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

NCT02773030 | Active Not Recruiting Phase 1 Results DMC

• 3 other identifiers: CC-220-MM-001U1111-1182-92002016-000860-40
• Study Type: interventional
• Target: 466
• Locations: 11 countries
• Sites: 162

Brief 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 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.

Conditions

Multiple Myeloma

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

Outcome Measures

Primary Outcomes (2)

• 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.

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

• 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.

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

Secondary Outcomes (11)

• Number of Participants With Treatment Related Adverse Events

  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

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

  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

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

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

• Overall Response Rate (ORR)

  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

• Time to Response (TTR)

  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

Study Arms (11)

Cohort A: CC-220 Monotherapy - Part 1

EXPERIMENTAL

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

Drug: CC-220

Cohort B: CC-220 in combination with Dexamethasone - Part 1

EXPERIMENTAL

* Oral CC-220 at dose specified by cohort dose level from Day 1-21 of each 28-day cycle. * For subjects ≤ 75 years old, oral DEX 40 mg on Days 1, 8, 15, and 22 of each 28-day cycle. For subjects \>75 years old, DEX will be administered at 20 mg on Days 1, 8,15, and 22 of each 28-day cycle. Subjects who surpass the age of 75 years while on treatment may be switched to the 20 mg QD dosage based on the investigator's best judgment.

Drug: CC-220; Drug: Dexamethasone

Cohort D: CC-220 in combination with Dexamethasone - Part 2

EXPERIMENTAL

* 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.

Drug: CC-220; Drug: Dexamethasone

Cohort E: CC-220 with DEX and daratumumab (DARA) - Part 1

EXPERIMENTAL

* 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.

Drug: CC-220; Drug: Dexamethasone; Drug: Daratumumab; Drug: Daratumumab - 16mg/kg; Drug: Daratumumab- 1800mg

Cohort F: CC-220 with DEX and bortezomib - Part 1

EXPERIMENTAL

* 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.

Drug: CC-220; Drug: Dexamethasone; Drug: Bortezomib; Drug: Bortezomib (BTZ)

Cohort G1-CC-220 in combination with CFZ and DEX -Part 1

EXPERIMENTAL

* 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

Drug: CC-220; Drug: Dexamethasone; Drug: Carfilzomib

Cohort G2 - CC-220 in combination with CFZ and DEX - Part 1

EXPERIMENTAL

* 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

Drug: CC-220; Drug: Dexamethasone; Drug: Carfilzomib

CohortI-CC-220 in combination with DEX in post BCMA RRMM-Part2

EXPERIMENTAL

* Oral CC-220 at Recommended Phase 2 dose (RP2D) from Day 1-21 of each 28-day cycle * Oral DEX 40 mg on Days 1, 8, 15, and 22 of each 28-day cycle. For subjects \>75 years old, oral DEX will be administered at 20 mg on Days 1, 8, 15, and 22 of each 28-day cycle.

Drug: CC-220; Drug: Dexamethasone

CohortJ1:CC-220 in combination with DEX and BTZ in NDMM-Part 2

EXPERIMENTAL

* 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.

Drug: CC-220; Drug: Dexamethasone; Drug: Bortezomib; Drug: Bortezomib (BTZ)

CohortJ2:CC-220 in combination with DEX and BTZ in NDMM-Part 2

EXPERIMENTAL

* Oral CC-220 at Recommended Phase 2 Dose from Day 1-14 of each 21-day cycle. * Oral DEX at 20 mg/day (≤ 75 years old) or 10 mg/day (\> 75 years old) for Cycles 1 to 6 on Days 1, 2, 4, 5, 8, 9, 11 and 12 of a 21-day cycle. * Subcutaneous BTZ at dose 1.3 mg/m2 on Days 1, 4, 8 and 11 at Cycle 1-6 of each 21-day cycle.

