A Study of Modakafusp Alfa on Adult Participants With Relapsed/Refractory Multiple Myeloma
NCT ID: NCT03215030
Last Updated: 2026-01-29
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE1/PHASE2
272 participants
INTERVENTIONAL
2017-10-04
2024-11-07
Brief Summary
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Part 1: To determine any side effects from modakafusp alfa single treatment and how often they occur. The dose of modakafusp alfa will be increased a little at a time until the highest dose that does not cause harmful side effects is found.
Part 2: To assess clinical activity of one or more dosing schedules of modakafusp alfa alone in participants with relapsed/refractory multiple myeloma. Dexamethasone standard dose will be administered with one or more selected dose of modakafusp alfa in selected group of participants.
Part 3: To find the optimal dose with the more favorable risk-benefit profile of modakafusp alfa.
Participants will receive modakafusp alfa at one of two doses which will be given through a vein.
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Detailed Description
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Part 1: Dose Escalation, Part 2: Dose Expansion, Part 3: Dose Extension
The study will enroll approximately 65 participants in Part 1, 35 in Part 2, and 236 in Part 3. Participants will be assigned to one of the following treatment groups in Parts 1 and 2 of the study. Participants will be randomly assigned in Part 3 of the study as given below:
* Part 1 (Dose Escalation) Schedule A: Modakafusp alfa 0.001 Up to 14 mg/kg
* Part 1 (Dose Escalation) Schedule B: Modakafusp alfa TBD
* Part 1 (Dose Escalation) Schedule C: Modakafusp alfa TBD
* Part 1 (Dose Escalation) Schedule D: Modakafusp alfa TBD
* Part 2 (Dose Expansion): Modakafusp alfa TBD + Dexamethasone 40 mg
* Part 3 (Dose Extension): Modakafusp alfa 120 mg
* Part 3 (Dose Extension): Modakafusp alfa 240 mg
The Part 1 (Dose Escalation) portion of the study will follow a 3+3 dose escalation design to evaluate once-weekly up to 4 different schedules of administration of modakafusp alfa starting at 0.001 mg/kg for dose limiting toxicity (DLT) evaluation and to determine the maximum tolerated dose (MTD) or an optimal biological dose (OBD) for assessments in Part 2.
The Part 2 (Dose Expansion) will further assess the safety profile of modakafusp alfa and its efficacy at MTD or OBD.
For Part 3 (Dose Extension) participants will be randomized 1:1 to receive single-agent modakafusp alfa 120 mg or 240 mg Q4W.
Parts 1 and 2 will be conducted at multiple centers in the United States. Part 3 will be conducted worldwide. The maximum treatment duration in this study is up to 12 months (Parts 1 and 2) or until disease progression (Part 3) and overall time to participate in the study is approximately up to 90 months. Participants with clinical benefit may continue treatment after sponsor approval.
Conditions
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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Part 1 (Dose Escalation) Schedule A
Participants received Modakafusp alfa 0.001 up to 0.75 milligram per kilogram (mg/kg), infusion, intravenously (IV), once every week (Q1W) on Days 1, 8, 15 and 22 of each 28-day treatment cycle up to 2 cycles, followed by once every 2 weeks (Q2W) on Days 1 and 15 of each 28-day treatment cycle up to 4 cycles, followed by once every 4 weeks (Q4W) on Day 1 of each 28-day treatment cycle until treatment discontinuation.
Modakafusp alfa
Modakafusp alfa intravenous infusion.
Part 1 (Dose Escalation) Schedule B
Participants received Modakafusp alfa 0.20 up to 0.30 mg/kg, infusion, IV, Q2W on Days 1 and 15 of each 28-day treatment cycle until treatment discontinuation.
Modakafusp alfa
Modakafusp alfa intravenous infusion.
Part 1 (Dose Escalation) Schedule C
Participants received Modakafusp alfa 0.40 up to 0.75 mg/kg, infusion, IV, once every 3 weeks (Q3W) on Day 1 of each 21-day treatment cycle until treatment discontinuation.
Modakafusp alfa
Modakafusp alfa intravenous infusion.
Part 1 (Dose Escalation) Schedule D
Participants received Modakafusp alfa 1.5 up to 6.0 mg/kg, infusion, IV, Q4W on Day 1 of each 28-day treatment cycle until treatment discontinuation.
Modakafusp alfa
Modakafusp alfa intravenous infusion.
Part 2 (Dose Expansion): Schedule C: Modakafusp Alfa
Participants received modakafusp alfa 0.400 mg/kg infusion, IV, Q3W on Day 1 of each 21-day treatment cycle until treatment discontinuation.
Modakafusp alfa
Modakafusp alfa intravenous infusion.
Part 2 (Dose Expansion):ScheduleC:Modakafusp Alfa+Dexamethasone
Participants received modakafusp alfa 0.400 mg/kg infusion, IV, and dexamethasone 40 mg, orally, Q3W on Day 1 of each 21-day treatment cycle until treatment discontinuation.
Modakafusp alfa
Modakafusp alfa intravenous infusion.
Dexamethasone
Dexamethasone.
Part 2 (Dose Expansion): Schedule D: Modakafusp Alfa
Participants received modakafusp alfa 1.500 mg/kg infusion, IV, Q4W on Day 1 of each 28-day treatment cycle until treatment discontinuation.
Modakafusp alfa
Modakafusp alfa intravenous infusion.
Part 2 (Dose Expansion): Schedule D: Modakafusp Alfa + Dexamethasone
Participants received modakafusp alfa 1.500 mg/kg infusion, IV, and dexamethasone 40 mg, orally, Q4W on Day 1 of each 28-day treatment cycle until treatment discontinuation.
Modakafusp alfa
Modakafusp alfa intravenous infusion.
Dexamethasone
Dexamethasone.
Part 3 (Dose Extension): Modakafusp Alfa 120 mg
Participants received modakafusp alfa 120 mg, infusion, IV, Q4W, for each 28-day treatment cycle until disease progression or treatment discontinuation.
Modakafusp alfa
Modakafusp alfa intravenous infusion.
Part 3 (Dose Extension): Modakafusp Alfa 240 mg
Participants received modakafusp alfa 240 mg, infusion, IV, Q4W, for each 28-day treatment cycle until disease progression or treatment discontinuation.
Modakafusp alfa
Modakafusp alfa intravenous infusion.
Japan Lead-in: Modakafusp Alfa 60 mg
Participants received modakafusp alfa 60 mg, infusion, IV, Q4W, for each 28-day treatment cycle until disease progression or treatment discontinuation.
Modakafusp alfa
Modakafusp alfa intravenous infusion.
Japan Lead-in: Modakafusp Alfa 120 mg
Participants received modakafusp alfa 120 mg, infusion, IV, Q4W, for each 28-day treatment cycle until disease progression or treatment discontinuation.
Modakafusp alfa
Modakafusp alfa intravenous infusion.
Interventions
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Modakafusp alfa
Modakafusp alfa intravenous infusion.
Dexamethasone
Dexamethasone.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
1\. Has MM defined by the IMWG criteria with evidence of disease progression and:
* In need of additional myeloma therapy as determined by the investigator.
* Has previously received at least 3 lines of myeloma therapy (for example, containing an Immunomodulatory imide drug \[IMiD\], a proteasome inhibitor \[PI\], an alkylating agent, and/or an anti-CD38 as single agents or in combination).
* Is either refractory to or intolerant of at least 1 PI and a least 1 IMiD.
For Part 3:
1. Has MM defined by the IMWG criteria with evidence of disease progression and:
* In need of additional myeloma therapy as determined by the investigator.
* Has previously received at least 3 lines of myeloma therapy.
* Is refractory to at least 1 IMiD (ie, lenalidomide or pomalidomide \[thalidomide excluded\]), at least 1 PI (ie, bortezomib, ixazomib, or carfilzomib), and refractory to at least 1 anti-CD38 antibody (ie, daratumumab or isatuximab) and has demonstrated disease progression with the last therapy. Participants who are primary refractory, meaning they never achieved at least a MR with any previous treatment line, are not eligible.
2. For participants in Part 2 and 3 only: Measurable disease is defined as :
1. Serum M-protein ≥500 mg/dL (≥5 g/L)
2. Urine M-protein ≥200 mg/24 hours.
3. Serum free light chain (FLC) assay, with involved FLC level ≥10 mg/dL (≥100 mg/L) provided serum FLC ratio is abnormal.
3. During Part 1 only, participants not meeting the above criteria for measurable disease should, at least, have measurable bone marrow plasmacytosis (greater than or equal to \[≥ \] 10 percent \[%\]) and/or plasmacytoma (≥1 centimeter \[cm\] in diameter) detected by physical examination or imaging.
4. Eastern Cooperative Oncology Group (ECOG) performance status of ≤2.
Exclusion Criteria
1. Has polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes (POEMS) syndrome, monoclonal gammopathy of unknown significance, smoldering myeloma, solitary plasmacytoma, amyloidosis, Waldenstrom macroglobulinemia or immunoglobulin M (IgM) myeloma, or lymphoplasmacytic lymphoma (LPL).
2. Who have received autologous stem cell transplant (SCT) 60 days before first infusion of modakafusp alfa or participants who have received allogeneic SCT 6 months before first infusion. Graft-versus-host disease that is active or requires ongoing systemic immunosuppression.
3. Has not recovered from adverse reactions to prior myeloma treatment or procedures (chemotherapy, immunotherapy, radiation therapy) to NCI CTCAE less than or equal to (≤) Grade 1 or baseline, except for sensory or motor neuropathy which should have recovered to ≤ Grade 2 or baseline.
4. Has clinical signs of central nervous system involvement of MM.
For Part 3:
* Hepatitis B virus (HBV) or hepatitis C virus (HCV) infection. Seropositive for hepatitis B (defined by a positive test for hepatitis B surface antigen \[HBsAg\]. Participants with resolved infection (that is, participants who are HBsAg negative but positive for antibodies to hepatitis B core antigen \[anti-HBc\] and/or antibodies to hepatitis B surface antigen \[anti-HBs\]) must be screened using real-time polymerase chain reaction (PCR) measurement of HBV DNA levels. Those who are PCR positive will be excluded.
* In addition to the above criteria, participants must not have plasma cell leukemia or have had primary refractory MM, current central nervous system involvement of MM, myelodysplastic syndrome, myeloproliferative syndrome, or have had a second malignancy within the previous 3 years, except treated basal cell or localized squamous skin carcinomas, localized prostate cancer, cervical carcinoma in situ, resected colorectal adenomatous polyps, breast cancer in situ, or other malignancy for which the participant is not on active anticancer therapy.
18 Years
ALL
No
Sponsors
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Teva Branded Pharmaceutical Products R&D LLC
INDUSTRY
Responsible Party
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Locations
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Highlands Oncology Group
Springdale, Arkansas, United States
Los Angeles Cancer Network - Glendale Adventist Medical Center
Glendale, California, United States
University of California Irvine
Orange, California, United States
Office of James R. Berenson MD
West Hollywood, California, United States
Smilow Cancer Hospital at Yale New Haven
New Haven, Connecticut, United States
Winship Cancer Institute of Emory University
Atlanta, Georgia, United States
Northwestern Medicine - Northwestern Medical Group
Chicago, Illinois, United States
Loyola University Medical Center
Maywood, Illinois, United States
Investigative Clinical Research of Indiana, LLC
Noblesville, Indiana, United States
June E. Nylen Cancer Center
Sioux City, Iowa, United States
Johns Hopkins Hospital
Baltimore, Maryland, United States
Boston Medical Center
Boston, Massachusetts, United States
Dana Farber Cancer Institute
Boston, Massachusetts, United States
Univeristy of Nebraska Medical Center
Omaha, Nebraska, United States
USOR - Comprehensive Cancer Centers of Nevada - Central Valley
Las Vegas, Nevada, United States
John Theurer Cancer Center
Hackensack, New Jersey, United States
University of Rochester
Rochester, New York, United States
Montefiore Medical Center
The Bronx, New York, United States
Levine Cancer Center
Charlotte, North Carolina, United States
Levine Cancer Institute - Concord
Concord, North Carolina, United States
Duke University Medical Center
Durham, North Carolina, United States
Gabrail Cancer Center
Canton, Ohio, United States
The Ohio State University
Columbus, Ohio, United States
Oregon Health and Science University
Portland, Oregon, United States
University of Pennsylvania
Philadelphia, Pennsylvania, United States
Baptist Cancer Center - Memphis - Walnut Grove
Memphis, Tennessee, United States
Lumi Research
Houston, Texas, United States
British Columbia Cancer Agency Vancouver Centre
Vancouver, British Columbia, Canada
Juravinski Cancer Centre
Hamilton, Ontario, Canada
Centre de Recherche du CHUM
Montreal, Quebec, Canada
Sir Mortimer B. Davis Jewish General Hospital
Montreal, Quebec, Canada
Peking University People's Hospital
Beijing, Beijing Municipality, China
Peking University Third Hospital
Beijing, Beijing Municipality, China
Sun Yat-Sen University Cancer Center
Guangzhou, Guangdong, China
Henan Cancer Hospital
Zhengzhou, Henan, China
Wuhan Union Hospital
Wuhan, Hubei, China
Zhongnan Hospital of Wuhan University
Wuhan, Hubei, China
Nanjing Drum Tower Hospital
Nanjing, Jiangsu, China
The First Affiliated Hospital of Soochow University - Suzhou First People's Hospital
Suzhou, Jiangsu, China
Shanghai Fourth People's Hospital
Shanghai, Shanghai Municipality, China
Tianjin Medical University Cancer Institute & Hospital
Tianjin, Tianjin Municipality, China
The First Affiliated Hospital, Zhejiang University
Hangzhou, Zhejiang, China
Institut de cancerologie Strasbourg Europe
Strasbourg, Alsace, France
Hopital Saint-Vincent de Paul - Lille
Lille, Hauts-de-France, France
Centre Hospitalier Regional Universitaire de Lille
Lille, Hauts-de-France, France
Centre Hospitalier Universitaire de Toulouse Hopital Purpan
Toulouse, Midi-pyrenees, France
Centre Hospitalier Universitaire Nantes - Hotel Dieu
Nantes, Pays de la Loire Region, France
Centre Hospitalier Universitaire de Poitiers
Poitiers, Poitou-charentes, France
Centre Hospitalier d'Argenteuil - Centre Hospitalier Victor Dupouy
Argenteuil, , France
Centre Hospitalier Universitaire Henri Mondor
Créteil, Île-de-France Region, France
Hopital Saint-Antoine
Paris, Île-de-France Region, France
Hopital Necker-Enfants Malades
Paris, Île-de-France Region, France
Universitatsklinik Tubingen
Tübingen, Baden-Wurttemberg, Germany
Universitatsklinikum Leipzig
Leipzig, Saxony, Germany
Evaggelismos General Hospital
Athens, Attica, Greece
Alexandra General Hospital of Athens
Athens, Attica, Greece
University Regional General Hospital of Patras
Patra, Peloponnese, Greece
The Chaim Sheba Medical Center
Ramat Gan, Tel Aviv, Israel
Hadassah Medical Center
Jerusalem, , Israel
Tel Aviv Sourasky Medical Center
Tel Aviv, , Israel
AON SS Antonio e Biagio e Cesare Arrigo
Alessandria, , Italy
Azienda Ospedaliero Universitaria Ospedali Riuniti di Ancona
Ancona, , Italy
Azienda Ospedaliero-Universitaria di Bologna - Policlinico Sant'Orsola-Malpighi
Bologna, , Italy
Azienda Ospedaliero - Universitaria Policlinico - Vittorio Emanuele
Catania, , Italy
Fondazione IRCCS Policlinico San Matteo
Pavia, , Italy
Nagoya City University Hospital
Nagoya, Aichi-ken, Japan
Ogaki Municipal Hospital
Gifu, Gifu, Japan
University Hospital Kyoto Prefectural University of Medicine
Kyoto, Kyoto, Japan
National Hospital Organization Okayama Medical Center
Okayama, Okayama-ken, Japan
Japanese Red Cross Medical Center
Tokyo, , Japan
Oslo Universitetssykehus-Ulleval Hospital
Oslo, , Norway
Ad-Vance Medical Research
Ponce, PR, Puerto Rico
Hospital Espanol Auxilio Mutuo
San Juan, , Puerto Rico
Chonnam National University Hwasun Hospital
Hwasun, Jeollanam-do, South Korea
Seoul National University Hospital
Seoul, , South Korea
The Catholic University of Korea - Seoul St. Mary's Hospital
Seoul, , South Korea
Hospital Universitari Germans Trias i Pujol
Badalona, Barcelona, Spain
Hospital Universitari Vall d'Hebron
Barcelona, , Spain
Hospital Clinic de Barcelona
Barcelona, , Spain
Hospital Universitario 12 de Octubre
Madrid, , Spain
Hospital Universitario Virgen de la Arrixaca
Murcia, , Spain
Hospital Universitario de Salamanca
Salamanca, , Spain
Hospital Universitario Marques de Valdecilla
Santander, , Spain
Tri-Service General Hospital
Taipei, Taipei CITY, Taiwan
National Taiwan University Hospital
Taipei, , Taiwan
Ankara Universitesi
Yenimahalle, Ankara, Turkey (Türkiye)
Ondokuz Mayis Universitesi Tp Fakultesi
Samsun, , Turkey (Türkiye)
University Hospitals Birmingham NHS Foundation Trust
Birmingham, England, United Kingdom
Royal Cornwall Hospital NHS Trust
Cornwell, England, United Kingdom
University College London Hospitals NHS Foundation Trust
London, England, United Kingdom
Genesis Care - Milton Keynes
Milton Keynes, England, United Kingdom
Oxford University Hospitals NHS Foundation Trust
Oxford, England, United Kingdom
The Royal Marsden NHS Foundation Trust
Sutton, England, United Kingdom
Genesis Care Windsor - Genesis Care UK Ltd.
Windsor, England, United Kingdom
Countries
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References
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Vogl DT, Atrash S, Holstein SA, Nadeem O, Benson D, Chaudry M, Biran N, Suryanarayan K, Li C, Liu Y, Collins S, Parot X, Kaufman JL. Targeted interferon therapy with modakafusp alfa for relapsed or refractory multiple myeloma. Blood. 2025 Feb 27;145(9):944-955. doi: 10.1182/blood.2024026124.
Holstein SA, Atrash S, Mian H, Dimopoulos MA, Schjesvold F, Popat R, Shah N, Gatt ME, Gocke CB, Frenzel L, Touzeau C, Beksac M, Manier S, Magen H, Travis P, Nadeem O, Suryanarayan K, Li C, Li S, Nelson A, Cherepanov D, Parot X, Vogl DT. A phase 2 randomized study of modakafusp alfa as a single agent for patients with relapsed/refractory multiple myeloma. Blood. 2025 Aug 28;146(9):1051-1064. doi: 10.1182/blood.2024027873.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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TV48573-ONC-10128
Identifier Type: OTHER
Identifier Source: secondary_id
U1111-1195-8134
Identifier Type: REGISTRY
Identifier Source: secondary_id
2021-006038-37
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
jRCT2061220078
Identifier Type: REGISTRY
Identifier Source: secondary_id
TAK-573-1501
Identifier Type: -
Identifier Source: org_study_id
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