:
City:
Vienna
Zip:
1140
Country:
Austria
Contact:
Last name:
Site 0166
Facility:
Name:
Local Institution - 0162
Address:
City:
Yvoir
Zip:
5530
Country:
Belgium
Contact:
Last name:
Site 0162
Facility:
Name:
Local Institution - 0160
Address:
City:
Gent
Zip:
9000
Country:
Belgium
Facility:
Name:
Local Institution - 0175
Address:
City:
Gent
Zip:
9000
Country:
Belgium
Contact:
Last name:
Site 0175
Facility:
Name:
Local Institution - 0012
Address:
City:
Nova Lima
Zip:
34000-000
Country:
Brazil
Contact:
Last name:
Site 0012
Facility:
Name:
Local Institution - 0103
Address:
City:
São Paulo
Zip:
04501-000
Country:
Brazil
Contact:
Last name:
Site 0103
Facility:
Name:
Local Institution - 0013
Address:
City:
Sao Paulo
Zip:
01509-010
Country:
Brazil
Contact:
Last name:
Site 0013
Facility:
Name:
Local Institution - 0069
Address:
City:
Calgary
Zip:
T2N 4N2
Country:
Canada
Contact:
Last name:
Site 0069
Facility:
Name:
Local Institution - 0003
Address:
City:
Vancouver
Zip:
V5Z 1M9
Country:
Canada
Contact:
Last name:
Site 0003
Facility:
Name:
Local Institution - 0004
Address:
City:
Halifax
Zip:
B3H 2Y9
Country:
Canada
Contact:
Last name:
Site 0004
Facility:
Name:
Local Institution - 0001
Address:
City:
Montreal
Zip:
H1T 2M4
Country:
Canada
Contact:
Last name:
Site 0001
Facility:
Name:
Local Institution - 0094
Address:
City:
Brno
Zip:
625 00
Country:
Czechia
Contact:
Last name:
Site 0094
Facility:
Name:
Local Institution - 0129
Address:
City:
Praha 2
Zip:
12808
Country:
Czechia
Contact:
Last name:
Site 0129
Facility:
Name:
Local Institution - 0019
Address:
City:
Copenhagen
Zip:
2100
Country:
Denmark
Contact:
Last name:
Site 0019
Facility:
Name:
Local Institution - 0020
Address:
City:
Aarhus
Zip:
8200
Country:
Denmark
Contact:
Last name:
Site 0020
Facility:
Name:
Local Institution - 0022
Address:
City:
Odense
Zip:
5000
Country:
Denmark
Contact:
Last name:
Site 0022
Facility:
Name:
Local Institution - 0026
Address:
City:
Helsinki
Zip:
00029
Country:
Finland
Contact:
Last name:
Site 0026
Facility:
Name:
Local Institution - 0081
Address:
City:
Lille
Zip:
59000
Country:
France
Contact:
Last name:
Site 0081
Facility:
Name:
Local Institution - 0079
Address:
City:
Creteil
Zip:
94010
Country:
France
Contact:
Last name:
Site 0079
Facility:
Name:
Local Institution - 0185
Address:
City:
München
Zip:
81675
Country:
Germany
Contact:
Last name:
Site 0185
Facility:
Name:
Local Institution - 0187
Address:
City:
Nürnberg
Zip:
90419
Country:
Germany
Contact:
Last name:
Site 0187
Facility:
Name:
Local Institution - 0164
Address:
City:
Leipzig
Zip:
04103
Country:
Germany
Contact:
Last name:
Site 0164
Facility:
Name:
Local Institution - 0188
Address:
City:
Hamburg
Zip:
20246
Country:
Germany
Contact:
Last name:
Site 0188
Facility:
Name:
Local Institution - 0186
Address:
City:
Hannover
Zip:
30625
Country:
Germany
Contact:
Last name:
Site 0186
Facility:
Name:
Local Institution - 0165
Address:
City:
Heidelberg
Zip:
D-69120
Country:
Germany
Contact:
Last name:
Site 0165
Facility:
Name:
Local Institution - 0153
Address:
City:
Wuerzburg
Zip:
97080
Country:
Germany
Facility:
Name:
Local Institution - 0169
Address:
City:
Wuerzburg
Zip:
97080
Country:
Germany
Contact:
Last name:
Site 0169
Facility:
Name:
Local Institution - 0111
Address:
City:
Patras
Zip:
26504
Country:
Greece
Contact:
Last name:
Site 0111
Facility:
Name:
Local Institution - 0117
Address:
City:
Athens
Zip:
106 76
Country:
Greece
Contact:
Last name:
Site 0117
Facility:
Name:
Local Institution - 0115
Address:
City:
Chaidari
Zip:
12462
Country:
Greece
Contact:
Last name:
Site 0115
Facility:
Name:
Local Institution - 0125
Address:
City:
Budapest
Zip:
1097
Country:
Hungary
Contact:
Last name:
Site 0125
Facility:
Name:
Local Institution - 0124
Address:
City:
Debrecen
Zip:
4032
Country:
Hungary
Contact:
Last name:
Site 0124
Facility:
Name:
Local Institution - 0112
Address:
City:
Ramat Gan
Zip:
5262100
Country:
Israel
Contact:
Last name:
Site 0112
Facility:
Name:
Local Institution - 0118
Address:
City:
Tel Aviv
Zip:
6423906
Country:
Israel
Contact:
Last name:
Site 0118
Facility:
Name:
Local Institution - 0116
Address:
City:
Jerusalem
Zip:
9112001
Country:
Israel
Contact:
Last name:
Site 0116
Facility:
Name:
Local Institution - 0107
Address:
City:
Milan
Zip:
20133
Country:
Italy
Contact:
Last name:
Site 0107
Facility:
Name:
Local Institution - 0109
Address:
City:
Rozzano
Zip:
20089
Country:
Italy
Contact:
Last name:
Site 0109
Facility:
Name:
Local Institution - 0128
Address:
City:
Torino
Zip:
10126
Country:
Italy
Contact:
Last name:
Site 0128
Facility:
Name:
Local Institution - 0108
Address:
City:
Bologna
Zip:
40138
Country:
Italy
Contact:
Last name:
Site 0108
Facility:
Name:
Local Institution - 0098
Address:
City:
Nagoya
Zip:
467-8602
Country:
Japan
Contact:
Last name:
Site 0098
Facility:
Name:
Local Institution - 0105
Address:
City:
Kashiwa
Zip:
277-8577
Country:
Japan
Contact:
Last name:
Site 0105
Facility:
Name:
Local Institution - 0087
Address:
City:
Nishinomiya
Zip:
663-8501
Country:
Japan
Contact:
Last name:
Site 0087
Facility:
Name:
Local Institution - 0104
Address:
City:
Kanazawa
Zip:
920-8641
Country:
Japan
Contact:
Last name:
Site 0104
Facility:
Name:
Local Institution - 0089
Address:
City:
Fukuoka
Zip:
812-8582
Country:
Japan
Contact:
Last name:
Site 0089
Facility:
Name:
Local Institution - 0102
Address:
City:
Kumamoto
Zip:
860-8556
Country:
Japan
Contact:
Last name:
Site 0102
Facility:
Name:
Local Institution - 0090
Address:
City:
Okayama
Zip:
701-1192
Country:
Japan
Contact:
Last name:
Site 0090
Facility:
Name:
Local Institution - 0099
Address:
City:
Osaka
Zip:
543-8555
Country:
Japan
Contact:
Last name:
Site 0099
Facility:
Name:
Local Institution - 0091
Address:
City:
Tokyo
Zip:
150-8935
Country:
Japan
Contact:
Last name:
Site 0091
Facility:
Name:
Local Institution - 0100
Address:
City:
Yamagata
Zip:
990-9585
Country:
Japan
Contact:
Last name:
Site 0100
Facility:
Name:
Local Institution - 0147
Address:
City:
Seoul
Zip:
03080
Country:
Korea, Republic of
Contact:
Last name:
Site 0147
Facility:
Name:
Local Institution - 0146
Address:
City:
Seoul
Zip:
05505
Country:
Korea, Republic of
Contact:
Last name:
Site 0146
Facility:
Name:
Local Institution - 0148
Address:
City:
Seoul
Zip:
06351
Country:
Korea, Republic of
Contact:
Last name:
Site 0148
Facility:
Name:
Local Institution - 0149
Address:
City:
Seoul
Zip:
06591
Country:
Korea, Republic of
Contact:
Last name:
Site 0149
Facility:
Name:
Local Institution - 0176
Address:
City:
Nijmegen
Zip:
6525 GA
Country:
Netherlands
Contact:
Last name:
Site 0176
Facility:
Name:
Local Institution - 0163
Address:
City:
Maastricht
Zip:
6229 HX
Country:
Netherlands
Contact:
Last name:
Site 0163
Facility:
Name:
Local Institution - 0179
Address:
City:
Amsterdam
Zip:
1081 HV
Country:
Netherlands
Contact:
Last name:
Site 0179
Facility:
Name:
Local Institution - 0161
Address:
City:
Groningen
Zip:
9700 RB
Country:
Netherlands
Contact:
Last name:
Site 0161
Facility:
Name:
Local Institution - 0159
Address:
City:
Utrecht
Zip:
3584 CX
Country:
Netherlands
Contact:
Last name:
Site 0159
Facility:
Name:
Local Institution - 0171
Address:
City:
Utrecht
Zip:
3584 CX
Country:
Netherlands
Contact:
Last name:
Site 0171
Facility:
Name:
Local Institution - 0016
Address:
City:
Oslo
Zip:
0450
Country:
Norway
Contact:
Last name:
Site 0016
Facility:
Name:
Local Institution - 0083
Address:
City:
Gdańsk
Zip:
80-214
Country:
Poland
Contact:
Last name:
Site 0083
Facility:
Name:
Local Institution - 0084
Address:
City:
Katowice
Zip:
40-519
Country:
Poland
Contact:
Last name:
Site 0084
Facility:
Name:
Local Institution - 0092
Address:
City:
Lublin
Zip:
20-090
Country:
Poland
Contact:
Last name:
Site 0092
Facility:
Name:
Local Institution - 0183
Address:
City:
Łódź
Zip:
93-513
Country:
Poland
Contact:
Last name:
Site 0183
Facility:
Name:
Local Institution - 0137
Address:
City:
Porto
Zip:
4200-072
Country:
Portugal
Contact:
Last name:
Site 0137
Facility:
Name:
Local Institution - 0173
Address:
City:
Bucuresti
Zip:
022328
Country:
Romania
Contact:
Last name:
Site 0173
Facility:
Name:
Local Institution - 0172
Address:
City:
Iași
Zip:
700483
Country:
Romania
Contact:
Last name:
Site 0172
Facility:
Name:
Local Institution - 0178
Address:
City:
Riyadh
Zip:
12713
Country:
Saudi Arabia
Contact:
Last name:
Site 0178
Facility:
Name:
Local Institution - 0180
Address:
City:
Singapore
Zip:
119074
Country:
Singapore
Contact:
Last name:
Site 0180
Facility:
Name:
Local Institution - 0181
Address:
City:
Singapore
Zip:
169608
Country:
Singapore
Contact:
Last name:
Site 0181
Facility:
Name:
Local Institution - 0136
Address:
City:
Santiago de Compostela
Zip:
15706
Country:
Spain
Contact:
Last name:
Site 0136
Facility:
Name:
Local Institution - 0135
Address:
City:
Pamplona
Zip:
31008
Country:
Spain
Contact:
Last name:
Site 0135
Facility:
Name:
Local Institution - 0134
Address:
City:
Salamanca
Zip:
37007
Country:
Spain
Contact:
Last name:
Site 0134
Facility:
Name:
Local Institution - 0027
Address:
City:
Huddinge
Zip:
141 86
Country:
Sweden
Contact:
Last name:
Site 0027
Facility:
Name:
Local Institution - 0168
Address:
City:
st.Gallen
Zip:
9007
Country:
Switzerland
Contact:
Last name:
Site 0168
Facility:
Name:
Local Institution - 0150
Address:
City:
Taipei City
Zip:
106
Country:
Taiwan
Contact:
Last name:
Site 0150
Facility:
Name:
Local Institution - 0151
Address:
City:
Taichung
Zip:
404332
Country:
Taiwan
Contact:
Last name:
Site 0151
Facility:
Name:
Local Institution - 0152
Address:
City:
Taipei
Zip:
10002
Country:
Taiwan
Contact:
Last name:
Site 0152
Facility:
Name:
Local Institution - 0170
Address:
City:
Ankara
Zip:
06200
Country:
Turkey
Contact:
Last name:
Site 0170
Facility:
Name:
Local Institution - 0182
Address:
City:
Cambridge
Zip:
CB2 2QQ
Country:
United Kingdom
Contact:
Last name:
Site 0182
Facility:
Name:
Local Institution - 0156
Address:
City:
Cambridge
Zip:
CB2 0QQ
Country:
United Kingdom
Facility:
Name:
Local Institution - 0155
Address:
City:
London
Zip:
NW1 2PG
Country:
United Kingdom
Contact:
Last name:
Site 0155
Facility:
Name:
Local Institution - 0157
Address:
City:
Oxford
Zip:
OX3 7LE
Country:
United Kingdom
Contact:
Last name:
Site 0157
Facility:
Name:
Local Institution - 0158
Address:
City:
Manchester
Zip:
M20 4BX
Country:
United Kingdom
Facility:
Name:
Local Institution - 0174
Address:
City:
Manchester
Zip:
M20 4BX
Country:
United Kingdom
Contact:
Last name:
Site 0174
Facility:
Name:
Local Institution - 0154
Address:
City:
Newcastle upon Tyne
Zip:
NE7 7DN
Country:
United Kingdom
Contact:
Last name:
Site 0154
Start date:
February 15, 2025
Completion date:
July 21, 2032
Lead sponsor:
Agency:
Juno Therapeutics, Inc., a Bristol-Myers Squibb Company
Agency class:
Industry
Collaborator:
Agency:
Celgene Corporation
Agency class:
Industry
Source:
Juno Therapeutics, Inc., a Bristol-Myers Squibb Company
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06615479
https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html
http://www.BMSClinicalTrials.com
