Clinical trial 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)
Official 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)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE1
PHASE2
Conditions: Multiple Myeloma
Keywords: Relapsed or Refractory Multiple Myeloma
Newly Diagnosed Multiple Myeloma
Multiple Myeloma
CC-92480
Lead sponsor: Celgene
Sponsor class: INDUSTRY
First posted: 2019-06-18
Enrollment: 424
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: 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

Primary outcomes:
measure: Recommended Dose
timeFrame: Up to approximately 3 years
measure: Recommended regimen as measured by dose-limiting toxicities
timeFrame: Up to approximately 3 years
measure: Number of participants with Adverse Events (AEs)
timeFrame: From first participant first visit until 28 days after the last subject discontinues study treatment, up to 5 years
measure: Overall response rate (ORR)
timeFrame: Up to approximately 5 years
Secondary outcomes:
measure: Time-to-response (TTR)
timeFrame: Up to approximately 5 years
measure: Duration of response (DOR)
timeFrame: Up to approximately 5 years
measure: Complete Response (CR) rate
timeFrame: Up to approximately 5 years
measure: Very good partial response (VGPR) rate - Cohorts D and E
timeFrame: Up to approximately 5 years
Other outcomes:
Locations:
city: Denver
country: United States
facility: Local Institution - 119
state: Colorado
city: Tampa
country: United States
facility: Local Institution - 104
state: Florida
city: Atlanta
country: United States
facility: Local Institution - 108
state: Georgia
city: Chicago
country: United States
facility: Local Institution - 112
state: Illinois
city: Chicago
country: United States
facility: Local Institution - 107
state: Illinois
city: Boston
country: United States
facility: Local Institution - 117
state: Massachusetts
city: Boston
country: United States
facility: Local Institution - 101
state: Massachusetts
city: Boston
country: United States
facility: Local Institution - 118
state: Massachusetts
city: Detroit
country: United States
facility: Local Institution - 113
state: Michigan
city: Rochester
country: United States
facility: Local Institution - 106
state: Minnesota
city: Hackensack
country: United States
facility: Hackensack University Medical Center
state: New Jersey
city: Winston-Salem
country: United States
facility: Local Institution - 110
state: North Carolina
city: Columbus
country: United States
facility: Local Institution - 115
state: Ohio
city: Nashville
country: United States
facility: Local Institution - 114
state: Tennessee
city: Houston
country: United States
facility: Local Institution - 116
state: Texas
city: Seattle
country: United States
facility: Swedish Cancer Institute
state: Washington
city: Calgary
country: Canada
facility: Local Institution - 201
state: Alberta
city: Edmonton
country: Canada
facility: Local Institution - 205
state: Alberta
city: Halifax
country: Canada
facility: Local Institution - 204
state: Nova Scotia
city: Toronto
country: Canada
facility: Local Institution - 203
state: Ontario
city: Montreal
country: Canada
facility: Local Institution - 202
state: Quebec
city: Brno
country: Czechia
facility: Local Institution - 802
city: Ostrava-Poruba
country: Czechia
facility: Local Institution - 801
city: Praha 2
country: Czechia
facility: Local Institution - 803
city: Odense
country: Denmark
facility: Local Institution - 902
city: Vejle
country: Denmark
facility: Local Institution - 903
city: Lille cedex
country: France
facility: Local Institution - 703
city: Marseille cedex
country: France
facility: Local Institution - 705
city: Nantes Cedex 01
country: France
facility: Local Institution - 704
city: Toulouse Cedex 9
country: France
facility: Local Institution - 701
city: Tours cedex
country: France
facility: Local Institution - 702
city: Freiburg
country: Germany
facility: Local Institution - 604
city: Hamburg
country: Germany
facility: Local Institution - 605
city: Heidelberg
country: Germany
facility: Local Institution - 601
city: Munchen
country: Germany
facility: Local Institution - 602
city: Wuerzburg
country: Germany
facility: Local Institution - 603
city: Athens
country: Greece
facility: Local Institution - 301
city: Brescia
country: Italy
facility: Local Institution - 404
city: Milan
country: Italy
facility: Local Institution - 401
city: Reggio Emilia
country: Italy
facility: Local Institution - 403
city: Torino
country: Italy
facility: Local Institution - 402
city: Badalona
country: Spain
facility: Local Institution - 504
city: Madrid
country: Spain
facility: Local Institution - 508
city: Madrid
country: Spain
facility: Local Institution - 501
city: Malaga
country: Spain
facility: Local Institution - 506
city: Pamplona
country: Spain
facility: Local Institution - 505
city: Salamanca
country: Spain
facility: Local Institution - 502
city: Santander
country: Spain
facility: Local Institution - 503
city: Valencia
country: Spain
facility: Local Institution - 507
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: