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Search / Trial NCT06232707

A Study to Evaluate Efficacy and Safety of Alnuctamab Compared to Standard of Care Regimens in Participants With Relapsed or Refractory Multiple Myeloma (RRMM)
Launched by CELGENE · Jan 22, 2024

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Nctid: NCT06232707

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"abbrev"=>"ANeo"}, {"name"=>"Antiemetics", "abbrev"=>"AnEm"}, {"name"=>"Gastrointestinal Agents", "abbrev"=>"Gast"}, {"name"=>"All Drugs and Chemicals", "abbrev"=>"All"}]}}, "protocolSection"=>{"designModule"=>{"phases"=>["PHASE3"], "studyType"=>"INTERVENTIONAL", "designInfo"=>{"allocation"=>"RANDOMIZED", "maskingInfo"=>{"masking"=>"NONE"}, "primaryPurpose"=>"TREATMENT", "interventionModel"=>"PARALLEL"}, "enrollmentInfo"=>{"type"=>"ACTUAL", "count"=>0}}, "statusModule"=>{"whyStopped"=>"Business objectives have changed", "overallStatus"=>"WITHDRAWN", "startDateStruct"=>{"date"=>"2024-05-03", "type"=>"ESTIMATED"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2024-05", "completionDateStruct"=>{"date"=>"2030-09-21", "type"=>"ESTIMATED"}, "lastUpdateSubmitDate"=>"2024-05-30", "studyFirstSubmitDate"=>"2024-01-22", "studyFirstSubmitQcDate"=>"2024-01-22", "lastUpdatePostDateStruct"=>{"date"=>"2024-05-31", "type"=>"ACTUAL"}, "studyFirstPostDateStruct"=>{"date"=>"2024-01-31", "type"=>"ACTUAL"}, "primaryCompletionDateStruct"=>{"date"=>"2025-11-16", "type"=>"ESTIMATED"}}, "outcomesModule"=>{"primaryOutcomes"=>[{"measure"=>"Progression-free Survival (PFS)", "timeFrame"=>"Up to 5 years"}], "secondaryOutcomes"=>[{"measure"=>"Overall Survival (OS)", "timeFrame"=>"Up to 5 years"}, {"measure"=>"Overall response (OR)", "timeFrame"=>"Up to 5 years"}, {"measure"=>"Complete response (CR) or better", "timeFrame"=>"Up to 5 years"}, {"measure"=>"Very good partial response (VGPR) or better", "timeFrame"=>"Up to 5 years"}, {"measure"=>"Time to response (TTR)", "timeFrame"=>"Up to 5 years"}, {"measure"=>"Duration of response (DOR)", "timeFrame"=>"Up to 5 years"}, {"measure"=>"Time to progression (TTP)", "timeFrame"=>"Up to 5 years"}, {"measure"=>"Time to next treatment (TTNT)", "timeFrame"=>"Up to 5 years"}, {"measure"=>"Progression-free survival 2 (PFS2)", "timeFrame"=>"Up to 5 years"}, {"measure"=>"Restricted mean DOR (RMDOR)", "timeFrame"=>"Up to 5 years"}, {"measure"=>"Minimal residual disease (MRD) negativity rate", "timeFrame"=>"Up to 5 years"}, {"measure"=>"Incidence of adverse events (AEs)", "timeFrame"=>"Up to 5 years"}, {"measure"=>"Incidence of serious adverse events (SAEs)", "timeFrame"=>"Up to 5 years"}, {"measure"=>"Change from baseline in subscale scores of European organization for research and treatment of cancer - quality of life core 30 (EORTC QLQ-C30)", "timeFrame"=>"Up to 5 years"}, {"measure"=>"Change from baseline in subscale scores of European quality of life multiple myeloma module (EORTC QLQ-MY20)", "timeFrame"=>"Up to 5 years"}]}, "oversightModule"=>{"oversightHasDmc"=>true, "isFdaRegulatedDrug"=>true, "isFdaRegulatedDevice"=>false}, "conditionsModule"=>{"keywords"=>["Relapsed or Refractory Multiple Myeloma", "BMS-986349", "CC-93269", "RRMM", "Alnuctamab", "CA058-1019", "ALUMMINATE RRMM"], "conditions"=>["Multiple Myeloma"]}, "referencesModule"=>{"seeAlsoLinks"=>[{"url"=>"https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html", "label"=>"BMS Clinical Trial Information"}, {"url"=>"https://www.bmsstudyconnect.com/s/US/English/USenHome", "label"=>"BMS Clinical Trial Patient Recruiting"}]}, "descriptionModule"=>{"briefSummary"=>"The purpose of this study is to evaluate the efficacy and safety of alnuctamab compared to standard of care regimens in participants with relapsed or refractory multiple myeloma (RRMM)."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["ADULT", "OLDER_ADULT"], "minimumAge"=>"18 years", "healthyVolunteers"=>false, "eligibilityCriteria"=>"Inclusion Criteria\n\n* Participant is willing and able to adhere to the study visit schedule and other protocol requirements including bone marrow aspirations and/or biopsies and hospitalization during the first cycle.\n* Documented diagnosis of multiple myeloma (MM), and must:.\n\n i) Received at least 1 but not more than 3 prior lines of anti-myeloma therapy.\n\nii) Received prior treatment with lenalidomide and an anti-CD38 monoclonal antibody (for at least 2 consecutive cycles).\n\niii) Achieved minimal response (MR) or better to at least 1 prior anti-myeloma therapy.\n\niv) Documented PD during or after their last anti-myeloma therapy or failure to achieve response.\n\n* Must have measurable disease (as determined by central laboratory).\n* Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0, 1, or 2 at the time of the screening.\n\nExclusion Criteria\n\n* Active, uncontrolled, or suspected infection.\n* Known current, or history of, central nervous system involvement of multiple myeloma.\n* History or presence of clinically relevant CNS pathology.\n* Received prior BCMA-targeted TCE or BCMA-targeted CAR-T therapy.\n* Previously received allogeneic stem cell transplantation at any time or received autologous stem cell transplantation within 3 months of initiating study intervention.\n* Other protocol-defined Inclusion/Exclusion criteria apply."}, "identificationModule"=>{"nctId"=>"NCT06232707", "acronym"=>"ALUMMINATE", "briefTitle"=>"A Study to Evaluate Efficacy and Safety of Alnuctamab Compared to Standard of Care Regimens in Participants With Relapsed or Refractory Multiple Myeloma (RRMM)", "organization"=>{"class"=>"INDUSTRY", "fullName"=>"Celgene"}, "officialTitle"=>"A Phase 3, Randomized, Multicenter, Open-label Study to Evaluate the Efficacy and Safety of Alnuctamab Compared to Standard of Care Regimens in Participants With Relapsed or Refractory Multiple Myeloma (RRMM) - ALUMMINATE RRMM", "orgStudyIdInfo"=>{"id"=>"CA058-1019"}, "secondaryIdInfos"=>[{"id"=>"2023-509472-42", "type"=>"REGISTRY", "domain"=>"EU Trial Number"}, {"id"=>"U1111-1281-8227", "type"=>"REGISTRY", "domain"=>"WHO"}]}, "armsInterventionsModule"=>{"armGroups"=>[{"type"=>"EXPERIMENTAL", "label"=>"Arm A: Alnuctamab", "interventionNames"=>["Drug: Alnuctamab"]}, {"type"=>"ACTIVE_COMPARATOR", "label"=>"Arm B: Standard of Care Regimens", "interventionNames"=>["Drug: Pomalidomide", "Drug: Daratumumab", "Drug: Elotuzumab", "Drug: Carfilzomib", "Drug: Dexamethasone"]}], "interventions"=>[{"name"=>"Alnuctamab", "type"=>"DRUG", "otherNames"=>["BMS-986349", "CC-93269"], "description"=>"Specified dose on specified days", "armGroupLabels"=>["Arm A: Alnuctamab"]}, {"name"=>"Pomalidomide", "type"=>"DRUG", "otherNames"=>["POMALYST®", "IMNOVID®", "CC-4047", "BMS-986379"], "description"=>"Specified dose on specified days", "armGroupLabels"=>["Arm B: Standard of Care Regimens"]}, {"name"=>"Daratumumab", "type"=>"DRUG", "otherNames"=>["DARZALEX®", "DARZALEX", "FASPRO®"], "description"=>"Specified dose on specified days", "armGroupLabels"=>["Arm B: Standard of Care Regimens"]}, {"name"=>"Elotuzumab", "type"=>"DRUG", "otherNames"=>["Empliciti®", "BMS-901608"], "description"=>"Specified dose on specified days", "armGroupLabels"=>["Arm B: Standard of Care Regimens"]}, {"name"=>"Carfilzomib", "type"=>"DRUG", "otherNames"=>["KYPROLIS®"], "description"=>"Specified dose on specified days", "armGroupLabels"=>["Arm B: Standard of Care Regimens"]}, {"name"=>"Dexamethasone", "type"=>"DRUG", "description"=>"Specified dose on specified days", "armGroupLabels"=>["Arm B: Standard of Care Regimens"]}]}, "contactsLocationsModule"=>{"locations"=>[{"zip"=>"35294", "city"=>"Birmingham", "state"=>"Alabama", "country"=>"United States", "facility"=>"Local Institution - 0151", "geoPoint"=>{"lat"=>33.52066, "lon"=>-86.80249}}, {"zip"=>"90095", "city"=>"Los Angeles", "state"=>"California", "country"=>"United States", "facility"=>"Local Institution - 0088", "geoPoint"=>{"lat"=>34.05223, "lon"=>-118.24368}}, {"zip"=>"94305", "city"=>"Stanford", "state"=>"California", "country"=>"United States", "facility"=>"Local Institution - 0358", "geoPoint"=>{"lat"=>37.42411, "lon"=>-122.16608}}, {"zip"=>"06520", "city"=>"New Haven", "state"=>"Connecticut", 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"affiliation"=>"Bristol-Myers Squibb"}]}, "ipdSharingStatementModule"=>{"url"=>"https://www.bms.com/researchers-and-partners/clinical-trials-and-research/disclosure-commitment.html", "infoTypes"=>["STUDY_PROTOCOL", "SAP", "CSR"], "timeFrame"=>"See Plan Description", "ipdSharing"=>"YES", "description"=>"BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria.\n\nAdditional information regarding Bristol Myer Squibb's data sharing policy and process can be found at:\n\nhttps://www.bms.com/researchers-and-partners/clinical-trials-and-research/disclosurecommitment.html", "accessCriteria"=>"See Plan Description"}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"Celgene", "class"=>"INDUSTRY"}, "responsibleParty"=>{"type"=>"SPONSOR"}}}}

