A Study of Modakafusp Alfa on Adult Participants With Relapsed/Refractory Multiple Myeloma (iinnovate-1)

January 12, 2026 updated by: Teva Branded Pharmaceutical Products R&D LLC

A Phase 1/2 Open-label Study to Investigate the Safety and Tolerability, Efficacy, Pharmacokinetics, and Immunogenicity of Modakafusp Alfa (TAK-573) as a Single Agent in Patients With Relapsed Refractory Multiple Myeloma

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

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

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
272

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Canada
    • British Columbia
      • Vancouver, British Columbia, Canada, V5Z 4E6
        • British Columbia Cancer Agency Vancouver Centre
    • Ontario
      • Hamilton, Ontario, Canada, L8V 5C2
        • Juravinski Cancer Centre
    • Quebec
      • Montreal, Quebec, Canada, H3T 1E2
        • Sir Mortimer B. Davis Jewish General Hospital
      • Montreal, Quebec, Canada, H2X 0C1
        • Centre de recherche du CHUM
  • China
    • Beijing Municipality
      • Beijing, Beijing Municipality, China, 100044
        • Peking University People's Hospital
      • Beijing, Beijing Municipality, China, 100089
        • Peking University Third Hospital
    • Guangdong
      • Guangzhou, Guangdong, China, 510060
        • Sun Yat-sen University Cancer Center
    • Henan
      • Zhengzhou, Henan, China, 450003
        • Henan Cancer Hospital
    • Hubei
      • Wuhan, Hubei, China, 430071
        • Zhongnan Hospital of Wuhan University
      • Wuhan, Hubei, China, 430023
        • Wuhan Union Hospital
    • Jiangsu
      • Nanjing, Jiangsu, China, 210008
        • Nanjing Drum Tower Hospital
      • Suzhou, Jiangsu, China, 215006
        • The First Affiliated Hospital of Soochow University - Suzhou First People's Hospital
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, China, 200003
        • Shanghai Fourth People's Hospital
    • Tianjin Municipality
      • Tianjin, Tianjin Municipality, China, 300060
        • Tianjin Medical University Cancer Institute & Hospital
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310003
        • The First Affiliated Hospital, Zhejiang University
  • France
      • Argenteuil, France, 95107
        • Centre Hospitalier d'Argenteuil - Centre Hospitalier Victor Dupouy
    • Alsace
      • Strasbourg, Alsace, France, 67200
        • Institut de cancérologie Strasbourg Europe
    • Hauts-de-France
      • Lille, Hauts-de-France, France, 59020
        • Hopital Saint-Vincent de Paul - Lille
      • Lille, Hauts-de-France, France, 59037
        • Centre Hospitalier Régional Universitaire de Lille
    • Midi-pyrenees
      • Toulouse, Midi-pyrenees, France, 31059
        • Centre Hospitalier Universitaire de Toulouse Hopital Purpan
    • Pays de la Loire Region
      • Nantes, Pays de la Loire Region, France, 44093
        • Centre Hospitalier Universitaire Nantes - Hotel Dieu
    • Poitou-charentes
      • Poitiers, Poitou-charentes, France, 86000
        • Centre Hospitalier Universitaire de Poitiers
    • Île-de-France Region
      • Créteil, Île-de-France Region, France, 91010
        • Centre Hospitalier Universitaire Henri Mondor
      • Paris, Île-de-France Region, France, 75015
        • Hôpital Necker-Enfants Malades
      • Paris, Île-de-France Region, France, 75012
        • Hôpital Saint-Antoine
  • Germany
    • Baden-Wurttemberg
      • Tübingen, Baden-Wurttemberg, Germany, 72076
        • Universitätsklinik Tübingen
    • Saxony
      • Leipzig, Saxony, Germany, 04103
        • Universitatsklinikum Leipzig
  • Greece
    • Attica
      • Athens, Attica, Greece, 10676
        • Evaggelismos General Hospital
      • Athens, Attica, Greece, 11528
        • Alexandra General Hospital of Athens
    • Peloponnese
      • Patra, Peloponnese, Greece, 26504
        • University Regional General Hospital of Patras
  • Israel
      • Jerusalem, Israel, 9112001
        • Hadassah Medical Center
      • Tel Aviv, Israel, 6423906
        • Tel Aviv Sourasky Medical Center
    • Tel Aviv
      • Ramat Gan, Tel Aviv, Israel, 52621
        • The Chaim Sheba Medical Center
  • Italy
      • Alessandria, Italy, 15121
        • AON SS Antonio e Biagio e Cesare Arrigo
      • Ancona, Italy, 60126
        • Azienda Ospedaliero Universitaria Ospedali Riuniti di Ancona
      • Bologna, Italy, 40138
        • Azienda Ospedaliero-Universitaria di Bologna - Policlinico Sant'Orsola-Malpighi
      • Catania, Italy, 95125
        • Azienda Ospedaliero - Universitaria Policlinico - Vittorio Emanuele
      • Pavia, Italy, 27100
        • Fondazione IRCCS Policlinico San Matteo
  • Japan
      • Tokyo, Japan, 150-8935
        • Japanese Red Cross Medical Center
    • Aichi-ken
      • Nagoya, Aichi-ken, Japan, 467-8601
        • Nagoya City University Hospital
    • Gifu
      • Gifu, Gifu, Japan, 503-8502
        • Ogaki Municipal Hospital
    • Kyoto
      • Kyoto, Kyoto, Japan, 602-855
        • University Hospital Kyoto Prefectural University of Medicine
    • Okayama-ken
      • Okayama, Okayama-ken, Japan, 701-1192
        • National Hospital Organization Okayama Medical Center
  • Norway
      • Oslo, Norway, 0450
        • Oslo Universitetssykehus-Ulleval Hospital
  • Puerto Rico
      • San Juan, Puerto Rico, 00919
        • Hospital Español Auxilio Mutuo
    • PR
      • Ponce, PR, Puerto Rico, 00730
        • Ad-Vance Medical Research
  • South Korea
      • Seoul, South Korea, 03080
        • Seoul National University Hospital
      • Seoul, South Korea, 06591
        • The Catholic University of Korea - Seoul St. Mary's Hospital
    • Jeollanam-do
      • Hwasun, Jeollanam-do, South Korea, 58128
        • Chonnam National University Hwasun Hospital
  • Spain
      • Barcelona, Spain, 08036
        • Hospital Clinic De Barcelona
      • Barcelona, Spain, 08035
        • Hospital Universitari Vall d'Hebron
      • Madrid, Spain, 28041
        • Hospital Universitario 12 de Octubre
      • Murcia, Spain, 30120
        • Hospital Universitario Virgen de La Arrixaca
