Multiple Myeloma (MM)MEDICINCT04721002
Study to Evaluate t(11;14) Status and BCL2 Expression in Adult Participants With Multiple Myeloma (MM)
An observational study of Multiple Myeloma (MM), run by AbbVie at 40 sites in 22 countries.
Trial summary
Multiple myeloma (MM) is a rare cancer caused by abnormal survival of plasma cells (blood cells). Most trial participants with MM relapse (cancer has come back) or become non- responsive to treatment and remission gets shorter after each line of treatment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Myeloma (MM)
- How many people
- 514 participants
- Where
- 40 sitesin 22 countries
- Study dates
- 7 Jul 2021to 30 Sep 2023
- Phase
- Observational
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: Adult participants with confirmed newly diagnosed or relapsed/refractory multiple myeloma
Who may be able to join
- Confirmed newly diagnosed or relapsed/refractory (R/R) Multiple myeloma (MM) who have signed informed consent for the use of their biological material for research purposes.
Who cannot join
- Participants who do not have Bone Marrow (BM) and blood sample at time of diagnosis or at confirmation of relapse.
Trial locations and contacts
40 sites in 22 countries.
40 sites in 22 countries
Brazil7 sites
Hospital de Clinicas de Porto Alegre /ID# 224274
Porto Alegre, Rio Grande do Sul, 90035-903
Instituto COI de Educacao e Pesquisa /ID# 224245
Rio de Janeiro, 22793-080
Hospital São Rafael /ID# 224307
Salvador, Estado de Bahia, 41253-190
Clinica Sao Germano /ID# 224239
São Paulo, São Paulo, 04537-080
Sociedade Beneficente Israelita Brasileira Hospital Albert Einstein /ID# 224303
São Paulo, São Paulo, 05652-900
Real e Benemérita Associação Portuguesa de Beneficência /ID# 224305
São Paulo, 01323-001
Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo /ID# 225749
São Paulo, 05403-000
Spain6 sites
Hospital Universitario Germans Trias i Pujol /ID# 229281
Badalona, Barcelona, 08916
Hospital Clinic de Barcelona /ID# 224804
Barcelona, 08036
Hospital de Leon /ID# 229191
León, 24071
Hospital Universitario Fundacion Jimenez Diaz /ID# 229524
Madrid, 28040
Hospital Universitario 12 de Octubre /ID# 225617
Madrid, 28041
Hospital Universitario de Salamanca /ID# 224803
Salamanca, 37711
France3 sites
CHRU Lille - Hopital Claude Huriez /ID# 228919
Lille, Hauts-de-France, 59037
CHU de Nantes, Hotel Dieu -HME /ID# 223702
Nantes, Pays de la Loire Region, 44000
AP-HP - Hopital Necker /ID# 228062
Paris, 75015
United States2 sites
University of Texas Southwestern Medical Center /ID# 223865
Dallas, Texas, 75390-7208
Tulane School of Medicine /ID# 223864
New Orleans, Louisiana, 70112
Czechia2 sites
Fakultni nemocnice Hradec Kralove /ID# 224089
Hradec Králové, 500 05
Fakultni nemocnice Ostrava /ID# 224090
Ostrava, 708 52
Germany2 sites
Praxis am Volkspark /ID# 224763
Berlin, 10715
Asklepios Klinik Altona /ID# 224761
Hamburg, 22763
Italy2 sites
Azienda Ospedaliero Universitaria Ospedali Riuniti di Ancona /ID# 224690
Ancona, 60126
ASST Grande Ospedale Metropolitano Niguarda /ID# 224608
Milan, 20162
Poland2 sites
Szpital Kliniczny im. Heliodora Swiecickiego Uniwersytetu Medycznego im. Karola /ID# 227038
Poznan, Greater Poland Voivodeship, 60-569
Instytut Hematologii i Transfuzjologii /ID# 227039
Warsaw, Masovian Voivodeship, 02-776
Argentina1 site
Hospital Italiano de Buenos Aires /ID# 224153
Ciudad Autonoma Buenos Aires, Buenos Aires F.D., 1199
Croatia1 site
Klinicki bolnicki centar Zagreb /ID# 226969
Zagreb, City of Zagreb, 10000
Israel1 site
Hadassah Medical Center-Hebrew University /ID# 224884
Jerusalem, Jerusalem, 91120
Netherlands1 site
Maastricht Universitair Medisch Centrum /ID# 224694
Maastricht, 6229 HX
Romania1 site
Institutul Clinic Fundeni /ID# 224574
Bucharest, Bucharest, 022328
Saudi Arabia1 site
Princess Noorah Oncology Center /ID# 224968
Jeddah, 22384
Turkey (Türkiye)1 site
Bagcilar Medipol Mega Universite Hastanesi /ID# 225515
Istanbul, 34214
About this study
Official title: MEDICI - t(11;14) and BCL2 Expression in Patients With Multiple Myeloma: Prevalence, Stability Across Lines of Therapy and Concordance Across Sample Types
Multiple myeloma (MM) is a rare cancer caused by abnormal survival of plasma cells (blood cells). Most trial participants with MM relapse (cancer has come back) or become non- responsive to treatment and remission gets shorter after each line of treatment. This is a study to assess t(11;14) and BCL2 expression in adult participants with newly diagnosed and relapsed/refractory (R/R) MM.
Approximately 500 adult participants with newly confirmed or relapsed/refractory (R/R) multiple myeloma (MM) will be enrolled in around 15-20 countries.
Read more
Participants will receive standard of care while participating in this study. No drug will be administered as a part of this study.
Participants will attend regular visits during the course of the study at a hospital or clinic and will be asked to provide bone marrow and blood samples.
- Conditions
- Multiple Myeloma (MM)
- Keywords
- Multiple myeloma (MM), Relapsed/Refractory (R/R) Multiple myeloma (MM), t(11, 14), BCL2
- Medical subject headings
- Multiple Myeloma, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Participants With Multiple Myeloma | Participants with newly diagnosed and relapsed/refractory multiple myeloma will receive standard of care. Bone marrow and blood samples will be collected. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants With t(11;14) Status by Fluorescence In Situ Hybridization (FISH) Analysis of Bone Marrow Plasma Cells
t(11;14) status (positive or negative) of the earliest multiple myeloma (MM) sample collected at initial diagnosis or across lines of therapies, by FISH analysis of bone marrow plasma cells is evaluated.
Measured: Up to approximately 2.5 months following last subject last visit
Percentage of Participants With BCL2 Status by Quantitative Polymerase Chain Reaction (qPCR) Analysis of Bone Marrow Plasma Cells
BCL2 status (BCL2 high or not) of the earliest MM sample collected, either at initial diagnosis or across lines of therapies, by qPCR analysis of bone marrow plasma cells is evaluated.
Measured: Up to approximately 2.5 months following last subject last visit
Secondary outcomes (11)
Percentage of Participants Achieving Stability of t(11;14) Status
Stability of t(11;14) status across intra-patient longitudinal bone marrow (BM) samples (changed vs not changed) collected at initial diagnosis and across lines of therapies.
Measured: Up to approximately 2.5 months following last subject last visit
Percentage of Participants Achieving Stability of BCL2 Status
Stability of BCL2 status across intra-patient longitudinal BM samples (changed vs not changed) collected at initial diagnosis and across lines of therapies.
Measured: Up to approximately 2.5 months following last subject last visit
Percentage of Participants With t(11;14) Status Determined by Bone Marrow (BM) Biopsy
t(11;14) status (positive or negative) at initial diagnosis and across lines of therapy as determined by BM biopsy.
Measured: Up to approximately 2.5 months following last subject last visit
Percentage of Participants With BCL2 Status Determined by Bone Marrow Biopsy
BCL2 status (BCL2high or BCL2low) at initial diagnosis and across lines of therapy as determined by BM biopsy.
Measured: Up to approximately 2.5 months following last subject last visit
Percentage of Participants With t(11;14) Status of MM Samples
t(11;14) status (positive or negative) of MM samples at different disease stages as determined by BM biopsy.
Measured: Up to approximately 2.5 months following last subject last visit
Percentage of Participants With BCL2 Status of MM Samples
BCL2 status (BCL2high or BCL2low) of MM samples at different disease stages as determined by BM biopsy.
Measured: Up to approximately 2.5 months following last subject last visit
Percentage of Participants With t(11;14) Status of MM Samples at Different Treatment Lines Stages
t(11;14) status (positive or negative) of MM samples at different treatment lines stages as determined by BM biopsy.
Measured: Up to approximately 2.5 months following last subject last visit
Percentage of Participants With BCL2 Status of MM Samples at Different Treatment Lines Stages
BCL2 status (BCL2high or BCL2low) status of MM samples at different treatment lines stages as determined by BM biopsy.
Measured: Up to approximately 2.5 months following last subject last visit
Percentage of Participants With t(1;14) Status and BCL2 Status
t(11;14) and BCL2 status (Positive and BCL2high, Negative and BCL2high, Positive and BCL2low, Negative and BCL2low) of the earliest MM samples collected, at initial diagnosis or across lines of therapies, by FISH and qPCR analyses of bone marrow plasma cells, respectively.
Measured: Up to approximately 2.5 months following last subject last visit
Percentage of Participants With FISH Fusion (F) Categories as Determined by BM Biopsy
FISH fusion (F) categories (1F, 2F, >=3F) among t(11;14) positive samples as determined by BM biopsy.
Measured: Up to approximately 2.5 months following last subject last visit
Percentage of Participants With FISH Fusion (F) Categories Across Lines of Therapies as Determined by BM Biopsy
FISH fusion (F) categories (1F, 2F, >=3F) among t(11;14) positive samples across lines of therapies as determined by BM biopsy.
Measured: Up to approximately 2.5 months following last subject last visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2021
- Study start7 Jul 2021
- Primary completion30 Sep 2023
- Study completion30 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Multiple Myeloma (MM)Studies of the same condition, open and under way.
- More trials run by AbbVieThe sponsor's other registered studies.
- 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
- Prospective
- Enrolment
- 514 participants (actual)
Sponsor and investigators
- Lead sponsor
- AbbVie
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- ABBVIE INC., Study director, AbbVie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04721002
- Sponsor's protocol ID
- H20-126
- Acronym
- MEDICI
- Status last verified
- Oct 2023
- First submitted
- 21 Jan 2021
- Last updated
- 18 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Spencer A, Gavriatopoulou M, Coriu D, Lysen A, Gutierrez NC, Escalante F, Eugenia Fantl DB, Hajek R, Seguro F, Kaur G, Bittencourt R, Kinda SB, Chu MP, Safah H, Martinez-Lopez J, de Queiroz Crusoe E, Cordeiro de Farias DL, Offidani M, Askari E, Sevindik OG, Maisnar V, Teng CL, Hughes O, Taylor R, Lehn K, Feng D, Thiebaut-Millot R, Li X, Murray L, Jung P, Rossi EL, Kongpachith S, Nichol A, Ross JA, Hader C. Prospective real-world evaluation of t(11;14) prevalence and disease biology in multiple myeloma: MEDICI study analysis. Blood Adv. 2025 Nov 25;9(22):5814-5827. doi: 10.1182/bloodadvances.2025017214.
PubMed 40829119