A Study to Determine Dose, Safety, Tolerability, Drug Levels, and Efficacy of CC-220 Monotherapy, and in Combination With Other Treatments in Participants With Multiple Myeloma

April 19, 2024 updated by: Celgene

A Phase 1b/2a Multicenter, Open-label, Dose-escalation Study to Determine the Maximum Tolerated Dose, Assess the Safety, Tolerability, Pharmacokinetics and Efficacy of CC-220 as Monotherapy and in Combination With Other Treatments in Subjects With Multiple Myeloma

This is a multicenter, multi-country, open-label, Phase 1b/2a dose-escalation study consisting of two parts: dose escalation (Part 1) for CC-220 monotherapy, CC-220 in combination with DEX, CC-220 in combination with DEX and DARA, CC-220 in combination with DEX and BTZ and CC-220 in combination with DEX and CFZ; and the expansion of the RP2D (Part 2) for CC-220 monotherapy and CC-220 in combination with DEX for Relapsed Refractory Multiple Myeloma (RRMM), CC-220 in combination with DEX and BTZ, and CC-220 in combination with DEX and DARA for Newly Diagnosed Multiple Myeloma (NDMM).

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

Subjects assigned to CC-220 monotherapy, who develop progressive disease (PD) will have the option to receive DEX in addition to CC-220 after consultation with the Medical Monitor. The dose of CC-220 will not be higher than the dose of CC-220 used in combination with dexamethasone in Cohort B that has been determined to be safe. Progressive disease must be confirmed in accordance with international myeloma working group (IMWG) criteria.

For Cohorts A and B, the starting dose level of CC-220, dose level 1, is 0.3 mg. A dose level -1, of 0.15 mg, may also be evaluated if the starting dose level of 0.3 mg for 21 days of a 28-day cycle is not tolerated. For Cohorts E and F, the starting dose level of CC-220, dose level 1, is one dose level below the maximum dose for Cohort B that has been determined to be safe by the dose escalation committee (DEC) at the start of enrollment for both cohorts. For Cohort E in addition to CC-220 and DEX, daratumumab will be administered intravenously (IV) at a 16mg/kg dose. For Cohort F in addition to CC-220 and DEX, bortezomib will be administered subcutaneous (SC) at a 1.3mg/m2 dose.

All subjects who discontinue study treatment in Part 1 or Part 2 of the study for a reason other than PD or withdrawal of consent from the study will be followed for response assessment every 28 days (every 21 days for Cohort F) until PD.

The study will be conducted in compliance with the International Council for Harmonisation (ICH) of Technical Requirements for Registration of Pharmaceuticals for Human Use/Good Clinical Practice (GCP) and applicable regulatory requirements.

The initiation of Part 2 will begin when the recommended phase 2 dose (RP2D) is established in Part 1 in either Cohort A, Cohort B, Cohort E or Cohort F. The cohorts may begin once the RP2D is determined for each cohort independently during Part 1. All expansion decisions will be determined by the DEC after review of all safety, PK, biomarker and preliminary efficacy data, as applicable. During Part 2, the Independent Expert Reviewer will review safety data and any other data deemed relevant so that subject safety is ensured.

Study Type

Interventional

Enrollment (Estimated)

532

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • South Australia
      • Adelaide, South Australia, Australia, 5000
        • Local Institution - 854
    • Victoria
      • Box Hill, Victoria, Australia, 3128
        • Local Institution - 852
  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2N 4N2
        • Local Institution - 904
    • British Columbia
      • Vancouver, British Columbia, Canada, V5Z 1M9
        • Local Institution - 901
    • Nova Scotia
      • Halifax, Nova Scotia, Canada, B3H 1V7
        • Local Institution - 902
    • Quebec
      • Montreal, Quebec, Canada, H4A 3J1
        • Local Institution - 903
  • France
      • Lile Cedax, France, 59037
        • Local Institution - 704
      • Pessac, France, 33604
        • Local Institution - 701
      • Pierre Benite cedex, France, 69495
        • Local Institution - 703
      • Poitiers Cedex, France, 86021
        • Local Institution - 702
  • Germany
      • Dresden, Germany, 01307
        • Local Institution - 605
      • Dusseldorf, Germany, 40225
        • Local Institution - 603
      • Hamburg, Germany, 20246
        • Local Institution - 604
      • Heidelberg, Germany, 69120
        • Local Institution - 602
      • Tuebingen, Germany, 72076
        • Local Institution - 601
      • Wuerzburg, Germany, 97080
        • Local Institution - 606
  • Israel
      • Tel Hashomer, Israel, 52620
        • Local Institution - 754
      • Tel-Aviv, Israel, 64239
        • Local Institution - 755
    • Yerushalayim
      • Jerusalem, Yerushalayim, Israel, 91031
        • Local Institution - 751
  • Italy
      • Meldola, Italy, 47014
        • Local Institution - 307
      • Pavia, Italy, 27100
        • Local Institution - 305
      • Reggio Emilia, Italy, 42100
        • Local Institution - 302
      • Rome, Italy, 00161
        • Local Institution - 303
      • Torino, Italy, 10126
        • Local Institution - 301
  • Japan
      • Aomori, Japan, 030-8553
        • Local Institution - 805
      • Hiroshima City, Japan, 730-8619
        • Local Institution - 813
      • Isehara City, Kanagawa, Japan, 259-1193
        • Local Institution - 812
      • Kamogawa, Japan, 296-8602
        • Local Institution - 809
      • Kyoto-city, Japan, 602-8566
        • Local Institution - 802
      • Nagasaki-shi, Japan, 8528511
        • Local Institution - 811
      • Nagoya, Japan, 464-8681
        • Local Institution - 810
      • Nagoya, Japan, 467-8602
        • Local Institution - 801
      • Ogaki, Japan, 503-8502
        • Local Institution - 815
      • Osaka, Japan, 545-8586
        • Local Institution - 804
      • Sendai, Japan, 980-8574
        • Local Institution - 803
      • Shinagawa-ku, Tokyo, Japan, 141-8625
        • Local Institution - 806
      • Sunto-gun, Japan, 411-8777
        • Local Institution - 814
      • Toyohashi, Japan, 441-8570
        • Local Institution - 807
    • Ehime
      • Matsuyama, Ehime, Japan, 790-8524
        • Local Institution - 808
  • Netherlands
      • Amsterdam, Netherlands, 1081 HV
        • Local Institution - 503
      • Maastrich, Netherlands, 6202 AZ
        • Local Institution - 504
      • Rotterdam, Netherlands, 3075 EA
        • Local Institution - 501
      • Utrecht, Netherlands, 3584 CX
        • Local Institution - 502
  • Spain
      • Badalona (Barcelona), Spain, 08916
        • Local Institution - 404
      • Barcelona, Spain, 08035
        • Local Institution - 401
      • Barcelona, Spain, 08908
        • Local Institution - 405
      • Madrid, Spain, 28007
        • Local Institution - 408
      • Madrid, Spain, 28034
        • Local Institution - 407
      • Pamplona, Spain, 31008
        • Local Institution - 402
      • Valencia, Spain, 46017
        • Local Institution - 406
  • United Kingdom
      • Birmingham, United Kingdom, B15 2TH
        • Local Institution - 205
      • Leeds, United Kingdom, LS9 7TF
        • Local Institution - 202
      • Oxford, United Kingdom, OX4 6LB
        • Local Institution - 204
      • Sutton, United Kingdom, SM2 5NG
        • Local Institution - 201
      • Sutton, United Kingdom, SM2 5PT
        • Local Institution - 203
  • United States
    • Arizona
      • Scottsdale, Arizona, United States, 85259
        • Local Institution - 102
    • Arkansas
      • Little Rock, Arkansas, United States, 72205
        • Local Institution - 107
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Local Institution - 101
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Local Institution - 120
    • Kansas
      • Fairway, Kansas, United States, 66205
        • Local Institution - 113
    • Maryland
      • Baltimore, Maryland, United States, 21201
        • Local Institution - 106
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Local Institution - 114
      • Boston, Massachusetts, United States, 02117
        • Local Institution - 115
      • Boston, Massachusetts, United States, 02215
        • Local Institution - 110
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • Local Institution - 104
      • Detroit, Michigan, United States, 48201
        • Local Institution - 103
    • Nebraska
      • Grand Island, Nebraska, United States, 68803
        • Local Institution - 140
      • Grand Island, Nebraska, United States, 68803
        • Local Institution - 141
      • Omaha, Nebraska, United States, 68114
        • Local Institution - 137
      • Omaha, Nebraska, United States, 68124
        • Local Institution - 138
      • Omaha, Nebraska, United States, 68130
        • Local Institution - 131
      • Papillion, Nebraska, United States, 68046
        • Local Institution - 139
    • New Jersey
      • Cherry Hill, New Jersey, United States, 08003
        • Local Institution - 756
      • Hackensack, New Jersey, United States, 07601
        • Local Institution - 108
    • New York
      • Mineola, New York, United States, 11501
        • Local Institution - 122
      • New York, New York, United States, 10016
        • Local Institution - 121
      • New York, New York, United States, 10029
        • Local Institution - 109
      • New York, New York, United States, 10065
        • Local Institution - 111
      • Rochester, New York, United States, 14642
        • Local Institution - 125
    • North Carolina
      • Charlotte, North Carolina, United States, 28204
        • Local Institution - 112
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • Local Institution - 117
      • Columbus, Ohio, United States, 43210
        • Local Institution - 124
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • Local Institution - 116
    • South Carolina
      • Greenville, South Carolina, United States, 29605
        • Local Institution - 123
    • Tennessee
      • Memphis, Tennessee, United States, 38120
        • Local Institution - 134
    • Texas
      • Dallas, Texas, United States, 75390
        • Local Institution - 118
    • Utah
      • Salt Lake City, Utah, United States, 84112-5550
        • Local Institution - 119
    • Washington
      • Seattle, Washington, United States, 98109
        • Local Institution - 126
      • Tacoma, Washington, United States, 98405
        • Local Institution - 132

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1 or 2
  • Relapsed and refractory multiple myeloma (RRMM) participants must have documented disease progression on or within 60 days from the last dose of their last myeloma therapy
  • Newly diagnosed multiple myeloma (NDMM) participants must have documented diagnosis with previously untreated symptomatic multiple myeloma (MM)
  • Participants in Cohorts J1 and K are those for whom autologous stem cell transplantation is not planned for initial therapy or are not considered by the investigator as eligible for high-dose chemotherapy and autologous stem cell transplantation

Exclusion Criteria:

  • Any significant medical condition, laboratory abnormality, or psychiatric illness that would prevent the participant from participating in the study
  • Nonsecretory multiple myeloma
  • Prior history of malignancies, other than MM and select non-invasive malignancies, unless the participant has been free of the disease for ≥ 5 years

Other protocol-defined inclusion/exclusion criteria apply

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Cohort A: CC-220 Monotherapy - Part 1
Oral CC-220 at dose specified by cohort dose level from Day 1-21 of each 28-day cycle
Drug: CC-220
Specified dose on specified days
Other Names:
  • Iberdomide
Experimental: Cohort B: CC-220 in combination with Dexamethasone (DEX) - Part 1

Oral CC-220 at dose specified by cohort dose level from Day 1-21 of each 28-day cycle.

For subjects ≤ 75 years old, oral DEX 40 mg on Days 1, 8, 15, and 22 of each 28-day cycle. For subjects >75 years old, DEX will be administered at 20 mg on Days 1, 8,15, and 22 of each 28-day cycle. Subjects who surpass the age of 75 years while on treatment may be switched to the 20 mg QD dosage based on the investigator's best judgment.
Drug: Dexamethasone
Specified dose on specified days
Other Names:
  • Decadron
Drug: CC-220
Specified dose on specified days
Other Names:
  • Iberdomide
Experimental: Cohort D: CC-220 in combination with Dexamethasone - Part 2

Oral CC-220 at Recommended Phase 2 dose (RP2D) from Day 1-21 of each 28-day cycle

For subjects ≤ 75 years old, oral DEX 40 mg on Days 1, 8, 15, and 22 of each 28-day cycle. For subjects >75 years old, DEX will be administered at 20 mg on Days 1, 8, 15, and 22 of each 28-day cycle
Drug: Dexamethasone
Specified dose on specified days
Other Names:
  • Decadron
Drug: CC-220
Specified dose on specified days
Other Names:
  • Iberdomide
Experimental: Cohort E: CC-220 with DEX and daratumumab (DARA) - Part 1

Oral CC-220 at dose specified by cohort dose level from Day 1-21 of each 28-day cycle.

Oral DEX for subjects ≤ 75 years old at 40 mg on Days 1, 8, 15, and 22 of each 28-day cycle. For subjects >75 years old, oral DEX at 20 mg on Days 1, 8, 15, and 22 of each 28-day cycle.

Intravenous DARA at dose 16mg/kg on Days 1, 8, 15, and 22 at cycle 1-2, Days 1, 15 at cycle 3-6, and Day 1 at cycle ≥7 of each 28-day cycle.

Once the MTD and/or RP2D is determined in Cohort E (CC-220Dd), subjects will be enrolled at a dose of Subcutaneous DARA at 1800 mg over 3 to 5minutes on Days 1, 8, 15,and 22 at cycle 1-2 of a 28-day cycle, Days1, and 15 at cycle 3-6 of a 28-day cycle, and Day1 at cycle ≥7 of each 28-day cycle.
Drug: Dexamethasone
Specified dose on specified days
Other Names:
  • Decadron
Drug: Daratumumab
Specified dose on specified days
Other Names:
  • Darzalex
Drug: CC-220
Specified dose on specified days
Other Names:
  • Iberdomide
Experimental: Cohort F: CC-220 with DEX and bortezomib - Part 1

Oral CC-220 at dose specified by cohort dose level from Day 1-14 of each 21-day cycle.

Oral DEX for subjects ≤ 75 years old at 40 mg on Days 1, 8, and 15 of each 21-day cycle. For subjects >75 years old, oral DEX at 20 mg on Days 1, 8, and 15 of each 21-day cycle.

Subcutaneous BTZ at dose 1.3 mg/m^2 on Days 1, 4, 8 and 11 at cycle 1-8, and Days 1, and 8 at cycle ≥9 of each 21-day cycle.
Drug: Bortezomib
Specified dose on specified days
Other Names:
  • Velcade
Drug: Dexamethasone
Specified dose on specified days
Other Names:
  • Decadron
Drug: CC-220
Specified dose on specified days
Other Names:
  • Iberdomide
Experimental: Cohort G1: CC-220 in combination with CFZ and DEX - Part 1

Oral CC-220 at dose specified by cohort dose level from Day 1-21 of each 28-day cycle

Intravenous (IV) CFZ (Carfilzomib)administered at a starting dose of 20 mg/m2 on C1D1; and at a dose specified by cohort dose level thereafter on days 1, 8, and 15 of each 28-day cycle.

Oral DEX (Dexamethasone) on Days 1, 8, 15, and 22 of each 28-day cycle. For subjects ≤ 75 years old, the DEX dose will be 40 mg. For subjects > 75 years old, the DEX dose will be 20 mg
Drug: Dexamethasone
Specified dose on specified days
Other Names:
  • Decadron
Drug: Carfilzomib
Specified dose on specified days
Other Names:
  • Kyprolis
Drug: CC-220
Specified dose on specified days
Other Names:
  • Iberdomide
Experimental: Cohort G2 - CC-220 in combination with CFZ and DEX - Part 1

Oral CC-220 at dose specified by cohort dose level from Day 1-21 of each 28-day cycle.

