New drug cocktail aims to improve multiple myeloma treatment before and after stem cell transplant

NCT ID NCT03896737

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 16, 2026 · Last updated Jul 17, 2026 · Updated 1 time

Summary

This phase 2 trial tests whether adding the drug daratumumab to a standard chemotherapy combination (bortezomib, cyclophosphamide, and dexamethasone) works better than the current standard (bortezomib, thalidomide, and dexamethasone) for newly diagnosed multiple myeloma patients aged 18 to 65 who are eligible for a stem cell transplant. The study compares these two approaches as initial treatment and as consolidation after transplant, followed by maintenance therapy with either ixazomib alone or ixazomib plus daratumumab. The goal is to see which combination delays disease progression longer and achieves deeper remission.

What this could mean

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

Active substance
daratumumab, bortezomib, cyclophosphamide, dexamethasone, thalidomide, ixazomib
What this could lead to
If successful, this could lead to a more effective and safer treatment regimen for younger patients with newly diagnosed multiple myeloma, potentially improving long-term disease control.
What could go wrong
This is a phase 2 trial, so results are preliminary. The combination may cause significant side effects, and the benefit over current standard therapy is not yet proven.

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

401 people

The number who actually took part.

Started

Apr 2019

Expected to finish

Sep 2027

An estimate. End dates often move.

Lead sponsor

A research network

The lead sponsor is a research network or cooperative group.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 65 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: * Patient at least 18 years of age and ≤ 65 years. * Patient eligible for autologous stem cell transplantation (ASCT). * Left Ventricular Ejection Fraction (LVEF) ≥ 40%. 2-D transthoracic echocardiogram (ECHO) is the preferred method of evaluation. Multigated Acquisition Scan (MUGA) is acceptable if ECHO is not available. * Newly diagnosed multiple myeloma patient. * Patient has given voluntary written informed consent before performance of any study related procedure not part of standard medical care, with the understanding that consent may be withdrawn by the patient at any time without prejudice to future medical care. * Patient with documented multiple myeloma and measurable disease as defined by: * Monoclonal plasma cells in the bone marrow ≥10% or presence of a biopsy proven plasmacytoma * Measurable disease as defined by at least one of the following: * serum M-protein level ≥1 g/dL or urine M-protein level ≥200 mg/24 hours; or * Light chain multiple myeloma: Serum immunoglobulin free light chain ≥10 mg/dL and abnormal serum immunoglobulin kappa lambda free light chain ratio. * Evidence of end organ damage/presence of biomarkers of malignancies, specifically: * Hypercalcaemia: serum calcium \>0.25 mmol/L (\>1 mg/dL) higher than the upper limit of normal or \>2.75 mmol/L (\>11 mg/dL) * Renal insufficiency: creatinine clearance (CLcr)\<40 mL per minute (measured or estimated by validated equations) or serum creatinine \>177 μmol/L (\>2 mg/dL) * Anaemia: haemoglobin value of \>20 g/L below the lower limit of normal, or haemoglobin value \<100 g/L * Bone lesions: one or more osteolytic lesions on skeletal radiography, CT, or PET-CT. If bone marrow has \<10% clonal plasma cells, more than one bone lesion is required to distinguish from solitary plasmacytoma with minimal marrow involvement * Any one or more of the following biomarkers of malignancy: * Clonal bone marrow plasma cell percentage ≥ 60% (clonality should be established by showing κ/λ-light-chain restriction on flow cytometry, immunohistochemistry, or immunofluorescence. Bone marrow plasma cell percentage should preferably be estimated from a core biopsy specimen; in case of a disparity between the aspirate and core biopsy, the highest value should be used) * Involved:uninvolved serum free light chain ration ≥ 100 (values based on the serum Free light assay. The involved free light chain must be ≥100 mg/L) -\> 1 focal lesion on MRI (magnetic resonance imaging) studies (each focal lesion must be 5 mm or more in size) Patient is, in the investigator(s) opinion willing and able to comply with the protocol requirements. * Women of childbearing potential must commit to either abstain continuously from heterosexual intercourse or to use 2 methods of reliable birth control simultaneously. This includes one highly effective form of contraception (tubal ligation, intrauterine device, hormonal \[birth control pills, hormonal patches, vaginal rings or implants\] or partner's vasectomy) and one additional effective contraceptive method (male latex or synthetic condom, diaphragm, or cervical cap). Contraception must begin prior to dosing through 90 days after the last dose of study drug. Reliable contraception is indicated even where there has been a history of infertility, unless due to hysterectomy or bilateral oophorectomy. * Male patient agrees to use an acceptable method for contraception (i.e., condom or abstinence) during study drug therapy (including dose interruption) and for 90 days after the last dose of study drug. * Patient with an Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1, or 2 or Karnofsky performance status ≥ 60%. * Pretreatment clinical laboratory values within 30 days of enrolment: * Platelet count ≥75 x 109/L; * Absolute neutrophil count (ANC) ≥ 1 x 109/L (G-CSF use is permitted); * Corrected serum calcium \<14 mg/dL (\<3.5 mmol/L); * Aspartate transaminase (AST) ≤ 2.5 x the upper limit of normal (ULN); * Alanine transaminase (ALT) ≤ 2.5 x the ULN; * Total bilirubin ≤ 1.5 x the ULN; * Calculated or measured creatinine clearance ≥ 30 mL/minute. * Patient has a life-expectancy \>3 months. Exclusion Criteria: * Patient with a diagnosis of primary amyloidosis, monoclonal gammopathy of undetermined significance, smoldering MM or Plasma Cell Leukemia (PCL). Monoclonal gammopathy of undetermined significance is defined by presence of serum M-protein \<3 g/dL, clonal bone marrow plasma cells \<10%, and absence of end-organ damage or amyloidosis that can be attributed to the plasma cell proliferative disorder. Smoldering multiple myeloma is defined as serum monoclonal protein ≥ 30 g/L or urinary monoclonal protein ≥ 500 mg per 24 h and/or clonal bone marrow plasma cell 10-60% with absence of related organ or tissue impairment or end-organ damage or amyloidosis. Plasma cell leukemia is defined as presence of circulating plasmacells (PCs) \>2×109/L in peripheral blood or a peripheral blood plasmacytosis \>20% * Patient with a diagnosis of Waldenström's disease, or other conditions in which immunoglobulin M (IgM) M-protein is present in the absence of a clonal plasma cell infiltration with lytic bone lesions. * Patient has prior or current systemic therapy or SCT for multiple myeloma, with the exception of an emergency use of a short course (equivalent of dexamethasone 40 mg/day for a maximum 4 days) of corticosteroids before treatment. * Patient has peripheral neuropathy of grade 2 or higher as defined by National Cancer Institute Common Toxicity Criteria (NCI CTC) 4.0. * Patient is exhibiting clinical signs of meningeal involvement of multiple myeloma. * Clinical active infectious hepatitis type A, B, C or HIV. * Subject has known chronic obstructive pulmonary disease (COPD) (defined as a Forced Expiratory Volume In 1 second (FEV1) \<60% of predicted normal), persistent asthma, or a history of asthma within the last 2 years. Subjects with known or suspected COPD or asthma must have a FEV1 test during screening. * Evidence of current uncontrolled cardiovascular conditions, including uncontrolled hypertension, uncontrolled cardiac arrhythmias, symptomatic congestive heart failure, unstable angina, or myocardial infarction within the past 6 months. * Known allergy to any of the study medications, their analogues, or excipients in the various formulations. * Contraindication to any of the required concomitant drugs or supportive treatments. * Pregnant or lactating females.

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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. Papa Giovanni XXIII

    Bergamo, Italy

  • A.O. Spedali Civili di brescia

    Brescia, Italy

  • A.O. di Perugia-Ospedale S. Maria della Misericordia

    Perugia, Italy

  • A.O.U. Maggiore della Carità di Novara

    Novara, 28100, Italy

  • A.O.U. Ospedali Riuniti Umberto I - G.M. Lancisi - G. Salesi di Ancona

    Ancona, Italy

  • A.O.U. Policlinico San Martino

    Genova, Italy

  • A.O.U. Policlinico Vittorio Emanuele di Catania

    Catania, Italy

  • AOU Città della Salute e della Scienza di Torino

    Torino, Italy

  • Arcispedale S. Maria Nuova

    Reggio Emilia, Italy

  • Az. Osp. S. Maria

    Terni, Italy

  • Dipartimento Medicina Clinica e Sperimentale - AO di Padova

    Padova, Italy

  • General Hospital of Athens "Alexandra"

    Athens, 115 28, Greece

  • General Hospital of Athens 'Evangelismos

    Athens, Greece

  • General University Hospital (VFN)-Internal Medicine, Hematology Clinic

    Prague, Czechia

  • Hradec Kralove-University Hospital Hradec Kralove

    Hradec Králové, Czechia

  • I.R.C.C.S. Ospedale Casa Sollievo della Sofferenza

    San Giovanni Rotondo, Italy

  • Ospedale Niguarda

    Milan, Italy

  • Policlinico S. Matteo Fondazione IRCCS

    Pavia, Italy

  • Policlinico S. Orsola

    Bologna, Italy

  • University General Hospital of Patras

    Pátrai, Greece

  • University Hospital Olomouc

    Olomouc, Czechia

  • University Hospital Ostrava

    Ostrava, 708 52, Czechia

  • University Hospital Ostrava

    Ostrava, Czechia

  • University Hospital Plzen

    Pilsen, Czechia

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