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AzTrials

Multiple MyelomaPhase 1/2NCT02773030

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

A Phase 1/2 study testing CC-220, Dexamethasone and Daratumumab in people with Multiple Myeloma, run by Celgene at 162 sites in 11 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

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… 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-220, Dexamethasone and Daratumumab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
466 participants
Where
162 sitesin 11 countries
Study dates
14 Oct 2016to 28 Jul 2028
Phase
Phase 1/2
Are there results?
Yes, posted in the registrySummary in the doctors' view

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

  • 1. All subjects in RRMM cohorts must have a documented diagnosis of Multiple Myeloma and have measurable disease defined as:
  • M-protein (serum and/or urine protein electrophoresis (sPEP or uPEP)): sPEP ≥0.5 g/dL or uPEP ≥200 mg/24 hours and/or
  • Light chain Multiple Myeloma without measurable disease in the serum or urine: serum immunoglobulin free light chain ≥ 10 mg/dL (100 mg/L) and abnormal serum immunoglobulin kappa lambda free light chain ratio 2. All subjects in RRMM cohorts must have 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 must have documented disease progression.
  • 3. Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1 or 2 3. Subject must have documented diagnosis with previously untreated symptomatic MM as defined by the criteria below (Rajkumar, 2016): MM diagnostic criteria;
  • Clonal bone marrow plasma cells ≥ 10% or biopsy-proven bony or extramedullary plasmacytoma
  • Any one or more of the following myeloma defining events:
Show all 22Show fewer
  • One or more of the following myeloma-related organ dysfunction (at least one of the following);
  • [C] Calcium elevation (serum calcium > 0.25 mmol/L [> 1 mg/dL] higher than the upper limit of laboratory normal or > 2.75 mmol/L [> 11 mg/dL])
  • [R] Renal insufficiency (serum creatinine > 2 mg/dl [> 177 μmol/L] or creatinine clearance < 40 ml/min)
  • [A] Anemia (hemoglobin < 10 g/dl or > 2 g/dL below the lower limit of laboratory normal)
  • [B] Bone lesions (lytic or osteopenic) one or more bone lesions on skeletal radiography, computed tomography (CT), or positron emission tomography (PET)/CT
  • One or more of the following biomarkers of malignancy:
  • Clonal bone marrow plasma cell percentage* ≥ 60%
  • Abnormal serum free light-chain (FLC) ratio ≥ 100 (involved kappa) or <0.01 (involved lambda) and involved FLC level must be ≥ 100 mg/L
  • >1 focal lesion detected by magnetic resonance imaging (MRI) (at least 5 mm in size)
  • AND have measurable disease, as assessed by central laboratory, defined by any of the following:
  • Immunoglobulin (Ig)G myeloma: serum M-protein level ≥ 1.0 g/dL or urine M-protein level ≥ 200 mg/24 hours; or
  • IgA, IgM, IgD, or IgE multiple myeloma: serum M-protein level ≥ 0.5 g/dL or urine M-protein level ≥ 200 mg/24 hours; or
  • Light chain multiple myeloma without measurable disease in serum or urine: serum FLC ≥ 100 mg/L and abnormal kappa lambda (κ/λ) ratio 4. Subjects in Cohort J1 are not considered by the investigator as eligible for high-dose chemotherapy and autologous stem cell transplantation due to:
  • Age ≥65 years, OR
  • In subjects <65 years: presence of important comorbid condition(s) likely to have a negative impact on tolerability of high-dose chemotherapy with autologous stem cell transplantation.
  • 5. Subjects in Cohort J2 are considered by the investigator as eligible for high-dose chemotherapy and autologous stem cell transplantation according to the institution's criteria based on age, medical history, cardiac and pulmonary status, overall health and condition, co-morbid condition(s), physical examination, and laboratory data.

Who cannot join

  • 1. Subject has nonsecretory multiple myeloma 2. Subjects with Plasma Cell leukemia or amyloidosis 3. Any of the following laboratory abnormalities
  • Absolute neutrophil count (ANC) <1,000/μL
  • Platelet count < 75,000/μL for Part 1. For Part 2; platelet count < 75,000/μL for subjects in whom < 50% of bone marrow nucleated cells are plasma cells; otherwise platelet count < 50,000/μL (transfusions are not permitted to achieve minimum platelet counts
  • Corrected serum calcium >13.5 mg/dL (>3.4 mmol/L)
  • Serum glutamic oxaloacetic transaminase (SGOT)/aspartate aminotransferase (AST) or serum glutamic pyruvic transaminase (SGPT)/alanine aminotransferase (ALT)≥2.0 x upper limit of normal (ULN)
  • Serum total bilirubin and alkaline phosphatase >1.5 x ULN
  • Subjects with serious renal impairment creatinine clearance ([CrCl] <45 mL/min) or requiring dialysis would be excluded 4. Subjects with peripheral neuropathy ≥Grade 2

Trial locations and contacts

162 sites in 11 countries.

162 sites in 11 countries

United States58 sites

  • Local Institution - 104

    Ann Arbor, Michigan, 48109

  • University of Michigan Comprehensive Cancer Center

    Ann Arbor, Michigan, 48109

  • Local Institution - 101

    Atlanta, Georgia, 30322

  • Winship Cancer Institute of Emory University

    Atlanta, Georgia, 30322

  • Local Institution - 106

    Baltimore, Maryland, 21201

  • University of Maryland School of Med

    Baltimore, Maryland, 21201

  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts, 02115

  • Local Institution - 114

    Boston, Massachusetts, 02115

  • Local Institution - 115

    Boston, Massachusetts, 02117

  • Massachusetts General Hospital

    Boston, Massachusetts, 02117

  • Dana-Farber/Mass General Brigham Cancer Care, Inc

    Boston, Massachusetts, 02215

  • Local Institution - 110

    Boston, Massachusetts, 02215

  • Levine Cancer Institute

    Charlotte, North Carolina, 28204

  • Local Institution - 112

    Charlotte, North Carolina, 28204

  • Local Institution - 756

    Cherry Hill, New Jersey, 08003

  • Local Institution - 120

    Chicago, Illinois, 60611

  • Robert H Lurie Comprehensive Cancer Center NW Univ

    Chicago, Illinois, 60611

  • Cleveland Clinic Foundation

    Cleveland, Ohio, 44195

  • Local Institution - 117

    Cleveland, Ohio, 44195

  • Local Institution - 124

    Columbus, Ohio, 43210

  • The Ohio State University Comprehensive Cancer Center

    Columbus, Ohio, 43210

  • Local Institution - 118

    Dallas, Texas, 75390

  • University of Texas Southwestern Medical Center

    Dallas, Texas, 75390

  • Karmanos Cancer Institute

    Detroit, Michigan, 48201

  • Local Institution - 103

    Detroit, Michigan, 48201

  • Local Institution - 113

    Fairway, Kansas, 66205

  • University of Kansas Cancer Center

    Fairway, Kansas, 66205

  • Local Institution - 140

    Grand Island, Nebraska, 68803

  • Local Institution - 141

    Grand Island, Nebraska, 68803

  • Local Institution - 123

    Greenville, South Carolina, 29605

  • Prisma Health Cancer Institute

    Greenville, South Carolina, 29605

  • Hackensack University Medical Center

    Hackensack, New Jersey, 07601

  • Local Institution - 108

    Hackensack, New Jersey, 07601

  • Local Institution - 107

    Little Rock, Arkansas, 72205

  • University of Arkansas for Medical Sciences

    Little Rock, Arkansas, 72205

  • Local Institution - 134

    Memphis, Tennessee, 38120

  • Local Institution - 122

    Mineola, New York, 11501

  • NYU Winthrop Hospital

    Mineola, New York, 11501

  • Local Institution - 121

    New York, New York, 10016

  • New York University School of Medicine

    New York, New York, 10016

  • Icahn School of Medicine at Mount Sinai Medical Center

    New York, New York, 10029

  • Local Institution - 109

    New York, New York, 10029

  • Local Institution - 111

    New York, New York, 10065

  • New York Presbyterian Hospital Weil Cornell Medical College

    New York, New York, 10065

  • Local Institution - 137

    Omaha, Nebraska, 68114

  • Local Institution - 138

    Omaha, Nebraska, 68124

  • Local Institution - 131

    Omaha, Nebraska, 68130

  • Local Institution - 139

    Papillion, Nebraska, 68046

  • Local Institution - 116

    Philadelphia, Pennsylvania, 19104

  • University of Pennsylvania

    Philadelphia, Pennsylvania, 19104

  • Local Institution - 125

    Rochester, New York, 14642

  • University of Rochester Cancer Center

    Rochester, New York, 14642

  • Huntsman Cancer Institute at the University of Utah

    Salt Lake City, Utah, 84112-5550

  • Local Institution - 119

    Salt Lake City, Utah, 84112-5550

  • Local Institution - 102

    Scottsdale, Arizona, 85259

  • Mayo Clinic

    Scottsdale, Arizona, 85259

  • Local Institution - 126

    Seattle, Washington, 98109

  • Local Institution - 132

    Tacoma, Washington, 98405

Other trials in United States

Japan30 sites

  • Aomori Prefectural Central Hospital

    Aomori, 030-8553

  • Local Institution - 805

    Aomori, 030-8553

  • Hiroshima Red Cross Hospital & Atomic-bomb Survivors Hospital

    Hiroshima, 730-8619

  • Local Institution - 813

    Hiroshima, 730-8619

  • Local Institution - 812

    Isehara City, Kanagawa, 259-1193

  • Tokai University Hospital

    Isehara City, Kanagawa, 259-1193

  • Kameda Medical Center

    Kamogawa, 296-8602

  • Local Institution - 809

    Kamogawa, 296-8602

  • Local Institution - 802

    Kyoto, 602-8566

  • University Hospital, Kyoto Prefectural University of Medicine

    Kyoto, 602-8566

  • Local Institution - 808

    Matsuyama, Ehime, 790-8524

  • Matsuyama Red Cross Hospital

    Matsuyama, 790-8524

  • Japanese Red Cross Nagasaki Genbaku Hospital

    Nagasaki, 8528511

  • Local Institution - 811

    Nagasaki, 8528511

  • Aichi Cancer Center

    Nagoya, 464-8681

  • Local Institution - 810

    Nagoya, 464-8681

  • Local Institution - 801

    Nagoya, 467-8602

  • Nagoya City University Hospital

    Nagoya, 467-8602

  • Local Institution - 815

    Ōgaki, 503-8502

  • Ogaki Municipal Hospital

    Ōgaki, 503-8502

  • Local Institution - 804

    Osaka, 545-8586

  • Osaka City University Hospital

    Osaka, 545-8586

  • Local Institution - 803

    Sendai, 980-8574

  • Tohoku University Hospital

    Sendai, 980-8574

  • Local Institution - 806

    Shinagawa-ku, Tokyo, 141-8625

  • NTT Medical Center Tokyo

    Shinagawa-ku, Tokyo, 141-8625

  • Local Institution - 814

    Sunto-gun, 411-8777

  • Shizuoka Cancer Center

    Sunto-gun, 411-8777

  • Local Institution - 807

    Toyohashi, 441-8570

  • Toyohashi Municipal Hospital

    Toyohashi, 441-8570

Other trials in Japan

Spain14 sites

  • Hospital Universitari Germans Trias i Pujol Can Ruti

    Badalona (Barcelona), 08916

  • Local Institution - 404

    Badalona (Barcelona), 08916

  • Hospital Val d'Hebron

    Barcelona, 08035

  • Local Institution - 401

    Barcelona, 08035

  • Instituto Catalan de Oncologia-Hospital Duran i Reynals

    Barcelona, 08908

  • Local Institution - 405

    Barcelona, 08908

  • Hospital Gregorio Maranon

    Madrid, 28007

  • Local Institution - 408

    Madrid, 28007

  • Hospital Universitario Ramon y Cajal

    Madrid, 28034

  • Local Institution - 407

    Madrid, 28034

  • Clinica Universidad de Navarra

    Pamplona, 31008

  • Local Institution - 402

    Pamplona, 31008

  • Hospital Universitario Dr. Pesset

    Valencia, 46017

  • Local Institution - 406

    Valencia, 46017

Other trials in Spain

Germany12 sites

  • Local Institution - 605

    Dresden, 01307

  • Medizinische Kinik und Poliklinik I

    Dresden, 01307

  • Local Institution - 603

    Düsseldorf, 40225

  • Universitaetsklinikum Duesseldorf

    Düsseldorf, 40225

  • Local Institution - 604

    Hamburg, 20246

  • Universitaetsklinik Hamburg - Eppendorf

    Hamburg, 20246

  • Local Institution - 602

    Heidelberg, 69120

  • Universitaetsklinikum Heidelberg

    Heidelberg, 69120

  • Local Institution - 601

    Tübingen, 72076

  • UKT Universitaetsklinikum Tuebingen

    Tübingen, 72076

  • Local Institution - 606

    Würzburg, 97080

  • Universitaets-klinikum Wuerzburg

    Würzburg, 97080

Other trials in Germany

United Kingdom10 sites

  • Local Institution - 205

    Birmingham, B15 2TH

  • University Hospitals Birmingham NHS Foundation Trust - Queen Elizabeth Hospital

    Birmingham, B15 2TH

  • Local Institution - 202

    Leeds, LS9 7TF

  • Saint James University Hospital

    Leeds, LS9 7TF

  • Genesis Care

    Oxford, OX4 6LB

  • Local Institution - 204

    Oxford, OX4 6LB

  • Local Institution - 201

    Sutton, SM2 5NG

  • The Institut of Cancer Research

    Sutton, SM2 5NG

  • Local Institution - 203

    Sutton, SM2 5PT

  • The Royal Marsden NHS Foundation Trust

    Sutton, SM2 5PT

Other trials in United Kingdom

Italy9 sites

  • Local Institution - 307

    Meldola, 47014

  • I.R.C.C.S. Policlinico San Matteo - Universita di Pavia

    Pavia, 27100

  • Local Institution - 305

    Pavia, 27100

  • Azienda Ospedaliera di Reggio Emilia - Arcispedale Santa Maria Nuova

    Reggio Emilia, 42100

  • Local Institution - 302

    Reggio Emilia, 42100

  • Local Institution - 303

    Rome, 00161

  • Universita degli Studi di Roma La Sapienza - Umberto I Policlinico di Roma - Centro di Ematologia

    Rome, 00161

  • Local Institution - 301

    Torino, 10126

  • Osp. S.Giovanni Battista Le Molinette

    Torino, 10126

Other trials in Italy

Canada8 sites

  • Local Institution - 904

    Calgary, Alberta, T2N 4N2

  • Tom Baker Cancer Centre

    Calgary, Alberta, T2N 4N2

  • Local Institution - 902

    Halifax, Nova Scotia, B3H 1V7

  • Queen Elizabeth II Health Sciences Centre

    Halifax, Nova Scotia, B3H 1V7

  • Local Institution - 903

    Montreal, Quebec, H4A 3J1

  • McGill University Health Center - Royal Victoria Hospital

    Montreal, Quebec, H4A 3J1

  • Local Institution - 901

    Vancouver, British Columbia, V5Z 1M9

  • Vancouver General Hospital

    Vancouver, British Columbia, V5Z 1M9

Other trials in Canada

France8 sites

  • CHRU Hopital Claude Huriez

    Lile Cedax, 59037

  • Local Institution - 704

    Lile Cedax, 59037

  • CHU Bordeaux

    Pessac, 33604

  • Local Institution - 701

    Pessac, 33604

  • Centre Hospitalier Lyon Sud

    Pierre-Bénite, 69495

  • Local Institution - 703

    Pierre-Bénite, 69495

  • CHU La Miletrie

    Poitiers, 86021

  • Local Institution - 702

    Poitiers, 86021

Other trials in France

Netherlands8 sites

  • Local Institution - 503

    Amsterdam, North Holland, 1081 HV

  • VU University Medical Center

    Amsterdam, 1081 HV

  • Local Institution - 504

    Maastrich, 6202 AZ

  • Maastricht University Medical Center

    Maastrich, 6202 AZ

  • Erasmus Medical Center

    Rotterdam, 3075 EA

  • Local Institution - 501

    Rotterdam, 3075 EA

  • Local Institution - 502

    Utrecht, 3584 CX

  • University Medical Center Utrecht

    Utrecht, 3584 CX

Other trials in Netherlands

Israel3 sites

  • Local Institution - 751

    Jerusalem, Jerusalem, 91031

  • Local Institution - 755

    Tel Aviv, 64239

  • Local Institution - 754

    Tel HaShomer, 52620

Other trials in Israel

Australia2 sites

  • Local Institution - 854

    Adelaide, South Australia, 5000

  • Local Institution - 852

    Box Hill, Victoria, 3128

Other trials in Australia

About this study

Official title: 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 in combination with DEX for Relapsed Refractory Multiple Myeloma and CC-220 in combination with DEX and BTZ for Newly Diagnosed Multiple Myeloma.

Read the 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.

The starting dose of DEX will be 40 mg for subjects who are ≤75 years of age and 20 mg for subjects who are >75 years of age, given once weekly. This treatment will continue until PD, unacceptable toxicity or the subject withdraws consent.

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 with a minimal response (MR) or better 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 RP2D is established in Part 1 in either Cohort A or Cohort B. Either cohort 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.

Keywords
Multiple Myeloma, Relapsed, Refractory, Pharmacokinetics, Safety, Efficacy, CC-220, Relapsed and refractory multiple myeloma, Dexamethasone, Daratumumab, Bortezomib, Newly diagnosed multiple myeloma, Newly diagnosed multiple myeloma transplant non-eligible
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-220Drug

    Also called Iberdomide

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

  • DexamethasoneDrug

    Also called Decadron

    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.

  • DaratumumabDrug

    Also called Darzalex

    Specified dose on specified days

  • BortezomibDrug

    Also called Velcade

    Specified dose on specified days

  • CarfilzomibDrug

    Also called Kyprolis

    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.

  • Daratumumab - 16mg/kgDrug

    Also called Darzalex

    Daratumumab (DARA) 16mg/kg by intravenous infusion 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.

  • Bortezomib (BTZ)Drug

    Also called Velcade

    Bortezomib 1.3 mg/m^2 on Days 1, 4, 8 and 11 at cycle 1-8, and Days 1, 8 at cycle ≥9 of each 21-day cycle.

  • Daratumumab- 1800mgDrug

    Also called Darzalex Faspro

    Daratumumab (DARA) 1800 mg by subcutaneous injection 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.

Study groups in NCT02773030
Study groupRoleWhat they receive
Cohort A: CC-220 Monotherapy - Part 1ExperimentalOral CC-220 at dose specified by cohort dose level from Day 1-21 of each 28-day cycle
Receives: Drug: CC-220
Cohort B: CC-220 in combination with Dexamethasone - Part 1Experimental* 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.
Receives: Drug: CC-220; Drug: Dexamethasone
Cohort D: CC-220 in combination with Dexamethasone - Part 2Experimental* 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, DEX will be administered at 20 mg on Days 1, 8, 15, and 22 of each 28-day cycle.
Receives: Drug: CC-220; Drug: Dexamethasone
Cohort E: CC-220 with DEX and daratumumab (DARA) - Part 1Experimental* 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 this dose level using SC DARA. * 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. * Subcutaneous DARA at dose 1800 mg over 3 to 5 minutes 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.
Receives: Drug: CC-220; Drug: Dexamethasone; Drug: Daratumumab; Drug: Daratumumab - 16mg/kg; Drug: Daratumumab- 1800mg
Cohort F: CC-220 with DEX and bortezomib - Part 1Experimental* 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, 8 at cycle ≥9 of each 21-day cycle.
Receives: Drug: CC-220; Drug: Dexamethasone; Drug: Bortezomib; Drug: Bortezomib (BTZ)
Cohort G1-CC-220 in combination with CFZ and DEX -Part 1Experimental* 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, 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
Receives: Drug: CC-220; Drug: Dexamethasone; Drug: Carfilzomib
Cohort G2 - CC-220 in combination with CFZ and DEX - Part 1Experimental* 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 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, 23 of each 28-day cycle. The DEX dose will be 20 mg
Receives: Drug: CC-220; Drug: Dexamethasone; Drug: Carfilzomib
CohortI-CC-220 in combination with DEX in post BCMA RRMM-Part2Experimental* 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.
Receives: Drug: CC-220; Drug: Dexamethasone
CohortJ1:CC-220 in combination with DEX and BTZ in NDMM-Part 2Experimental* Oral CC-220 at Recommended Phase 2 Dose from Day 1-14 of each 21-day cycle (Cycle 1 to 8) and from Day 1-21 of each 28-day cycle (Cycle 9 and above). * 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.
Receives: Drug: CC-220; Drug: Dexamethasone; Drug: Bortezomib; Drug: Bortezomib (BTZ)
CohortJ2:CC-220 in combination with DEX and BTZ in NDMM-Part 2Experimental* 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.
Receives: Drug: CC-220; Drug: Dexamethasone; Drug: Bortezomib; Drug: Bortezomib (BTZ)
Cohort K: CC-220 with DEX and DARA in NDMM and not autologous stem cell transplant eligible - Part 2ExperimentalOral 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.
Receives: Drug: Daratumumab

What is being measured

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

  1. Number of Participants With Dose Limiting Toxicities in Part 1.

    The dose-limiting toxicity (DLT) population includes subjects who missed no more than 4 doses of CC-220, 2 doses of DEX, 1 dose of IV DARA (Cohort E), 1 dose of BTZ (Cohort F), or 1 dose of CFZ (Cohort G1 or G2) during Cycle 1 for reasons other than DLT. This population will be used for analyzing the primary endpoint regarding the determination of the MTD.

    Hematologic DLTs:

    Grade 4 neutropenia (ANC <500/μL for >5 days) Grade 3 neutropenia (ANC <1,000/μL) with fever ≥38.5°C Grade 4 thrombocytopenia (platelet count <25,000/μL) or Grade 3 thrombocytopenia with bleeding or need for platelet transfusion Any other grade 4 hematologic toxicity, except anemia, not resolving to pretreatment baseline within 72 hours.

    Non-hematologic DLT:

    Any non-hematological toxicity ≥ Grade 3, except alopecia and nausea controlled by medical management.

    Measured: From first dose to 28 days post last dose (up to 28 days)

  2. Overall Response Rate (ORR) in Cohort D and Cohort H2

    Tumor response, including progressive disease (PD) according to the IMWG Uniform Response Criteria (Kumar, 2016) for subjects who achieved partial response (PR) or better.

    Measured: Approximately on average (Cohort D: 21.14 weeks, Cohort H2: 22.11 Weeks)

Secondary outcomes (11)

  1. Number of Participants With Treatment Related Adverse Events

    An AE is any noxious, unintended, or untoward medical occurrence that may appear or worsen in a participant during the course of a study. It may be a new intercurrent illness, a worsening concomitant illness, an injury, or any concomitant impairment of the subject's health, including laboratory test values, regardless of etiology.

    Any worsening (ie, any clinically significant adverse change in the frequency or intensity of a preexisting condition) should be considered an AE.

    Measured: Approximately on average of (Cohort A: 16.23 Cohort B: 10.32 Cohort D: 18.68 Cohort E: 15.65 Cohort F: 12.66 Cohort G: 16.03 Cohort H1: 17.22 Cohort H2: 21.07 Cohort I: 17.10 Cohort J: 20.56 Cohort K: 13.56) Months

  2. Number of Participants With Treatment Emergent Adverse Events of Special Interest (AESI)

    An adverse event of special interest (AESI) is one of scientific and medical interest specific to understanding the safety profile of the Investigational Product, CC-220, and may require close monitoring and rapid communication by the Investigator to the Sponsor. An AESI may be serious or nonserious. The rapid reporting of AESIs allows ongoing surveillance of these events in order to characterize and understand their association with the use of this investigational product.

    Measured: Approximately on average of (Cohort A: 16.23 Cohort B: 10.32 Cohort D: 18.68 Cohort E: 15.65 Cohort F: 12.66 Cohort G: 16.03 Cohort H1: 17.22 Cohort H2: 21.07 Cohort I: 17.10 Cohort J: 20.56 Cohort K: 13.56) Months

  3. Very Good Partial Response Rate (ORR) in Cohort J1 and Cohort K

    The very good partial response or better (≥ VGPR) rate is defined as the proportion of subjects with best response of VGPR or better during the trial without administration of myeloma therapy other than study treatment. The ≥ VGPR rate with 95% confidence interval (CI) together with the proportions in each response category based on the IMWG Uniform Response Criteria.

    Measured: On Average of (Cohort J: 86.21, Cohort K: 56.29) Weeks

  4. Overall Response Rate (ORR)

    Tumor response, including progressive disease (PD) according to the IMWG Uniform Response Criteria (Kumar, 2016) for subjects who achieved partial response (PR) or better.

    Measured: On Average of (Cohort A: 44.96, Cohort B: 32.79, Cohort D: 21.14, Cohort E: 53.74, Cohort F: 46.34, Cohort G: 63.26, Cohort H1: 58.10, Cohort H2: 22.11, Cohort I: 20.96, Cohort J: 86.21, Cohort K: 56.29) Weeks

  5. Time to Response (TTR)

    Time to response is defined as the time from the first dose date of study treatment to the first date of documented response (PR or better).

    Time to response will be summarized for responders using descriptive statistics by cohort and dose level.

    Measured: On Average of (Cohort A:19.14, Cohort B: 12.39, Cohort D: 7.54, Cohort E: 5.44, Cohort F: 4.97, Cohort G: 12.30, Cohort H: 4.14, Cohort I: 8.79, Cohort J: 4.76, Cohort K: 6.51) Weeks

  6. Duration of Response

    Duration of response is defined as time from the earliest date of documented response (PR or better) to the earliest date of disease progression per IMWG Uniform Response Criteria or death, whichever occurred first. Participants who do not have progression of disease or death will be censored on the last adequate response assessment date. Duration of response for responders will be summarized using Kaplan-Meier estimates by cohort and dose level as appropriate.

    Data will be collected and analyzed per Cohort Totals.