      • Salamanca, Spain, 37007
        • Hospital Universitario de Salamanca
      • Santander, Spain, 39008
        • Hospital Universitario Marques de Valdecilla
    • Barcelona
      • Badalona, Barcelona, Spain, 08916
        • Hospital Universitari Germans Trias i Pujol
  • Taiwan
      • Taipei, Taiwan, 100
        • National Taiwan University Hospital
    • Taipei CITY
      • Taipei, Taipei CITY, Taiwan, 11490
        • Tri-Service General Hospital
  • Turkey (Türkiye)
      • Samsun, Turkey (Türkiye), 55139
        • Ondokuz Mayis Universitesi Tp Fakultesi
    • Ankara
      • Yenimahalle, Ankara, Turkey (Türkiye), 06560
        • Ankara Universitesi
  • United Kingdom
    • England
      • Birmingham, England, United Kingdom, B9 5SS
        • University Hospitals Birmingham NHS Foundation Trust
      • Cornwell, England, United Kingdom, TR1 3LI
        • Royal Cornwall Hospital NHS Trust
      • London, England, United Kingdom, NW1 2BU
        • University College London Hospitals Nhs Foundation Trust
      • Milton Keynes, England, United Kingdom, MK14 6LS
        • Genesis Care - Milton Keynes
      • Oxford, England, United Kingdom, OX3 7LE
        • Oxford University Hospitals NHS Foundation Trust
      • Sutton, England, United Kingdom, SM2 5PT
        • The Royal Marsden NHS Foundation Trust
      • Windsor, England, United Kingdom, SL43HD
        • Genesis Care Windsor - Genesis Care UK Ltd.
  • United States
    • Arkansas
      • Springdale, Arkansas, United States, 72762
        • Highlands Oncology Group
    • California
      • Glendale, California, United States, 91204
        • Los Angeles Cancer Network - Glendale Adventist Medical Center
      • Orange, California, United States, 92868
        • University of California Irvine
      • West Hollywood, California, United States, 90069
        • Office of James R. Berenson MD
    • Connecticut
      • New Haven, Connecticut, United States, 06520
        • Smilow Cancer Hospital at Yale New Haven
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Winship Cancer Institute of Emory University
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Northwestern Medicine - Northwestern Medical Group
      • Maywood, Illinois, United States, 60153
        • Loyola University Medical Center
    • Indiana
      • Noblesville, Indiana, United States, 46062
        • Investigative Clinical Research of Indiana, LLC
    • Iowa
      • Sioux City, Iowa, United States, 51101
        • June E. Nylen Cancer Center
    • Maryland
      • Baltimore, Maryland, United States, 21287
        • Johns Hopkins Hospital
    • Massachusetts
      • Boston, Massachusetts, United States, 02118
        • Boston Medical Center
      • Boston, Massachusetts, United States, 02215
        • Dana Farber Cancer Institute
    • Nebraska
      • Omaha, Nebraska, United States, 68198
        • Univeristy of Nebraska Medical Center
    • Nevada
      • Las Vegas, Nevada, United States, 89119
        • USOR - Comprehensive Cancer Centers of Nevada - Central Valley
    • New Jersey
      • Hackensack, New Jersey, United States, 07601
        • John Theurer Cancer Center
    • New York
      • Rochester, New York, United States, 14627
        • University of Rochester
      • The Bronx, New York, United States, 10467
        • Montefiore Medical Center
    • North Carolina
      • Charlotte, North Carolina, United States, 28402
        • Levine Cancer Center
      • Concord, North Carolina, United States, 28205
        • Levine Cancer Institute - Concord
      • Durham, North Carolina, United States, 27710
        • Duke University Medical Center
    • Ohio
      • Canton, Ohio, United States, 44718-2566
        • Gabrail Cancer Center
      • Columbus, Ohio, United States, 43210
        • The Ohio State University
    • Oregon
      • Portland, Oregon, United States, 97239
        • Oregon Health and Science University
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • University of Pennsylvania
    • Tennessee
      • Memphis, Tennessee, United States, 38120
        • Baptist Cancer Center - Memphis - Walnut Grove
    • Texas
      • Houston, Texas, United States, 77002
        • Lumi Research

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

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:

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. 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: 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.
Drug: Modakafusp alfa
Modakafusp alfa intravenous infusion.
Other Names:
  • TAK-573
  • TEV-48573
Experimental: 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.
Drug: Modakafusp alfa
Modakafusp alfa intravenous infusion.
Other Names:
  • TAK-573
  • TEV-48573
Experimental: 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.
Drug: Modakafusp alfa
Modakafusp alfa intravenous infusion.
Other Names:
  • TAK-573
  • TEV-48573
Experimental: 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.
Drug: Modakafusp alfa
Modakafusp alfa intravenous infusion.
Other Names:
  • TAK-573
  • TEV-48573
Experimental: 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.
Drug: Modakafusp alfa
Modakafusp alfa intravenous infusion.
Other Names:
  • TAK-573
  • TEV-48573
Experimental: 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.
Drug: Modakafusp alfa
Modakafusp alfa intravenous infusion.
Other Names:
  • TAK-573
  • TEV-48573
Drug: Dexamethasone
Dexamethasone.
Experimental: 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.
Drug: Modakafusp alfa
Modakafusp alfa intravenous infusion.
Other Names:
  • TAK-573
  • TEV-48573
Experimental: 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.
Drug: Modakafusp alfa
Modakafusp alfa intravenous infusion.
Other Names:
  • TAK-573
  • TEV-48573
Drug: Dexamethasone
Dexamethasone.
Experimental: 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.
Drug: Modakafusp alfa
Modakafusp alfa intravenous infusion.
Other Names:
  • TAK-573
  • TEV-48573
Experimental: 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.
Drug: Modakafusp alfa
Modakafusp alfa intravenous infusion.
Other Names:
  • TAK-573
  • TEV-48573
Experimental: 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.
Drug: Modakafusp alfa
Modakafusp alfa intravenous infusion.
Other Names:
  • TAK-573
  • TEV-48573
Experimental: 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.
Drug: Modakafusp alfa
Modakafusp alfa intravenous infusion.
Other Names:
  • TAK-573
  • TEV-48573

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Part 1: Percentage of Participants Reporting One or More Treatment Emergent Adverse Events (TEAEs)
Time Frame: Up to 54.3 months in Part 1
An adverse event (AE) is defined as any untoward medical occurrence in a participants administered a pharmaceutical product; the untoward medical occurrence does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product whether or not it is related to the medicinal product. A TEAE is defined as any AE either reported for the first time or worsening of a pre-existing event after first dose of study drug and within 30 days of the last administration of study drug.
Up to 54.3 months in Part 1
Part 1: Number of Participants With Dose-limiting Toxicities (DLTs)
Time Frame: Up to Cycle 1 (cycle length was 28 days for Schedule A, B and D; 21 days for Schedule C)
DLTs were evaluated as per National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version 5.0. Nonhematologic TEAEs of NCI CTCAE Grade ≥3 clearly unrelated to the underlying disease and occurring during the first cycle were considered DLTs.
Up to Cycle 1 (cycle length was 28 days for Schedule A, B and D; 21 days for Schedule C)
Part 1: Percentage of Participants Reporting One or More Grade 3 or Higher TEAEs
Time Frame: Up to 54.3 months in Part 1
An AE is defined as any untoward medical occurrence in a participants administered a pharmaceutical product; the untoward medical occurrence does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product whether or not it is related to the medicinal product. TEAEs grades were evaluated as per NCI CTCAE, Version 5.0. Grade 1 scaled as mild; Grade 2 scaled as moderate; Grade 3 scaled as severe or medically significant but not immediately life-threatening; Grade 4 scaled as life-threatening consequences; and Grade 5 scaled as death related to AE. Percentages were rounded off to the nearest decimal.
Up to 54.3 months in Part 1
Part 1: Percentage of Participants Reporting One or More Serious Treatment-emergent Adverse Events (Serious TEAEs)
Time Frame: Up to approximately 54.3 months in Part 1
AE: any untoward medical occurrence in participants administered a pharmaceutical product; untoward medical occurrence does not necessarily have causal relationship with this treatment. AE can therefore be any unfavorable & unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with use of medicinal (investigational) product whether or not it is related to medicinal product. TEAE: any AE either reported for first time or worsening of pre-existing event after first dose of study drug & within 30 days of last administration of study drug. Serious TEAEs: any untoward medical occurrence that: 1)results in death, 2) is life-threatening, 3) requires inpatient hospitalization or prolongation of existing hospitalization, 4) results in persistent or significant disability/incapacity, 5) leads to a congenital anomaly/birth defect in the offspring of the participant or 6) is medically important event. Percentages were rounded off to nearest decimal.
Up to approximately 54.3 months in Part 1
Part 1: Percentage of Participants Who Discontinued the Treatment Because of TEAE
Time Frame: Up to 54.3 months in Part 1
An AE is defined as any untoward medical occurrence in a participants administered a pharmaceutical product; the untoward medical occurrence does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product whether or not it is related to the medicinal product. A TEAE is defined as any AE either reported for the first time or worsening of a pre-existing event after first dose of study drug and within 30 days of the last administration of study drug. Percentages were rounded off to the nearest decimal.
Up to 54.3 months in Part 1
Part 1: Percentage of Participants With TEAEs Resulting in Dose Modifications: Dose Delay
Time Frame: Up to 54.3 months in Part 1
Percentages were rounded off to the nearest decimal.
Up to 54.3 months in Part 1
Part 1: Percentage of Participants With TEAEs Resulting in Dose Modifications: Dose Interruptions
Time Frame: Up to 54.3 months in Part 1
Percentages were rounded off to the nearest decimal.
Up to 54.3 months in Part 1
Part 1: Percentage of Participants With TEAEs Resulting in Dose Modifications: Dose Reductions
Time Frame: Up to 54.3 months in Part 1
Percentages were rounded off to the nearest decimal.
Up to 54.3 months in Part 1
Part 1: Percentage of Participants With Clinically Significant Laboratory Values
Time Frame: Up to 54.3 months in Part 1
Laboratory values included hematology, chemistry, and urinalysis and were assessed per investigator's interpretation.
Up to 54.3 months in Part 1
Part 1: Percentage of Participants With Clinically Significant Vital Signs Measurements
Time Frame: Up to 54.3 months in Part 1
Vital signs included temperature, pulse, respiratory rate, oxygen saturation, and blood pressure.
Up to 54.3 months in Part 1
Part 2: Overall Response Rate (ORR)
Time Frame: Up to 34.7 months in Part 2
ORR was defined as the percentage of participants who achieved a partial response (PR) rate or better (stringent complete response [sCR] + complete response [CR] + very good partial response [VGPR] + PR) during the study as defined by international myeloma working group (IMWG) uniform response criteria. PR: ≥50% reduction of serum M-protein and reduction in 24-hour urinary M-protein by ≥90% or to <200 mg/24 hours. CR: negative immunofixation of serum and urine, disappearance of any soft tissue plasmacytomas, and <5% plasma cells in bone marrow. sCR: CR+normal free light chain (FLC) ratio and absence of clonal cells in bone marrow biopsy by immunohistochemistry. VGPR:serum and urine M-protein detectable by immunofixation but not on electrophoresis, or ≥90% reduction in serum M-protein plus urine M-protein <100 mg/24 hours.
Up to 34.7 months in Part 2
Part 3: Overall Response Rate (ORR) Assessed by Independent Review Committee (IRC)
Time Frame: Up to 20.5 months in Part 3
ORR was defined as the percentage of participants who achieved a PR rate or better (sCR + CR + VGPR + PR) during the study as defined by IMWG uniform response criteria. PR :≥50% reduction of serum M-protein and reduction in 24-hour urinary M-protein by ≥90% or to <200 mg/24 hours. CR:negative immunofixation of serum and urine, disappearance of any soft tissue plasmacytomas, and <5% plasma cells in bone marrow. Scr: CR+normal FLC ratio and absence of clonal cells in bone marrow biopsy by immunohistochemistry. VGPR:serum and urine M-protein detectable by immunofixation but not on electrophoresis, or ≥90% reduction in serum M-protein plus urine M-protein <100 mg/24 hours.
Up to 20.5 months in Part 3

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Parts 1 and 2: Percentage of Participants With Dose-limiting Toxicities (DLTs)- Like Events
Time Frame: Up to 54.3 months in Part 1; Up to 34.7 months in Part 2
Percentage of participants with TEAEs meeting DLT definition were reported. Toxicity was evaluated as per the NCI CTCAE, Version 5.0. The hematologic TEAEs of Grade ≥3 clearly unrelated to the underlying disease and occur during the first cycle that are considered DLTs: Grade ≥3 hemolysis; Grade 4 neutropenia for >7 consecutive days; Grade 4 thrombocytopenia for >14 consecutive days; Grade 3 thrombocytopenia with clinically significant bleeding; Any other Grade ≥4 hematologic toxicity except for Grade 4 lymphopenia. An incomplete recovery from treatment-related toxicity causing >2-week delay in the next scheduled infusion before the initiation of Cycle 2 were considered a DLT. Percentages were rounded off to the nearest decimal.
Up to 54.3 months in Part 1; Up to 34.7 months in Part 2
Part 1: Cmax: Maximum Observed Serum Concentration for Modakafusp Alfa
Time Frame: Part 1:Schedule A:Day 1&15 in Cycles 1&2; Schedule B: Day1&15 in Cycles 1&2; Schedule C:Day1 in Cycles 1&2; Schedule D: Day 1 in Cycles 1&2: Pre-infusion&at multiple times post-infusion (cycle length was 28 days for Schedule A, B&D;21 days for Schedule C)
As per planned analysis, data for this outcome measure was collected and reported dose-wise for each treatment schedule.
Part 1:Schedule A:Day 1&15 in Cycles 1&2; Schedule B: Day1&15 in Cycles 1&2; Schedule C:Day1 in Cycles 1&2; Schedule D: Day 1 in Cycles 1&2: Pre-infusion&at multiple times post-infusion (cycle length was 28 days for Schedule A, B&D;21 days for Schedule C)
Part 1: Tmax: Time to Reach the Cmax for Modakafusp Alfa
Time Frame: Part 1:Schedule A:Day 1&15 in Cycles 1&2; Schedule B: Day1&15 in Cycles 1&2; Schedule C:Day1 in Cycles 1&2; Schedule D: Day 1 in Cycles 1&2: Pre-infusion&at multiple times post-infusion (cycle length was 28 days for Schedule A, B&D;21 days for Schedule C)
As per planned analysis, data for this outcome measure was collected and reported dose-wise for each treatment schedule.
Part 1:Schedule A:Day 1&15 in Cycles 1&2; Schedule B: Day1&15 in Cycles 1&2; Schedule C:Day1 in Cycles 1&2; Schedule D: Day 1 in Cycles 1&2: Pre-infusion&at multiple times post-infusion (cycle length was 28 days for Schedule A, B&D;21 days for Schedule C)
Part 1: AUC∞: Area Under the Serum Concentration-time Curve From Time 0 to Infinity for Modakafusp Alfa
Time Frame: Part1:Schedule A:Day 1 in Cycles1&2&Day15 in Cycle1;Schedule B: Day1&15 in Cycle 1;Schedule C:Day1 in Cycles1&2; Schedule D:Day 1 in Cycles1&2: Pre-infusion&at multiple times post-infusion (cycle length= 28 days for Schedule A, B&D;21 days for Schedule C)
As per planned analysis, data for this outcome measure was collected and reported dose-wise for each treatment schedule. Given the low exposure at the 0.1 mg/kg dose, there was insufficient data to characterize the terminal phase PK required for calculating this parameter. Consequently, this parameter has been marked as "Not Calculated" - and therefore not reported - for the Part 1, Schedule A, 0.1 mg/kg dose group, in accordance with non-compartmental PK analysis standards.
Part1:Schedule A:Day 1 in Cycles1&2&Day15 in Cycle1;Schedule B: Day1&15 in Cycle 1;Schedule C:Day1 in Cycles1&2; Schedule D:Day 1 in Cycles1&2: Pre-infusion&at multiple times post-infusion (cycle length= 28 days for Schedule A, B&D;21 days for Schedule C)
Part 1: AUClast: Area Under the Serum Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for Modakafusp Alfa
Time Frame: Part1:Schedule A:Day 1 in Cycles1&2&Day15 in Cycle1;Schedule B: Day1&15 in Cycle 1;Schedule C:Day1 in Cycles1&2; Schedule D:Day 1 in Cycles1&2: Pre-infusion&at multiple times post-infusion (cycle length= 28 days for Schedule A, B&D;21 days for Schedule C)
As per planned analysis, data for this outcome measure was collected and reported dose-wise for each treatment schedule.
Part1:Schedule A:Day 1 in Cycles1&2&Day15 in Cycle1;Schedule B: Day1&15 in Cycle 1;Schedule C:Day1 in Cycles1&2; Schedule D:Day 1 in Cycles1&2: Pre-infusion&at multiple times post-infusion (cycle length= 28 days for Schedule A, B&D;21 days for Schedule C)
Part 1: λz: Terminal Disposition Rate Constant for Modakafusp Alfa
Time Frame: Part1:Schedule A:Day 1 in Cycles1&2&Day15 in Cycle1;Schedule B: Day1&15 in Cycle 1;Schedule C:Day1 in Cycles1&2; Schedule D:Day 1 in Cycles1&2: Pre-infusion&at multiple times post-infusion (cycle length= 28 days for Schedule A, B&D;21 days for Schedule C)
As per planned analysis, data for this outcome measure was collected and reported dose-wise for each treatment schedule. Given the low exposure at the 0.1 mg/kg dose, there was insufficient data to characterize the terminal phase PK required for calculating this parameter. Consequently, this parameter has been marked as "Not Calculated" - and therefore not reported - for the Part 1, Schedule A, 0.1 mg/kg dose group, in accordance with non-compartmental PK analysis standards.
