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New drug cocktail shows promise for relapsed myeloma

NCT ID NCT04191616

Disease control Sponsor: Amgen 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 This study
The trial has finished. Results may not be published yet.
Stopped early
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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Updated 1 time

Summary

This phase 2 study tested a combination of three drugs—carfilzomib, pomalidomide, and dexamethasone—in 54 adults whose multiple myeloma had come back after one or two prior treatments. The goal was to see how many patients responded to the therapy. The study is complete, and results help understand if this combo is effective and safe for this group.

What this could mean

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

Active substance
carfilzomib, pomalidomide, and dexamethasone (a three-drug combination)
What this could lead to
If successful, this combination could offer a new treatment option for patients whose multiple myeloma has returned after earlier therapies.
What could go wrong
This is a small, early-phase study (54 participants) with no comparison group, so results may not apply broadly. Side effects from the drugs can be serious.

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 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

54 people

The number who actually took part.

Started

Aug 2020

Finished

Oct 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 to 99 years

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 * Subject has provided informed consent prior to initiation of any study specific activities or procedures. * Male or female subjects age ≥ 18 years * First or second relapse of multiple myeloma by IMWG criteria (subjects refractory to the most recent line of therapy, excluding carfilzomib, are eligible) * Refractory to lenalidamide * Measurable disease with at least 1 of the following assessed within 28 days prior to enrollment: * IgG multiple myeloma: serum monoclonal protein (M-protein) level ≥ 1.0 g/dL * IgA, IgD, IgE multiple myeloma: serum M-protein level ≥ 0.5 g/dL * urine M-protein ≥ 200 mg per 24 hours * in subjects without measurable serum or urine M-protein, serum-free light chain (SFLC) ≥ 100 mg/L (involved light chain) and an abnormal serum kappa lambda ratio * Must have at least a PR to at least 1 line of prior therapy * Prior therapy with proteasome inhibitors is allowed. Subjects receiving prior carfilzomib therapy must have achieved at least a PR, was not removed due to toxicity, did not relapse within 60 days from discontinuation of carfilzomib, and must have at least a 6 month carfilzomib treatment-free interval from their last dose of carfilzomib * ECOG PS of 0 to 2 Exclusion Criteria * Primary refractory multiple myeloma * Waldenström macroglobulinemia * Multiple myeloma of IgM subtype * POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes) * Plasma cell leukemia ( greater than 2.0 × 109/L circulating plasma cells by differential). If automated differential shows ≥ 20% of other cells, obtain manual differential to identify other cells. * Primary amyloidosis (patients with multiple myeloma with asymptomatic deposition of amyloid plaques found on biopsy would be eligible if all other criteria are met) * Previous diagnosis of amyloidosis associated with myeloma * Myelodysplastic syndrome * Toxicity requiring discontinuation of lenalidomide therapy * Prior treatment with pomalidomide

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Conditions

The condition(s) this trial relates to.

plasma cell myeloma Recurrence refractory plasma cell neoplasm

As listed by the trial registrant

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

Relapsed or refractory multiple myeloma

Contacts and locations

Locations

  • Aalborg Universitetshospital

    Aalborg, 9000, Denmark

  • Aarhus Universitetshospital

    Aarhus N, 8200, Denmark

  • Affiliated Oncologists, LLC

    Chicago Ridge, Illinois, 60415, United States

  • Alexandra Hospital

    Athens, 11528, Greece

  • Asklepios Klinik Altona

    Hamburg, 22763, Germany

  • Azienda Ospedaliera Citta della Salute e della Scienza di Torino Ospedale Molinette

    Torino, 10126, Italy

  • Azienda Ospedaliero Universitaria Ospedali Riuniti di Ancona

    Ancona, 60126, Italy

  • Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia

    Brescia, 25123, Italy

  • Azienda Unita Sanitaria Locale LE Presidio Ospedaliero Vito Fazzi Polo Oncologico Giovanni Paolo II

    Lecce, 73100, Italy

  • Baylor Charles A Sammons Cancer Center at Dallas

    Dallas, Texas, 75246, United States

  • Blue Ridge Cancer Care

    Roanoke, Virginia, 24014, United States

  • CHU Grenoble Alpes

    Grenoble, 38043, France

  • Centre Hospitalier Régional Universitaire de Lille - Hôpital Claude Huriez

    Lille, 59037, France

  • Centre Hospitalier Universitaire de Bordeaux - Hôpital Haut Lévêque

    Pessac, 33604, France

  • Centre Hospitalier Universitaire de Nantes

    Nantes, 44093, France

  • Centre Hospitalier de Saint Quentin

    Saint-Quentin, 02321, France

  • Clinique Sainte Anne

    Strasbourg, 67000, France

  • General Hospital Evangelismos

    Athens, 10676, Greece

  • General Hospital of Thessaloniki Georgios Papanikolaou

    Thessaloniki, 57010, Greece

  • General University Hospital of Patras Panagia i Voithia

    Pátrai, 26504, Greece

  • Hospital Clinic i Provincial de Barcelona

    Barcelona, Catalonia, 08036, Spain

  • Hospital Clinico Universitario de Salamanca

    Salamanca, Castille and León, 37007, Spain

  • Hospital Universitari Germans Trias i Pujol

    Badalona, Catalonia, 08916, Spain

  • Hospital Universitari i Politecnic La Fe

    Valencia, Valencia, 46026, Spain

  • Hospital Universitario 12 de Octubre

    Madrid, 28041, Spain

  • Institut Universitaire du Cancer Toulouse Oncopole

    Toulouse, 31059, France

  • Klinikum Chemnitz gGmbH

    Chemnitz, 09113, Germany

  • Minnesota Oncology Hematology PA

    Saint Paul, Minnesota, 55102, United States

  • North Estonia Medical Centre

    Tallinn, 13419, Estonia

  • Oncology Hematology Care Incorporated

    Cincinnati, Ohio, 45236, United States

  • Policlinico Universitario Agostino Gemelli

    Roma, 00168, Italy

  • Rocky Mountain Cancer Centers Denver Midtown

    Denver, Colorado, 80218, United States

  • Sjaellands Universitetshospital

    Roskilde, 4000, Denmark

  • Texas Oncology - Austin Midtown

    Austin, Texas, 78705, United States

  • Texas Oncology, Fort Worth

    Fort Worth, Texas, 76104, United States

  • Texas Oncology- Tyler

    Tyler, Texas, 75702, United States

  • Theagenion Cancer Hospital of Thessaloniki

    Thessaloniki, 54007, Greece

  • US Oncology Research Investigational Products Center

    Austin, Texas, 78705, United States

  • United States Oncology Regulatory Affairs Corporate Office

    Austin, Texas, 78705, United States

  • Universitatsklinikum Tubingen

    Tübingen, 72076, Germany

  • University General Hospital of Evros-Alexandroupolis District

    Alexandroupoli, 68100, Greece

  • University Hospital of Ioannina

    Ioannina, 45500, Greece

  • University of Alabama at Birmingham

    Birmingham, Alabama, 35249, United States

  • Universitätsklinikum Münster

    Münster, 48149, Germany

  • Vejle Sygehus

    Vejle, 7100, Denmark

  • Yale Cancer Center

    New Haven, Connecticut, 06510, United States

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