Multiple Myeloma Clinical Trial

A Study of Modakafusp Alfa Together With Daratumumab Adults With Relapsed or Refractory Multiple Myeloma

Summary

The main aim of this study is to determine safety and tolerability of modakafusp alfa given together with daratumumab to find out the best treatment dose. Another aim of this study is to learn more about the characteristics of modakafusp alfa.

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Full Description

The drug being tested in this study is called modakafusp alfa (TAK-573). Modakafusp alfa is being tested to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics, and preliminary efficacy in combination with daratumumab in participants with relapsed or refractory multiple myeloma (RRMM). The study will consist of 2 phases: Phase 1 Dose Escalation and a Phase 2a Dose Finding.

The study will enroll approximately 58 patients. Approximately 18 participants will be enrolled in the Phase 1 Dose Escalation/De-escalation and two dose levels of modakafusp alfa in combination with daratumumab SC will be selected to be further explored in the randomized Phase 2a Dose Finding part of the study wherein, approximately 40 participants will be randomly assigned by chance (like flipping a coin) to one of the two treatment groups:

Phase 2a Dose Finding: Modakafusp Alfa (DL1) + Daratumumab
Phase 2a Dose Finding: Modakafusp Alfa (DL2) + Daratumumab This multi-center trial will be conducted worldwide. The overall time to participate in this study is approximately 60 months. Participants who discontinue study drug treatment for reasons other than progressive disease will continue progression-free survival (PFS) follow-up every 4 weeks from the end of treatment (EOT) visit until the occurrence of progressive disease, death, the start of subsequent systemic antineoplastic therapy, study termination, whichever occurs first.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

Documented multiple myeloma (MM) diagnosis per IMWG criteria.

Measurable disease, defined as at least 1 of the following:

Serum M protein ≥0.5 grams per deciliter [g/dL] (≥5 g/L) on serum protein electrophoresis (SPEP).
Urine M protein ≥200 mg/24 hours on urine protein electrophoresis (UPEP).
Serum free light chain (FLC) assay with involved FLC level ≥10 mg/dL (≥100 mg/L) provided serum FLC ratio is abnormal.

For participants in the Phase 1 Dose Escalation only:

Must have received at least 3 prior lines of therapy, including at least 1 proteosome inhibitor (PI), 1 immunomodulatory imide drug (IMiD), and 1 anti-CD38 monoclonal antibody (mAb) drug; or who are triple refractory to a PI, an IMiD, and an anti-CD38 mAb drug, regardless of the number of prior line(s) or therapy.

For participants in Phase 2a Dose Finding only:

Received 1 to 3 prior line(s) of antimyeloma therapy.
Must be refractory to prior lenalidomide treatment.
Participants must be sensitive (nonrefractory) or naïve to prior anti-CD38 mAb treatment.
Documented progressive disease on or after the last regimen.
Participants must have PR or better to at least 1 line of prior therapy.
Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2 at screening.

Exclusion Criteria:

Prior exposure to modakafusp alfa.
Participant has polyneuropathy, organomegaly, endocrinopathy, monoclonal gammopathy, and skin changes (POEMS) syndrome, solitary plasmacytoma, amyloidosis, Waldenström macroglobulinemia, plasma cell leukemia, or lymphoplasmacytic lymphoma.
Participant has not recovered from adverse reactions to prior myeloma treatment or procedures (chemotherapy, immunotherapy, radiation therapy) to NCI CTCAE, Version 5 Grade ≤1 or baseline, except for alopecia.
Previous allogeneic stem cell transplant at any time or autologous stem cell transplant (ASCT) within 12 weeks of planned start of dosing.
Seropositive for hepatitis B, or known history of seropositivity for hepatitis C or of seropositivity for human immunodeficiency virus (HIV).
Participant has congestive heart failure (New York Heart Association Grade ≥II), cardiac myopathy, active ischemia, or any other uncontrolled cardiac condition such as angina pectoris, clinically significant arrhythmia requiring therapy including anticoagulants, or clinically significant uncontrolled hypertension.
Participant has QT interval corrected by the Fridericia method >480 milliseconds [msec] (Grade ≥2).
Participant has a chronic condition that will require the chronic use of systemic corticosteroids >10 milligrams per day (mg/d) of prednisone or equivalent on top of any required corticosteroids for multiple myeloma (MM).

