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Can a stronger drug cocktail give older myeloma patients a better start?

NCT ID NCT04096066

NEW Disease control Sponsor: Fondazione EMN Italy Onlus 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 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 21, 2026 · Last updated Sep 21, 2026

Summary

Researchers are comparing two drug combinations for people newly diagnosed with multiple myeloma who are not eligible for a stem cell transplant. One group receives carfilzomib, lenalidomide and dexamethasone (KRd), and the other receives the standard lenalidomide and dexamethasone (Rd). The trial measures how long patients live without the disease worsening and whether the cancer becomes undetectable at a very low level. It also tracks heart and blood vessel side effects, which are a known concern with carfilzomib.

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 carfilzomib, lenalidomide and dexamethasone
What this could lead to
If the three-drug combination works better than the standard two-drug regimen, it could give older myeloma patients a more effective first-line treatment option.
What could go wrong
The trial is small and the three-drug combination carries a known risk of heart and blood vessel side effects, which may be harder for older patients to tolerate. The results may not hold up in a larger population.

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 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

84 people

The number who actually took part.

Started

Jul 2019

Expected to finish

Sep 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

65 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: * Newly diagnosed symptomatic MM based on either standard CRAB criteria (at least 10% of clonal bone marrow plasma cells plus CRAB defined as the onset of any of the following clinical symptoms: hypercalcemia, renal failure, anemia and bone lesions) or at least 10% of bone marrow plasma cells plus the presence of at least one of the following biomarkers of malignancy: * 60% or greater clonal plasma cells on bone marrow examination; * Serum involved/uninvolved free light chain (FLC) ratio of 100 or greater; * More than one focal lesion on magnetic resonance imaging (MRI) that is at least 5 mm or greater in size. * Patient not eligible for ASCT (age ≥ 65 years or abnormal cardiac, pulmonary and liver function). * Patient defined as fit or intermediate according to the IMWG (International Myeloma Working Group) frailty score * Patient has given voluntary written informed consent. * Patient is able to be compliant with hospital visits and procedures required per protocol. * Patient agrees to use acceptable methods for contraception. * Patient has measurable disease according to IMWG criteria. * Patient has ECOG (Eastern Cooperative Oncology Group) performance status \< 3. * Pre-treatment clinical laboratory values within 30 days before randomization: * Platelet count ≥50 x 109/L (≥30 x 109 /L if myeloma involvement in the bone marrow is \> 50%) * 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 ULN * Total bilirubin: ≤ 2 x the ULN * Calculated or measured creatinine clearance: ≥ 30 mL/minute. * LVEF≥ 40%: 2-D transthoracic echocardiogram (ECHO) is the preferred method of evaluation; multigated Acquisition Scan (MUGA) is acceptable if ECHO is not available * Pre-treatment blood pressure value \< 140/90 mmHg even with adequate therapy: 24 hours blood pressure monitoring is the preferred method of evaluation; blood pressure diary at home for 2 weeks is acceptable. * Females of childbearing potential (FBCP) comply with the conditions of the Pregnancy Prevention Plan, including confirmation that she has an adequate level of understanding. * FBCP must follow the Pregnancy Prevention Plan and use a highly effective and an additional barrier contraception method simultaneously for 4 weeks before starting therapy, during treatment and dose interruptions and for at least 30 days after the last dose of study drugs\* * Males must use an effective barrier method of contraception if sexually active with FCBP during the treatment and for at least 90 days after the last administration of study drug/s. Male subjects must agree to refrain from sperm donation for at least 90 days after the last dose of carfilzomib. Exclusion Criteria: * Serious medical condition, laboratory abnormality or psychiatric illness that prevented the subject from the screening or place the subject at unacceptable risk. * Patient defined as frail according to the IMWG frailty score. * Previous treatment with anti-myeloma therapy (does not include radiotherapy, bisphosphonates, or a single short course of steroid \< to the equivalent of dexamethasone 40 mg/day for 4 days). * Pregnant or lactating females. * Presence of: * Clinical active infectious hepatitis type A, B, C or HIV * Acute active infection requiring antibiotics or infiltrative pulmonary disease * Pulmonary hypertension and interstitial lung disease * Uncontrolled arrhythmias or history of QT prolongation * Myocardial infarction or unstable angina ≤ 6 months or other clinically significant heart disease * Peripheral neuropathy or neuropathic pain grade 2 or higher, as defined by National Cancer Institute Common Toxicity Criteria (NCI CTC) 5.0 (Appendix A) * Uncontrolled hypertension defined as persistent hypertension (\>140/90 mmHg) regardless treatment with 3 drugs, including a diuretic. * Contraindication to any of the required drugs or supportive treatments and hypersensitivity to any excipient of the study drugs. * Known history of allergy to Captisol (a cyclodextrin derivative used to solubilize carfilzomib). * Invasive malignancy within the past 3 years. * Administration of any experimental drug within 4 weeks prior the baseline or within 5 drug half-lives.