    Measured: On Average of (Cohort A:161.33, Cohort B: 63.74, Cohort D: 39.16, Cohort E: 89.56, Cohort F: 69.24, Cohort G: 80.93, Cohort H1: 77.11, Cohort H2: 42.71, Cohort I: 36.80, Cohort J: 92.36, Cohort K: 51.85) Weeks

  7. Progression Free Survival

    Time from the first dose of investigational product (IP) to the first documentation of PD or death from any cause, whichever occurs first Data will be collected and analyzed per Cohort Totals.

    Measured: On Average of (Cohort A: 44.96, Cohort B: 32.79, Cohort D: 21.14, Cohort E: 53.74, Cohort F: 46.34, Cohort G: 63.26, Cohort H1: 58.10, Cohort H2: 22.11, Cohort I: 20.96, Cohort J: 86.21, Cohort K: 56.29) Weeks

  8. Overall Survival for Cohort D, Cohort H2 and Cohort I

    Time from first dose of IP to death due to any cause

    Data will be collected and analyzed per Cohort Totals.

    Measured: On Average of (Cohort D: 81.14 Cohort H2: 91.54 Cohort I: 74.20)Weeks

  9. Auc(Tau)

    Area under the plasma concentration time-curve. AUC over the dosing interval.

    Measured: From Cycle 1 Day 1 to Cycle 1 Day 15 (15 days)

  10. Cmax

    Cmax is defined as maximum plasma concentration of the drug.

    Measured: From Cycle 1 Day 1 to Cycle 1 Day 15 (15 days)

  11. Tmax

    Tmax is defined is the time to maximum plasma concentration.

    Measured: From Cycle 1 Day 1 to Cycle 1 Day 15 (15 days)

Timeline

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

  1. First posted16 May 2016 (estimated)
  2. Study start14 Oct 2016
  3. Primary completion9 May 2024
  4. Study completion28 Jul 2028 (estimated)

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
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
466 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02773030
Sponsor's protocol ID
CC-220-MM-001
Other IDs
U1111-1182-9200, 2016-000860-40, 2016
Status last verified
Mar 2026
First submitted
12 May 2016
Last updated
20 Mar 2026
Data monitoring committee
Yes
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

  • Amatangelo M, Flynt E, Stong N, Ray P, Van Oekelen O, Wang M, Ortiz M, Maciag P, Peluso T, Parekh S, van de Donk NWCJ, Lonial S, Thakurta A. Pharmacodynamic changes in tumor and immune cells drive iberdomide's clinical mechanisms of activity in relapsed and refractory multiple myeloma. Cell Rep Med. 2024 Jun 18;5(6):101571. doi: 10.1016/j.xcrm.2024.101571. Epub 2024 May 21.

    PubMed 38776914

  • Lonial S, Popat R, Hulin C, Jagannath S, Oriol A, Richardson PG, Facon T, Weisel K, Larsen JT, Minnema MC, Abdallah AO, Badros AZ, Knop S, Stadtmauer EA, Cheng Y, Amatangelo M, Chen M, Nguyen TV, Amin A, Peluso T, van de Donk NWCJ. Iberdomide plus dexamethasone in heavily pretreated late-line relapsed or refractory multiple myeloma (CC-220-MM-001): a multicentre, multicohort, open-label, phase 1/2 trial. Lancet Haematol. 2022 Nov;9(11):e822-e832. doi: 10.1016/S2352-3026(22)00290-3. Epub 2022 Oct 6.

    PubMed 36209764

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing CC-220, Dexamethasone and Daratumumab in people with Multiple Myeloma, run by Celgene at 162 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 22 inclusion and 7 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: under way, not looking for participants, as of the sponsor's last update on 20 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 162 sites in United States, Japan, Spain, Germany, 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?

Yes. Results are posted in the registry (first posted 20 Mar 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Number of Participants With Dose Limiting Toxicities in Part 1. (time frame: From first dose to 28 days post last dose (up to 28 days)). The study lists 2 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 NCT02773030, which also lists 2 linked publications.

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 20 Mar 2026.

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Clinical Trial NCT02773030 | AzTrials