A Study of Modakafusp Alfa on Adult Participants With Relapsed/Refractory Multiple Myeloma
Study Purpose
The main aims of this 3-part study are as follows: 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.
Recruitment Criteria
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Accepts Healthy Volunteers
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms |
No |
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Study Type
An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies. |
Interventional |
| Eligible Ages | 18 Years and Over |
| Gender | All |
Inclusion Criteria:
For Parts 1 and 2: 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.
- - 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.
Exclusion Criteria:
For Parts 1 and 2: 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.
- - 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.
Trial Details
|
Trial ID:
This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries. |
NCT03215030 |
|
Phase
Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use. |
Phase 1/Phase 2 |
|
Lead Sponsor
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data. |
Takeda |
|
Principal Investigator
The person who is responsible for the scientific and technical direction of the entire clinical study. |
Study Director |
| Principal Investigator Affiliation | Takeda |
|
Agency Class
Category of organization(s) involved as sponsor (and collaborator) supporting the trial. |
Industry |
| Overall Status | Recruiting |
| Countries | Canada, China, Czechia, France, Germany, Greece, Ireland, Israel, Italy, Japan, Korea, Republic of, Norway, Puerto Rico, Spain, Taiwan, Turkey, United Kingdom, United States |
|
Conditions
The disease, disorder, syndrome, illness, or injury that is being studied. |
Multiple Myeloma |
| Study Website: | View Trial Website |
The drug being tested in this study, and which will be given through a vein, is called modakafusp alfa (TAK-573 ) as single agent or in combination with dexamethasone. The study will determine the safety, tolerability, and efficacy of modakafusp alfa as single agent and in combination with dexamethasone in participants with relapsed/refractory multiple myeloma (RRMM). The study consists of 3 Parts: 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.
Arms
Experimental: Part 1 (Dose Escalation) Schedule A: Modakafusp alfa 0.001 Up to 14 mg/kg
Modakafusp alfa 0.001 up to 14 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 on Days 1 and 15 of each 28-day treatment cycle up to 4 cycles, followed by once on Day 1 of each 28-day treatment cycle until treatment discontinuation.
Experimental: Part 1 (Dose Escalation) Schedule B: Modakafusp alfa TBD
Modakafusp alfa TBD, infusion, IV, once every 2 weeks (Q2W) on Days 1 and 15 of each 28-day treatment cycle until treatment discontinuation. The starting dose will be decided by the investigators and sponsor representatives based on all available clinical information.
Experimental: Part 1 (Dose Escalation) Schedule C: Modakafusp alfa TBD
Modakafusp alfa TBD, infusion, IV, once every 3 weeks (Q3W) on Day 1 of each 21-day treatment cycle until treatment discontinuation. The starting dose will be decided by the investigators and sponsor representatives based on all available clinical information.
Experimental: Part 1 (Dose Escalation) Schedule D: Modakafusp alfa TBD
Modakafusp alfa TBD, infusion, IV, once every 4 weeks (Q4W) on Day 1 of each 28-day treatment cycle until treatment discontinuation. The starting dose will be decided by the investigators and sponsor representatives based on all available clinical information.
Experimental: Part 2 (Dose Expansion): Modakafusp alfa TBD + Dexamethasone 40 mg
Dose(s) for Phase 2 will be based on safety and tolerability results from the preceding Phase 1 dose escalation cohorts. Participants in Phase 2 cohorts will receive modakafusp alfa TBD as a single agent. Participants in at least 1 cohort will receive modakafusp alfa TBD and modakafusp alfa TBD and dexamethasone 40 mg, orally, once weekly of each 28-day treatment cycle until treatment discontinuation.
Experimental: Part 3 (Dose Extension): Modakafusp alfa 120 mg
Participants will receive modakafusp alfa 120 mg, infusion, IV, Q4W, for each 28-day treatment cycle until disease progression or treatment discontinuation.
Experimental: Part 3 (Dose Extension): Modakafusp alfa 240 mg
Participants will receive modakafusp alfa 240 mg, infusion, IV, Q4W, for each 28-day treatment cycle until disease progression or treatment discontinuation.
Interventions
Drug: - Modakafusp alfa
Modakafusp alfa intravenous infusion.
