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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
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
More Inclusion & Exclusion Criteria

Inclusion Criteria:

1. Documented multiple myeloma (MM) diagnosis per IMWG criteria. 2. Measurable disease, defined as at least 1 of the following: 1. Serum M protein ≥0.5 grams per deciliter [g/dL] (≥5 g/L) on serum protein electrophoresis (SPEP). 2. Urine M protein ≥200 mg/24 hours on urine protein electrophoresis (UPEP). 3. Serum free light chain (FLC) assay with involved FLC level ≥10 mg/dL (≥100 mg/L) provided serum FLC ratio is abnormal. 3. 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. 4. For participants in Phase 2a Dose Finding only: 1. Received 1 to 3 prior line(s) of antimyeloma therapy. 2. Must be refractory to prior lenalidomide treatment. 3. Participants must be sensitive (nonrefractory) or naïve to prior anti-CD38 mAb treatment. 4. Documented progressive disease on or after the last regimen. 5. Participants must have PR or better to at least 1 line of prior therapy. 5. Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2 at screening.

Exclusion Criteria:

1. Prior exposure to modakafusp alfa. 2. Participant has polyneuropathy, organomegaly, endocrinopathy, monoclonal gammopathy, and skin changes (POEMS) syndrome, solitary plasmacytoma, amyloidosis, Waldenström macroglobulinemia, plasma cell leukemia, or lymphoplasmacytic lymphoma. 3. 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. 4. Previous allogeneic stem cell transplant at any time or autologous stem cell transplant (ASCT) within 12 weeks of planned start of dosing. 5. Seropositive for hepatitis B, or known history of seropositivity for hepatitis C or of seropositivity for human immunodeficiency virus (HIV). 6. 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. 7. Participant has QT interval corrected by the Fridericia method >480 milliseconds [msec] (Grade ≥2). 8. 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).

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.

NCT05590377
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 Australia, Canada, China, Czechia, France, Germany, Hungary, Korea, Republic of, Puerto Rico, Spain, United Kingdom, United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Multiple Myeloma
Study Website: View Trial Website
Additional Details

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.

Arms & Interventions

Arms

Experimental: Phase 1 Dose Escalation

Modakafusp alfa 60 to 240 mg, infusion, intravenously, once every 4 weeks (Q4W) with daratumumab 1800 mg, subcutaneously (SC), once weekly (QW) in Cycles 1 and 2, twice weekly (Q2W) in Cycles 3 to 6, and Q4W thereafter in each 28-day treatment cycle until disease progression.

Experimental: Phase 2a Dose Finding: Modakafusp Alfa (DL1) + Daratumumab

Modakafusp alfa at dose level 1 (DL1) [selected from Phase 1 Dose Escalation] with daratumumab SC 1800 mg, SC, QW in Cycles 1 and 2, Q2W in Cycles 3 to 6, and Q4W thereafter in each 28-day treatment cycle until disease progression.

Experimental: Phase 2a Dose Finding: Modakafusp Alfa (DL2) + Daratumumab

Modakafusp alfa at dose level 2 (DL2) [selected from Phase 1 Dose Escalation] with daratumumab SC 1800 mg, SC, QW in Cycles 1 and 2, Q2W in Cycles 3 to 6, and Q4W thereafter in each 28-day treatment cycle until disease progression.

Interventions

Drug: - Modakafusp Alfa

Modakafusp alfa intravenous infusion

Drug: - Daratumumab

Daratumumab SC injection

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.

Banner MD Anderson Cancer Center, Gilbert, Arizona

Status

Recruiting

Address

Banner MD Anderson Cancer Center

Gilbert, Arizona, 85234

Site Contact

Site Contact

sumit.madan@bannerhealth.com

210-450-1132

Cedars-Sinai Medical Center, Los Angeles, California

Status

Recruiting

Address

Cedars-Sinai Medical Center

Los Angeles, California, 77598

Site Contact

Site Contact

david.oveisi@cshs.org

+1-877-825-3327

James R Berenson, MD Inc., West Hollywood, California

Status

Not yet recruiting

Address

James R Berenson, MD Inc.

West Hollywood, California, 90069

Site Contact

Site Contact

jberenson@imbcr.org

310-623-1222

Fort Wayne, Indiana

Status

Recruiting

Address

Fort Wayne Medical Oncology and Hematology, Inc

Fort Wayne, Indiana, 46060

Site Contact

Site Contact

sunil_gos@yahoo.com

260-484-8830

Overland Park, Kansas

Status

Recruiting

Address

HCA Midwest Health (Midwest Ventures Group HCA MidAmerica Division)

Overland Park, Kansas, 66211

Site Contact

Site Contact

suman.kambhampati@va.gov

816-861-4700

Tulane University Health Sciences Center, New Orleans, Louisiana

Status

Recruiting

Address

Tulane University Health Sciences Center

New Orleans, Louisiana, 70112

Site Contact

Site Contact

hsafah@tulane.edu

504-988-6070

Boston, Massachusetts

Status

Recruiting

Address

Floating Hospital for Children at Tufts Medical Center

Boston, Massachusetts, 02111

Site Contact

Site Contact

rcomenzo@tuftsmedicalcenter.org

617-636-6454

Washington University School of Medicine, Saint Louis, Missouri

Status

Recruiting

Address

Washington University School of Medicine

Saint Louis, Missouri, 63130

Site Contact

Site Contact

markschroeder@wustl.edu

314-454-8304

University of Nebraska Medical Center, Omaha, Nebraska

Status

Recruiting

Address

University of Nebraska Medical Center

Omaha, Nebraska, 68198

Site Contact

Site Contact

sarah.holstein@unmc.edu

716-845-8969

Summit Medical Group PA, Florham Park, New Jersey

Status

Recruiting

Address

Summit Medical Group PA

Florham Park, New Jersey, 07932

Site Contact

Site Contact

wderosa@smgnj.com

973-538-5210 #2338

New York Cancer and Blood Specialists, Bay Shore, New York

Status

Recruiting

Address

New York Cancer and Blood Specialists

Bay Shore, New York, 11706

Site Contact

Site Contact

zunigaresearch@nycancer.com

978-937-6800

Stony Brook University Hospital, Stony Brook, New York

Status

Recruiting

Address

Stony Brook University Hospital

Stony Brook, New York, 11794

Site Contact

Site Contact

mwschuster@gmail.com

631-371-6348

Cincinnati, Ohio

Status

Recruiting

Address

University of Cincinnati - Vontz Center for Molecular Studies

Cincinnati, Ohio, 45267

Site Contact

Site Contact

fabered@ucmail.uc.edu

513-558-2115

Tranquil Clinical Research, Webster, Texas

Status

Recruiting

Address

Tranquil Clinical Research

Webster, Texas, 78041

Site Contact

Site Contact

joknecht29@gmail.com

713-907-6054

Madison, Wisconsin

Status

Not yet recruiting

Address

University of Wisconsin Hospitals and Clinics

Madison, Wisconsin, 53792

Site Contact

Site Contact

nsc@medicine.wisc.edu

608-262-1671

International Sites

Concord Repatriation General Hospital, Concord, New South Wales, Australia

Status

Recruiting

Address

Concord Repatriation General Hospital

Concord, New South Wales, 2139

The Alfred Hospital, Melbourne, Victoria, Australia

Status

Recruiting

Address

The Alfred Hospital

Melbourne, Victoria, 3004

Site Contact

Site Contact

andrew.spencer@monash.edu

390763393

William Osler Health Center, Brampton, Ontario, Canada

Status

Not yet recruiting

Address

William Osler Health Center

Brampton, Ontario, L6R 3J7

Sherbrooke, Quebec, Canada

Status

Recruiting

Address

Centre Hospitalier Universitaire De Sherbrooke (CHUS) - Centre de Recherche Clinique Etienne-Le Bel (CRCELB) Hopital Fleurimont

Sherbrooke, Quebec, J1H 5N4

Site Contact

Site Contact

Michel.Pavic@USherbrooke.ca

+1 8193461110

Sun Yat-Sen University Cancer Center, Guangzhou, Guangdong, China

Status

Recruiting

Address

Sun Yat-Sen University Cancer Center

Guangzhou, Guangdong, 510060

Site Contact

Site Contact

xiazhj@mail.sysu.edu.cn

+86 (0) 20-87343088

Wuhan Union Hospital, Wuhan, Hubei, China

Status

Recruiting

Address

Wuhan Union Hospital

Wuhan, Hubei, 430022

Site Contact

Site Contact

suncy0618@163.com

15342346782

Tianjin, Tianjin, China

Status

Recruiting

Address

Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College

Tianjin, Tianjin, 300020

Site Contact

Site Contact

qiulg@ihcams.ac.cn

2227301963

Hangzhou, Zhejiang, China

Status

Not yet recruiting

Address

Zhejiang University School of Medicine - The First Affiliated Hospital (Zhejiang Provincial First Hospital)

