Tailored Three-Drug combo targets Myeloma's toughest genetic weak spot

NCT ID NCT04124497

What the study statuses mean

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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 This study
Running, but no longer taking on new participants.
Completed
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 09, 2026 · Last updated Sep 10, 2026 · Updated 1 time

Summary

Researchers are testing whether a combination of daratumumab, pomalidomide and dexamethasone can help people whose multiple myeloma has come back and carries a genetic change called del(17p). This change, found in about 10% of patients at diagnosis, makes the cancer harder to treat and is linked to worse outcomes. The trial enrolls adults with relapsed or relapsed/refractory myeloma who have del(17p) in at least 10% of their bone marrow plasma cells. The main goal is to see how many patients who reach complete remission also test negative for minimal residual disease, a sign that very few cancer cells remain.

What this could mean

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

Active substance
a three-drug combination of daratumumab, pomalidomide and dexamethasone
What this could lead to
If it works, this could give doctors a treatment plan built specifically for relapsed myeloma driven by the del(17p) genetic change, a group with few good options.
What could go wrong
This is a small phase 2 trial, so any benefit seen here would need confirmation in larger studies. The combination can cause infusion reactions, low blood counts and infections, and the cancer may still resist treatment.

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

About 45 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jul 2019

Expected to finish

Jul 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

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: * Patient has given voluntary written informed consent * Subject must be at least 18 years of age. * Subject must have documented MM. * Subject must have del(17p) observed by FISH in at least 10% of bone marrow plasma cells at any time of MM history. * Subject must have serum monoclonal paraprotein (M-protein) level \>=0.5 g/dL or urine M-protein, level \>=200 mg/24 hours, or light chain MM, or serum immunoglobulin free light chain ≥10 mg/dL and abnormal serum immunoglobulin kappa lambda free light chain ratio. * Subject must have received at least 1 and no more than 3 prior lines of therapy for MM. * Subject must have received at least 2 consecutive cycles of lenalidomide in a previous line of therapy. * Subject must have achieved a response (PR or better) to at least one prior regimen. * Subjects must have either refractory or relapsed and refractory disease defined as documented disease progression during or within 60 days of completing their last myeloma therapy. * Subject must have an ECOG Performance Status score of 0, 1, or 2. * Subject must have the following laboratory values: * Platelet count \>=50 x 109/L (≥30 x 109 /L if myeloma involvement in the bone marrow is \> 50%) within 14 days prior to drug administration). * Absolute neutrophil count (ANC) \>= 1 x 109/L without the use of growth factors. * Corrected serum calcium \<=14 mg/dL (3.5 mmol/L) * Alanine transaminase (ALT): \<= 3 x the upper limit normal (ULN). * Total bilirubin: \<= 2 x the ULN. * Calculated or measured creatinine clearance: \>= 15 mL/minute * Females of childbearing potential (FBCP) must follow the Pregnancy Prevention Plan and use a highly effective and an additional barrier contraception method simultaneously for 28 days before starting pomalidomide, during treatment and dose interruptions, for at least 28 days after the last dose of pomalidomide and 3 months after the last dose of daratumumab Males must use an effective barrier method of contraception if sexually active with FCBP for at least 28 days before starting pomalidomide, during the treatment and dose interruptions, for at least 28 days after the last dose of pomalidomide and 3 months after the last dose of daratumumab. Male subjects must agree to refrain from sperm donation for at least 3 months after the last dose of daratumumab. Exclusion Criteria: * Subject has received daratumumab or other anti-CD38 monoclonal antibody previously. * Subject's disease shows evidence of refractoriness or intolerance to pomalidomide. If previously treated with a pomalidomide-containing regimen, the subject is excluded if he or she: * Discontinued due to any adverse event related to prior pomalidomide treatment, or * If, at any time point, the subject was refractory to any dose of pomalidomide. Refractory to pomalidomide is defined either: * Subjects whose disease progresses within 60 days of pomalidomide; or * Subjects whose disease is nonresponsive while on lenalidomide. Nonresponsive disease is defined as either failure to achieve at least an MR or development of PD while on pomalidomide. * Subject has received anti-myeloma treatment within 2 weeks or 5 pharmacokinetic half-lives of the treatment, whichever is longer, before the date of randomization. * Subjects who received an allogeneic bone marrow or allogeneic peripheral blood stem cell transplant less than 12 months prior to initiation of study treatment and who have not discontinued immunosuppressive treatment for at least 16 weeks prior to initiation of study treatment and are currently dependent on such treatment. * Subjects unable or unwilling to undergo antithrombotic prophylactic treatment. * Subject has a history of malignancy (other than multiple myeloma) within 3 years before the date of randomization (exceptions are squamous and basal cell carcinomas of the skin and carcinoma in situ of the cervix, or malignancy that in the opinion of the investigator, in agreement with the medical monitor, is considered cured with minimal risk of recurrence within 3 years). * Subject has known chronic obstructive pulmonary disease (COPD) (defined as a forced expiratory volume in 1 second (FEV1) \<60% of predicted normal), asthma, or a history of asthma within the last 2 years. Subjects with known or suspected COPD must have a forced expiratory volume (FEV) test during Screening. * Subject is known to be seropositive for human immunodeficiency virus (HIV) or hepatitis B (defined by a positive test for hepatitis B surface antigen \[HBsAg\] or antibodies to hepatitis B surface and core antigens \[anti-HBs and anti-HBc, respectively\]) or hepatitis C (anti-HCV antibody positive or HCV-RNA quantitation positive). * Subject has any concurrent medical condition or disease (eg, active systemic infection) that is likely to interfere with study procedures or results, or that in the opinion of the investigator would constitute a hazard for participating in this study. * Subject has clinically significant cardiac disease, including: * Myocardial infarction within 6 months before Cycle 1, Day 1, or unstable or * uncontrolled disease/condition related to or affecting cardiac function (eg, unstable angina, congestive heart failure, New York Heart Association Class III-IV) * Cardiac arrhythmia (Common Terminology Criteria for Adverse Events \[CTCAE\] Version 4 Grade 2 or higher) or clinically significant ECG abnormalities. * Screening 12-lead ECG showing a baseline QT interval as corrected by Fridericia's formula (QTcF) \>500 msec.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

Contacts and locations

Locations

  • A.O. Santa Maria

    Terni, Italy

  • A.O. Spedali Civili di Brescia

    Brescia, Italy

  • AOU Città della Salute e della Scienza di Torino - Presidio Molinette

    Torino, Italy

  • AOU Ospedali Riuniti Umberto I

    Ancona, Italy

  • AOU Policlinico Vittorio Emanuele

    Catania, Italy

  • Dipart. Di Medicina Interna e Scienze Biomediche

    Parma, Italy

  • Istituto Clinico Humanitas

    Rozzano, Italy

  • Ospedale Maggiore

    Novara, Italy

  • Ospedale Niguarda Cà Grande

    Milan, Italy

  • Ospedale Oncologico Regionale

    Rionero in Vulture, Italy

  • Ospedali Riuniti

    Bergamo, Italy

  • Policlinico S. Orsola

    Bologna, Italy

  • Policlinico Umberto I - Università La Sapienza

    Roma, Italy

  • Policlinico Universitario di Udine

    Udine, Italy

  • Policlinico-Università degli Studi

    Bari, Italy

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