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NCT Number: NCT04721002

Study to Evaluate t(11;14) Status and BCL2 Expression in Adult Participants With Multiple Myeloma (MM)

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.

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.

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Key information

Conditions

Multiple Myeloma (MM) Blood Protein Disorders Cardiovascular Diseases Disease Attributes Hematologic Diseases Hemic and Lymphatic Diseases Hemorrhagic Disorders Hemostatic Disorders Immune System Diseases Immunoproliferative Disorders Lymphoproliferative Disorders Multiple Myeloma Neoplasms Neoplasms by Histologic Type Neoplasms, Plasma Cell Paraproteinemias Pathologic Processes Pathological Conditions, Signs and Symptoms Recurrence Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hospital Italiano de Buenos Aires /ID# 224153, Ciudad Autonoma Buenos Aires, Buenos Aires F.D., Argentina

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • Participants who do not have Bone Marrow (BM) and blood sample at time of diagnosis or at confirmation of relapse.

Treatment and study plan

Primary outcomes

  1. Percentage of Participants With t(11;14) Status by Fluorescence In Situ Hybridization (FISH) Analysis of Bone Marrow Plasma Cells

    Time frame: Up to approximately 2.5 months following last subject last visit

    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.

  2. Percentage of Participants With BCL2 Status by Quantitative Polymerase Chain Reaction (qPCR) Analysis of Bone Marrow Plasma Cells

    Time frame: Up to approximately 2.5 months following last subject last visit

    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.

Secondary outcomes

  1. Percentage of Participants Achieving Stability of t(11;14) Status

    Time frame: Up to approximately 2.5 months following last subject last visit

    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.

  2. Percentage of Participants Achieving Stability of BCL2 Status

    Time frame: Up to approximately 2.5 months following last subject last visit

    Stability of BCL2 status across intra-patient longitudinal BM samples (changed vs not changed) collected at initial diagnosis and across lines of therapies.

  3. Percentage of Participants With t(11;14) Status Determined by Bone Marrow (BM) Biopsy

    Time frame: Up to approximately 2.5 months following last subject last visit

    t(11;14) status (positive or negative) at initial diagnosis and across lines of therapy as determined by BM biopsy.

  4. Percentage of Participants With BCL2 Status Determined by Bone Marrow Biopsy

    Time frame: Up to approximately 2.5 months following last subject last visit

    BCL2 status (BCL2high or BCL2low) at initial diagnosis and across lines of therapy as determined by BM biopsy.

  5. Percentage of Participants With t(11;14) Status of MM Samples

    Time frame: Up to approximately 2.5 months following last subject last visit

    t(11;14) status (positive or negative) of MM samples at different disease stages as determined by BM biopsy.

  6. Percentage of Participants With BCL2 Status of MM Samples

    Time frame: Up to approximately 2.5 months following last subject last visit

    BCL2 status (BCL2high or BCL2low) of MM samples at different disease stages as determined by BM biopsy.

  7. Percentage of Participants With t(11;14) Status of MM Samples at Different Treatment Lines Stages

    Time frame: Up to approximately 2.5 months following last subject last visit

    t(11;14) status (positive or negative) of MM samples at different treatment lines stages as determined by BM biopsy.

  8. Percentage of Participants With BCL2 Status of MM Samples at Different Treatment Lines Stages

    Time frame: Up to approximately 2.5 months following last subject last visit

    BCL2 status (BCL2high or BCL2low) status of MM samples at different treatment lines stages as determined by BM biopsy.

  9. Percentage of Participants With t(1;14) Status and BCL2 Status

    Time frame: Up to approximately 2.5 months following last subject last visit

    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.

  10. Percentage of Participants With FISH Fusion (F) Categories as Determined by BM Biopsy

    Time frame: Up to approximately 2.5 months following last subject last visit

    FISH fusion (F) categories (1F, 2F, >=3F) among t(11;14) positive samples as determined by BM biopsy.

  11. Percentage of Participants With FISH Fusion (F) Categories Across Lines of Therapies as Determined by BM Biopsy

    Time frame: Up to approximately 2.5 months following last subject last visit

    FISH fusion (F) categories (1F, 2F, >=3F) among t(11;14) positive samples across lines of therapies as determined by BM biopsy.

Sponsors and collaborators

Lead sponsor

AbbVie

Industry

Registry information

Official study title

MEDICI - t(11;14) and BCL2 Expression in Patients With Multiple Myeloma: Prevalence, Stability Across Lines of Therapy and Concordance Across Sample Types

Acronym: MEDICI

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Jan 22, 2021
Registry last updated
Oct 18, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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