Intravenous (IV) CFZ administered at a starting dose of 20 mg/m2 on C1D1 and C1D2; and at a dose level specified by cohort dose level thereafter Days 1, 2, 8, 9, 15, 16 of each 28-day cycle.

Oral DEX on Days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28-day cycle. The DEX dose will be 20 mg.
Drug: Dexamethasone
Specified dose on specified days
Other Names:
  • Decadron
Drug: Carfilzomib
Specified dose on specified days
Other Names:
  • Kyprolis
Drug: CC-220
Specified dose on specified days
Other Names:
  • Iberdomide
Experimental: Cohort I: CC-220 in combination with DEX in post BCMA RRMM - Part 2

Oral CC-220 at Recommended Phase 2 dose (RP2D) from Day 1-21 of each 28-day cycle

Oral DEX 40 mg on Days 1, 8, 15, and 22 of each 28-day cycle. For subjects >75 years old, oral DEX will be administered at 20 mg on Days 1, 8, 15, and 22 of each 28-day cycle.
Drug: Dexamethasone
Specified dose on specified days
Other Names:
  • Decadron
Drug: CC-220
Specified dose on specified days
Other Names:
  • Iberdomide
Experimental: Cohort J1: CC-220 in combination with DEX and BTZ in NDMM - Part 2

Oral CC-220 at 1.0mg, 1.3mg or 1.6mg administered at cycles 1 to 8 on Days 1 to 14 of each 21-day cycle and cycles ≥ 9 on Days 1 to 21 of each 28-day cycle.

Oral DEX at Cycles 1 to 8, 20 mg (≤ 75 years old) or 10 mg (> 75 years old) on Days 1, 2, 4, 5, 8, 9, 11 and 12 of each 21-day cycle and Cycles ≥ 9, 40 mg (≤ 75 years old) or 20 mg (> 75 years old) on Days 1, 8, 15, and 22 of each 28-day cycle.

Subcutaneous BTZ at dose 1.3 mg/m2 on Days 1, 4, 8 and 11 at Cycle 1-8 of each 21-day cycle.
Drug: Bortezomib
Specified dose on specified days
Other Names:
  • Velcade
Drug: Dexamethasone
Specified dose on specified days
Other Names:
  • Decadron
Drug: CC-220
Specified dose on specified days
Other Names:
  • Iberdomide
Experimental: Cohort J2: CC-220 in combination with DEX and BTZ in NDMM - Part 2

Oral CC-220 at Recommended Phase 2 Dose from Day 1-14 of each 21-day cycle.

Oral DEX at 20 mg/day (≤ 75 years old) or 10 mg/day (> 75 years old) for Cycles 1 to 6 on Days 1, 2, 4, 5, 8, 9, 11 and 12 of a 21-day cycle.

Subcutaneous BTZ at dose 1.3 mg/m2 on Days 1, 4, 8 and 11 at Cycle 1-6 of each 21-day cycle.
Drug: Bortezomib
Specified dose on specified days
Other Names:
  • Velcade
Drug: Dexamethasone
Specified dose on specified days
Other Names:
  • Decadron
Drug: CC-220
Specified dose on specified days
Other Names:
  • Iberdomide
Experimental: Cohort K: CC-220 with DEX and DARA in NDMM and not autologous stem cell transplant eligible - Part 2

Oral CC-220 at 1.0mg, 1.3mg or 1.6mg from Days 1-21 of each 28-day cycle.

Oral DEX 40 mg on Days 1, 8, 15, and 22 of each 28-day cycle. For subjects >75 years old, oral DEX will be administered at 20 mg on Days 1, 8, 15, and 22 of each 28-day cycle.

Subcutaneous DARA at 1800 mg over 3 to 5minutes on Days 1, 8, 15, and 22 at cycle 1-2 of a 28-day cycle, Days1, and 15 at cycle 3-6 of a 28-day cycle, and Day1 at cycle ≥7 of each 28-day cycle.
Drug: Dexamethasone
Specified dose on specified days
Other Names:
  • Decadron
Drug: Daratumumab
Specified dose on specified days
Other Names:
  • Darzalex
Drug: CC-220
Specified dose on specified days
Other Names:
  • Iberdomide
Experimental: Cohort C: CC-220 Monotherapy in RRMM - Part 2
CC-220 at dose specified by cohort dose level from Day 1-21 of each 28-day cycle.
Drug: CC-220
Specified dose on specified days
Other Names:
  • Iberdomide

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Establish maximum tolerated doses (MTDs) of CC-220 as monotherapy and in combination with other treatment
Time Frame: Approximately 3 years
Establish the maximum tolerated doses (MTDs) of CC-220 monotherapy, in combination with DEX, and in combination with DEX and daratumumab (CC-220Dd), in combination with DEX and bortezomib (CC-220Vd), and in combination with DEX and carfilzomib (CC-220Kd)
Approximately 3 years
Establish Recommended Phase 2 doses (RP2Ds) of CC-220 as monotherapy and in combination with other treatment
Time Frame: Approximately 3 years
RP2D is defined as the dose selected for phase 2 based on safety, pharmacokinetics and biomarker data from phase 1 of the study
Approximately 3 years
Overall response rate (ORR) of CC-220 in combination with Dexamethasone (DEX) in Cohort D
Time Frame: Approximately 5 years
Tumor response, including progressive disease (PD) according to the International Myeloma Working Group (IMWG) Uniform Response Criteria (Kumar, 2011) in CC-220 in combination with DEX
Approximately 5 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pharmacokinetics - Area under the plasma concentration-time curve from time zero to tau, where tau is the dosing interval (AUC[TAU])
Time Frame: Approximately 1 year
Approximately 1 year
Pharmacokinetics - Maximum plasma concentration of drug (Cmax)
Time Frame: Approximately 1 year
Approximately 1 year
Pharmacokinetics - Time to maximum plasma concentration of drug (Tmax)
Time Frame: Approximately 1 year
Approximately 1 year
Very good partial response or better rate (VGPR)
Time Frame: Approximately 4 years
Tumor response, including progressive disease (PD) according to the International Myeloma Working Group (IMWG) Uniform Response Criteria (Kumar, 2016) for subjects who achieved VGPR or better
Approximately 4 years
Adverse Events (AEs)
Time Frame: Approximately 5 years
Type, frequency, seriousness and severity of adverse events (AEs) (and AEs of special interest) and relationship of AEs to investigational product
Approximately 5 years
Overall response rate (ORR)
Time Frame: Approximately 5 years
Tumor response, including progressive disease (PD) according to the International Myeloma Working Group (IMWG) Uniform Response Criteria (Kumar, 2016) for subjects who achieved partial response (PR) or better
Approximately 5 years
Time to Response (TTR)
Time Frame: Approximately 5 years
Is defined as the time from the first date of dosing of IP to the first date of documented response (partial response [PR] or greater)
Approximately 5 years
Duration of Response (DOR)
Time Frame: Approximately 5 years
Is defined as Time from the first documentation of response (PR or greater) to the first documentation of Progressive disease (PD)
Approximately 5 years
Progression-free Survival (PFS)
Time Frame: Approximately 5 years
Time from the first dose of investigational product (IP) to the first documentation of PD or death from any cause, whichever occurs first
Approximately 5 years
Overall Survival (OS) in Part 2 relapsed and refractory multiple myeloma (RRMM) cohorts
Time Frame: Approximately 5 years
Time from first dose of IP to death due to any cause
Approximately 5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Celgene

Investigators

  • Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 14, 2016

Primary Completion (Estimated)

April 30, 2024

Study Completion (Estimated)

February 6, 2028

Study Registration Dates

First Submitted

May 12, 2016

First Submitted That Met QC Criteria

May 12, 2016

First Posted (Estimated)

May 16, 2016

Study Record Updates

Last Update Posted (Actual)

April 22, 2024

Last Update Submitted That Met QC Criteria

April 19, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CC-220-MM-001
  • U1111-1182-9200 (Registry Identifier: WHO)
  • 2016-000860-40 (EudraCT Number)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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