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Trial Information

Current as of December 30, 2024

Withdrawn

Keywords

Relapsed Or Refractory Multiple Myeloma Bms 986349 Cc 93269 Rrmm Alnuctamab Ca058 1019 Alumminate Rrmm

ClinConnect Summary

No description provided

Gender

ALL

Eligibility criteria

• Inclusion Criteria
• Participant is willing and able to adhere to the study visit schedule and other protocol requirements including bone marrow aspirations and/or biopsies and hospitalization during the first cycle.
• Documented diagnosis of multiple myeloma (MM), and must:.
• i) Received at least 1 but not more than 3 prior lines of anti-myeloma therapy.
• ii) Received prior treatment with lenalidomide and an anti-CD38 monoclonal antibody (for at least 2 consecutive cycles).
• iii) Achieved minimal response (MR) or better to at least 1 prior anti-myeloma therapy.
• iv) Documented PD during or after their last anti-myeloma therapy or failure to achieve response.
• Must have measurable disease (as determined by central laboratory).
• Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0, 1, or 2 at the time of the screening.
• Exclusion Criteria
• Active, uncontrolled, or suspected infection.
• Known current, or history of, central nervous system involvement of multiple myeloma.
• History or presence of clinically relevant CNS pathology.
• Received prior BCMA-targeted TCE or BCMA-targeted CAR-T therapy.
• Previously received allogeneic stem cell transplantation at any time or received autologous stem cell transplantation within 3 months of initiating study intervention.
• Other protocol-defined Inclusion/Exclusion criteria apply.

Trial Officials

Bristol-Myers Squibb

Study Director

Bristol-Myers Squibb

About Celgene

Celgene, now a part of Bristol Myers Squibb, is a global biopharmaceutical company dedicated to advancing innovative therapies for patients with cancer and other serious diseases. With a strong emphasis on research and development, Celgene focuses on discovering and delivering transformative medicines that address unmet medical needs. The company is committed to enhancing patient outcomes through rigorous clinical trials, cutting-edge science, and collaboration with healthcare professionals, ultimately striving to improve the quality of life for patients worldwide.

Locations

Orange, California, United States

Columbus, Ohio, United States

Milwaukee, Wisconsin, United States

Iowa City, Iowa, United States

Buffalo, New York, United States

Little Rock, Arkansas, United States

Rochester, New York, United States

New Orleans, Louisiana, United States

Duarte, California, United States

Chicago, Illinois, United States

New York, New York, United States

Cleveland, Ohio, United States

Atlanta, Georgia, United States

Dallas, Texas, United States

Stanford, California, United States

Lubbock, Texas, United States

Birmingham, Alabama, United States

Clovis, California, United States

Cleveland, Ohio, United States

Jacksonville, Florida, United States

Pembroke Pines, Florida, United States

Portland, Oregon, United States

Seattle, Washington, United States

Omaha, Nebraska, United States

New Haven, Connecticut, United States

Park Ridge, Illinois, United States

Tucson, Arizona, United States

New York, New York, United States

Hackensack, New Jersey, United States

Seattle, Washington, United States

Cincinnati, Ohio, United States

Johnson City, New York, United States

Detroit, Michigan, United States

Anchorage, Alaska, United States

Atlanta, Georgia, United States

Kansas City, Missouri, United States

Jacksonville, Florida, United States

Baltimore, Maryland, United States

Atlanta, Georgia, United States

Baltimore, Maryland, United States

New York, New York, United States

Augusta, Georgia, United States

Winston Salem, North Carolina, United States

Cleveland, Ohio, United States

Encinitas, California, United States

New York, New York, United States

Indianapolis, Indiana, United States

Gilbert, Arizona, United States

Blacksburg, Virginia, United States

Southfield, Michigan, United States

Fresno, California, United States

Chapel Hill, North Carolina, United States

Athens, Georgia, United States

Louisville, Kentucky, United States

Bethesda, Maryland, United States

Providence, Rhode Island, United States

Rochester, New York, United States

Melbourne, Victoria, Australia

Rochester, Minnesota, United States

Mobile, Alabama, United States

Madison, Wisconsin, United States

Clayton, Victoria, Australia

Spokane, Washington, United States

Portland, Oregon, United States

Worcester, Massachusetts, United States

Los Angeles, California, United States

Florham Park, New Jersey, United States

Philadelphia, Pennsylvania, United States

Sacramento, California, United States

Neptune, New Jersey, United States

Santiago, Región Metropolitana De Santiago, Chile

Charlotte, North Carolina, United States

Dallas, Texas, United States

Guangzhou, Guangdong, China

Saint Louis, Missouri, United States

Summit, New Jersey, United States

Baton Rouge, Louisiana, United States

Wenatchee, Washington, United States