Hangzhou, Zhejiang, 310003

Site Contact

Site Contact

caiz@zju.edu.cn

13857311031

Fakultni nemocnice Olomouc, Olomouc, Czech, Czechia

Status

Not yet recruiting

Address

Fakultni nemocnice Olomouc

Olomouc, Czech, 77900

Site Contact

Site Contact

jiri.minarik2@fnol.cz

+1-877-825-3327

Vseobecna Fakultni Nemocnice v Praze, Prague, Praha, Czechia

Status

Not yet recruiting

Address

Vseobecna Fakultni Nemocnice v Praze

Prague, Praha, 12802

Site Contact

Site Contact

spicka@cesnet.cz

+420 224962551

FNsP Ostrava, Ostrava, Czechia

Status

Not yet recruiting

Address

FNsP Ostrava

Ostrava, , 708 52

Site Contact

Site Contact

roman.hajek@fno.cz

597372088

CHRU Lille, Lille, Hauts-de-France, France

Status

Recruiting

Address

CHRU Lille

Lille, Hauts-de-France, 59037

Institut Paoli-Calmettes, Marseille, Provence-Alpes-Cote d'Azur, France

Status

Recruiting

Address

Institut Paoli-Calmettes

Marseille, Provence-Alpes-Cote d'Azur, 13273

Site Contact

Site Contact

schianojm@ipc.unicancer.fr

+33 4 91 22 38 66

Klinikum Nuernberg Nord, Nuremberg, Bavaria, Germany

Status

Not yet recruiting

Address

Klinikum Nuernberg Nord

Nuremberg, Bavaria, 90419

Universitaetsklinikum Koeln, Cologne, North Rhine-Westphalia, Germany

Status

Not yet recruiting

Address

Universitaetsklinikum Koeln

Cologne, North Rhine-Westphalia, 50931

Site Contact

Site Contact

c.scheid@uni-koeln.de

22147886712

Debrecen, Norhtern Great Plain, Hungary

Status

Not yet recruiting

Address

Debreceni Egyetem - Orvos es Egeszsegtudomanyi Centrum (DEOEC) (University of Debrecen Medical and Health Science Center)

Debrecen, Norhtern Great Plain, 4032

Site Contact

Site Contact

illesarpaddr@gmail.com

52255601

Semmelweis University, Budapest, Pannonia, Hungary

Status

Not yet recruiting

Address

Semmelweis University

Budapest, Pannonia, 1088

Site Contact

Site Contact

vargager@gmail.com

+36 208250799

Budapest, Pannonia, Hungary

Status

Not yet recruiting

Address

Del-Pesti Centrumkorhaz Orszagos Hematologiai es Infektologiai Intezet

Budapest, Pannonia, 1097

Site Contact

Site Contact

gmikala@dpckorhaz.hu

209139907

Hwasun, Jeollanam-do, Korea, Republic of

Status

Recruiting

Address

Chonnam National University Hwasun Hospital

Hwasun, Jeollanam-do, 58128

Site Contact

Site Contact

shglory@hanmail.net

+1-877-825-3327

Samsung Medical Center, Seoul, Korea, Republic of

Status

Recruiting

Address

Samsung Medical Center

Seoul, , 06351

Site Contact

Site Contact

kihyunk@skky.edu

+82 234103459

Seoul, Korea, Republic of

Status

Recruiting

Address

The Catholic University of Korea, Seoul St. Marys Hospital

Seoul, , 06591

Site Contact

Site Contact

ckmin@catholic.ac.kr

+82 222586053

San Juan, Puerto Rico

Status

Not yet recruiting

Address

Hospital Espanol Auxilio Mutuo de Puerto Rico, Inc.

San Juan, , 00918

Site Contact

Site Contact

cabanillasmd@gmail.com

7877717933

Hospital Universitario Vall d'Hebron, Barcelona, Spain

Status

Recruiting

Address

Hospital Universitario Vall d'Hebron

Barcelona, , 08035

Site Contact

Site Contact

mgironel@vhebron.net

934893000

Salamanca, Spain

Status

Recruiting

Address

Fundacion Instituto de Estudios Ciencias de la Salud de Castilla y Leon-Investigacion Biomedica de Salamanca (IBSAL)

Salamanca, , 37007

Site Contact

Site Contact

mvmateos@usal.es

923291200

Leeds, West Yorkshire, United Kingdom

Status

Not yet recruiting

Address

St James's University Hospital - Leeds Teaching Hospitals NHS Trust

Leeds, West Yorkshire, LS9 7TF

Site Contact

Site Contact

gordoncook@nhs.net

1132068433

Derby, United Kingdom

Status

Not yet recruiting

Address

University Hospitals of Derby and Burton NHS Foundation Trust

Derby, , DE22 3NE

Site Contact

Site Contact

firas.abed@nhs.net

1332783095