Drug: - Dexamethasone
Dexamethasone.
Contact a Trial Team
If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.
Status
Active, not recruiting
Address
Highlands Oncology Group
Springdale, Arkansas, 72762
Status
Active, not recruiting
Address
Los Angeles Cancer Network - Glendale Adventist Medical Center
Glendale, California, 91204
Status
Active, not recruiting
Address
University of California Irvine
Orange, California, 92868
Status
Active, not recruiting
Address
Office of James R. Berenson MD
West Hollywood, California, 90069
Status
Active, not recruiting
Address
Smilow Cancer Hospital at Yale New Haven
New Haven, Connecticut, 06520
Status
Active, not recruiting
Address
Winship Cancer Institute of Emory University
Atlanta, Georgia, 30322
Status
Active, not recruiting
Address
Northwestern Medicine - Northwestern Medical Group
Chicago, Illinois, 60611
Status
Active, not recruiting
Address
Loyola University Medical Center
Maywood, Illinois, 60153
Status
Active, not recruiting
Address
Investigative Clinical Research of Indiana, LLC
Noblesville, Indiana, 46062
Status
Active, not recruiting
Address
June E. Nylen Cancer Center
Sioux City, Iowa, 51101
Status
Active, not recruiting
Address
Johns Hopkins Hospital
Baltimore, Maryland, 21287
Status
Active, not recruiting
Address
Boston Medical Center
Boston, Massachusetts, 02118
Status
Active, not recruiting
Address
Dana Farber Cancer Institute
Boston, Massachusetts, 02215
Status
Active, not recruiting
Address
Univeristy of Nebraska Medical Center
Omaha, Nebraska, 68198
Status
Active, not recruiting
Address
USOR - Comprehensive Cancer Centers of Nevada - Central Valley
Las Vegas, Nevada, 89119
Status
Active, not recruiting
Address
John Theurer Cancer Center
Hackensack, New Jersey, 07601
Status
Active, not recruiting
Address
Montefiore Medical Center
Bronx, New York, 10467
Status
Active, not recruiting
Address
University of Rochester
Rochester, New York, 14627
Status
Active, not recruiting
Address
Levine Cancer Center
Charlotte, North Carolina, 28402
Status
Active, not recruiting
Address
Levine Cancer Institute - Concord
Concord, North Carolina, 28205
Status
Active, not recruiting
Address
Duke University Medical Center
Durham, North Carolina, 27710
Status
Active, not recruiting
Address
Gabrail Cancer Center
Canton, Ohio, 44718
Status
Active, not recruiting
Address
The Ohio State University
Columbus, Ohio, 43210
Status
Active, not recruiting
Address
Oregon Health and Science University
Portland, Oregon, 97239
Status
Active, not recruiting
Address
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Status
Active, not recruiting
Address
Baptist Cancer Center - Memphis - Walnut Grove
Memphis, Tennessee, 38120
Status
Active, not recruiting
Address
Lumi Research
Houston, Texas, 77002
International Sites
Status
Recruiting
Address
British Columbia Cancer Agency Vancouver Centre
Vancouver, British Columbia, V5Z 4E6
Status
Recruiting
Address
Juravinski Cancer Centre
Hamilton, Ontario, L8V 5C2
Status
Not yet recruiting
Address
Victoria Hospital
London, Ontario, N6A 4G5
Status
Recruiting
Address
Centre de Recherche du CHUM
Montreal, Quebec, H2X 0C1
Status
Recruiting
Address
Sir Mortimer B. Davis Jewish General Hospital
Montreal, Quebec, H3T 1E2
Status
Not yet recruiting
Address
Beijing Chao-Yang Hospital
Beijing, Beijing, 100020
Status
Not yet recruiting
Address
Beijing Chao-Yang Hospital
Beijing, Beijing, 100040
Status
Recruiting
Address
Peking University People's Hospital
Beijing, Beijing, 100044
Status
Recruiting
Address
Peking University Third Hospital
Beijing, Beijing, 100089
Status
Recruiting
Address
Sun Yat-Sen University Cancer Center
Guangzhou, Guangdong, 510060
Status
Recruiting
Address
Henan Cancer Hospital
Zhengzhou, Henan, 450003
Status
Recruiting
Address
Wuhan Union Hospital
Wuhan, Hubei, 430023
Status
Recruiting
Address
Zhongnan Hospital of Wuhan University
Wuhan, Hubei, 430071
Status
Recruiting
Address
Nanjing Drum Tower Hospital
Nanjing, Jiangsu, 210008
Status
Recruiting
Address
The First Affiliated Hospital of Soochow University - Suzhou First People's Hospital
Suzhou, Jiangsu, 215006
Status
Not yet recruiting
Address
Shanghai Fourth People's Hospital
Shanghai, Shanghai, 200003
Status
Recruiting
Address
Tianjin Medical University Cancer Institute & Hospital
Tianjin, Tianjin, 300060
Status
Recruiting
Address
The First Affiliated Hospital, Zhejiang University
Hangzhou, Zhejiang, 310003
Status
Not yet recruiting
Address
Fakultni nemocnice Ostrava
Ostrava, Moravian-Silesian, 708 52
Status
Not yet recruiting
Address
Fakultni Nemocnice Brno
Brno, , 625 00
Status
Not yet recruiting
Address
Univerzita Karlova - 1. Lekarska Fakulta
Praha, , 128 08
Status
Recruiting
Address
Institut de cancerologie Strasbourg Europe
Strasbourg, Alsace, 67200
Status
Recruiting
Address
Centre Hospitalier Universitaire Henri Mondor
Creteil Cedex, Ile-de-france, 91010
Status
Recruiting
Address
Hopital Saint-Antoine
Paris Cedex 12, Ile-de-france, 75012
Status
Recruiting
Address
Hopital Necker-Enfants Malades
Paris, Ile-de-france, 75015
Status
Recruiting
Address
Centre Hospitalier Universitaire de Toulouse Hopital Purpan
Toulouse, Midi-pyrenees, 31059
Status
Recruiting
Address
Hopital Saint-Vincent de Paul - Lille
Lille Cedex, NORD Pas-de-calais, 59020
Status
Recruiting
Address
Centre Hospitalier Regional Universitaire de Lille
Lille Cedex, NORD Pas-de-calais, 59037
Status
Recruiting
Address
Centre Hospitalier Universitaire Nantes - Hotel Dieu
Nantes Cedex 1, PAYS DE LA Loire, 44093
Status
Recruiting
Address
Centre Hospitalier Universitaire de Poitiers
Poitiers, Poitou-charentes, 86000
Status
Not yet recruiting
Address
Centre Hospitalier d'Argenteuil - Centre Hospitalier Victor Dupouy
Argenteuil Cedex, , 95107
Status
Not yet recruiting
Address
Universitatsklinik Tubingen
Tuebingen, Baden-wuerttemberg, 72076
Status
Not yet recruiting
Address
Universitatsklinikum Leipzig
Leipzig, Sachsen, 04103
Status
Not yet recruiting
Address
Universitatsklinikum Hamburg-Eppendorf
Hamburg, , 20251
Status
Recruiting
Address
Evaggelismos General Hospital
Athens, Attica, 10676
Status
Recruiting
Address
Alexandra General Hospital of Athens
Athens, Attica, 11528
Status
Recruiting
Address
University Regional General Hospital of Patras
Patra, Peloponnese, 26504
Status
Not yet recruiting
Address
Cork University Hospital
Cork, , T12 DC4A
Status
Not yet recruiting
Address
Saint Vincent's University Hospital
Dublin, , D04 T6F4
Status
Not yet recruiting
Address
National University of Ireland Galway
Galway, , H91 TK 33
Status
Recruiting
Address
The Chaim Sheba Medical Center
Ramat Gan, Tel Aviv, 52621
Status
Recruiting
Address
Hadassah Medical Center
Jerusalem, , 9112001
Status
Recruiting
Address
Tel Aviv Sourasky Medical Center
Tel Aviv, , 6423906
Status
Not yet recruiting
Address
AON SS Antonio e Biagio e Cesare Arrigo
Alessandria, , 15121
Status
Not yet recruiting
Address
Azienda Ospedaliero Universitaria Ospedali Riuniti di Ancona
Ancona, , 60126
Status
Recruiting
Address