San Diego, California, United States

New Haven, Connecticut, United States

Norwalk, Connecticut, United States

Ames, Iowa, United States

Cincinnati, Ohio, United States

Watertown, South Dakota, United States

Federal Way, Washington, United States

Ciudad Autonoma De Buenos Aires, Buenos Aires, Argentina

Florencio Varela, Buenos Aires, Argentina

La Plata, Buenos Aires, Argentina

Pilar, Buenos Aires, Argentina

Buenos Aires, Ciudad Autónoma De Buenos Aires, Argentina

San Miguel De Tucumán, Tucumán, Argentina

Brisbane, Queensland, Australia

Southport, Queensland, Australia

Melbourne, Victoria, Australia

St. Polten, Niederösterreich, Austria

Innsbruck, Tirol, Austria

Salzburg, , Austria

Wien, , Austria

Brasschaat, Antwerpen, Belgium

Anderlecht, Bruxelles Capitale, Région De, Belgium

Brussels, Bruxelles Capitale, Région De, Belgium

Charleroi, Hainaut, Belgium

Verviers, Liège, Belgium

Yvoir, Namur, Belgium

Leuven, Vlaams Brabant, Belgium

Belo Horizonte, Minas Gerais, Brazil

João Pessoa, Paraíba, Brazil

Natal, Rio Grande Do Norte, Brazil

Sao Paulo, São Paulo, Brazil

Rio De Janeiro, , Brazil

São Paulo, , Brazil

Vancouver, British Columbia, Canada

London, Ontario, Canada

Ottawa, Ontario, Canada

Toronto, Ontario, Canada

Montreal, Quebec, Canada

Montréal, Quebec, Canada

Puerto Montt, Los Lagos, Chile

Santiago, Metropolitana De Santiago, Chile

Santiago, Región Metropolitana De Santiago, Chile

Hefei, Anhui, China

Beijing, Beijing, China

Changping, Beijing, China

Chongqing, Chongqing, China

Guangzhou, Guangdong, China

Shenzhen, Guangdong, China

Nanning, Guangxi, China

Baoding, Hebei, China

Shijiazhuang, Hebei, China

Harbin, Heilongjiang, China

Zhengzhou, Henan, China

Wuhan, Hubei, China

Changsha, Hunan, China

Nanjing, Jiangsu, China

Suzhou, Jiangsu, China

Xuzhou, Jiangsu, China

Nanchang, Jiangxi, China

Changchun, Jilin, China

Shenyang, Liaoning, China

Xi'an, Shaanxi, China

Jinan, Shandong, China

Shanghai, Shanghai, China

Taiyuan, Shanxi, China

Cheng Du, Sichuan, China

Tianjin, Tianjin, China

Hangzhou, Zhejiang, China

Qingdao, , China

Brno, Brno Město, Czechia

Hradec Kralove, Hradec Králové, Czechia

Ostrava, Moravskoslezský Kraj, Czechia

Olomouc, Olomoucký Kraj, Czechia

Prague, Praha 10, Czechia

Praha 2, , Czechia

Toulouse, Haute Garonne, France

Montpellier, Languedoc Roussillon, France

Vandoeuvre Lès Nancy, Lorraine, France

Lille, Nord, France

Nantes, Pays De La Loire, France

Pierre Bénite, Rhône, France

Heidelberg, Baden Württemberg, Germany

Tübingen, Baden Württemberg, Germany

Erlangen, Bayern, Germany

Dresden, Sachsen, Germany

Leipzig, Sachsen, Germany

Erlangen, , Germany

Hamburg, , Germany

Patras, Achaḯa, Greece

Athens, Attikí, Greece

Chaidari, Attikí, Greece

Pécs, Baranya, Hungary

Szeged, Csongrád, Hungary

Kaposvár, Somogy, Hungary

Nyiregyhaza, Szabolcs Szatmár Bereg, Hungary

Szombathely, Vas, Hungary

Budapest, , Hungary

Visakhapatnam, Andhra Pradesh, India

Gurgaon, Haryana, India

Bangalore, Karnataka, India

Mumbai, Maharashtra, India

Bhubaneswar, Odisha, India

Lucknow, Uttar Pradesh, India

Kolkata, West Bengal, India

Galway, Connaught, Ireland

Cork, , Ireland

Dublin, , Ireland

Limerick, , Ireland

Meldola, Emilia Romagna, Italy

Legnano, Milano, Italy

Milan, Milano, Italy

Palermo, Sicilia, Italy

Napoli, , Italy

Roma, , Italy

Kamogawa, Chiba, Japan

Kashiwa, Chiba, Japan

Osaka Sayama, Osaka, Japan

Shimotsuga, Tochigi, Japan