Part1:Schedule A:Day 1 in Cycles1&2&Day15 in Cycle1;Schedule B: Day1&15 in Cycle 1;Schedule C:Day1 in Cycles1&2; Schedule D:Day 1 in Cycles1&2: Pre-infusion&at multiple times post-infusion (cycle length= 28 days for Schedule A, B&D;21 days for Schedule C)
Part 1: T1/2z: Terminal Elimination Phase Half-life for Modakafusp Alfa
Time Frame: Part1:Schedule A:Day 1 in Cycles1&2&Day15 in Cycle1;Schedule B: Day1&15 in Cycle 1;Schedule C:Day1 in Cycles1&2; Schedule D:Day 1 in Cycles1&2: Pre-infusion&at multiple times post-infusion (cycle length= 28 days for Schedule A, B&D;21 days for Schedule C)
As per planned analysis, data for this outcome measure was collected and reported dose-wise for each treatment schedule.
Part1:Schedule A:Day 1 in Cycles1&2&Day15 in Cycle1;Schedule B: Day1&15 in Cycle 1;Schedule C:Day1 in Cycles1&2; Schedule D:Day 1 in Cycles1&2: Pre-infusion&at multiple times post-infusion (cycle length= 28 days for Schedule A, B&D;21 days for Schedule C)
Part 1: CL: Clearance for Modakafusp Alfa
Time Frame: Part1:Schedule A:Day 1 in Cycles1&2&Day15 in Cycle1;Schedule B: Day1&15 in Cycle 1;Schedule C:Day1 in Cycles1&2; Schedule D:Day 1 in Cycles1&2: Pre-infusion&at multiple times post-infusion (cycle length= 28 days for Schedule A, B&D;21 days for Schedule C)
Clearance is defined as a quantitative measure of the rate at which a drug substance is removed from the body. CL = dose/AUC. As per planned analysis, data for this outcome measure was collected and reported dose-wise for each treatment schedule.
Part1:Schedule A:Day 1 in Cycles1&2&Day15 in Cycle1;Schedule B: Day1&15 in Cycle 1;Schedule C:Day1 in Cycles1&2; Schedule D:Day 1 in Cycles1&2: Pre-infusion&at multiple times post-infusion (cycle length= 28 days for Schedule A, B&D;21 days for Schedule C)
Part 1: Vss: Volume of Distribution at Steady State for Modakafusp Alfa
Time Frame: Part1:Schedule A:Day 1 in Cycles1&2&Day15 in Cycle1;Schedule B: Day1&15 in Cycle 1;Schedule C:Day1 in Cycles1&2; Schedule D:Day 1 in Cycles1&2: Pre-infusion&at multiple times post-infusion (cycle length= 28 days for Schedule A, B&D;21 days for Schedule C)
Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired serum concentration of a drug. V(ss) = (dose/AUC)*MRT, where MRT is mean residence time. As per planned analysis, data for this outcome measure was collected and reported dose-wise for each treatment schedule.
Part1:Schedule A:Day 1 in Cycles1&2&Day15 in Cycle1;Schedule B: Day1&15 in Cycle 1;Schedule C:Day1 in Cycles1&2; Schedule D:Day 1 in Cycles1&2: Pre-infusion&at multiple times post-infusion (cycle length= 28 days for Schedule A, B&D;21 days for Schedule C)
Parts 1, 2 and 3: Percentage of Participants With Positive Anti-drug Antibody (ADA) at Any Scheduled and Unscheduled Post-Baseline Visit
Time Frame: Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3
ADA samples scoring equal to or above the cut-point (titer of 75) were defined as ADA positive. Percentages were rounded off to the nearest decimal.
Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3
Part 1: Overall Response Rate (ORR)
Time Frame: Up to 54.3 months in Part 1
ORR was defined as the percentage of participants who achieved a PR rate or better (sCR + CR + VGPR + PR) during the study as defined by IMWG uniform response criteria. PR: ≥50% reduction of serum M-protein and reduction in 24-hour urinary M-protein by ≥90% or to <200 mg/24 hours. CR: negative immunofixation of serum and urine, disappearance of any soft tissue plasmacytomas, and <5% plasma cells in bone marrow. sCR: CR+normal FLC ratio and absence of clonal cells in bone marrow biopsy by immunohistochemistry. VGPR: serum and urine M-protein detectable by immunofixation but not on electrophoresis, or ≥90% reduction in serum M-protein plus urine M-protein <100 mg/24 hours. Percentages were rounded off to the nearest decimal.
Up to 54.3 months in Part 1
Parts 1 and 2: Clinical Benefit Rate (CBR)
Time Frame: Up to 54.3 months in Part 1; Up to 34.7 months in Part 2
The CBR was defined as the percentage of participants with a confirmed response of sCR, CR, VGPR, PR, or minimal response (MR) during the study per investigator assessment as defined by IMWG Uniform Response Criteria. PR: ≥50% reduction of serum M-protein and reduction in 24-hour urinary M-protein by ≥90% or to <200 mg/24 hours. CR: negative immunofixation of serum and urine, disappearance of any soft tissue plasmacytomas, and <5% plasma cells in bone marrow. sCR: CR+normal FLC ratio and absence of clonal cells in bone marrow biopsy by immunohistochemistry. VGPR: serum and urine M-protein detectable by immunofixation but not on electrophoresis, or ≥90% reduction in serum M-protein plus urine M-protein <100 mg/24 hours. MR: ≥25% but ≤49% reduction of serum M-protein and reduction in 24-hour urine M-protein by 50% to 89%. Percentages were rounded off to the nearest decimal.
Up to 54.3 months in Part 1; Up to 34.7 months in Part 2
Parts 1 and 2: Disease Control Rate (DCR)
Time Frame: Up to 54.3 months in Part 1; Up to 34.7 months in Part 2
The DCR was defined as the proportion of participants with a confirmed response of sCR, CR, VGPR, PR, MR, or stable disease (SD) during the study per investigator assessment as defined by IMWG Uniform Response Criteria. PR: ≥50% reduction of serum M-protein and reduction in 24-hour urinary M-protein by ≥90% or to <200 mg/24 hours. CR: negative immunofixation of serum and urine, disappearance of any soft tissue plasmacytomas, and <5% plasma cells in bone marrow. sCR: CR+normal FLC ratio and absence of clonal cells in bone marrow biopsy by immunohistochemistry. VGPR: serum and urine M-protein detectable by immunofixation but not on electrophoresis, or ≥90% reduction in serum M-protein plus urine M-protein <100 mg/24 hours. MR: ≥25% but ≤49% reduction of serum M-protein and reduction in 24-hour urine M-protein by 50% to 89%. SD: no known evidence of progressive or new bone lesions if radiographic studies were performed. Percentages were rounded off to the nearest decimal.
Up to 54.3 months in Part 1; Up to 34.7 months in Part 2
Parts 1, 2, and 3: Duration of Response (DOR)
Time Frame: Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3
DOR was defined as the time from the date of first documentation of response PR or better (sCR + CR + VGPR + PR) to the time of disease progression or death, whichever occurs first. PR: ≥50% reduction of serum M-protein and reduction in 24-hour urinary M-protein by ≥90% or to <200 mg/24 hours. CR: negative immunofixation of serum and urine, disappearance of any soft tissue plasmacytomas, and <5% plasma cells in bone marrow. sCR: CR+normal FLC ratio and absence of clonal cells in bone marrow biopsy by immunohistochemistry. VGPR: serum and urine M-protein detectable by immunofixation but not on electrophoresis, or ≥90% reduction in serum M-protein plus urine M-protein <100 mg/24 hours.
Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3
Parts 1 and 2: Time to Response
Time Frame: Up to 54.3 months in Part 1; Up to 34.7 months in Part 2
Time to response was defined as the time from first dose to the date of first documentation of response (PR or better [sCR + CR + VGPR + PR]) PR: ≥50% reduction of serum M-protein and reduction in 24-hour urinary M-protein by ≥90% or to <200 mg/24 hours. CR: negative immunofixation of serum and urine, disappearance of any soft tissue plasmacytomas, and <5% plasma cells in bone marrow. sCR: CR+normal FLC ratio and absence of clonal cells in bone marrow biopsy by immunohistochemistry. VGPR: serum and urine M-protein detectable by immunofixation but not on electrophoresis, or ≥90% reduction in serum M-protein plus urine M-protein <100 mg/24 hours.
Up to 54.3 months in Part 1; Up to 34.7 months in Part 2
Parts 1, 2, and 3: Progression Free Survival (PFS)
Time Frame: Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3
PFS was defined as the time from the date of enrollment until the date of progressive disease (PD) or death due to any cause, whichever occurs first as defined by IMWG Criteria. Per IMWG criteria, PD: serum M-component increase ≥0.5 g/dl or urine M-component increase ≥ 200 mg/24-hour/ difference between involved and uninvolved FLC levels increase >10 mg/dl or bone marrow plasma cell ≥10%/ development of new/ increase in size of existing bone lesions or soft tissue plasmacytoma or development of hypercalcemia.
Up to 54.3 months in Part 1; Up to 34.7 months in Part 2; Up to 20.5 months in Part 3
Parts 2 and 3: Overall Survival (OS)
Time Frame: Up to 34.7 months in Part 2; Up to 20.5 months in Part 3
The OS was defined as the time from the date of first dose to the date of death due to any cause.
Up to 34.7 months in Part 2; Up to 20.5 months in Part 3
Part 2: Cmax: Maximum Observed Serum Concentration for Modakafusp Alfa
Time Frame: Schedule C and D: Pre-infusion and at multiple times post-infusion on Day 1 of Cycles 1 and 2: (cycle length was 21 days for Schedule C and 28 days for Schedule D)
Schedule C and D: Pre-infusion and at multiple times post-infusion on Day 1 of Cycles 1 and 2: (cycle length was 21 days for Schedule C and 28 days for Schedule D)
Part 2: AUC∞: Area Under the Serum Concentration-time Curve From Time 0 to Infinity for Modakafusp Alfa
Time Frame: Schedule C and D: Pre-infusion and at multiple times post-infusion on Day 1 of Cycles 1 and 2: (cycle length was 21 days for Schedule C and 28 days for Schedule D)
Schedule C and D: Pre-infusion and at multiple times post-infusion on Day 1 of Cycles 1 and 2: (cycle length was 21 days for Schedule C and 28 days for Schedule D)
Part 2: AUClast: Area Under the Serum Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for Modakafusp Alfa
Time Frame: Schedule C and D: Pre-infusion and at multiple times post-infusion on Day 1 of Cycles 1 and 2: (cycle length was 21 days for Schedule C and 28 days for Schedule D)
Schedule C and D: Pre-infusion and at multiple times post-infusion on Day 1 of Cycles 1 and 2: (cycle length was 21 days for Schedule C and 28 days for Schedule D)
Part 2: λz: Terminal Disposition Rate Constant for Modakafusp Alfa
Time Frame: Schedule C and D: Pre-infusion and at multiple times post-infusion on Day 1 of Cycles 1 and 2: (cycle length was 21 days for Schedule C and 28 days for Schedule D)
Schedule C and D: Pre-infusion and at multiple times post-infusion on Day 1 of Cycles 1 and 2: (cycle length was 21 days for Schedule C and 28 days for Schedule D)
Part 2: Tmax: Time to Reach the Cmax for Modakafusp Alfa
Time Frame: Schedule C and D: Pre-infusion and at multiple times post-infusion on Day 1 of Cycles 1 and 2: (cycle length was 21 days for Schedule C and 28 days for Schedule D)
Schedule C and D: Pre-infusion and at multiple times post-infusion on Day 1 of Cycles 1 and 2: (cycle length was 21 days for Schedule C and 28 days for Schedule D)
Part 2: CL: Clearance for Modakafusp Alfa
Time Frame: Schedule C and D: Pre-infusion and at multiple times post-infusion on Day 1 of Cycles 1 and 2: (cycle length was 21 days for Schedule C and 28 days for Schedule D)
Clearance is defined as a quantitative measure of the rate at which a drug substance is removed from the body. CL = dose/AUC.
Schedule C and D: Pre-infusion and at multiple times post-infusion on Day 1 of Cycles 1 and 2: (cycle length was 21 days for Schedule C and 28 days for Schedule D)
Part 2: Vss: Volume of Distribution at Steady State for Modakafusp Alfa
Time Frame: Schedule C and D: Pre-infusion and at multiple times post-infusion on Day 1 of Cycles 1 and 2: (cycle length was 21 days for Schedule C and 28 days for Schedule D)
Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired serum concentration of a drug. V(ss) = (dose/AUC)*MRT, where MRT is mean residence time.
Schedule C and D: Pre-infusion and at multiple times post-infusion on Day 1 of Cycles 1 and 2: (cycle length was 21 days for Schedule C and 28 days for Schedule D)
Part 2: T1/2z: Terminal Elimination Phase Half-life for Modakafusp Alfa
Time Frame: Schedule C and D: Pre-infusion and at multiple times post-infusion on Day 1 of Cycles 1 and 2: (cycle length was 21 days for Schedule C and 28 days for Schedule D)
Schedule C and D: Pre-infusion and at multiple times post-infusion on Day 1 of Cycles 1 and 2: (cycle length was 21 days for Schedule C and 28 days for Schedule D)
Part 3: Objective Response Rate (ORR) by Investigator Assessment
Time Frame: Up to 20.5 months in Part 3
ORR was defined as the percentage of participants who achieved a PR rate or better (sCR + CR + VGPR + PR) during the study as defined by IMWG uniform response criteria. PR :≥50% reduction of serum M-protein and reduction in 24-hour urinary M-protein by ≥90% or to <200 mg/24 hours. CR:negative immunofixation of serum and urine, disappearance of any soft tissue plasmacytomas, and <5% plasma cells in bone marrow. sCR: CR+normal FLC ratio and absence of clonal cells in bone marrow biopsy by immunohistochemistry. VGPR:serum and urine M-protein detectable by immunofixation but not on electrophoresis, or ≥90% reduction in serum M-protein plus urine M-protein <100 mg/24 hours. Percentages were rounded off to the nearest decimal.
Up to 20.5 months in Part 3
Part 3: Clinical Benefit Rate (CBR) by IRC and Investigator Assessment
Time Frame: Up to 20.5 months in Part 3
The CBR was defined as the percentage of participants with a confirmed response of sCR, CR, VGPR, PR, or minimal response (MR) during the study per investigator assessment as defined by IMWG Uniform Response Criteria. PR: ≥50% reduction of serum M-protein and reduction in 24-hour urinary M-protein by ≥90% or to <200 mg/24 hours. CR: negative immunofixation of serum and urine, disappearance of any soft tissue plasmacytomas, and <5% plasma cells in bone marrow. sCR: CR+normal FLC ratio and absence of clonal cells in bone marrow biopsy by immunohistochemistry. VGPR: serum and urine M-protein detectable by immunofixation but not on electrophoresis, or ≥90% reduction in serum M-protein plus urine M-protein <100 mg/24 hours. MR: ≥25% but ≤49% reduction of serum M-protein and reduction in 24-hour urine M-protein by 50% to 89%. Percentages were rounded off to the nearest decimal.
Up to 20.5 months in Part 3
Part 3: Duration of Clinical Benefit
Time Frame: Up to 20.5 months in Part 3
Duration of clinical benefit was defined as the time from first documented evidence of confirmed MR or better until the earliest date of a confirmed PD per IMWG, or death among participants who achieve a confirmed MR or better. MR: ≥25% but ≤49% reduction of serum M-protein and reduction in 24-hour urine M-protein by 50% to 89%. Per IMWG criteria, PD: serum M-component increase ≥0.5 g/dl or urine M-component increase ≥ 200 mg/24-hour/ difference between involved and uninvolved FLC levels increase >10 mg/dl or bone marrow plasma cell ≥10%/ development of new/ increase in size of existing bone lesions or soft tissue plasmacytoma or development of hypercalcemia.
Up to 20.5 months in Part 3
Part 3: Disease Control Rate (DCR) by IRC and Investigator Assessment
Time Frame: Up to 20.5 months in Part 3
The DCR was defined as the proportion of participants with a confirmed response of sCR, CR, VGPR, PR, MR, or stable disease (SD) during the study per investigator assessment as defined by IMWG Uniform Response Criteria. PR: ≥50% reduction of serum M-protein and reduction in 24-hour urinary M-protein by ≥90% or to <200 mg/24 hours. CR: negative immunofixation of serum and urine, disappearance of any soft tissue plasmacytomas, and <5% plasma cells in bone marrow. sCR: CR+normal FLC ratio and absence of clonal cells in bone marrow biopsy by immunohistochemistry. VGPR: serum and urine M-protein detectable by immunofixation but not on electrophoresis, or ≥90% reduction in serum M-protein plus urine M-protein <100 mg/24 hours. MR: ≥25% but ≤49% reduction of serum M-protein and reduction in 24-hour urine M-protein by 50% to 89%. SD: no known evidence of progressive or new bone lesions if radiographic studies were performed. Percentages were rounded off to the nearest decimal.
Up to 20.5 months in Part 3
Part 3: Duration of Disease Control
Time Frame: Up to 20.5 months in Part 3
Duration of disease control was defined as the time from first documented evidence of SD or better until the earliest date of a confirmed PD per IMWG, or death among participants who achieved a SD or better. SD: no known evidence of progressive or new bone lesions if radiographic studies were performed. Per IMWG criteria, PD: serum M-component increase ≥0.5 g/dl or urine M-component increase ≥200 mg/24-hour/ difference between involved and uninvolved FLC levels increase >10 mg/dl or bone marrow plasma cell ≥10%/ development of new/ increase in size of existing bone lesions or soft tissue plasmacytoma or development of hypercalcemia.
Up to 20.5 months in Part 3
Part 3: Time to Progression (TTP) by IRC and Investigator Assessment
Time Frame: Up to 20.5 months in Part 3
TTP was defined as the time from the date of the first dose until the earliest date of confirmed PD per IMWG, or death due to PD. Per IMWG criteria, PD: serum M-component increase ≥0.5 g/dl or urine M-component increase ≥200 mg/24-hour/ difference between involved and uninvolved FLC levels increase >10 mg/dl or bone marrow plasma cell ≥10%/ development of new/ increase in size of existing bone lesions or soft tissue plasmacytoma or development of hypercalcemia.
