Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

Cure My Disease

Don't miss your cure!

 Log in / Sign up

New drug combo for blood cancer tested in early trial

NCT ID NCT05590377

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This early-phase study tested a new drug called modakafusp alfa combined with daratumumab in 15 people with multiple myeloma that had returned or not responded to prior treatments. The main goals were to check safety and find the best dose. The trial was terminated early, so full results are not available.

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 and daratumumab
What this could lead to
If it works, this combination could offer a new treatment option for people with multiple myeloma that has come back or stopped responding to other therapies.
What could go wrong
This was a very early, small trial (only 15 participants) that was terminated, so results are limited. The combination may cause side effects and may not work for everyone.

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

15 people

The number who actually took part.

Started

Jan 2023

Finished

May 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: 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).

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Multiple myeloma are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

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

  • Banner MD Anderson Cancer Center

    Gilbert, Arizona, 85234, United States

  • CHRU Lille

    Lille, Hauts-de-France, 59037, France

  • Cedars-Sinai Medical Center

    Los Angeles, California, 77598, United States

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

    Sherbrooke, Quebec, J1H 5N4, Canada

  • Chonnam National University Hwasun Hospital

    Hwasun, Jeollanam-do, 58128, South Korea

  • Concord Repatriation General Hospital

    Concord, New South Wales, 2139, Australia

  • Floating Hospital for Children at Tufts Medical Center

    Boston, Massachusetts, 02111, United States

  • Fort Wayne Medical Oncology and Hematology, Inc

    Fort Wayne, Indiana, 46060, United States

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

    Salamanca, 37007, Spain

  • HCA Midwest Health (Midwest Ventures Group HCA MidAmerica Division)

    Overland Park, Kansas, 66211, United States

  • Hospital Universitario Vall d'Hebron

    Barcelona, 08035, Spain

  • Institut Paoli-Calmettes

    Marseille, Provence-Alpes-Côte d'Azur Region, 13273, France

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

    Tianjin, Tianjin Municipality, 300020, China

  • New York Cancer and Blood Specialists

    Bay Shore, New York, 11706, United States

  • Samsung Medical Center

    Seoul, 06351, South Korea

  • Stony Brook University Hospital

    Stony Brook, New York, 11794, United States

  • Summit Medical Group PA

    Florham Park, New Jersey, 07932, United States

  • Sun Yat-Sen University Cancer Center

    Guangzhou, Guangdong, 510060, China

  • The Alfred Hospital

    Melbourne, Victoria, 3004, Australia

  • The Catholic University of Korea, Seoul St. Marys Hospital

    Seoul, 06591, South Korea

  • Tranquil Clinical Research

    Webster, Texas, 78041, United States

  • Tulane University Health Sciences Center

    New Orleans, Louisiana, 70112, United States

  • University of Cincinnati - Vontz Center for Molecular Studies

    Cincinnati, Ohio, 45267, United States

  • University of Nebraska Medical Center

    Omaha, Nebraska, 68198, United States

  • Washington University School of Medicine

    St Louis, Missouri, 63130, United States

  • Wuhan Union Hospital

    Wuhan, Hubei, 430022, China

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

    Hangzhou, Zhejiang, 310003, China

More trials for these conditions

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