An observational study in Relapsed Multiple Myeloma, Refractory Multiple Myeloma and B-Cell Non-Hodgkin Lymphoma, sponsored by IRCCS Azienda Ospedaliero-Universitaria di Bologna. Not yet recruiting at 1 site in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-20.
Sponsored by IRCCS Azienda Ospedaliero-Universitaria di Bologna · Observational
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Among 287 studies in Multiple Myeloma with a site in Italy — 58 open to participants now, 99 under way, 44 of them phase 3. Multiple Myeloma · Italy.
Among the 287 studies in Multiple Myeloma with a site in Italy, this one is the 21st largest by planned enrollment of the 56 observational ones that give a count, is one of 16 that started in 2026, is one of 57 observational ones, reaches primary completion later than 57 of the 98 other live ones, and was the 281st registered.
3,763 studies on the registry are indexed under Multiple Myeloma; 770 are open to participants now.
Browse Multiple Myeloma studies →58 of the 287 studies in Multiple Myeloma with a site in Italy are open now. Recruiting first, the newest first:
Gruppo Italiano Malattie EMatologiche dell'Adulto · Sites in Italy
Ages 18–75 · Healthy volunteers
AstraZeneca · Sites in Italy, United States, Australia and 15 more countries
Ages 18–130
CSL Behring · Sites in Italy, United States, Belgium and 8 more countries
Ages 18+
Janssen Research & Development, LLC · Sites in Italy, Australia, Czechia and 11 more countries
Ages 18+
AstraZeneca · Sites in Italy, United States, Australia and 12 more countries
Ages 18+
A study can be open while its sites in Italy have not opened yet or have stopped. Only those recruiting at a site in Italy →
Of the 585 Multiple Myeloma studies recruiting now, 430 (74%) set no upper age limit and 106 (18%) stop at 75 or younger; 36 take children under 18; 24 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
287 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 66 · Phase 2 96 · Phase 3 96 · Phase 4 1
First in 1997; this study’s year is marked. 16 started in 2026.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 290 is above the median of 150 across 486 observational studies indexed under Multiple Myeloma.
Median enrollment 169 across the 228 interventional studies, 198 across the 56 observational. Of the 173 that completed or were terminated, 69 (40%) have results posted.
This tab as a report to print or save as PDF → With an account.
162 of 287 have an industry lead sponsor. The 10 most frequent:
IRCCS Azienda Ospedaliero-Universitaria di Bologna is the lead sponsor of 513 studies on the registry; 288 are open to participants now.
IRCCS Azienda Ospedaliero-Universitaria di Bologna has 6 studies filed under Multiple Myeloma — fewer than ten, so there is no comparison to draw.
23 of the studies in Multiple Myeloma with a site in Italy that are under way reach primary completion within a year, 6 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05519085Phase 3CelgeneA Study to Evaluate Mezigdomide, Bortezomib and Dexamethasone (MEZIVd) Versus Pomalidomide, Bortezomib and Dexamethasone (PVd) in Participants With Relapsed or Refractory Multiple Myeloma (RRMM) | 2027-01-10 |
| NCT03319667Phase 3SanofiA Study to Investigate the Clinical Benefit of Isatuximab in Combination With Bortezomib, Lenalidomide and Dexamethasone in Adults With Newly Diagnosed Multiple Myeloma Not Eligible for Transplant | 2027-04-05 |
| NCT05455320Phase 3Janssen Research & Development, LLCA Study Comparing Talquetamab in Combination With Daratumumab or in Combination With Daratumumab and Pomalidomide Versus Daratumumab in Combination With Pomalidomide and Dexamethasone in Participants With Multiple Myeloma That Returns After Treatment or is Resistant to Treatment | 2027-07-30 |
| NCT05317416Phase 3PfizerStudy With Elranatamab Versus Lenalidomide in Patients With Newly Diagnosed Multiple Myeloma After Transplant | 2027-08-04 |
| NCT04096066Phase 3Fondazione EMN Italy OnlusA Trial That Compare Two Treatments in Newly Diagnosed Myeloma Patients Not Eligible for Transplant | 2027-09-01 |
Add all 23 to your calendar (.ics) → With an account.
Among the 287 studies in Multiple Myeloma with a site in Italy, from their registry updates:
This tab as a report to print or save as PDF → With an account.
This study includes adults with multiple myeloma or B-cell lymphoma who were/will be treated with CAR-T cell therapy at the IRCCS Azienda Ospedaliero-Universitaria di Bologna. The aim is to better understand infections that may occur during the first year after CAR-T treatment, including how often they happen, their causes, and factors that may increase the risk. The study will use information from patients treated in the past and from newly enrolled patients. For some patients who develop fever after CAR-T therapy, a rapid molecular blood test will be used alongside standard tests to help identify bloodstream infections more quickly and support timely clinical care.
This is a single-center observational study involving adult patients with relapsed/refractory multiple myeloma or B-cell non-Hodgkin lymphoma who received/will receive CAR-T cell therapy at the IRCCS Azienda Ospedaliero-Universitaria di Bologna. The study aims to evaluate how often infections occur during the first 12 months after CAR-T infusion and to describe their main characteristics and risk factors. Both patients treated since 2019 (retrospective cohort) and newly enrolled patients during the year following study approval (prospective cohort) will be included, with one year of follow-up after infusion.
The study will investigate factors associated with infection risk, the impact of preventive and therapeutic anti-infective strategies, the distinction between infection-related fever and cytokine release syndrome (CRS), post-discharge infections, and immune recovery after CAR-T therapy. In the prospective cohort, patients who develop their first fever episode after CAR-T infusion will also undergo a validated rapid molecular blood test (PilotGene ddPCR Blood System), alongside standard blood cultures, to improve the speed of bloodstream infection diagnosis. The test is already used in clinical practice and will serve as a complementary diagnostic tool without changing standard patient management. Approximately 290 patients are expected to be included, most of whom with lymphoma.
Adult patients (≥18 years old) diagnosed with relapsed/refractory multiple myeloma or B-cell non-Hodgkin lymphoma who receive CAR-T cell therapy at the IRCCS AOUBo during the study periods
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Relapsed and refractory
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Adult patients (≥18 years old) diagnosed with relapsed/refractory multiple myeloma or B-cell non-Hodgkin lymphoma who receive CAR-T cell therapy at the IRCCS AOUBo during the study periods
Cumulative Incidence of Participants With at Least One Infectious Complication After CAR-T Infusion.
Percentage of participants experiencing at least one infectious complication of any type within 12 months after CAR-T infusion.
Time frame: Within 12 months after CAR-T infusion
Adjusted Odds Ratios for Predefined Pre- and Post-Infusion Factors Associated With Infectious Complications.
Adjusted odds ratios with 95% confidence intervals for the association between predefined pre-infusion and post-infusion variables and the occurrence of at least one infectious complication after CAR-T infusion.
Time frame: Within 12 months after CAR-T infusion
Classification of the first febrile episode within 30 days after CAR-T infusion.
Classification of each participant's first febrile episode as no fever, infection-related fever, indeterminate fever, or cytokine release syndrome (CRS)-related fever.
Time frame: Within the first 30 days after CAR-T infusion
Participants with microbiologically documented infection at the first febrile episode.
Number (or percentage) of participants with a microbiologically documented infection identified at the time of the first febrile episode.
Time frame: Within the first 30 days after CAR-T infusion.
Post-Discharge Infectious Complications.
Percentage of participants with at least one infectious complication occurring after hospital discharge.
Time frame: From hospital discharge up to 12 months after CAR-T infusion.
Diagnostic Yield of the Pilot Gene ddPCR Blood Test.
Percentage of first febrile episodes with at least one pathogen and/or antimicrobial resistance marker detected by the Pilot Gene droplet digital polymerase chain reaction blood test.
Time frame: Up to 12 months after enrollment (at the first febrile episode)
Start is estimated for Nov 2026; primary completion for Oct 2027, 11 months later.
Of 173 non-industry observational studies under Multiple Myeloma, half reached primary completion within 70 months of starting (the median), counting those still running; a quarter within 33. This study's planned 11 months is below that.
Counting every sponsor, half of 239 studies reached it within 61 months; a quarter within 30 and three quarters within 126.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.
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