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

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ClinicalTrials.gov Identifier: NCT04721002
Recruitment Status : Recruiting
First Posted : January 22, 2021
Last Update Posted : September 26, 2022
Sponsor:
Information provided by (Responsible Party):
AbbVie

Brief 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. 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.


Condition or disease
Multiple Myeloma (MM)

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Study Type : Observational
Estimated Enrollment : 500 participants
Observational Model: Cohort
Time Perspective: Prospective
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
Actual Study Start Date : July 7, 2021
Estimated Primary Completion Date : December 31, 2022
Estimated Study Completion Date : December 31, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Multiple Myeloma

Group/Cohort
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.



Primary Outcome Measures :
  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 Outcome Measures :
  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.


Biospecimen Retention:   Samples With DNA
Bone marrow aspirate and peripheral blood


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Adult participants with confirmed newly diagnosed or relapsed/refractory multiple myeloma
Criteria

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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04721002


Contacts
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Contact: ABBVIE CALL CENTER 844-663-3742 abbvieclinicaltrials@abbvie.com

Locations
Show Show 40 study locations
Sponsors and Collaborators
AbbVie
Investigators
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Study Director: ABBVIE INC. AbbVie
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Responsible Party: AbbVie
ClinicalTrials.gov Identifier: NCT04721002    
Other Study ID Numbers: H20-126
First Posted: January 22, 2021    Key Record Dates
Last Update Posted: September 26, 2022
Last Verified: September 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by AbbVie:
Multiple myeloma (MM)
Relapsed/Refractory (R/R) Multiple myeloma (MM)
t(11
14)
BCL2
Additional relevant MeSH terms:
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Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases