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Can an antibody drug boost transplant results in relapsed myeloma?

NCT ID NCT04965155

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 11, 2026 · Last updated Sep 11, 2026

Summary

Researchers are testing whether adding the antibody drug isatuximab to dexamethasone before and after an autologous stem cell transplant helps patients with relapsed multiple myeloma. About 50 adults who already had a transplant and later relapsed will receive three cycles of isatuximab plus dexamethasone, then a stem cell transplant, followed by maintenance treatment. The main goal is to see how many patients reach a very deep remission, called MRD negativity, within a year after transplant.

What this could mean

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

Active substance
isatuximab combined with dexamethasone
What this could lead to
If it works, this approach could help more patients with relapsed multiple myeloma reach deep, lasting remissions after a stem cell transplant.
What could go wrong
This is a small phase 2 trial, so any benefit seen may not hold up in larger studies. The treatment can cause infusion reactions and other side effects, and the cancer may still return.

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 50 people

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

Started

Mar 2021

Expected to finish

Mar 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 to 70 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: 1. Patient has given voluntary written informed consent 2. Patient is willing and able to comply with the study visits and procedures required per protocol 3. Subject must have at least 18 and = 70 years of age 4. Patient has a life-expectancy = 3 months 5. Subject has received an ASCT in the first line of therapy with a progression/relapse after at least 24 months 6. Subject must have received any cytoreductive treatment, excluding anti-CD38 antibodies containing regimens, as per local practice for the first relapse, according to local guidelines. Carfilzomib-based combinations are recommended (eg. carfilzomib-lenalidomidedexamethasone or carfilzomib-dexamethasone). After the salvage duration phase (reinduction therapy), subject has achieved at least a PR according to IMWG Response criteria. 7. Subject must have documented relapsed MM as per IMWG criteria, and achieved at least a partial remission with treatments as per local guidelines 8. Subject must have at least 2.0 x 106 CD34+/Kg cryopreserved autologous stem cells 9. Subject must have an ECOG Performance Status score of 0, 1 10. 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 ULN * Total bilirubin: = 2 x the ULN * Calculated or measured creatinine clearance: = 30 mL/minute 11. Female subjects are eligible to participate if they are not pregnant, not breastfeeding, and at least one of the following conditions applies: * they are not females of childbearing potential (FCBP), OR * they are FCBP who have a negative serum or urine pregnancy test with a sensitivity of at least 25 mIU/mL within 10 - 14 days prior to and again within 24 hours of starting study medication and before each cycle of study treatment and must either commit to continue abstinence from heterosexual intercourse or apply a highly effective method of birth control during the intervention period and for at least 5 months after the last dose of study treatment. Of note: contraception duration should take also into consideration any backbone therapy 12. Male subjects must agree to use contraception on this protocol during the intervention period and for at least 5 months after the last dose of study treatment and refrain from donating sperm during this period Exclusion Criteria: 1. Previous therapy with daratumumab, isatuximab or any other anti-CD38 monoclonal antibody 2. MM localization to the central nervous system 3. Subjects who have received any investigational drug within 14 days or 5 half-lives of the investigational drug from eligibility confirmation, whichever is longer 4. Subjects who have received an allogeneic stem cell transplant 5. Subject with a history of malignancy (other than multiple myeloma) within 3 years before the date of eligibility confirmation (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) 6. Subject is known to be seropositive for human immunodeficiency virus (HIV) or with an active hepatitis A, B and C infection, defined as a positive test for hepatitis B surface antigen \[HBsAg\] and a positivity for HAV-RNA, HBV-DNA or HCV-RNA 7. Subject with any concurrent, clinically significant, uncontrolled 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 8. Subject with active tuberculosis and severe infections requiring treatment with an antibiotic parenteral administration 9. Subject with hypersensitivity or history of intolerance to steroids, mannitol, pregelatinized starch, sodium stearyl fumarate, histidine (as base and hydrochloride salt), arginine hydrochloride, poloxamer 188, sucrose or any of the other components of study therapy that are not amenable to premedication with steroids and H2 blockers or would prohibit further treatment with these agents 10. Subject with pulmonary deficit, defined as FEV1 \<65% and/or DLCO \<65% 11. Subject with clinically significant cardiac disease, including: * LVEF \<50% * Myocardial infarction within 6 months before eligibility confirmation, 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 5 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

  • AO di Perugia-Ospedale S. Maria della Misericordia

    Perugia, Italy

  • AOU Ospedali Riuniti di Trieste

    Trieste, Italy

  • AOU Policlinico di Bari

    Bari, Italy

  • I.R.C.C.S. Ospedale S. Raffaele

    Milan, Italy

  • Ospedale S. Maria della Misericordia di Udine

    Udine, Italy

  • Policlinico Umberto I - Università 'Sapienza'

    Roma, Italy

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