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A Study to Evaluate Mezigdomide, Bortezomib and Dexamethasone (MEZIVd) Versus Pomalidomide, Bortezomib and Dexamethasone (PVd) in Participants With Relapsed or Refractory Multiple Myeloma (RRMM) (SUCCESSOR-1)

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ClinicalTrials.gov Identifier: NCT05519085
Recruitment Status : Recruiting
First Posted : August 29, 2022
Last Update Posted : April 17, 2024
Sponsor:
Information provided by (Responsible Party):
Celgene

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Relapsed or Refractory Multiple Myeloma Drug: mezigdomide Drug: Pomalidomide Drug: Bortezomib Drug: Dexamethasone Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 810 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official 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
Actual Study Start Date : September 20, 2022
Estimated Primary Completion Date : November 3, 2025
Estimated Study Completion Date : November 30, 2033

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Multiple Myeloma

Arms and Interventions
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Arm Intervention/treatment
Experimental: MeziVd (mezigdomide, bortezomib and dexamethasone) Drug: mezigdomide
Specified dose on specified days
Other Names:
  • BMS-986348
  • CC-92480

Drug: Bortezomib
Specified dose on specified days
Other Names:
  • Velcade
  • BTZ

Drug: Dexamethasone
Specified dose on specified days
Other Names:
  • Decadron
  • Dex
Experimental: PVd (pomalidomide, bortezomib and dexamethasone) Drug: Pomalidomide
Specified dose on specified days
Other Names:
  • Pomalyst
  • Imnovid
  • Pom

Drug: Bortezomib
Specified dose on specified days
Other Names:
  • Velcade
  • BTZ

Drug: Dexamethasone
Specified dose on specified days
Other Names:
  • Decadron
  • Dex


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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 negative (defined at a sensitivity of a minimum of 1 in 105 nucleated cells)

  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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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 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.
Contacts and Locations
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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): NCT05519085


Contacts
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Contact: BMS Study Connect Contact Center www.BMSStudyConnect.com 855-907-3286 Clinical.Trials@bms.com
Contact: First line of the email MUST contain the NCT# and Site #.

Locations
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Sponsors and Collaborators
Celgene
Investigators
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Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
More Information
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Additional Information:

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Responsible Party: Celgene
ClinicalTrials.gov Identifier: NCT05519085    
Other Study ID Numbers: CA057-001
2021-001957-30 ( EudraCT Number )
First Posted: August 29, 2022    Key Record Dates
Last Update Posted: April 17, 2024
Last Verified: April 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. Additional information regarding Bristol Myers Squibb's data sharing policy and process can be found at: https://www.bms.com/researchers-and-partners/clinical-trials-and-research/disclosurecommitment.html
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)
Time Frame: See Plan Description
Access Criteria: See Plan Description
URL: https://www.bms.com/researchers-and-partners/clinical-trials-and-research/disclosure-commitment.html

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Celgene:
Multiple myeloma
RRMM
MeziVd
PVd
CC92480
 pomalidomide
bortezomib
dexamethasone
mezigdomide
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
Dexamethasone
 Bortezomib
Pomalidomide
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Immunologic Factors
Angiogenesis Inhibitors