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KarMMa-9: 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

Sponsor
Bristol-Myers Squibb (Industry)
Overall Status
Not yet recruiting
CT.gov ID
NCT06045806
Collaborator
(none)
618
Enrollment
108
Locations
2
Arms
105.2
Anticipated Duration (Months)
5.7
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

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).

Condition or Disease Intervention/Treatment Phase
Phase 3

Study Design

Study Type:
Interventional
Anticipated Enrollment :
618 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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)
Anticipated Study Start Date :
Sep 27, 2023
Anticipated Primary Completion Date :
Mar 27, 2031
Anticipated Study Completion Date :
Jul 4, 2032

Arms and Interventions

Arm Intervention/Treatment
Experimental: Arm A

Biological: idecabtagene vicleucel
Specified dose on specified days
Other Names:
  • BMS-986395
  • Abecma
  • bb2121
  • ide-cel

    • Drug: Lenalidomide
    Specified dose on specified days
    Other Names:
  • Revlimid
  • LEN

    • Drug: Fludarabine
    Specified dose on specified days
    Other Names:
  • FLUDARA
  • BENDARBIN

    • Drug: Cyclophosphamide
    Specified dose on specified days
    Other Names:
  • ENDOXAN
  • CYTOXAN

    		•
    Active Comparator: Arm B

    Drug: Lenalidomide
    Specified dose on specified days
    Other Names:
  • Revlimid
  • LEN

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Progression Free Survival (PFS) [Up to approximately 49 months after the first participant is randomized]

      PFS as assessed by Independent Review Committee (IRC)

    Secondary Outcome Measures

    1. Overall Survival (OS) [Up to approximately 60 months after the last participant is randomized]

    2. Percentage of Participants with Sustained Minimal Residual Disease Negative (MRDneg) Complete Response (CR) for 12 months [From randomization up to 27 months from randomization]

    3. Percentage of Participants with Minimal Residual Disease Negative (MRDneg) Complete Response (CR) [From randomization up to 15 months from randomization]

    4. Event-Free Survival (EFS) [Up to approximately 60 months after the last participant is randomized]

    5. Duration of Response (DOR) [Up to approximately 60 months after the last participant is randomized]

    6. Percentage of Participants with Complete Response (CR) [Up to approximately 60 months after the last participant is randomized]

      CR as assessed by IRC

    7. Time to Progression (TTP) [Up to approximately 60 months after the last participant is randomized]

      Progression as assessed by IRC

    8. Progression post-next line of treatment (PFS2) [Up to approximately 60 months after the last participant is randomized]

    9. Time to Next Treatment (TTNT) [Up to approximately 60 months after the last participant is randomized]

    10. Number of Participants Experiencing Adverse Events (AEs) [Up to approximately 60 months after the last participant is randomized]

    11. Number of Participants Experiencing Adverse Events of Special Interest (AESI) [Up to approximately 60 months after the last participant is randomized]

    12. Maximum Observed Plasma Concentration (Cmax) [Up to approximately 60 months after the last participant is randomized]

    13. Time of Maximum Observed Plasma Concentration (Tmax) [Up to approximately 60 months after the last participant is randomized]

    14. Area Under the Curve (AUC) from time zero to 28 days post infusion (AUC [0- 28D]) [Up to 28 days post infusion]

    15. Time of Last Measurable Observed Plasma Concentration (Tlast) [Up to approximately 60 months after the last participant is randomized]

    16. Time-to-Definitive Deterioration [Up to approximately 49 months after the first participant is randomized]

      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

    17. Mean Change from Baseline in EORTC QLQ-C30 Selected Subscales [Up to approximately 49 months after the first participant is randomized]

      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

    18. Mean Change from Baseline in EORTC QLQ-MY20 Selected Subscales [Up to approximately 49 months after the first participant is randomized]

      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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Banner MD Anderson Cancer Center Gilbert Arizona United States 85234
    2 Mayo Clinic in Arizona - Scottsdale Scottsdale Arizona United States 85259
    3 University of California, Irvine (UCI) Health - UC Irvine Medical Center Orange California United States 92868
    4 University of California Davis (UC Davis) Comprehensive Cancer Center Sacramento California United States 95817
    5 Stanford University Medical Center Stanford California United States 94305
    6 Colorado Blood Cancer Institute Denver Colorado United States 80218
    7 Yale University School of Medicine New Haven Connecticut United States 06510
    8 Mayo Clinic in Florida Jacksonville Florida United States 32224
    9 Winship Cancer Institute, Emory University Atlanta Georgia United States 30322
    10 Northside Hospital Atlanta Georgia United States 30342
    11 Massachusetts General Hospital Boston Massachusetts United States 02114
    12 Boston Medical Center Boston Massachusetts United States 02118
    13 Boston Medical Center Boston Massachusetts United States 02118
    14 Ascension Providence Hospital Southfield Michigan United States 48075
    15 Mayo Clinic in Rochester, Minnesota Rochester Minnesota United States 55905
    16 Washington University School of Medicine Saint Louis Missouri United States 63110
    17 Columbia University Irving Medical Center New York New York United States 10032
    18 Wake Forest Baptist Health Winston-Salem North Carolina United States 27157
    19 University Hospitals Cleveland Medical Center Cleveland Ohio United States 44106
    20 The James Cancer Hospital and Solove Research Institute at The Ohio State University Comprehensive Cancer Center Columbus Ohio United States 43210
    21 UT Southwestern Medical Center Dallas Texas United States 75390-88520
    22 University of Texas MD Anderson Cancer Center Houston Texas United States 77030
    23 Local Institution - 0007 Camperdown New South Wales Australia 2050
    24 Local Institution - 0005 Brisbane Queensland Australia 4029
    25 Local Institution - 0004 Melbourne Victoria Australia 3000
    26 Local Institution - 0006 Melbourne Victoria Australia 3004
    27 Local Institution - 0008 Melbourne Victoria Australia 3065
    28 Local Institution - 0011 Murdoch Western Australia Australia 6150
    29 Local Institution - 0089 Salzburg Austria 5020
    30 Local Institution - 0090 Wien Austria 1090
    31 Local Institution - 0083 Anderlecht Bruxelles-Capitale, Région De Belgium 1070
    32 Local Institution - 0084 Brussels Bruxelles-Capitale, Région De Belgium 1090
    33 Local Institution - 0003 Calgary Alberta Canada T2N 4N2
    34 Local Institution - 0001 Hamilton Ontario Canada L8V5C2
    35 Local Institution - 0036 Brno Brno-město Czechia 625 00
    36 Local Institution - 0034 Hradec Kralove Hradec Králové Czechia 500 05
    37 Local Institution - 0035 Olomouc Olomoucký Kraj Czechia 779 00
    38 Local Institution - 0033 Praha 2 Czechia 12808
    39 Local Institution - 0070 Odense Syddanmark Denmark 5000
    40 CHU Bordeaux Haut-Leveque Pessac Aquitaine France 33600
    41 Institut Paoli-Calmettes Marseille Bouches-du-Rhône France 13273
    42 Hopital Claude Huriez - CHU de Lille Lille Nord France 59000
    43 Centre Hospitalier Universitaire de Nantes - L' Hopital l'hôtel-Dieu Nantes Pays-de-la-Loire France 44000
    44 Centre Hospitalier Lyon Sud Pierre-Bénite Rhône France 69310
    45 Henri Mondor Hospital Créteil Val-de-Marne France 94010
    46 Gustave Roussy Villejuif Val-de-Marne France 94800
    47 Centre Hospitalier Universitaire de Poitiers Poitiers Vienne France 86021
    48 Hôpital Saint-Louis Paris France 75010
    49 Institut Universitaire du Cancer Toulouse - Oncopole - CHU de TOULOUSE Toulouse France 31100
    50 Hôpital Saint Antoine Paris Île-de-France France 75571
    51 Local Institution - 0072 Heidelberg Baden-Württemberg Germany 69120
    52 Local Institution - 0078 Ulm Baden-Württemberg Germany 89081
    53 Local Institution - 0077 Nuremberg Bayern Germany 90419
    54 Local Institution - 0074 Wuerzburg Bayern Germany 97080
    55 Local Institution - 0073 Köln Nordrhein-Westfalen Germany 50937
    56 Local Institution - 0079 Dresden Sachsen Germany 01307
    57 Local Institution - 0087 Leipzig Sachsen Germany 04103
    58 Local Institution - 0075 Kiel Schleswig-Holstein Germany 24105
    59 Local Institution - 0115 Essen Germany 45122
    60 Local Institution - 0076 Hamburg Germany 20246
    61 Local Institution - 0063 Patras Achaḯa Greece 26504
    62 Local Institution - 0061 Athens Attikí Greece 106 76
    63 Local Institution - 0062 Chaidari Attikí Greece 12462
    64 Local Institution - 0060 Thessaloniki Thessaloníki Greece 570 10
    65 Local Institution - 0055 Be'er Sheva HaDarom Israel 8410101
    66 Local Institution - 0058 Petah-Tikva HaMerkaz Israel 4910021
    67 Local Institution - 0057 Ramat Gan HaMerkaz Israel 5262100
    68 Local Institution - 0088 Tel Aviv Tell Abīb Israel 6423906
    69 Local Institution - 0056 Haifa Israel 31096
    70 Local Institution - 0059 Jerusalem Israel 9112001
    71 Local Institution - 0064 Rozzano Milano Italy 20089
    72 Local Institution - 0067 Torino Piemonte Italy 10126
    73 Local Institution - 0065 Bologna Italy 40138
    74 Local Institution - 0066 Roma Italy 00161
    75 Local Institution - 0052 Nagoya Aichi Japan 467-8602
    76 Local Institution - 0048 Sapporo Hokkaido Japan 060-8648
    77 Local Institution - 0086 Nishinomiya Hyogo Japan 663-8501
    78 Local Institution - 0051 Kanazawa Ishikawa Japan 920-8641
    79 Local Institution - 0085 Isehara Kanagawa Japan 259-1193
    80 Local Institution - 0049 Chiba Japan 260-8677
    81 Local Institution - 0054 Fukuoka Japan 812-8582
    82 Local Institution - 0053 Okayama Japan 700-8558
    83 Local Institution - 0071 Shimotsuke Japan 329-0498
    84 Local Institution - 0050 Tokyo Japan 150-8935
    85 Local Institution - 0041 Hwasun Gun Jeonranamdo Korea, Republic of 58128
    86 Local Institution - 0039 Seoul Seoul-teukbyeolsi [Seoul] Korea, Republic of 03080
    87 Local Institution - 0040 Seoul Seoul-teukbyeolsi [Seoul] Korea, Republic of 05505
    88 Local Institution - 0038 Seoul Seoul-teukbyeolsi [Seoul] Korea, Republic of 06351
    89 Local Institution - 0043 Seoul Seoul-teukbyeolsi [Seoul] Korea, Republic of 06591
    90 Local Institution - 0069 Oslo Norway 0450
    91 Local Institution - 0027 Lublin Lubelskie Poland 20-090
    92 Local Institution - 0095 Warsaw Mazowieckie Poland 02-097
    93 Local Institution - 0023 Warsaw Mazowieckie Poland 02-776
    94 Local Institution - 0026 Gdańsk Pomorskie Poland 80-952
    95 Local Institution - 0024 Poznań Wielkopolskie Poland 60-569
    96 Local Institution - 0022 Gliwice Śląskie Poland 44-101
    97 Local Institution - 0091 Bucuresti București Romania 022328
    98 Local Institution - 0020 Badalona Barcelona [Barcelona] Spain 08916
    99 Local Institution - 0017 L'Hospitalet Del Llobregat Barcelona [Barcelona] Spain 08908
    100 Local Institution - 0016 Barcelona Catalunya [Cataluña] Spain 08036
    101 Local Institution - 0012 Pamplona Navarra Spain 31008
    102 Local Institution - 0021 Madrid Spain 28041
    103 Local Institution - 0013 Salamanca Spain 37007
    104 Local Institution - 0014 València Spain 46026
    105 Local Institution - 0093 Birmingham England United Kingdom B15 2TH
    106 Local Institution - 0080 London London, City Of United Kingdom SE5 9RS
    107 Local Institution - 0094 London London, City Of United Kingdom W12 0HS
    108 Local Institution - 0081 Glasgow United Kingdom G12 0YN

    Sponsors and Collaborators

    • Bristol-Myers Squibb

    Investigators

    • Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Bristol-Myers Squibb
    ClinicalTrials.gov Identifier:
    NCT06045806
    Other Study ID Numbers:
    • CA089-1043
    • 2022-501346-30
    • U1111-1280-9736
    First Posted:
    Sep 21, 2023
    Last Update Posted:
    Sep 27, 2023
    Last Verified:
    Sep 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Bristol-Myers Squibb
    CAR-T
    Additional relevant MeSH terms:
    Multiple Myeloma
    Neoplasms, Plasma Cell
    Cyclophosphamide
    Fludarabine
    Lenalidomide
    Idecabtagene vicleucel

    Study Results

    No Results Posted as of Sep 27, 2023