Up to 20.5 months in Part 3
Part 3: Rate of Minimal Residual Disease (MRD) Negativity Status at a Sensitivity of 10^-5 in Participants Achieving CR
Time Frame: Up to 20.5 months in Part 3
MRD negativity rate at a sensitivity of 10^-5 was defined as participants who were MRD negative at a sensitivity of 10^-5 in participants achieving suspected complete response (CR). CR was defined as negative immunofixation of serum and urine, disappearance of any soft tissue plasmacytomas, and <5% plasma cells in bone marrow; in participants for whom only measurable disease is by serum FLC level, normal FLC ratio of 0.26 to 1.65 in addition to CR criteria was required.
Up to 20.5 months in Part 3
Part 3: Duration of MRD Negativity Status at a Sensitivity of 10^-5 in Participants Achieving CR
Time Frame: Up to 20.5 months in Part 3
Duration of MRD negativity (10^-5) was defined as the time from the first MRD negative status (10^-5) to the earliest date of the MRD positive status (10^-5), confirmed PD per IMWG or death.
Up to 20.5 months in Part 3
Part 3: Percentage of Participants With Treatment -Emergent Adverse Events (TEAEs)
Time Frame: Up to 20.5 months in Part 3
An AE is defined as any untoward medical occurrence in a participants administered a pharmaceutical product; the untoward medical occurrence does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product whether or not it is related to the medicinal product. A TEAE is defined as any AE either reported for the first time or worsening of a pre-existing event after first dose of study drug and within 30 days of the last administration of study drug. Percentages were rounded off to the nearest decimal.
Up to 20.5 months in Part 3
Part 3: Percentage of Participants With Serious Treatment-emergent Adverse Events (Serious TEAEs)
Time Frame: Up to 20.5 months in Part 3
AE: any untoward medical occurrence in participants administered pharmaceutical product; untoward medical occurrence does not necessarily have causal relationship with this treatment. AE can therefore be any unfavorable & unintended sign (including abnormal laboratory finding), symptom/disease temporally associated with use of medicinal (investigational) product whether or not it is related to medicinal product. TEAE: any AE either reported for first time or worsening of pre-existing event after first dose of study drug & within 30 days of last administration of study drug. Serious TEAEs: any untoward medical occurrence that: 1) results in death, 2) is life-threatening, 3) requires inpatient hospitalization or prolongation of existing hospitalization, 4) results in persistent or significant disability/incapacity, 5) leads to a congenital anomaly/birth defect in the offspring of the participant or 6) is a medically important event. Percentages were rounded off to the nearest decimal.
Up to 20.5 months in Part 3
Part 3: Percentage of Participants With Clinically Significant Laboratory Values
Time Frame: Up to 20.5 months in Part 3
Laboratory values included hematology, chemistry, and urinalysis as interpreted by the investigator.
Up to 20.5 months in Part 3
Part 3: Number of Participants at Baseline and at Worst Post-baseline Status as Categorized by Eastern Cooperative Oncology Group (ECOG) Performance Status
Time Frame: Up to 20.5 months in Part 3
ECOG performance status was measured at baseline and over time. ECOG performance status was measured on a 6 point scale: Grade 0: Normal activity, Grade 1: Symptoms but ambulatory, Grade 2: In bed <50% of the time, Grade 3: In bed >50% of the time, Grade 4: 100% bedridden, Grade 5: Dead. Reported here is the baseline status and the worst post-baseline status measured. A decrease in grade from baseline indicates an improvement. Only categories for which there was at least 1 participant are reported.
Up to 20.5 months in Part 3
Part 3: Health Care Utilization: Length of Hospital Stays
Time Frame: Up to 20.5 months in Part 3
Up to 20.5 months in Part 3
Part 3: Percentage of Participants With Neutralizing Antibodies (NAb) at Any Scheduled and Unscheduled Post-Baseline Visit
Time Frame: Up to 20.5 months in Part 3
Percentages were rounded off to the nearest decimal.
Up to 20.5 months in Part 3
Part 3: Health Care Utilization: Number of Participants With at Least One Medical Encounter
Time Frame: Up to 20.5 months in Part 3
Medical encounters included hospitalizations, emergency room stays, or outpatient visits.
Up to 20.5 months in Part 3
Part 3: Patient-reported Outcome (PRO): Change From Baseline to Cycle 9 in Instrument European Organisation for Research and Treatment of Cancer QLQ Questionnaire Multiple Myeloma Module (EORTC QLQ-MY20)
Time Frame: Baseline, Cycle 9 Day 8 [cycle length was 28 days] (up to 7.7 months)
EORTC QLQ-MY20 is a myeloma-specific module developed by the EORTC group specifically to assess quality of life in participants with multiple myeloma. It contains 20 items which can be grouped into a disease symptom subscale (6 items), side effects of treatment subscale (10 items), body image (1 item) and future perspective subscale (3 items). All transformed scale scores range from 0 to 100 with higher scores indicating worse symptoms (Disease Symptoms and Side Effects of Treatment) or better support/functioning (Future Perspective and Body Image).
Baseline, Cycle 9 Day 8 [cycle length was 28 days] (up to 7.7 months)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Teva Branded Pharmaceutical Products R&D LLC

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Medical Director, Takeda (Note: This product was divested to Teva Pharmaceuticals in 2025)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 4, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 1, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 7, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 11, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 11, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 12, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 29, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 12, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • TAK-573-1501
  • TV48573-ONC-10128 (Other Identifier: Former Id)
  • U1111-1195-8134 (Registry Identifier: WHO)
  • 2021-006038-37 (EudraCT Number)
  • jRCT2061220078 (Registry Identifier: jRCT)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Qualified researchers may request access to patient level data and related study documents including the study protocol and the statistical analysis plan. Requests will be assessed for scientific merit, product approval status, and conflicts of interest. If the request is approved, patient level data will be de-identified and study documents will be redacted to protect the privacy of trial participants and to protect commercially confidential information. Please visit USMedInfo@tevapharm.com to make your request.

IPD Sharing Access Criteria

IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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