Koto, Tokyo, Japan

Kyoto, , Japan

Okayama, , Japan

Tokyo, , Japan

Seongnam, Kyǒnggi Do, Korea, Republic Of

Busan, Pusan Kwangyǒkshi, Korea, Republic Of

Seoul, Seoul Teukbyeolsi [Seoul], Korea, Republic Of

Jung Gu, Taegu Kwangyǒkshi, Korea, Republic Of

Maastricht, Limburg, Netherlands

Sittard Geleen, Limburg, Netherlands

Utrecht, , Netherlands

Løenskog, Akershus, Norway

Bergen, Hordaland, Norway

Oslo, , Norway

Lisbon, Lisboa, Portugal

Lisboa, , Portugal

Porto, , Portugal

Brasov, Brașov, Romania

Bucuresti, București, Romania

Timișoara, Timiș, Romania

București, , Romania

Cluj, , Romania

Sibiu, , Romania

Santiago De Compostela, A Coruña [La Coruña], Spain

Badalona, Barcelona [Barcelona], Spain

Girona, Girona [Gerona], Spain

El Palmar, Murcia, Murcia, Región De, Spain

Pamplona, Navarra, Spain

Jerez De La Frontera, , Spain

Salamanca, , Spain

València, , Spain

Helsingborg, Skåne Län [Se 12], Sweden

Lund, Skåne Län [Se 12], Sweden

Stockholm, Stockholms Län [Se 01], Sweden

Borås, Västra Götalands Län [Se 14], Sweden

Gothenburg, Västra Götalands Län [Se 14], Sweden

Linköping, östergötlands Län [Se 05], Sweden

Bern, Berne, Switzerland

St.Gallen, Sankt Gallen, Switzerland

Zürich, , Switzerland

Stanbul, İstanbul, Turkey

Mersn, Mersin, Turkey

Adana, , Turkey

Ankara, , Turkey

Antalya, , Turkey

Istanbul, , Turkey

İzmir, , Turkey

Kayseri, , Turkey

Southampton, Hampshire, United Kingdom

London, London, City Of, United Kingdom

Belfast, , United Kingdom

Cardiff, , United Kingdom

Derby, , United Kingdom

Manchester, , United Kingdom

Birmingham, Alabama, United States

Los Angeles, California, United States

Stanford, California, United States

New Orleans, Louisiana, United States

Baltimore, Maryland, United States

Hackensack, New Jersey, United States

Summit, New Jersey, United States

New York, New York, United States

Cincinnati, Ohio, United States

Cleveland, Ohio, United States

Providence, Rhode Island, United States

Dallas, Texas, United States

Seattle, Washington, United States

Liverpool, New South Wales, Australia

Macquarie University, New South Wales, Australia

Waratah, New South Wales, Australia

Box Hill, Victoria, Australia

Calgary, Alberta, Canada

Tianjin, Tianjin, China

Gurugram, Haryana, India

Anjo, Aichi, Japan

Nagoya, Aichi, Japan

Isehara, Kanagawa, Japan

Osaka Sayama, Osaka, Japan

Chiba, , Japan

Kumamoto, , Japan

Lisbon, Lisboa, Portugal

Birmingham, Alabama, United States

Washington, District Of Columbia, United States

Billings, Montana, United States

Lake Success, New York, United States

Pittsburgh, Pennsylvania, United States

Edmonton, Alberta, Canada

Brasov, , Romania

Santiago De Compostela, , Spain

Wichita, Kansas, United States

Saint Matthews, Kentucky, United States

Bethesda, Maryland, United States

Aomori, , Japan

People applied

0 patients applied

Timeline

First submit

January 22, 2024

Trial launched

May 03, 2024

Trial updated

May 30, 2024

Estimated completion

Not reported

Discussion 0

A Study to Evaluate Efficacy and Safety of Alnuctamab Compared to Standard of Care Regimens in Participants With Relapsed or Refractory Multiple Myeloma (RRMM) Launched by CELGENE · Jan 22, 2024

Frequently Asked Questions About Clinical Trials

A Study to Evaluate Efficacy and Safety of Alnuctamab Compared to Standard of Care Regimens in Participants With Relapsed or Refractory Multiple Myeloma (RRMM)
Launched by CELGENE · Jan 22, 2024