Plasma Cell NeoplasmsMAIELLANCT07777406

Real-life Study on the Use of Allogeneic Hematopoietic Stem Cell Transplantation in Patients With Relapsed/Refractory Multiple Myeloma

An observational study of Plasma Cell Neoplasms, run by Università degli Studi 'G. d'Annunzio' Chieti e Pescara at 1 site in Italy.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts

Official record

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Trial summary

A multicenter, non-interventional, observational, retrospective and prospective pharmacological study aimed at evaluating the use of allogeneic hematopoietic stem cell transplantation in patients with relapsed/refractory multiple myeloma. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Plasma Cell Neoplasms
How many people: 60 participants
Where: 1 siteItaly
Study dates: 24 Mar 2026to 31 Dec 2027
How long will I take part?: 24 Months
Phase: Observational
Are there results?: Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Study population: primary care clinic

Who may be able to join

patients diagnosed with relapsed/refractory multiple myeloma according to IMWG criteria who have undergone allogeneic hematopoietic stem cell transplantation;
Age ≥ 18 years;
Signature of the informed consent form (where possible).

Who cannot join

Patients diagnosed with primary AL amyloidosis, monoclonal gammopathy of undetermined significance (MGUS), indolent multiple myeloma, or primary plasma cell leukemia;
Patients who have not undergone allogeneic hematopoietic stem cell transplantation;
Age < 18 years.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Carmine Liberatore, MD contact

+390854252853

carmine.liberatore@unich.it

Italy1 site, 1 recruiting

Dipartimento di Medicina e Scienze dell'Invecchiamento, Università degli Studi "G. d'Annunzio" di Chieti - Pescara
Chieti, CH, 66100
Carmine Liberatore, MD, +390854251, carmine.liberatore@unich.it
Recruiting

Other trials in Italy

About this study

Official title: Studio Real-life Sull'Utilizzo Del Trapianto Allogenico di Cellule Staminali Ematopoietiche in Pazienti Affetti da Mieloma Multiplo Recidivato Refrattario

Conditions: Plasma Cell Neoplasms
Keywords: multiple myeloma, allogeneic hematopoietic stem cell transplantation
Medical subject headings: Neoplasms, Plasma Cell, Multiple Myeloma

What is being measured

The primary outcome is the main question the study is designed to answer.

Progression-free survival (PFS)
Progression-free survival (PFS) of patients with relapsed/refractory multiple myeloma undergoing allogeneic hematopoietic stem cell transplantation.
PFS is defined as time from the date of allogeneic hematopoietic stem cell transplantation to the date of confirmed disease progression, or the date of death from any cause, whichever comes first.
Measured: 10 years from the date of allogeneic hematopoietic stem cell transplantation.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

24 Mar 202631 Dec 2027

First posted20 Aug 2026
Study start24 Mar 2026
Primary completion31 Dec 2027 (estimated)
Study completion31 Dec 2027 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Plasma Cell NeoplasmsStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Cross-sectional
Enrolment: 60 participants (estimated)
Target duration: 24 Months

IDs, dates and publications

ClinicalTrials.gov ID: NCT07777406
Sponsor's protocol ID: 4254
Other IDs: 4254
Acronym: MAIELLA
Status last verified: Aug 2026
First submitted: 10 Jul 2026
Last updated: 20 Aug 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Undecided

Interested in taking part?

Carmine Liberatore, MD

+390854252853

carmine.liberatore@unich.it

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See sites and contacts

Not yet recruitingPhase 2
Study of YKST02 in Adults With Relapsed or Refractory Multiple Myeloma
Relapsed or Refractory Multiple Myeloma (RRMM)
RecruitingPhase 2
Engaging T-cells to Eliminate MRD in Newly Diagnosed Myeloma Optimizing Response With Talquetmab and Teclistamab (ROTATE)
Multiple Myeloma
Active, not recruitingPhase 3
A Phase III Study of Eque-cel in Subjects With Len-refractory RRMM (FUMANBA-03)
Multiple Myeloma
Active, not recruitingPhase 1/2
A Window of Opportunity Trial to Learn if Linvoseltamab is Safe and Well Tolerated, and How Well it Works in Adult Participants With Recently Diagnosed Multiple Myeloma Who Have Not Already Received Treatment
Multiple Myeloma
RecruitingObservational study
Patient-Specific MRD Liquid Biopsy in Resected NSCLC: Plasma and Bronchial Washing ctDNA
Non-Small Cell Lung Cancer, Minimal Residual Disease

All Plasma Cell Neoplasms trials

Study at a glance

From the registry record, last updated by the sponsor on 20 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Studio Real-life Sull'Utilizzo Del Trapianto Allogenico di Cellule Staminali Ematopoietiche in Pazienti Affetti da Mieloma Multiplo Recidivato Refrattario
ClinicalTrials.gov ID: NCT07777406
Acronym / sponsor ID: MAIELLA / 4254
Conditions: Plasma Cell Neoplasms
Keywords: multiple myeloma, allogeneic hematopoietic stem cell transplantation
Study type: Observational
Recruitment status: Recruiting
Enrolment: 60 participants (estimated)
Lead sponsor: Università degli Studi 'G. d'Annunzio' Chieti e PescaraUniversity, hospital or other
Study start: 24 Mar 2026 (actual)
Primary completion: 31 Dec 2027 (estimated)
Study completion: 31 Dec 2027 (estimated)
First posted: 20 Aug 2026 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Observational model: Cohort
Time perspective: Cross-sectional
Target follow-up: 24 Months

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: primary care clinic

Key inclusion criteria (3 listed)

patients diagnosed with relapsed/refractory multiple myeloma according to IMWG criteria who have undergone allogeneic hematopoietic stem cell transplantation;
Age ≥ 18 years;
Signature of the informed consent form (where possible).

Key exclusion criteria (3 listed)

Patients diagnosed with primary AL amyloidosis, monoclonal gammopathy of undetermined significance (MGUS), indolent multiple myeloma, or primary plasma cell leukemia;
Patients who have not undergone allogeneic hematopoietic stem cell transplantation;
Age < 18 years.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Primary outcome

Progression-free survival (PFS)
Time frame: 10 years from the date of allogeneic hematopoietic stem cell transplantation.
Progression-free survival (PFS) of patients with relapsed/refractory multiple myeloma undergoing allogeneic hematopoietic stem cell transplantation. PFS is defined as time from the date of allogeneic hematopoietic stem cell transplantation to the date of confirmed disease progression, or the date of death from any cause, whichever comes first.

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2026.
Individual participant dataSharing planned: Undecided

Related trials for Plasma Cell Neoplasms

Not yet recruitingPhase 2
Study of YKST02 in Adults With Relapsed or Refractory Multiple Myeloma
Relapsed or Refractory Multiple Myeloma (RRMM)
RecruitingPhase 2
Engaging T-cells to Eliminate MRD in Newly Diagnosed Myeloma Optimizing Response With Talquetmab and Teclistamab (ROTATE)
Multiple Myeloma
Active, not recruitingPhase 3
A Phase III Study of Eque-cel in Subjects With Len-refractory RRMM (FUMANBA-03)
Multiple Myeloma
Active, not recruitingPhase 1/2
A Window of Opportunity Trial to Learn if Linvoseltamab is Safe and Well Tolerated, and How Well it Works in Adult Participants With Recently Diagnosed Multiple Myeloma Who Have Not Already Received Treatment
Multiple Myeloma
RecruitingObservational study
Patient-Specific MRD Liquid Biopsy in Resected NSCLC: Plasma and Bronchial Washing ctDNA
Non-Small Cell Lung Cancer, Minimal Residual Disease

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.

Carmine Liberatore, MD contact

+390854252853

carmine.liberatore@unich.it

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Plasma Cell Neoplasms, run by Università degli Studi 'G. d'Annunzio' Chieti e Pescara at 1 site in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 20 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Carmine Liberatore, MD (+390854252853, carmine.liberatore@unich.it), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression-free survival (PFS) (time frame: 10 years from the date of allogeneic hematopoietic stem cell transplantation.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07777406.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Aug 2026.