AzTrials
AzTrials

Multiple MyelomaPhase 1/2NCT03374085

A Safety, PK and Efficacy Study of CC-92480 Monotherapy and in Combination With Dexamethasone in Subjects With Relapsed and Refractory Multiple Myeloma (RRMM)

A Phase 1/2 study testing CC-92480 and Dexamethasone in people with Multiple Myeloma, run by Celgene at 54 sites in 11 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
Search all trials

Trial summary

This is an open-label, multi-center, international, Phase 1/2 study to assess the safety, PK and efficacy of CC-92480 monotherapy and in combination with dexamethasone in subjects with relapsed and refractory multiple myeloma (RRMM). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Multiple Myeloma
What is being tested?
CC-92480 and Dexamethasone
Could I receive a placebo?
No, everyone receives an active treatment
How many people
200 participants
Where
54 sitesin 11 countries
Study dates
6 Feb 2018to 23 Oct 2025
Phase
Phase 1/2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Subject is ≥ 18 years of age at the time of signing the informed consent form (ICF).
  • Subject must understand and voluntarily sign an ICF prior to any study-related assessments/procedures being conducted.
  • Subject is willing and able to adhere to the study visit schedule and other protocol requirements.
  • Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1 or 2.
  • Subjects must have a documented diagnosis of MM and measurable disease at enrollment. Measurable disease is defined as:
  • M-protein quantities ≥ 0.5 g/dL by sPEP or
Show all 33Show fewer
  • ≥ 200 mg/24 hour urine collection by uPEP or
  • Serum FLC levels > 100 mg/L (milligrams/liter) involved light chain and an abnormal kappa/lambda (κ/λ) ratio in subjects without measurable serum or urine M-protein or
  • For subjects with immunoglobulin class A (IgA), myeloma whose disease can only be reliably measured by quantitative immunoglobulin measurement, a serum IgA level ≥ 0.50 g/dL.
  • All subjects must have:
  • Received at least 3 prior anti-myeloma regimens including at least 2 consecutive cycles of lenalidomide, pomalidomide, a proteasome inhibitor, a glucocorticoid and a CD38 antibody (note: induction with or without bone marrow transplant and with or without maintenance therapy is considered one regimen).
  • Documented disease progression on or within 60 days from the last dose of their last myeloma therapy
  • Subjects who had CAR-T therapy as their last myeloma therapy are eligible as long as they have documented disease progression following CAR-T therapy.
  • In addition to criteria above (a and b), subjects enrolled in Part 2 must have disease refractory to an immunomodulatory agent (lenalidomide and/or pomalidomide), a glucocorticoid, a proteasome inhibitor, and a CD38 antibody. Refractory is defined as disease that is nonresponsive on therapy (failure to achieve minimal response or development of progressive disease), or progresses within 60 days of last dose.
  • Subjects must have the following laboratory values:
  • Absolute neutrophil count (ANC) ≥ 1.25 x 109/L without growth factor support for ≥ 7 days (≥ 14 days for pegfilgrastim). ANC of ≥ 1.00 x 109/L is permitted for the dose expansion cohorts (Part 2).
  • Hemoglobin (Hgb) ≥ 8 g/dL.
  • Platelets (plt) ≥ 75 x 109/L without transfusion for ≥ 7 days.
  • Corrected serum calcium ≤ 13.5 mg/dL (≤ 3.4 mmol/L).
  • Creatinine clearance (CrCl) based on Cockcroft-Gault formula ≥ 45 mL/min.
  • AST/SGOT and ALT/SGPT ≤ 3.0 x upper limit of normal (ULN).
  • Serum bilirubin ≤ 1.5 x ULN or < 3.0 mg/dL for subjects with documented Gilbert's syndrome.
  • Uric acid ≤ 7.5 mg/dL (446 µmol/L).
  • PT/INR < 1.5 x ULN and partial thromboplastin time (PTT) < 1.5 x ULN, (for subjects not receiving therapeutic anticoagulation).
  • Females of childbearing potential (FCBP) must:
  • Have two negative pregnancy tests as verified by the Investigator prior to starting study therapy. She must agree to ongoing pregnancy testing during the course of the study, and after discontinuation of CC-92480. This applies even if the subject practices true abstinence* from heterosexual contact.
  • Either commit to true abstinence* from heterosexual contact (which must be reviewed on a monthly basis and source documented) or agree to use, and be able to comply with, two reliable forms of contraception as defined in the PPP and provided to the subject at the time of informed consent, without interruption, 28 days prior to starting CC-92480, during the study therapy (including during dose interruptions), and for 184 days after the last dose of CC-92480.
  • Note: A female of childbearing potential (FCBP) is a female who: 1) has achieved menarche at some point and, 2) has not undergone a hysterectomy or bilateral oophorectomy, or 3) has not been naturally postmenopausal (amenorrhea following cancer therapy does not rule out childbearing potential) for at least 24 consecutive months (ie, has had menses at any time in the preceding 24 consecutive months).
  • Male subjects must:
  • Practice true abstinence (which must be reviewed on a monthly basis) or agree to use of a condom during sexual contact with a pregnant female or a female of childbearing potential while participating in the study (even during dose interruptions) and for at least 94 days following CC-92480 last dose in accordance with the PPP provided to the subject at the time of informed consent, even if he has undergone a successful vasectomy.
  • True abstinence is acceptable when this is in line with the preferred and usual lifestyle of the subject. Periodic abstinence (eg, calendar, ovulation, symptothermal, post-ovulation methods) and coitus interruptus (withdrawal) are not acceptable methods of contraception.
  • Males must agree to refrain from donating sperm while on CC-92480 for 94 days after the last dose of CC-92480. Females must agree to refrain from donating ova while on CC-92480 for 184 days after last dose.
  • All subjects must agree to refrain from donating blood while on CC-92480 and for 28 days after its discontinuation.

