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OpenTrials
Active, Not Recruiting

NCT Number: NCT03989414

A Study to Determine the Recommended Dose and Regimen and to Evaluate the Safety and Preliminary Efficacy of CC-92480 in Combination With Standard Treatments in Participants With Relapsed or Refractory Multiple Myeloma (RRMM) and Newly Diagnosed Multiple Myeloma (NDMM)

The purpose of this study is to evaluate the safety and preliminary efficacy of CC-92480 in combination with standard treatments.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

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 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 1 / Phase 2

Primary location

Local Institution - 201, Calgary, Alberta, Canada

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1 or 2

For participants in Cohorts A, B, C, D, E, F, H, I, J, and K the following inclusions will also apply:

  • Documented diagnosis of multiple myeloma (MM) and measurable disease
  • Documented disease progression during or after their last antimyeloma regimen
  • Achieved a response (minimal response [MR] or better) to at least 1 prior treatment regimen

Exclusion criteria

  • Plasma cell leukemia, Waldenstrom's macroglobulinemia, POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes) or clinically significant amyloidosis
  • Known central nervous system (CNS) involvement with myeloma
  • Received immunosuppressive medication within the last 14 days of initiating study treatment
  • Uncontrolled hypertension or uncontrolled diabetes within 14 days prior to enrollment

Other protocol-defined inclusion/exclusion criteria apply

Treatment and study plan

CC-92480

Drug

Specified dose on specified days

Other names: BMS-986348, mezigdomide

bortezomib

Drug

Specified dose on specified days

Dexamethasone

Drug

Specified dose on specified days

Daratumumab

Drug

Specified dose on specified days

Carfilzomib

Drug

Specified dose on specified days

Elotuzumab

Drug

Specified dose on specified days

Isatuximab

Drug

Specified dose on specified days

Primary outcomes

  1. Recommended Dose

    Time frame: Up to approximately 3 years

  2. Recommended regimen as measured by dose-limiting toxicities

    Time frame: Up to approximately 3 years

  3. Number of participants with Adverse Events (AEs)

    Time frame: From first participant first visit until 28 days after the last subject discontinues study treatment, up to 5 years

  4. Overall response rate (ORR)

    Time frame: Up to approximately 5 years

Secondary outcomes

  1. Time-to-response (TTR)

    Time frame: Up to approximately 5 years

  2. Duration of response (DOR)

    Time frame: Up to approximately 5 years

  3. Complete Response (CR) rate

    Time frame: Up to approximately 5 years

  4. Very good partial response (VGPR) rate - Cohorts D and E

    Time frame: Up to approximately 5 years

Sponsors and collaborators

Lead sponsor

Celgene

Industry

Registry information

Official study title

A Phase 1/2, Multicenter, Open-label, Study to Determine the Recommended Dose and Regimen, and Evaluate the Safety and Preliminary Efficacy of CC-92480 in Combination With Standard Treatments in Subjects With Relapsed or Refractory Multiple Myeloma (RRMM) and Newly Diagnosed Multiple Myeloma (NDMM)

Important dates

Study start
2019
Primary completion
2026
Study completion
2026
First posted
Jun 18, 2019
Registry last updated
Nov 29, 2024

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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