Azienda Ospedaliero-Universitaria di Bologna - Policlinico Sant'Orsola-Malpighi
Bologna, , 40138
Status
Recruiting
Address
Azienda Ospedaliero - Universitaria Policlinico - Vittorio Emanuele
Catania, , 95125
Status
Not yet recruiting
Address
Department of Medicine (DIMED) Hematology and Clinical Immunology
Padova, , 35128
Status
Recruiting
Address
Fondazione IRCCS Policlinico San Matteo
Pavia, , 27100
Status
Recruiting
Address
Nagoya City University Hospital
Nagoya, Aichi, 467-8601
Status
Recruiting
Address
Ogaki Municipal Hospital
Gifu-shi, Gifu, 503-8502
Status
Not yet recruiting
Address
University Hospital - Kyoto Preferctural University of Medicine
Kyoto-City, Kyoto, 602-8566
Status
Recruiting
Address
National Hospital Organization Okayama Medical Center
Okayama-city, Okayama, 701-1192
Status
Not yet recruiting
Address
Yamanashi Prefectural Central Hospital
Chuo-shi, Yamanasi, 409-3898
Status
Recruiting
Address
Japanese Red Cross Medical Center
Tokyo, , 150-8935
Status
Recruiting
Address
Chonnam National University Hwasun Hospital
Hwasun, Jeollanam-do, 58128
Status
Recruiting
Address
Seoul National University Hospital
Seoul, , 03080
Status
Recruiting
Address
The Catholic University of Korea - Seoul St. Mary's Hospital
Seoul, , 06591
Status
Recruiting
Address
Oslo Universitetssykehus-Ulleval Hospital
Oslo, , 0450
Status
Active, not recruiting
Address
Ad-Vance Medical Research
Ponce, , 00730
Status
Active, not recruiting
Address
Hospital Espanol Auxilio Mutuo
San Juan, , 00919
Status
Recruiting
Address
Hospital Universitari Germans Trias i Pujol
Badalona, Barcelona, 08916
Status
Recruiting
Address
Hospital Universitari Vall d'Hebron
Barcelona, , 08035
Status
Recruiting
Address
Hospital Clinic de Barcelona
Barcelona, , 08036
Status
Recruiting
Address
Hospital Universitario 12 de Octubre
Madrid, , 28041
Status
Recruiting
Address
Hospital Universitario Virgen de la Arrixaca
Murcia, , 30120
Status
Recruiting
Address
Hospital Universitario de Salamanca
Salamanca, , 37007
Status
Recruiting
Address
Hospital Universitario Marques de Valdecilla
Santander, , 39008
Status
Recruiting
Address
Tri-Service General Hospital
Taipei, Taipei CITY, 11490
Status
Recruiting
Address
National Taiwan University Hospital
Taipei, , 100
Status
Not yet recruiting
Address
Taipei Veterans General Hospital
Taipei, , 11217
Status
Recruiting
Address
Ankara Universitesi
Yenimahalle, Ankara, 06560
Status
Recruiting
Address
Ondokuz Mayis Universitesi Tp Fakultesi
Samsun, , 55139
Status
Not yet recruiting
Address
Hampshire Hospitals NHS Foundation Trust
Basingstoke, England, RG24 9NA
Status
Not yet recruiting
Address
University Hospitals Birmingham NHS Foundation Trust
Birmingham, England, B9 5SS
Status
Not yet recruiting
Address
Royal Cornwall Hospital NHS Trust
Cornwell, England, TR1 3LI
Status
Not yet recruiting
Address
The Leeds Teaching Hospitals NHS Trust
Leeds, England, LS9 7TF
Status
Recruiting
Address
University College London Hospitals NHS Foundation Trust
London, England, NW1 2BU
Status
Not yet recruiting
Address
King's College Hospital NHS Foundation Trust
London, England, SE5 9RS
Status
Not yet recruiting
Address
Nottingham University Hospitals NHS Trust
Nottingham, England, NG5 1PB
Status
Recruiting
Address
Oxford University Hospitals NHS Foundation Trust
Oxford, England, OX3 7LE
Status
Not yet recruiting
Address
The Royal Marsden NHS Foundation Trust
Sutton, England, SM2 5PT
Status
Recruiting
Address
Genesis Care Windsor - Genesis Care UK Ltd.
Windsor, England, SL43HD