Who cannot join

  • Subject has a significant medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from participating in the study.
  • Subject has any condition including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study.
  • Subject has any condition that confounds the ability to interpret data from the study.
  • Subject has non-secretory multiple myeloma.
  • Subject has refractory primary multiple myeloma (ie, no history of at least a minor response to a prior treatment regimen).
  • Subject has plasma cell leukemia or active leptomeningeal myelomatosis.
Show all 41Show fewer
  • Subject has documented, systemic light chain amyloidosis or Polyneuropathy, Organomegaly, Endocrinopathy, Monoclonal gammopathy, and Skin changes (POEMS) Syndrome.
  • Subject has immunoglobulin class M (IgM) myeloma.
  • Part 1: Subject has a history of allogeneic bone marrow transplantation. Part 2: Subject has a history of allogeneic bone marrow transplantation within 6 months prior to first dose. Subject should not have ongoing graft-versus-host disease (GVHD) requiring systemic immunosuppression.
  • Subject is undergoing dialysis.
  • Subjects with peripheral neuropathy ≥ Grade 2.
  • Subjects with gastrointestinal disease that may significantly alter the absorption of CC-92480.
  • Subject has impaired cardiac function or clinically significant cardiac disease, including any of the following:
  • LVEF < 45% as determined by ECHO or MUGA scan at Screening.
  • Complete left bundle branch, bifascicular block or other clinically significant abnormal electrocardiographic (ECG) finding at Screening.
  • A prolongation of QT interval on Screening ECG as defined by repeated demonstration of a QTc interval >480 milliseconds (ms) using Fridericia's QT correction formula; a history of or current risk factors for Torsades de Pointe (eg, heart failure, hypokalemia, or a family history of Long QT Syndrome); and concurrent administration of medications that prolong the QT/QTc interval.
  • Congestive heart failure (New York Heart Association Class III or IV).
  • Myocardial infarction ≤6 months prior to starting CC-92480.
  • Unstable or poorly controlled angina pectoris, including the Prinzmetal variant of angina pectoris.
  • Concurrent administration of strong CYP3A modulators; concurrent administration of proton-pump inhibitors (eg, omeprazole, esomeprazole, lansoprazole, pantoprazole) ≤ 2 weeks prior to starting CC-92480.
  • Subject had prior systemic myeloma treatment with an investigational anti-myeloma agent (eg, anti-PD-1, anti-PD-L1) ≤ 5 half-lives prior to starting CC-92480 (not applicable for subjects who had CAR-T as last prior regimen); subject had prior exposure to approved myeloma therapies (including therapeutic monoclonal antibodies such as anti-CD38 or anti-SLAMF7) ≤ 5 half-lives or within 4 weeks prior to starting CC-92480 whichever is shorter.
  • Subject had major surgery ≤ 2 weeks prior to starting CC-92480. Note: Subjects must have recovered from any clinically significant effects of recent surgery.
  • Subject is a pregnant or nursing female, or intends to become pregnant or donate ova during participation in the study.
  • Subject has known human immunodeficiency virus (HIV) infection.
  • Subject has known active chronic hepatitis B or C virus (HBV/HCV) infection.
  • Subject has a history of concurrent second cancer requiring ongoing systemic treatment.
  • Subjects has a history of prior malignancy other than MM, except if the subject has been free of disease for ≥3 years OR the subject had one of the following noninvasive malignancies treated with curative intent without known recurrence:
  • Basal or squamous cell carcinoma of the skin.
  • Carcinoma in situ of the cervix or breast.
  • Stage 1 bladder cancer.
  • Incidental histological findings of localized prostate cancer such as tumor stage 1a or 1b (T1a or T1b) using the Tumor/Node/Metastasis (TNM) classification of malignant tumors OR prostate cancer that has been treated with curative intent.
  • Subject has a history of anaphylaxis to thalidomide, lenalidomide, pomalidomide or dexamethasone.
  • Subject has known or suspected hypersensitivity to the excipients (excipients include silica dimethyl silylate, anhydrous colloidal silicon dioxide, mannitol, fumaric acid and stearic acid) contained in the formulation of CC-92480 or dexamethasone.
  • Subject has undergone either of the following within 14 days of initiating CC-92480:
  • Plasmapheresis.
  • Radiation therapy other than local therapy for symptomatic relief of MM associated bone lesions.
  • Subject has received immunosuppressive medication within 14 days prior to the first dose of CC-92480. The following are exceptions to this criterion:
  • Intranasal, inhaled, topical or local corticosteroid injections (eg, intra-articular injection).
  • Systemic corticosteroids at doses that do not exceed 10 mg/day of prednisone or the equivalent.
  • Steroids as premedication for hypersensitivity reactions (eg, computed tomography [CT] scan premedication).
  • Subject is unable or unwilling to undergo protocol required venous thromboembolism (VTE) prophylaxis.

Trial locations and contacts

54 sites in 11 countries.

54 sites in 11 countries

United States10 sites

  • Local Institution - 102

    Atlanta, Georgia, 30322

  • Local Institution - 105

    Boston, Massachusetts, 02115

  • Local Institution - 111

    Buffalo, New York, 14263

  • Local Institution - 112

    Charlottesville, Virginia, 22908

  • Local Institution - 103

    Duarte, California, 91010-300

  • Local Institution - 106

    Houston, Texas, 77030

  • Local Institution - 101

    Nashville, Tennessee, 37203

  • Local Institution - 104

    New York, New York, 10065

  • Local Institution - 109

    Seattle, Washington, 98104

  • Local Institution - 108

    Spartanburg, South Carolina, 29303

Other trials in United States

Spain9 sites

  • Local Institution - 403

    Badalona (Barcelona), 08916

  • Local Institution - 407

    Barcelona, 08025

  • Local Institution - 406

    Cáceres, 10003

  • Local Institution - 404

    Madrid, 28041

  • Local Institution - 401

    Pamplona, 31008

  • Local Institution - 409

    Pozuelo de Alarcón, 28223

  • Local Institution - 402

    Salamanca, 37007

  • Local Institution - 408

    Santander, 39008

  • Local Institution - 405

    Valencia, 46026

Other trials in Spain

Canada6 sites

  • Local Institution - 201

    Calgary, Alberta, T2N 4N2

  • Local Institution - 204

    London, Ontario, N6C 6B5

  • Local Institution - 206

    Montreal, Quebec, H4A 3J1

  • Local Institution - 205

    Ottawa, Ontario, K1H 8L6

  • Local Institution - 203

    Québec, Quebec, G1J 1Z4

  • Local Institution - 202

    Toronto, Ontario, M5G 2M9

Other trials in Canada

Japan6 sites

  • Local Institution - 705

    Chuo-ku,chiba, 260-8677

  • Local Institution - 703

    Fukuoka, 810-8563

  • Local Institution - 704

    Kashiwa, 277-8577

  • Local Institution - 702

    Kobe, 650-0047

  • Local Institution - 706

    Kyoto, 602-8566

  • Local Institution - 701

    Okayama, 701-1192

Other trials in Japan

United Kingdom6 sites

  • Local Institution - 306

    Cardiff, CF14 4XW

  • Local Institution - 303

    London, NW1 2PG

  • Local Institution - 305

    Newcastle upon Tyne, NE7 7DN

  • Local Institution - 302

    Oxford, OX3 7LE

  • Local Institution - 304

    Plymouth, Devon, PL6 8DH

  • Local Institution - 301

    Sutton, SM2 5PT

Other trials in United Kingdom

Australia5 sites

  • Local Institution - 802

    Adelaide, South Australia, 5000

  • Local Institution - 804

    Camperdown, New South Wales, 2050

  • Local Institution - 805

    Clayton, Victoria, 3168

  • Local Institution - 806

    Fitzroy, 3065

  • Local Institution - 803

    Melbourne, Victoria, 3004

Other trials in Australia

Belgium4 sites

  • Local Institution - 904

    Antwerp, 2060

  • Local Institution - 905

    Ghent, 9000

  • Local Institution - 901

    Leuven, 3000

  • Local Institution - 902

    Yvoir, 5530

Other trials in Belgium

Denmark3 sites

  • Local Institution - 503

    Aarhus N, DK-8200

  • Local Institution - 501

    Copenhagen, 2100

  • Local Institution - 502

    Odense, 5000

Other trials in Denmark

South Korea3 sites

  • Local Institution - 152

    Seoul, 120-752

  • Local Institution - 150

    Seoul, 135-710

  • Local Institution - 151

    Seoul, 3080

Other trials in South Korea

Finland1 site

  • Local Institution - 601

    Helsinki, 00029

Other trials in Finland

Greece1 site

  • Local Institution - 001

    Athens, 11528

Other trials in Greece

About this study

Official title: A Phase 1/2 Multicenter, Open-label Study to Assess the Safety, Pharmacokinetics and Efficacy of CC-92480 Monotherapy and in Combination With Dexamethasone in Subjects With Relapsed and Refractory Multiple Myeloma

This is an open-label, multi-center, international, Phase 1/2 study to assess the safety, PK and efficacy of CC-92480 monotherapy and in combination with dexamethasone in subjects with relapsed and refractory multiple myeloma (RRMM).

All eligible subjects must be previously treated with at least 3 prior regimens including lenalidomide, pomalidomide, a proteasome inhibitor and an anti-CD38 antibody and be refractory to their last line of therapy.

Being tested
CC-92480, Dexamethasone
Keywords
Multiple Myeloma, Safety, Efficacy, CC-92480, Relapsed, Refractory
Medical subject headings
Multiple Myeloma, Recurrence

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CC-92480Drug

    Also called BMS-986348, mezigdomide

    CC-92480

  • DexamethasoneDrug

    Dexamethasone

Study groups in NCT03374085
Study groupRoleWhat they receive
Administration of CC-92480 in combination with dexamethasoneExperimentalPart 1: Escalating doses of CC-92480 plus a fixed dose of dexamethasone Part 2: RP2D of CC-92480 in combination with dexamethasone
Receives: Drug: CC-92480; Drug: Dexamethasone
Administration of CC-92480 monotherapyExperimentalEscalating doses of CC-92480 Monotherapy administered according to different dosing schedules
Receives: Drug: CC-92480

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Adverse Events (AEs)

    Number of participants with AEs to CC-92480 and/or dexamethasone (Type, frequency, seriousness, severity and relationship of AEs to CC-92480 and dexamethasone; changes from baseline in clinically-relevant physical findings, vital signs, selected laboratory analytes, ECGs).

    Measured: From enrollment until at least 28 days after completion of study treatment

  2. Pharmacokinetics- AUC

    Area under the plasma concentration-time curve

    Measured: Up to approximately 28 days

  3. Pharmacokinetics- Cmax

    Maximal plasma concentration

    Measured: Up to approximately 28 days

  4. Pharmacokinetics- Tmax

    Time to Cmax

    Measured: Up to approximately 28 days

  5. Pharmacokinetics- t1/2

    Terminal-phase elimination half-life

    Measured: Up to approximately 28 days

  6. Pharmacokinetics- CL/F

    Apparent total clearance of the drug from plasma after oral administration

    Measured: Up to approximately 28 days

  7. Pharmacokinetics- Vz/F

    Apparent volume of distribution during terminal phase after non-intravenous administration

    Measured: Up to approximately 28 days

  8. Maximum tolerated dose (MTD)

    The highest dose of CC-92480 in combination with dexamethasone associated acceptable safety and tolerability.

    Measured: Up to approximately 28 days

  9. Overall Response Rate (ORR)

    Overall response rate (ORR) of CC-92480 in combination with dexamethasone in Part 2

    Measured: Up to approximately 3 years

Secondary outcomes (6)

  1. Overall response rate (ORR)

    Best response ≥ partial response (PR), according to the IMWG Uniform Response Criteria

    Measured: Up to approximately 3 years

  2. Time to response (TTR)

    Time from 1st dose of CC-92480 to the first documentation of response ≥ PR.

    Measured: Up to approximately 3 years

  3. Duration of response (DOR)

    Time from the first documentation of response (≥ PR) to the first documentation of PD or death.

    Measured: Up to approximately 3 years

  4. Progression free survival

    Time from 1st dose of CC-92480 to the first occurrence of disease progression or death from any cause.

    Measured: Up to approximately 3 years

  5. Overall survival (OS)

    Time from first dose of CC-92480 to death due to any cause

    Measured: Up to approximately 3 years

  6. Adverse Events (AEs)

    Number of participants with AEs to CC-92480 and/or dexamethasone (Type, frequency, seriousness, severity and relationship of AEs to CC-92480 and dexamethasone; changes from baseline in clinically-relevant physical findings, vital signs, selected laboratory analytes, ECGs).

    Measured: Time from first dose of CC-92480 to death due to any cause

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Dec 2017
  2. Study start6 Feb 2018
  3. Primary completion20 Aug 2025
  4. Study completion23 Oct 2025

Why it stopped: Business objectives have changed

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
200 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03374085
Sponsor's protocol ID
CC-92480-MM-001
Other IDs
U1111-1205-3650, 2017-001236-19, 2017
Status last verified
Feb 2026
First submitted
1 Dec 2017
Last updated
9 Feb 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. Additional information regarding Bristol Myer Squibb's data sharing policy and process can be found at https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html

Publications

  • Richardson PG, Trudel S, Popat R, Mateos MV, Vangsted AJ, Ramasamy K, Martinez-Lopez J, Quach H, Orlowski RZ, Arnao M, Lonial S, Karanes C, Pawlyn C, Kim K, Oriol A, Berdeja JG, Rodriguez Otero P, Casas-Aviles I, Spirli A, Poon J, Li S, Gong J, Wong L, Lamba M, Pierce DW, Amatangelo M, Peluso T, Maciag P, Katz J, Pourdehnad M, Bahlis NJ; CC-92480-MM-001 Study Investigators. Mezigdomide plus Dexamethasone in Relapsed and Refractory Multiple Myeloma. N Engl J Med. 2023 Sep 14;389(11):1009-1022. doi: 10.1056/NEJMoa2303194. Epub 2023 Aug 30.

    PubMed 37646702

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing CC-92480 and Dexamethasone in people with Multiple Myeloma, run by Celgene at 54 sites in 11 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 33 inclusion and 41 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 9 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 54 sites in United States, Spain, Canada, Japan, United Kingdom and 6 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: Business objectives have changed). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Adverse Events (AEs) (time frame: From enrollment until at least 28 days after completion of study treatment). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03374085, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Feb 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in