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Conditions

The condition(s) this trial relates to.

neoplasm plasma cell myeloma

As listed by the trial registrant

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

Multiple myeloma New diagnosis tumor

Contacts and locations

Locations

  • A.O. Spedali Civili di Brescia

    Brescia, Italy

  • AO "SS. Antonio e Biagio"

    Alessandria, Italy

  • AO Bianchi Melacrino Morelli

    Reggio Calabria, Italy

  • AO Cervello

    Palermo, Italy

  • AO S. Maria

    Terni, Italy

  • AO San Luigi Gonzaga

    Orbassano, Italy

  • AO di Padova

    Padova, Italy

  • AOU Careggi

    Florence, Italy

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

    Torino, Italy

  • AOU Città della Salute e della Scienza di Torino - PO Molinette - Ematologia U

    Torino, Italy

  • AOU Ospedali Riuniti Umberto I

    Ancona, Italy

  • ASL Roma 1

    Roma, Italy

  • ASST Grande Ospedale Metropolitano Niguarda

    Milan, Italy

  • Ausl-Irccs

    Reggio Emilia, Italy

  • Azienda Ospedaliera Papardo

    Messina, Italy

  • Azienda Ospedaliera Universitaria Policlinico Tor Vergata

    Roma, Italy

  • Azienda Sanitaria di Bolzano - Ospedale Lorenz B:Ohler

    Bolzano, Italy

  • IRCCS Ospedale Casa Sollievo della Sofferenza

    San Giovanni Rotondo, Italy

  • Istituto Clinico Humanitas

    Rozzano, Italy

  • Istituto Europeo Oncologico

    Milan, Italy

  • Istituto Nazionale Tumori

    Milan, Italy

  • Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (I.R.S.T.)

    Meldola, Italy

  • Istituto per la Cura e la RIcerca del Cancro di Candiolo

    Candiolo, Italy

  • Ospedale "A. Businco"

    Cagliari, Italy

  • Ospedale Civico S. Croce e Carle

    Cuneo, Italy

  • Ospedale Infermi

    Rimini, Italy

  • Ospedale Maggiore

    Novara, Italy

  • Ospedale Maggiore Policlinico di Milano

    Milan, Italy

  • Ospedale Mazzoni

    Ascoli Piceno, Italy

  • Ospedale Oncologico Regionale

    Rionero in Vulture, Italy

  • Ospedale S. Eugenio - Università Tor Vergata

    Roma, Italy

  • Ospedale S. Maria della Misericordia

    Perugia, Italy

  • Ospedale San Camillo Forlanini

    Roma, Italy

  • Ospedale Santa Maria delle Croci

    Ravenna, Italy

  • Ospedali Riuniti

    Bergamo, Italy

  • Policlinico Umberto I - Università La Sapienza

    Roma, Italy

  • Policlinico Universitario di Messina

    Messina, Italy

  • Policlinico Universitario di Udine

    Udine, Italy

  • Policlinico di Bari

    Bari, Italy

  • Università Federico II-Policlinico

    Naples, Italy

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