Multiple Myeloma Clinical Trial
— KarMMa-9Official 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)
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).
| Status | Recruiting |
| Enrollment | 618 |
| Est. completion date | July 4, 2032 |
| Est. primary completion date | March 27, 2031 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | 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. - Other protocol-defined Inclusion/Exclusion criteria apply. |
| Country | Name | City | State |
|---|---|---|---|
| Australia | Local Institution - 0005 | Brisbane | Queensland |
| Australia | Royal Prince Alfred Hospital | Camperdown | New South Wales |
| Australia | Peter MacCallum Cancer Centre | Melbourne | Victoria |
| Australia | St Vincent's Hospital | Melbourne | Victoria |
| Australia | The Alfred Hospital | Melbourne | Victoria |
| Australia | Fiona Stanley Hospital | Murdoch | Western Australia |
| Austria | Uniklinikum Salzburg | Salzburg | |
| Austria | Medizinische Universität Wien | Wien | |
| Belgium | Institut Jules Bordet | Anderlecht | Bruxelles-Capitale, Région De |
| Belgium | UZ Brussel | Brussels | Bruxelles-Capitale, Région De |
| Canada | Local Institution - 0133 | Edmonton | Alberta |
| Canada | Hamilton Health Sciences-Juravinski Cancer Centre | Hamilton | Ontario |
| Canada | Local Institution - 0134 | Montreal | Quebec |
| Czechia | Local Institution - 0036 | Brno | Brno-mesto |
| Czechia | Local Institution - 0034 | Hradec Kralove | Hradec Králové |
| Czechia | Local Institution - 0035 | Olomouc | Olomoucký Kraj |
| Czechia | Local Institution - 0033 | Praha 2 | |
| Denmark | Local Institution - 0070 | Odense | Syddanmark |
| France | Henri Mondor Hospital | Créteil | Val-de-Marne |
| France | Hopital Claude Huriez - CHU de Lille | Lille | Nord |
| France | Institut Paoli-Calmettes | Marseille | Bouches-du-Rhône |
| France | Centre Hospitalier Universitaire de Nantes - L' Hopital l'hôtel-Dieu | Nantes | Pays-de-la-Loire |
| France | Hôpital Saint Antoine | Paris | Île-de-France |
| France | Hôpital Saint-Louis | Paris | |
| France | CHU Bordeaux Haut-Leveque | Pessac | Aquitaine |
| France | Centre Hospitalier Lyon Sud | Pierre-Bénite | Rhône |
| France | Local Institution - 0029 | Poitiers | Vienne |
| France | Institut Universitaire du Cancer Toulouse - Oncopole - CHU de TOULOUSE | Toulouse | |
| France | Gustave Roussy | Villejuif | Val-de-Marne |
| Germany | Local Institution - 0079 | Dresden | Sachsen |
| Germany | Local Institution - 0115 | Essen | |
| Germany | Local Institution - 0076 | Hamburg | |
| Germany | Local Institution - 0072 | Heidelberg | Baden-Württemberg |
| Germany | Local Institution - 0075 | Kiel | Schleswig-Holstein |
| Germany | Local Institution - 0073 | Köln | Nordrhein-Westfalen |
| Germany | Local Institution - 0087 | Leipzig | Sachsen |
| Germany | Local Institution - 0077 | Nuremberg | Bayern |
| Germany | Local Institution - 0078 | Ulm | Baden-Württemberg |
| Germany | Local Institution - 0074 | Wuerzburg | |
| Greece | Evangelismos General Hospital of Athens | Athens | Attikí |
| Greece | Attikon General University Hospital | Chaidari | Attikí |
| Greece | University Hospital of Patras | Patras | Acha?a |
| Greece | G. Papanikolaou General Hospital | Thessaloniki | Thessaloníki |
| Israel | Local Institution - 0055 | Be'er Sheva | HaDarom |
| Israel | Rambam Health Care Campus | Haifa | |
| Israel | Hadassah Medical Center | Jerusalem | |
| Israel | Local Institution - 0058 | Petah-Tikva | HaMerkaz |
| Israel | Sheba Medical Center | Ramat Gan | HaMerkaz |
| Israel | Sourasky Medical Center | Tel Aviv | Tell Abib |
| Italy | IRCCS Azienda Ospedaliero-Universitaria di Bologna, Policlinico di Sant'Orsola | Bologna | |
| Italy | AOU Policlinico Umberto I | Roma | |
| Italy | Humanitas | Rozzano | Milano |
| Italy | Local Institution - 0067 | Torino | Piemonte |
| Japan | Chiba University Hospital | Chiba | |
| Japan | Local Institution - 0054 | Fukuoka | |
| Japan | Tokai University Hospital | Isehara | Kanagawa |
| Japan | Kanazawa University Hospital | Kanazawa | Ishikawa |
| Japan | Nagoya City University Hospital | Nagoya | Aichi |
| Japan | Hyogo Medical University Hospital | Nishinomiya | Hyogo |
| Japan | Okayama University Hospital | Okayama | |
| Japan | Hokkaido University Hospital | Sapporo | Hokkaido |
| Japan | Local Institution - 0071 | Shimotsuke | |
| Japan | Local Institution - 0050 | Tokyo | |
| Korea, Republic of | Local Institution - 0041 | Hwasun Gun | Jeonranamdo |
| Korea, Republic of | Local Institution - 0038 | Seoul | Seoul-teukbyeolsi [Seoul] |
| Korea, Republic of | Local Institution - 0039 | Seoul | Seoul-teukbyeolsi [Seoul] |
| Korea, Republic of | Local Institution - 0040 | Seoul | Seoul-teukbyeolsi [Seoul] |
| Korea, Republic of | Local Institution - 0043 | Seoul | Seoul-teukbyeolsi [Seoul] |
| Norway | Oslo Universitetssykehus Rikshospitalet | Oslo | |
| Poland | Uniwersyteckie Centrum Kliniczne | Gdansk | |
| Poland | Narodowy Instytut Onkologii - Oddzial w Gliwicach | Gliwice | Slaskie |
| Poland | Centrum Onkologii Ziemi Lubelskiej | Lublin | Lubelskie |
| Poland | Uniwersytecki Szpital Kliniczny w Poznaniu | Poznan | |
| Poland | Instytut Hematologii i Transfuzjologii | Warsaw | Mazowieckie |
| Poland | Samodzielny Publiczny Centralny Szpital Kliniczny w Warszawie | Warsaw | Mazowieckie |
| Romania | Institutul Clinic Fundeni | Bucharest | |
| Spain | Institut Català d'Oncologia (ICO) - Badalona | Badalona | Barcelona [Barcelona] |
| Spain | Hospital Clínic de Barcelona | Barcelona | Catalunya [Cataluña] |
| Spain | Institut Català d'Oncologia - L'Hospitalet | L'Hospitalet Del Llobregat | Barcelona [Barcelona] |
| Spain | Hospital Universitario 12 de Octubre | Madrid | |
| Spain | Clinica Universidad de Navarra | Pamplona | Navarra |
| Spain | Hospital Universitario de Salamanca - Complejo Asistencial Universitario de Salamanca | Salamanca | |
| Spain | Hospital Universitari i Politecnic La Fe | València | |
| United Kingdom | Local Institution - 0093 | Birmingham | England |
| United Kingdom | Local Institution - 0081 | Glasgow | |
| United Kingdom | Local Institution - 0080 | London | London, City Of |
| United Kingdom | Local Institution - 0094 | London | London, City Of |
| United States | Local Institution - 0123 | Ann Arbor | Michigan |
| United States | Northside Hospital | Atlanta | Georgia |
| United States | Winship Cancer Institute, Emory University | Atlanta | Georgia |
| United States | St. David's South Austin Medical Center | Austin | Texas |
| United States | Boston Medical Center | Boston | Massachusetts |
| United States | Massachusetts General Hospital | Boston | Massachusetts |
| United States | Novant Health Cancer Institute - Elizabeth | Charlotte | North Carolina |
| United States | University Hospitals Cleveland Medical Center | Cleveland | Ohio |
| United States | The James Cancer Hospital and Solove Research Institute at The Ohio State University Comprehensive Cancer Center | Columbus | Ohio |
| United States | UT Southwestern Medical Center | Dallas | Texas |
| United States | Colorado Blood Cancer Institute | Denver | Colorado |
| United States | Banner MD Anderson Cancer Center | Gilbert | Arizona |
| United States | Houston Methodist Hospital | Houston | Texas |
| United States | University of Texas MD Anderson Cancer Center | Houston | Texas |
| United States | Mayo Clinic in Florida | Jacksonville | Florida |
| United States | UCLA Hematology/Oncology - Westwood (Building 200 Suite 120) | Los Angeles | California |
| United States | Local Institution - 0119 | Minneapolis | Minnesota |
| United States | Yale University School of Medicine | New Haven | Connecticut |
| United States | Columbia University Irving Medical Center | New York | New York |
| United States | University of California, Irvine (UCI) Health - UC Irvine Medical Center | Orange | California |
| United States | AdventHealth Orlando | Orlando | Florida |
| United States | Hospital of the University of Pennsylvania | Philadelphia | Pennsylvania |
| United States | Local Institution - 0136 | Richmond | Virginia |
| United States | Mayo Clinic in Rochester, Minnesota | Rochester | Minnesota |
| United States | University of California Davis (UC Davis) Comprehensive Cancer Center | Sacramento | California |
| United States | Washington University School of Medicine | Saint Louis | Missouri |
| United States | Washington University School of Medicine | Saint Louis | Missouri |
| United States | Mayo Clinic in Arizona - Scottsdale | Scottsdale | Arizona |
| United States | Ascension Providence Hospital | Southfield | Michigan |
| United States | Moffitt Cancer Center | Tampa | Florida |
| United States | Wake Forest Baptist Health | Winston-Salem | North Carolina |
| Lead Sponsor | Collaborator |
|---|---|
| Celgene | Bristol-Myers Squibb |
United States, Australia, Austria, Belgium, Canada, Czechia, Denmark, France, Germany, Greece, Israel, Italy, Japan, Korea, Republic of, Norway, Poland, Romania, Spain, United Kingdom,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Progression Free Survival (PFS) | PFS as assessed by Independent Review Committee (IRC) | Up to approximately 49 months after the first participant is randomized | |
| Secondary | Overall Survival (OS) | Up to approximately 60 months after the last participant is randomized | ||
| Secondary | Percentage of Participants with Sustained Minimal Residual Disease Negative (MRDneg) Complete Response (CR) for 12 months | From randomization up to 27 months from randomization | ||
| Secondary | Percentage of Participants with Minimal Residual Disease Negative (MRDneg) Complete Response (CR) | From randomization up to 15 months from randomization | ||
| Secondary | Event-Free Survival (EFS) | Up to approximately 60 months after the last participant is randomized | ||
| Secondary | Duration of Response (DOR) | Up to approximately 60 months after the last participant is randomized | ||
| Secondary | Percentage of Participants with Complete Response (CR) | CR as assessed by IRC | Up to approximately 60 months after the last participant is randomized | |
| Secondary | Time to Progression (TTP) | Progression as assessed by IRC | Up to approximately 60 months after the last participant is randomized | |
| Secondary | Progression post-next line of treatment (PFS2) | Up to approximately 60 months after the last participant is randomized | ||
| Secondary | Time to Next Treatment (TTNT) | Up to approximately 60 months after the last participant is randomized | ||
| Secondary | Number of Participants Experiencing Adverse Events (AEs) | Up to approximately 60 months after the last participant is randomized | ||
| Secondary | Number of Participants Experiencing Adverse Events of Special Interest (AESI) | Up to approximately 60 months after the last participant is randomized | ||
| Secondary | Maximum Observed Plasma Concentration (Cmax) | Up to approximately 60 months after the last participant is randomized | ||
| Secondary | Time of Maximum Observed Plasma Concentration (Tmax) | Up to approximately 60 months after the last participant is randomized | ||
| Secondary | Area Under the Curve (AUC) from time zero to 28 days post infusion (AUC [0- 28D]) | Up to 28 days post infusion | ||
| Secondary | Time of Last Measurable Observed Plasma Concentration (Tlast) | Up to approximately 60 months after the last participant is randomized | ||
| Secondary | 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 | Up to approximately 49 months after the first participant is randomized | |
| Secondary | 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 |
Up to approximately 49 months after the first participant is randomized | |
| Secondary | 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 |
Up to approximately 49 months after the first participant is randomized |
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