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NCT Number: NCT05519085

A Study to Evaluate Mezigdomide, Bortezomib and Dexamethasone (MEZIVd) Versus Pomalidomide, Bortezomib and Dexamethasone (PVd) in Participants With Relapsed or Refractory Multiple Myeloma (RRMM)

The purpose of this study is to compare the efficacy and safety of mezigdomide (CC-92480), bortezomib and dexamethasone (MeziVd) versus pomalidomide, bortezomib and dexamethasone (PVd) in participants with relapsed or refractory multiple myeloma (RRMM) who received between 1 to 3 prior lines of therapy and who have had prior lenalidomide exposure.

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Key information

Conditions

Relapsed or Refractory Multiple Myeloma 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

Interventional

Phase

Phase 3

Primary location

Local Institution - 0318, Chivilcoy, Buenos Aires, 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

  • Participant has documented diagnosis of MM and measurable disease, defined as any of the following:.

i) M-protein ≥ 0.5 grams per deciliter (g/dL) by serum protein electrophoresis (sPEP) or.

ii) M-protein ≥ 200 milligrams (mg) per 24-hour urine collection by urine protein electrophoresis (uPEP).

iii) For participants without measurable disease in sPEP or uPEP: serum free light chain (sFLC) levels > 100 mg/L (10 mg/dL) involved light chain and an abnormal kappa/lambda FLC ratio.

  • Participants received 1 to 3 prior lines of antimyeloma therapy.
  • Participants achieved minimal response [MR] or better to at least 1 prior antimyeloma therapy.

Exclusion criteria

  • Participant has had progression during treatment or within 60 days of the last dose of a proteasome inhibitor, except as noted below:.

i) Subjects who progressed while being treated with, or within 60 days of last dose of bortezomib maintenance given once every 2 weeks (or less frequently) are not excluded.

ii) Participants who progressed while being treated with ixazomib monotherapy maintenance ≥ 6 months prior to the time of starting study treatment are not excluded.

  • For participants with prior treatment of a bortezomib containing regimen, the best response achieved was not a minimal response (MR) or better, or participant discontinued bortezomib due to toxicity.
  • Participant has had prior treatment with mezigdomide or pomalidomide.
  • Other protocol-defined Inclusion/Exclusion criteria apply.

Treatment and study plan

mezigdomide

Drug

Specified dose on specified days

Other names: BMS-986348, CC-92480

Pomalidomide

Drug

Specified dose on specified days

Other names: Pomalyst, Imnovid, Pom

bortezomib

Drug

Specified dose on specified days

Other names: Velcade, BTZ

Dexamethasone

Drug

Specified dose on specified days

Other names: Decadron, Dex

Primary outcomes

  1. Progression-free Survival (PFS)

    Time frame: From date of randomization to date of disease progression or death due to any cause (Up to approximately 5 years)

Secondary outcomes

  1. Recommended mezigdomide dose

    Time frame: Up to 12 Months

    Stage 1 only

  2. Plasma concentrations of mezigdomide

    Time frame: Up to 134 Days

    Stage 1 only

  3. Overall Survival (OS)

    Time frame: From date of randomization to date of death due to any cause (Up to approximately 5 years)

  4. Overall Response (OR)

    Time frame: Up to approximately 5 years

    OR is defined as the number of participants who achieve best response of partial response (PR) or better according to the International Myeloma Working Group (IMWG) Response Criteria for Multiple Myeloma

  5. Complete Response (CR) or better

    Time frame: Up to approximately 5 Years

    Defined as the number of participants who achieve best response of complete response (CR) or better according to the IMWG Uniform Response Criteria for Multiple Myeloma

  6. Very Good Partial Response (VGPR) or better

    Time frame: Up to approximately 5 years

    Defined as the number of participants who achieve best response of very good partial response (VGPR) or better according to the IMWG Uniform Response Criteria for Multiple Myeloma

  7. Time to Response (TTR)

    Time frame: Up to approximately 5 years

  8. Duration of Response (DOR)

    Time frame: Up to approximately 5 years

  9. Time to Progression (TTP)

    Time frame: Up to approximately 5 years

  10. Time to Next Treatment (TTNT)

    Time frame: Up to approximately 5 years

  11. Progression-free Survival 2 (PFS-2)

    Time frame: Up to approximately 5 years

  12. Minimal Residual Disease (MRD) negativity

    Time frame: Up to approximately 5 years

    Defined as the number of participants who achieve complete response (CR) or better and MRD negativity (defined as less than 1 in 10^5 nucleated cells [by next generation flow cytometry] in bone marrow aspirate)

  13. Number of participants with Adverse Events (AEs)

    Time frame: Up to approximately 5 years

  14. Change from baseline in European Organization for Research and Treatment of Cancer - Quality of Life C30 questionnaire (EORTC QLQ-C30) scores

    Time frame: Up to approximately 5 years

    The EORTC QLQ-C30 is the most commonly used quality of life instrument in oncology trials. The QLQ-C30 consists of 30 questions incorporated into 5 functional domains physical, role, cognitive, emotional, and social), 9 symptom/other scales (fatigue, pain, nausea and vomiting, dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties), and a single global Quality of Life (QoL)/global health status score. Items in the functional and symptom scale use raw participant response of 1 to 4, where 1 = "not at all" and 4 = "very much." The 2 global items contain responses ranging from 1 "very poor" to 7 "excellent." The recall period is 1 week. All domain scores are transformed in a range from 0 to 100, where a higher functional score indicates more favorable outcomes and a higher score on the symptom domains indicates a less favorable participant outcome. Stage 2 only.

  15. Change from baseline in European Organization for Research and Treatment of Cancer - Quality of Life Multiple Myeloma Module (EORTC QLQ-MY20) score

    Time frame: Up to approximately 5 years

    The EORTC QLQ-MY20 is a 20-item myeloma module intended for use among participants varying in disease stage and treatment modality. Participants rate symptoms or problems on a scale from 1 to 4 where 1 = "not at all" and 4 = "very much." Stage 2 only.

Study contacts

Contact information is provided by the study sponsor or research team.

BMS Clinical Trials Contact Center www.BMSClinicalTrials.com

CONTACT

[email protected]

855-907-3286

First line of the email MUST contain NCT # and Site #.

CONTACT

Sponsors and collaborators

Lead sponsor

Celgene

Industry

Registry information

Official study title

A Phase 3, Two-Stage, Randomized, Multicenter, Open-Label Study Comparing Mezigdomide (CC-92480), Bortezomib and Dexamethasone (MEZIVd) Versus Pomalidomide, Bortezomib and Dexamethasone (PVd) in Subjects With Relapsed or Refractory Multiple Myeloma (RRMM): SUCCESSOR-1

Acronym: SUCCESSOR-1

Important dates

Study start
2022
Primary completion
2027
Study completion
2033
First posted
Aug 29, 2022
Registry last updated
Jul 13, 2026

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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