ClinicalTrials.gg
TerminatedNCT03374085Updated Feb 9, 2026

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 interventional study of CC-92480 and Dexamethasone in Multiple Myeloma, sponsored by Celgene. Terminated at 54 sites in 11 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-02-09.

Sponsored by Celgene (part of Bristol-Myers Squibb) · Phase 1/2, Interventional, and Treatment

Why this study was terminated
Business objectives have changed

From the registry’s dates

  • Primary completion was Aug 2025, 1 year 2 months ago, and no results have been posted to the registry.
Phase
Phase 1/2
Study type
Interventional
Enrollment
200
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study 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).

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.

02

Conditions studied

  • Multiple Myeloma

Keywords

  • Multiple Myeloma
  • Safety
  • Efficacy
  • CC-92480
  • Relapsed
  • Refractory
03

In context

Multiple Myeloma

3,760 studies on the registry are indexed under Multiple Myeloma; 769 are open to participants now.

This study's enrollment of 200 is above the median of 41 across 3,005 interventional studies indexed under Multiple Myeloma.

Browse Multiple Myeloma studies →

Lead sponsor

Celgene is the lead sponsor of 428 studies on the registry; 12 are open to participants now.

Of its 104 completed or terminated interventional studies of FDA-regulated products, 30 (29%) have results posted.

First submitted before Celgene became part of Bristol-Myers Squibb.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Subject is ≥ 18 years of age at the time of signing the form (ICF).
  2. Subject must understand and voluntarily sign an ICF prior to any study-related assessments/procedures being conducted.
  3. Subject is willing and able to adhere to the study visit schedule and other protocol requirements.
  4. (ECOG) performance status score of 0, 1 or 2.
  5. Subjects must have a documented diagnosis of MM and at enrollment. Measurable disease is defined as:

    • M-protein quantities ≥ 0.5 g/dL by sPEP or
    • ≥ 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.
  6. 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 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 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.
  7. Subjects must have the following laboratory values:

    • (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).
    • (Hgb) ≥ 8 g/dL.
    • (plt) ≥ 75 x 109/L without transfusion for ≥ 7 days.
    • Corrected serum calcium ≤ 13.5 mg/dL (≤ 3.4 mmol/L).
    • (CrCl) based on Cockcroft-Gault formula ≥ 45 mL/min.
    • /SGOT and ALT/SGPT ≤ 3.0 x (ULN).
    • Serum ≤ 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).
    • \< 1.5 x ULN and partial thromboplastin time (PTT) \< 1.5 x ULN, (for subjects not receiving therapeutic anticoagulation).
  8. Females of (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 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 (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).

  1. 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.

  2. 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.
  3. All subjects must agree to refrain from donating blood while on CC-92480 and for 28 days after its discontinuation.

Exclusion criteria

Exclusion Criteria:

  1. Subject has a significant medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from participating in the study.
  2. 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.
  3. Subject has any condition that confounds the ability to interpret data from the study.
  4. Subject has non-secretory multiple myeloma.
  5. Subject has primary multiple myeloma (ie, no history of at least a minor response to a prior treatment regimen).
  6. Subject has plasma cell leukemia or active myelomatosis.
  7. Subject has documented, systemic light chain amyloidosis or Polyneuropathy, Organomegaly, Endocrinopathy, Monoclonal gammopathy, and Skin changes (POEMS) Syndrome.
  8. Subject has immunoglobulin class M (IgM) myeloma.
  9. Part 1: Subject has a history of 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 (GVHD) requiring systemic .
  10. Subject is undergoing dialysis.
  11. Subjects with peripheral neuropathy ≥ Grade 2.
  12. Subjects with gastrointestinal disease that may significantly alter the absorption of CC-92480.
  13. Subject has impaired cardiac function or cardiac disease, including any of the following:

    • \< 45% as determined by ECHO or MUGA scan at Screening.
    • Complete left bundle branch, bifascicular block or other clinically significant abnormal electrocardiographic () finding at Screening.
    • A prolongation of 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 ( 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.
  14. Concurrent administration of strong modulators; concurrent administration of proton-pump inhibitors (eg, omeprazole, esomeprazole, lansoprazole, pantoprazole) ≤ 2 weeks prior to starting CC-92480.
  15. Subject had prior systemic myeloma treatment with an anti-myeloma agent (eg, , 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.
  16. Subject had major surgery ≤ 2 weeks prior to starting CC-92480. Note: Subjects must have recovered from any clinically significant effects of recent surgery.
  17. Subject is a pregnant or nursing female, or intends to become pregnant or donate ova during participation in the study.
  18. Subject has known (HIV) infection.
  19. Subject has known active chronic or C virus (HBV/) infection.
  20. Subject has a history of concurrent second cancer requiring ongoing systemic treatment.
  21. Subjects has a history of prior 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/ (TNM) classification of malignant tumors OR prostate cancer that has been treated with curative intent.
  22. Subject has a history of anaphylaxis to thalidomide, lenalidomide, pomalidomide or dexamethasone.
  23. Subject has known or suspected to the (excipients include silica dimethyl silylate, anhydrous colloidal silicon dioxide, mannitol, fumaric acid and stearic acid) contained in the formulation of CC-92480 or dexamethasone.
  24. 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.
  25. 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 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).
  26. Subject is unable or unwilling to undergo protocol required venous thromboembolism (VTE) prophylaxis.
Terms in these criteria, in plain language(35)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

ECOG performance status

A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.

0
Fully active, no restrictions.
1
Limited in strenuous activity, but walking and able to do light work, such as housework or office work.
2
Walking and able to look after yourself, but unable to work; up and about more than half of waking hours.
3
Able to look after yourself only in part; in bed or a chair more than half of waking hours.
4
Unable to look after yourself at all; in bed or a chair all day.

Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.

Measurable disease

The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.

The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

Relapsed and refractory

Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.

Absolute neutrophil count (ANC)

The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.

It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.

Hemoglobin (Hb)

The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).

Platelets

Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.

Creatinine clearance (CrCl)

How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.

ALT and AST (liver enzymes)

Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.

Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.

ULN (upper limit of normal)

The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.

“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.

Bilirubin

A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.

Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.

INR, PT and aPTT (clotting tests)

Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.

Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.

Childbearing potential

Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).

Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

Postmenopausal

Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).

Leptomeningeal disease

Cancer that has spread to the leptomeninges, the thin layers covering the brain and spinal cord, and the fluid between them. It is not the same as brain metastases.

Criteria often treat it separately, and many studies leave it out even where treated brain metastases are allowed.

Allogeneic and autologous transplant

Stem cell (bone marrow) transplants. Allogeneic uses cells from a donor; autologous uses your own cells, collected earlier and given back.

GVHD (graft-versus-host disease)

After a transplant from a donor, the donor’s immune cells attack the recipient’s body, often the skin, gut or liver.

Immunosuppression

A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.

Read whether the line is about a condition or about medicines, and which medicines and doses it means.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

LVEF (left ventricular ejection fraction)

The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.

ECG (electrocardiogram)

A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.

QT and QTc

On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.

The study may name a correction formula and a limit in milliseconds, often around 450–480.

NYHA class (heart failure)

The New York Heart Association’s four classes of how much heart failure limits physical activity.

I
No limits: ordinary activity causes no undue tiredness or breathlessness.
II
Slight limits: comfortable at rest, ordinary activity causes symptoms.
III
Marked limits: comfortable at rest, less than ordinary activity causes symptoms.
IV
Symptoms even at rest; any activity makes them worse.

Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.

CYP3A (CYP3A4) inhibitors and inducers

CYP3A is a group of enzymes, mainly CYP3A4, in the liver and gut that break down many medicines. Some medicines, supplements and foods (grapefruit, St John’s wort) slow them down or speed them up, which changes how much of a study drug stays in the body.

Studies list them so they can be avoided or switched; bring a list of everything you take, including supplements.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

PD-1, PD-L1 and checkpoint inhibitors

PD-1, PD-L1 and CTLA-4 are proteins that act as brakes on the immune system. Checkpoint inhibitors, such as pembrolizumab or nivolumab, block them so the immune system can attack a cancer.

PD-L1 can also be measured in a tumour sample. Some scores count stained tumour cells only (TPS); others also count certain immune cells (CPS). The study names the score and the minimum it uses.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

Hepatitis B tests

Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.

Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.

Hepatitis C tests

Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.

After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

Metastases

Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

Excipients

The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.

05

Study design

Phase
Phase 1 / Phase 2
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
200 participants (actual)

Study arms

  • Experimental
    Administration of CC-92480 in combination with dexamethasone

    Part 1: Escalating doses of CC-92480 plus a fixed dose of dexamethasone Part 2: RP2D of CC-92480 in combination with dexamethasone

    Drug: CC-92480 · Drug: Dexamethasone

  • Experimental
    Administration of CC-92480 monotherapy

    Escalating doses of CC-92480 Monotherapy administered according to different dosing schedules

    Drug: CC-92480

Interventions

06

What researchers measure

Primary outcomes

  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).

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

  2. Pharmacokinetics- AUC

    Area under the plasma concentration-time curve

    Time frame: Up to approximately 28 days

  3. Pharmacokinetics- Cmax

    Maximal plasma concentration

    Time frame: Up to approximately 28 days

  4. Pharmacokinetics- Tmax

    Time to Cmax

    Time frame: Up to approximately 28 days

  5. Pharmacokinetics- t1/2

    Terminal-phase elimination half-life

    Time frame: Up to approximately 28 days

  6. Pharmacokinetics- CL/F

    Apparent total clearance of the drug from plasma after oral administration

    Time frame: Up to approximately 28 days

  7. Pharmacokinetics- Vz/F

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

    Time frame: 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.

    Time frame: Up to approximately 28 days

  9. Overall Response Rate (ORR)

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

    Time frame: Up to approximately 3 years

Secondary outcomes

  1. Overall response rate (ORR)

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

    Time frame: Up to approximately 3 years

  2. Time to response (TTR)

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

    Time frame: 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.

    Time frame: 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.

