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Experimental myeloma drug shows promise but trial halted early

NCT ID NCT03215030

Disease control Sponsor: Teva Branded Pharmaceutical Products R&D LLC Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early This study
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tested a new drug called modakafusp alfa in 272 people with multiple myeloma that had returned or stopped responding to other treatments. The goal was to check safety and see if the drug could shrink tumors. The trial was terminated early, but researchers collected data on side effects and response rates.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
modakafusp alfa (TAK-573)
What this could lead to
If successful, this could lead to a new treatment option for patients with multiple myeloma that has stopped responding to other therapies.
What could go wrong
The trial was terminated early, so results are limited. It is still early-stage research, and the drug may not prove effective or safe in larger studies.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

272 people

The number who actually took part.

Started

Oct 2017

Finished

Nov 2024

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

plasma cell myeloma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Multiple myeloma

Contacts and locations

Locations

  • AON SS Antonio e Biagio e Cesare Arrigo

    Alessandria, 15121, Italy

  • Ad-Vance Medical Research

    Ponce, PR, 00730, Puerto Rico

  • Alexandra General Hospital of Athens

    Athens, Attica, 11528, Greece

  • Ankara Universitesi

    Yenimahalle, Ankara, 06560, Turkey (Türkiye)

  • Azienda Ospedaliero - Universitaria Policlinico - Vittorio Emanuele

    Catania, 95125, Italy

  • Azienda Ospedaliero Universitaria Ospedali Riuniti di Ancona

    Ancona, 60126, Italy

  • Azienda Ospedaliero-Universitaria di Bologna - Policlinico Sant'Orsola-Malpighi

    Bologna, 40138, Italy

  • Baptist Cancer Center - Memphis - Walnut Grove

    Memphis, Tennessee, 38120, United States

  • Boston Medical Center

    Boston, Massachusetts, 02118, United States

  • British Columbia Cancer Agency Vancouver Centre

    Vancouver, British Columbia, V5Z 4E6, Canada

  • Centre Hospitalier Regional Universitaire de Lille

    Lille, Hauts-de-France, 59037, France

  • Centre Hospitalier Universitaire Henri Mondor

    Créteil, Île-de-France Region, 91010, France

  • Centre Hospitalier Universitaire Nantes - Hotel Dieu

    Nantes, Pays de la Loire Region, 44093, France

  • Centre Hospitalier Universitaire de Poitiers

    Poitiers, Poitou-charentes, 86000, France

  • Centre Hospitalier Universitaire de Toulouse Hopital Purpan

    Toulouse, Midi-pyrenees, 31059, France

  • Centre Hospitalier d'Argenteuil - Centre Hospitalier Victor Dupouy

    Argenteuil, 95107, France

  • Centre de Recherche du CHUM

    Montreal, Quebec, H2X 0C1, Canada

  • Chonnam National University Hwasun Hospital

    Hwasun, Jeollanam-do, 58128, South Korea

  • Dana Farber Cancer Institute

    Boston, Massachusetts, 02215, United States

  • Duke University Medical Center

    Durham, North Carolina, 27710, United States

  • Evaggelismos General Hospital

    Athens, Attica, 10676, Greece

  • Fondazione IRCCS Policlinico San Matteo

    Pavia, 27100, Italy

  • Gabrail Cancer Center

    Canton, Ohio, 44718-2566, United States

  • Genesis Care - Milton Keynes

    Milton Keynes, England, MK14 6LS, United Kingdom

  • Genesis Care Windsor - Genesis Care UK Ltd.

