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New drug cocktail shows promise for Tough-to-Treat myeloma

NCT ID NCT03590652

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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

Summary

This study tested a combination of four drugs (daratumumab, ixazomib, pomalidomide, and dexamethasone) in 23 people with multiple myeloma that had come back or stopped responding to earlier treatments. The goal was to see how many patients' tumors shrank or disappeared. The study was stopped early, but the results help doctors understand if this powerful mix can control the disease for a while longer.

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

23 people

The number who actually took part.

Started

Oct 2018

Finished

Jul 2025

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: * All participants must be registered into the mandatory POMALYST REMS program and be willing and able to comply with the requirements of the POMALYST REMS program. * Confirmed diagnosis of Multiple Myeloma having received 1 and 3 prior lines of treatment * Relapsed and/or refractory disease * Measurable disease * Life expectancy of more than 3 months * ECOG performance status of 0, 1, or 2 * No prior progression on pomalidomide * All pts must have received prior lenalidomide therapy and been determined to be relapsed and/or refractory. * Adequate hepatic function * Adequate renal function * Additional Laboratory Requirements 1. ANC ≥1.0 x 10\^9/L, Hgb ≥8 g/dL (transfusion permitted) 2. Platelet count ≥75 x 10\^9/L (≥ 50x10\^9/L if bone marrow plasma cells are ≥50% of cellularity) * Women of child-bearing potential and men with partners of child-bearing potential must agree to use 2 methods of birth control or be surgically sterile or abstain from heterosexual activity from the time of signing the informed consent for through 120 days after the last dose of study medication. * Women of childbearing potential have negative pregnancy test within 72 hours of initiating study drug dosing. * Male subjects must agree to use a latex condom during sexual contact with females of childbearing potential even if they have had a successful vasectomy starting with the first dose of study therapy through 120 days after the last dose of study therapy. * All subjects must be counseled at a minimum of every 28 days about pregnancy precautions and risks of fetal exposure. * Females of reproductive potential must adhere to the scheduled pregnancy testing as required in the POMALYST REMS program. * Subjects must agree to take enteric-coated aspirin 81 mg orally daily, or if history of prior thrombotic disease, must be fully anticoagulated with warfarin (INR 2-3) or be treated with full-dose, low molecular weight heparin, as if to treat deep venous thrombosis (DVT)/pulmonary embolism (PE) at the investigator's discretion. Exclusion Criteria: * Current or anticipated use of other investigational agents. * Prior daratumumab or ixazomib use * Patients who are refractory to pomalidom * Non-secretory or hyposecretory multiple myeloma defined as: * Plasma cell leukemia (\>2.0 x 10 9/L circulating plasma cells by standard differential) * Waldenström's macroglobulinemia or IgM myeloma * Known central nervous system involvement by multiple myeloma * Radiotherapy to multiple sites or immunotherapy within 2 weeks before enrollment (localized radiotherapy to a single site at least 1 week before start is permissible) * Participation in an investigational therapeutic study within 3 weeks or within 5 drug half-lives (t1/2) prior to first dose, whichever time is greater. Non-interventional trials (i.e. observational trials) are permitted at any time point * Female patients who are lactating or have a positive serum pregnancy test during the screening period. * Major surgery within 3 weeks prior to first dose * Myocardial infarction within 6 months prior to enrollment, NYHA (New York Heart Association) Class III or IV heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities * Acute active infection requiring systemic antibiotics, antivirals, or antifungals within two weeks prior to first dose * Systemic treatment, within 14 days before the first dose of ixazomib, with strong CYP3A inducers (rifampin, rifapentine, rifabutin, carbamazepine, phenytoin, phenobarbital), or use of St. John's wort. * Known or suspected HIV infection, known HIV seropositivity * Active hepatitis infection * Diagnosed or treated for another malignancy within 2 years before study enrollment or previously diagnosed with another malignancy and have any evidence of residual disease. Patients with nonmelanoma skin cancer or carcinoma in situ of any type are not excluded if they have undergone complete resection. * Subjects with known or suspected light chain amyloidosis of any organ. * Known allergies, hypersensitivity, or intolerance to monoclonal antibodies or human proteins, Daratumumab, or its excipients. or known sensitivity to mammalian-derived products. * Has known chronic obstructive pulmonary disease with a forced expiratory volume in 1 second (FEV1) \<50% of predicted normal * Has known moderate or severe persistent asthma within the past 2 years per asthma guidelines * Known gastrointestinal disease or procedure that could interfere with the oral absorption or tolerance of ixazomib or pomalidomide, including difficulty swallowing

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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

  • UCSD Moores Cancer Center

    La Jolla, California, 92093, United States

  • University of California, Davis

    Sacramento, California, 95817, United States

  • University of California, Los Angeles

    Los Angeles, California, 90024, United States

  • University of California, San Francisco

    San Francisco, California, 94115, United States

More trials for these conditions

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