    Time frame: Up to approximately 3 years

  5. Overall survival (OS)

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

    Time frame: 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).

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

07

Study locations

54 sites
  • Local Institution - 103
    Duarte, California 91010-300, United States
  • Local Institution - 102
    Atlanta, Georgia 30322, United States
  • Local Institution - 105
    Boston, Massachusetts 02115, United States
  • Local Institution - 111
    Buffalo, New York 14263, United States
  • Local Institution - 104
    New York, New York 10065, United States
  • Local Institution - 108
    Spartanburg, South Carolina 29303, United States
  • Local Institution - 101
    Nashville, Tennessee 37203, United States
  • Local Institution - 106
    Houston, Texas 77030, United States
  • Local Institution - 112
    Charlottesville, Virginia 22908, United States
  • Local Institution - 109
    Seattle, Washington 98104, United States
  • Local Institution - 804
    Camperdown, New South Wales 2050, Australia
  • Local Institution - 802
    Adelaide, South Australia 5000, Australia
  • Local Institution - 805
    Clayton, Victoria 3168, Australia
  • Local Institution - 803
    Melbourne, Victoria 3004, Australia
  • Local Institution - 806
    Fitzroy, 3065, Australia
  • Local Institution - 904
    Antwerp, 2060, Belgium
  • Local Institution - 905
    Ghent, 9000, Belgium
  • Local Institution - 901
    Leuven, 3000, Belgium
  • Local Institution - 902
    Yvoir, 5530, Belgium
  • Local Institution - 201
    Calgary, Alberta T2N 4N2, Canada
  • Local Institution - 204
    London, Ontario N6C 6B5, Canada
  • Local Institution - 205
    Ottawa, Ontario K1H 8L6, Canada
  • Local Institution - 202
    Toronto, Ontario M5G 2M9, Canada
  • Local Institution - 206
    Montreal, Quebec H4A 3J1, Canada
  • Local Institution - 203
    Québec, Quebec G1J 1Z4, Canada
  • Local Institution - 503
    Aarhus N, DK-8200, Denmark
  • Local Institution - 501
    Copenhagen, 2100, Denmark
  • Local Institution - 502
    Odense, 5000, Denmark
  • Local Institution - 601
    Helsinki, 00029, Finland
  • Local Institution - 001
    Athens, 11528, Greece
  • Local Institution - 705
    Chuo-ku,chiba, 260-8677, Japan
  • Local Institution - 703
    Fukuoka, 810-8563, Japan
  • Local Institution - 704
    Kashiwa, 277-8577, Japan
  • Local Institution - 702
    Kobe, 650-0047, Japan
  • Local Institution - 706
    Kyoto, 602-8566, Japan
  • Local Institution - 701
    Okayama, 701-1192, Japan
  • Local Institution - 152
    Seoul, 120-752, South Korea
  • Local Institution - 150
    Seoul, 135-710, South Korea
  • Local Institution - 151
    Seoul, 3080, South Korea
  • Local Institution - 403
    Badalona (Barcelona), 08916, Spain
  • Local Institution - 407
    Barcelona, 08025, Spain
  • Local Institution - 406
    Cáceres, 10003, Spain
  • Local Institution - 404
    Madrid, 28041, Spain
  • Local Institution - 401
    Pamplona, 31008, Spain
  • Local Institution - 409
    Pozuelo de Alarcón, 28223, Spain
  • Local Institution - 402
    Salamanca, 37007, Spain
  • Local Institution - 408
    Santander, 39008, Spain
  • Local Institution - 405
    Valencia, 46026, Spain
  • Local Institution - 304
    Plymouth, Devon PL6 8DH, United Kingdom
  • Local Institution - 306
    Cardiff, CF14 4XW, United Kingdom
  • Local Institution - 303
    London, NW1 2PG, United Kingdom
  • Local Institution - 305
    Newcastle upon Tyne, NE7 7DN, United Kingdom
  • Local Institution - 302
    Oxford, OX3 7LE, United Kingdom
  • Local Institution - 301
    Sutton, SM2 5PT, United Kingdom
08

References and documents

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 ↗

Individual participant data

Plan to share: 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

Supporting information: Study protocol, Statistical analysis plan, Clinical study report

Time frame: See Plan Description

Access criteria: See Plan Description

Data sharing details ↗ · www.bms.com

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Feb 2018 to primary completion in Aug 2025, 90 months.

How these figures are worked out, and which studies are left out of them.

Registered
Dec 1, 2017
First posted
Dec 15, 2017
StartActual
Feb 6, 2018
Primary completionActual
Aug 20, 2025
CompletionActual
Oct 23, 2025
Last update
Feb 9, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Feb 9, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03374085
Lead sponsor
Celgene
Responsible party
Sponsor
First posted
Dec 15, 2017
Start date
Feb 6, 2018
Primary completion
Aug 20, 2025
Completion
Oct 23, 2025
Last update
Feb 9, 2026

Study contacts

Bristol-Myers Squibb
study director · Bristol-Myers Squibb

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Feb 2026. You cannot join it, but the record below documents what was studied.

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Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

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Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Studies of the drug tested here: Mezigdomide

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