Study is for people with:

Multiple Myeloma

Phase:

Phase 1

Estimated Enrollment:

58

Study ID:

NCT05590377

Recruitment Status:

Recruiting

Sponsor:

Takeda

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There are 41 Locations for this study

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Banner MD Anderson Cancer Center
Gilbert Arizona, 85234, United States More Info
Site Contact
Contact
210-450-1132
[email protected]
Sumit Madan
Principal Investigator
Cedars-Sinai Medical Center
Los Angeles California, 77598, United States More Info
Site Contact
Contact
[email protected]
David Oveisi
Principal Investigator
James R Berenson, MD Inc.
West Hollywood California, 90069, United States More Info
Site Contact
Contact
310-623-1222
[email protected]
James Berenson
Principal Investigator
Fort Wayne Medical Oncology and Hematology, Inc
Fort Wayne Indiana, 46060, United States More Info
Site Contact
Contact
260-484-8830
[email protected]
Sunil Babu
Principal Investigator
HCA Midwest Health (Midwest Ventures Group HCA MidAmerica Division)
Overland Park Kansas, 66211, United States More Info
Site Contact
Contact
816-861-4700
[email protected]
Suman Kambphampati
Principal Investigator
Tulane University Health Sciences Center
New Orleans Louisiana, 70112, United States More Info
Site Contact
Contact
504-988-6070
[email protected]
Hana Safah
Principal Investigator
Floating Hospital for Children at Tufts Medical Center
Boston Massachusetts, 02111, United States More Info
Site Contact
Contact
617-636-6454
[email protected]
Raymond Comenzo
Principal Investigator
Washington University School of Medicine
Saint Louis Missouri, 63130, United States More Info
Site Contact
Contact
314-454-8304
[email protected]
Marc Schroder
Principal Investigator
University of Nebraska Medical Center
Omaha Nebraska, 68198, United States More Info
Site Contact
Contact
716-845-8969
[email protected]
Sarah Holstein
Principal Investigator
Summit Medical Group PA
Florham Park New Jersey, 07932, United States More Info
Site Contact
Contact
973-538-5210
[email protected]
William DeRosa
Principal Investigator
New York Cancer and Blood Specialists
Bay Shore New York, 11706, United States More Info
Site Contact
Contact
978-937-6800
[email protected]
Richard Zuniga
Principal Investigator
Stony Brook University Hospital
Stony Brook New York, 11794, United States More Info
Site Contact
Contact
631-371-6348
[email protected]
Michael Schuster
Principal Investigator
University of Cincinnati - Vontz Center for Molecular Studies
Cincinnati Ohio, 45267, United States More Info
Site Contact
Contact
513-558-2115
[email protected]
Edward Faber
Principal Investigator
Tranquil Clinical Research
Webster Texas, 78041, United States More Info
Site Contact
Contact
713-907-6054
[email protected]
John Knecht
Principal Investigator
University of Wisconsin Hospitals and Clinics
Madison Wisconsin, 53792, United States More Info
Site Contact
Contact
608-262-1671
[email protected]
Natalie Callander
Principal Investigator
Concord Repatriation General Hospital
Concord New South Wales, 2139, Australia More Info
Site Contact
Contact
[email protected]
Nicole Caroline Wong Doo
Principal Investigator
The Alfred Hospital
Melbourne Victoria, 3004, Australia More Info
Site Contact
Contact
390763393
[email protected]
Andrew Spencer
Principal Investigator
William Osler Health Center
Brampton Ontario, L6R 3, Canada More Info
Site Contact
Contact
[email protected]
Phillip Kuruvilla
Principal Investigator
Centre Hospitalier Universitaire De Sherbrooke (CHUS) - Centre de Recherche Clinique Etienne-Le Bel (CRCELB) Hopital Fleurimont
Sherbrooke Quebec, J1H 5, Canada More Info
Site Contact
Contact
+1 8193461110
[email protected]
Michel Pavic
Principal Investigator
Sun Yat-Sen University Cancer Center
Guangzhou Guangdong, 51006, China More Info
Zhong-jun Xia
Principal Investigator
Wuhan Union Hospital
Wuhan Hubei, 43002, China More Info
Site Contact
Contact