    Windsor, England, SL43HD, United Kingdom

  • Hadassah Medical Center

    Jerusalem, 9112001, Israel

  • Henan Cancer Hospital

    Zhengzhou, Henan, 450003, China

  • Highlands Oncology Group

    Springdale, Arkansas, 72762, United States

  • Hopital Necker-Enfants Malades

    Paris, Île-de-France Region, 75015, France

  • Hopital Saint-Antoine

    Paris, Île-de-France Region, 75012, France

  • Hopital Saint-Vincent de Paul - Lille

    Lille, Hauts-de-France, 59020, France

  • Hospital Clinic de Barcelona

    Barcelona, 08036, Spain

  • Hospital Espanol Auxilio Mutuo

    San Juan, 00919, Puerto Rico

  • Hospital Universitari Germans Trias i Pujol

    Badalona, Barcelona, 08916, Spain

  • Hospital Universitari Vall d'Hebron

    Barcelona, 08035, Spain

  • Hospital Universitario 12 de Octubre

    Madrid, 28041, Spain

  • Hospital Universitario Marques de Valdecilla

    Santander, 39008, Spain

  • Hospital Universitario Virgen de la Arrixaca

    Murcia, 30120, Spain

  • Hospital Universitario de Salamanca

    Salamanca, 37007, Spain

  • Institut de cancerologie Strasbourg Europe

    Strasbourg, Alsace, 67200, France

  • Investigative Clinical Research of Indiana, LLC

    Noblesville, Indiana, 46062, United States

  • Japanese Red Cross Medical Center

    Tokyo, 150-8935, Japan

  • John Theurer Cancer Center

    Hackensack, New Jersey, 07601, United States

  • Johns Hopkins Hospital

    Baltimore, Maryland, 21287, United States

  • June E. Nylen Cancer Center

    Sioux City, Iowa, 51101, United States

  • Juravinski Cancer Centre

    Hamilton, Ontario, L8V 5C2, Canada

  • Levine Cancer Center

    Charlotte, North Carolina, 28402, United States

  • Levine Cancer Institute - Concord

    Concord, North Carolina, 28205, United States

  • Los Angeles Cancer Network - Glendale Adventist Medical Center

    Glendale, California, 91204, United States

  • Loyola University Medical Center

    Maywood, Illinois, 60153, United States

  • Lumi Research

    Houston, Texas, 77002, United States

  • Montefiore Medical Center

    The Bronx, New York, 10467, United States

  • Nagoya City University Hospital

    Nagoya, Aichi-ken, 467-8601, Japan

  • Nanjing Drum Tower Hospital

    Nanjing, Jiangsu, 210008, China

  • National Hospital Organization Okayama Medical Center

    Okayama, Okayama-ken, 701-1192, Japan

  • National Taiwan University Hospital

    Taipei, 100, Taiwan

  • Northwestern Medicine - Northwestern Medical Group

    Chicago, Illinois, 60611, United States

  • Office of James R. Berenson MD

    West Hollywood, California, 90069, United States

  • Ogaki Municipal Hospital

    Gifu, Gifu, 503-8502, Japan

  • Ondokuz Mayis Universitesi Tp Fakultesi

    Samsun, 55139, Turkey (Türkiye)

  • Oregon Health and Science University

    Portland, Oregon, 97239, United States

  • Oslo Universitetssykehus-Ulleval Hospital

    Oslo, 0450, Norway

  • Oxford University Hospitals NHS Foundation Trust

    Oxford, England, OX3 7LE, United Kingdom

  • Peking University People's Hospital

    Beijing, Beijing Municipality, 100044, China

  • Peking University Third Hospital

    Beijing, Beijing Municipality, 100089, China

  • Royal Cornwall Hospital NHS Trust

    Cornwell, England, TR1 3LI, United Kingdom

  • Seoul National University Hospital

    Seoul, 03080, South Korea

  • Shanghai Fourth People's Hospital

    Shanghai, Shanghai Municipality, 200003, China

  • Sir Mortimer B. Davis Jewish General Hospital

    Montreal, Quebec, H3T 1E2, Canada

  • Smilow Cancer Hospital at Yale New Haven

    New Haven, Connecticut, 06520, United States

  • Sun Yat-Sen University Cancer Center

    Guangzhou, Guangdong, 510060, China

  • Tel Aviv Sourasky Medical Center

    Tel Aviv, 6423906, Israel

  • The Catholic University of Korea - Seoul St. Mary's Hospital

    Seoul, 06591, South Korea

  • The Chaim Sheba Medical Center

    Ramat Gan, Tel Aviv, 52621, Israel

  • The First Affiliated Hospital of Soochow University - Suzhou First People's Hospital

    Suzhou, Jiangsu, 215006, China

  • The First Affiliated Hospital, Zhejiang University

    Hangzhou, Zhejiang, 310003, China

  • The Ohio State University

    Columbus, Ohio, 43210, United States

  • The Royal Marsden NHS Foundation Trust

    Sutton, England, SM2 5PT, United Kingdom

  • Tianjin Medical University Cancer Institute & Hospital

    Tianjin, Tianjin Municipality, 300060, China

  • Tri-Service General Hospital

    Taipei, Taipei CITY, 11490, Taiwan

  • USOR - Comprehensive Cancer Centers of Nevada - Central Valley

    Las Vegas, Nevada, 89119, United States

  • Univeristy of Nebraska Medical Center

    Omaha, Nebraska, 68198, United States

  • Universitatsklinik Tubingen

    Tübingen, Baden-Wurttemberg, 72076, Germany

  • Universitatsklinikum Leipzig

    Leipzig, Saxony, 04103, Germany

  • University College London Hospitals NHS Foundation Trust

    London, England, NW1 2BU, United Kingdom

  • University Hospital Kyoto Prefectural University of Medicine

    Kyoto, Kyoto, 602-855, Japan

  • University Hospitals Birmingham NHS Foundation Trust

    Birmingham, England, B9 5SS, United Kingdom

  • University Regional General Hospital of Patras

    Patra, Peloponnese, 26504, Greece

  • University of California Irvine

    Orange, California, 92868, United States

  • University of Pennsylvania

    Philadelphia, Pennsylvania, 19104, United States

  • University of Rochester

    Rochester, New York, 14627, United States

  • Winship Cancer Institute of Emory University

    Atlanta, Georgia, 30322, United States

  • Wuhan Union Hospital

    Wuhan, Hubei, 430023, China

  • Zhongnan Hospital of Wuhan University

    Wuhan, Hubei, 430071, China

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Other studies related to the condition(s) this trial covers.