15342346782
[email protected]
Chunyan Sun
Principal Investigator
Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College
Tianjin Tianjin, 30002, China More Info
Site Contact
Contact
2227301963
[email protected]
Gang An
Principal Investigator
Zhejiang University School of Medicine - The First Affiliated Hospital (Zhejiang Provincial First Hospital)
Hangzhou Zhejiang, 31000, China More Info
Site Contact
Contact
13857311031
[email protected]
Zhen Cai
Principal Investigator
Fakultni nemocnice Olomouc
Olomouc Czech, 77900, Czechia More Info
Site Contact
Contact
[email protected]
Jiri Minarik
Principal Investigator
Vseobecna Fakultni Nemocnice v Praze
Prague Praha, 12802, Czechia More Info
Site Contact
Contact
+420 224962551
[email protected]
Ivan Spicka
Principal Investigator
FNsP Ostrava
Ostrava , 708 5, Czechia More Info
Site Contact
Contact
597372088
[email protected]
Roman Hajek
Principal Investigator
CHRU Lille
Lille Hauts-de-France, 59037, France More Info
Salomon Manier
Principal Investigator
Institut Paoli-Calmettes
Marseille Provence-Alpes-Cote d'Azur, 13273, France More Info
Jean-Marc Schiano de Colella
Principal Investigator
Klinikum Nuernberg Nord
Nuremberg Bavaria, 90419, Germany More Info
Site Contact
Contact
+49-911-398-3887
[email protected]
Stefan Knop
Principal Investigator
Universitaetsklinikum Koeln
Cologne North Rhine-Westphalia, 50931, Germany More Info
Site Contact
Contact
22147886712
[email protected]
Cristof Scheid
Principal Investigator
Debreceni Egyetem - Orvos es Egeszsegtudomanyi Centrum (DEOEC) (University of Debrecen Medical and Health Science Center)
Debrecen Norhtern Great Plain, 4032, Hungary More Info
Site Contact
Contact
52255601
[email protected]
Arpad Illes
Principal Investigator
Semmelweis University
Budapest Pannonia, 1088, Hungary More Info
Site Contact
Contact
+36 208250799
[email protected]
Gergely Varga
Principal Investigator
Del-Pesti Centrumkorhaz Orszagos Hematologiai es Infektologiai Intezet
Budapest Pannonia, 1097, Hungary More Info
Site Contact
Contact
209139907
[email protected]
Gabor Mikala
Principal Investigator
Chonnam National University Hwasun Hospital
Hwasun Jeollanam-do, 58128, Korea, Republic of More Info
Site Contact
Contact
[email protected]
Sung-Hoon Jung
Principal Investigator
Samsung Medical Center
Seoul , 06351, Korea, Republic of More Info
Site Contact
Contact
+82 234103459
[email protected]
Kihyun Kim
Principal Investigator
The Catholic University of Korea, Seoul St. Marys Hospital
Seoul , 06591, Korea, Republic of More Info
Site Contact
Contact
+82 222586053
[email protected]
Chang Ki Min
Principal Investigator
Hospital Espanol Auxilio Mutuo de Puerto Rico, Inc.
San Juan , 00918, Puerto Rico More Info
Site Contact
Contact
7877717933
[email protected]
Fernando Cabanillas Escalona
Principal Investigator
Hospital Universitario Vall d'Hebron
Barcelona , 08035, Spain More Info
Site Contact
Contact
934893000
[email protected]
Mercedes Gironella Mesa
Principal Investigator
Fundacion Instituto de Estudios Ciencias de la Salud de Castilla y Leon-Investigacion Biomedica de Salamanca (IBSAL)
Salamanca , 37007, Spain More Info
Site Contact
Contact
923291200
[email protected]
Maria Victoria Mateos Manteca
Principal Investigator
St James's University Hospital - Leeds Teaching Hospitals NHS Trust
Leeds West Yorkshire, LS9 7, United Kingdom More Info
Site Contact
Contact
1132068433
[email protected]
Gordon Cook
Principal Investigator
University Hospitals of Derby and Burton NHS Foundation Trust
Derby , DE22 , United Kingdom More Info
Site Contact
Contact
1332783095
[email protected]
Firas Al-Kaisi
Principal Investigator

How clear is this clinincal trial information?

Study is for people with:

Multiple Myeloma

Phase:

Phase 1

Estimated Enrollment:

58

Study ID:

NCT05590377

Recruitment Status:

Recruiting

Sponsor:


Takeda

How clear is this clinincal trial information?

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