Drug: 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 2

EXPERIMENTAL

Oral CC-220 at 1.0mg, 1.3mg or 1.6mg from Days 1-21 of each 28-day cycle. Oral DEX 40 mg on Days 1, 8, 15, and 22 of each 28-day cycle. For subjects \>75 years old, oral DEX will be administered at 20 mg on Days 1, 8, 15, and 22 of each 28-day cycle. Subcutaneous DARA at 1800 mg over 3 to 5minutes on Days 1, 8, 15, and 22 at cycle 1-2 of a 28-day cycle, Days1, and 15 at cycle 3-6 of a 28-day cycle, and Day1 at cycle ≥7 of each 28-day cycle.

Drug: Daratumumab

Interventions

Daratumumab - 16mg/kg DRUG

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.

Also known as: Darzalex

Cohort E: CC-220 with DEX and daratumumab (DARA) - Part 1

Bortezomib (BTZ) DRUG

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.

Also known as: Velcade

Cohort F: CC-220 with DEX and bortezomib - Part 1; CohortJ1:CC-220 in combination with DEX and BTZ in NDMM-Part 2; CohortJ2:CC-220 in combination with DEX and BTZ in NDMM-Part 2

Daratumumab- 1800mg DRUG

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.

Also known as: Darzalex Faspro

Cohort E: CC-220 with DEX and daratumumab (DARA) - Part 1

CC-220 DRUG

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

Also known as: Iberdomide

Cohort A: CC-220 Monotherapy - Part 1; Cohort B: CC-220 in combination with Dexamethasone - Part 1; Cohort D: CC-220 in combination with Dexamethasone - Part 2; Cohort E: CC-220 with DEX and daratumumab (DARA) - Part 1; Cohort F: CC-220 with DEX and bortezomib - Part 1; Cohort G1-CC-220 in combination with CFZ and DEX -Part 1; Cohort G2 - CC-220 in combination with CFZ and DEX - Part 1; CohortI-CC-220 in combination with DEX in post BCMA RRMM-Part2; CohortJ1:CC-220 in combination with DEX and BTZ in NDMM-Part 2; CohortJ2:CC-220 in combination with DEX and BTZ in NDMM-Part 2

Dexamethasone DRUG

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.

Also known as: Decadron

Cohort B: CC-220 in combination with Dexamethasone - Part 1; Cohort D: CC-220 in combination with Dexamethasone - Part 2; Cohort E: CC-220 with DEX and daratumumab (DARA) - Part 1; Cohort F: CC-220 with DEX and bortezomib - Part 1; Cohort G1-CC-220 in combination with CFZ and DEX -Part 1; Cohort G2 - CC-220 in combination with CFZ and DEX - Part 1; CohortI-CC-220 in combination with DEX in post BCMA RRMM-Part2; CohortJ1:CC-220 in combination with DEX and BTZ in NDMM-Part 2; CohortJ2:CC-220 in combination with DEX and BTZ in NDMM-Part 2

Daratumumab DRUG

Specified dose on specified days

Also known as: Darzalex

Cohort E: CC-220 with DEX and daratumumab (DARA) - Part 1; Cohort K: CC-220 with DEX and DARA in NDMM and not autologous stem cell transplant eligible - Part 2

Bortezomib DRUG

Specified dose on specified days

Also known as: Velcade

Cohort F: CC-220 with DEX and bortezomib - Part 1; CohortJ1:CC-220 in combination with DEX and BTZ in NDMM-Part 2; CohortJ2:CC-220 in combination with DEX and BTZ in NDMM-Part 2

Carfilzomib DRUG

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.

Also known as: Kyprolis

Cohort G1-CC-220 in combination with CFZ and DEX -Part 1; Cohort G2 - CC-220 in combination with CFZ and DEX - Part 1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. 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.
• \. 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:
• 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)

You may not qualify if:

• \. 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

Sponsors & Collaborators

• Celgene: lead

Study Sites (162)

Local Institution - 102

Scottsdale, Arizona, 85259, United States

Location

Mayo Clinic

Scottsdale, Arizona, 85259, United States

Location

Local Institution - 107

Little Rock, Arkansas, 72205, United States

Location

University of Arkansas for Medical Sciences

Little Rock, Arkansas, 72205, United States

Location

Local Institution - 101

Atlanta, Georgia, 30322, United States

Location

Winship Cancer Institute of Emory University

Atlanta, Georgia, 30322, United States

Location

Local Institution - 120

Chicago, Illinois, 60611, United States

Location

Robert H Lurie Comprehensive Cancer Center NW Univ

Chicago, Illinois, 60611, United States

Location

Local Institution - 113

Fairway, Kansas, 66205, United States

Location

University of Kansas Cancer Center

Fairway, Kansas, 66205, United States

Location

Local Institution - 106

Baltimore, Maryland, 21201, United States

Location

University of Maryland School of Med

Baltimore, Maryland, 21201, United States

Location

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02115, United States

Location

Local Institution - 114

Boston, Massachusetts, 02115, United States

Location

Local Institution - 115

Boston, Massachusetts, 02117, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02117, United States

Location

Dana-Farber/Mass General Brigham Cancer Care, Inc

Boston, Massachusetts, 02215, United States

Location

Local Institution - 110

Boston, Massachusetts, 02215, United States

Location

Local Institution - 104

Ann Arbor, Michigan, 48109, United States

Location

University of Michigan Comprehensive Cancer Center

Ann Arbor, Michigan, 48109, United States

Location

Karmanos Cancer Institute

Detroit, Michigan, 48201, United States

Location

Local Institution - 103

Detroit, Michigan, 48201, United States

Location

Local Institution - 140

Grand Island, Nebraska, 68803, United States

Location

Local Institution - 141

Grand Island, Nebraska, 68803, United States

Location

Local Institution - 137

Omaha, Nebraska, 68114, United States

Location

Local Institution - 138

Omaha, Nebraska, 68124, United States

Location

Local Institution - 131

Omaha, Nebraska, 68130, United States

Location

Local Institution - 139

Papillion, Nebraska, 68046, United States

Location

Local Institution - 756

Cherry Hill, New Jersey, 08003, United States

Location

Hackensack University Medical Center

Hackensack, New Jersey, 07601, United States

Location

Local Institution - 108

Hackensack, New Jersey, 07601, United States

Location

Local Institution - 122

Mineola, New York, 11501, United States

Location

NYU Winthrop Hospital

Mineola, New York, 11501, United States

Location

Local Institution - 121

New York, New York, 10016, United States

Location

New York University School of Medicine

New York, New York, 10016, United States

Location

Icahn School of Medicine at Mount Sinai Medical Center

New York, New York, 10029, United States

Location

Local Institution - 109

New York, New York, 10029, United States

Location

Local Institution - 111

New York, New York, 10065, United States

Location

New York Presbyterian Hospital Weil Cornell Medical College

New York, New York, 10065, United States

Location

Local Institution - 125

Rochester, New York, 14642, United States

Location

University of Rochester Cancer Center

Rochester, New York, 14642, United States

Location

Levine Cancer Institute

Charlotte, North Carolina, 28204, United States

Location

Local Institution - 112

Charlotte, North Carolina, 28204, United States

Location

Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States

Location

Local Institution - 117

Cleveland, Ohio, 44195, United States

Location

Local Institution - 124

Columbus, Ohio, 43210, United States

Location

The Ohio State University Comprehensive Cancer Center

Columbus, Ohio, 43210, United States

Location

Local Institution - 116

Philadelphia, Pennsylvania, 19104, United States

Location

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Local Institution - 123

Greenville, South Carolina, 29605, United States

Location

Prisma Health Cancer Institute

Greenville, South Carolina, 29605, United States

Location

Local Institution - 134

Memphis, Tennessee, 38120, United States

Location

Local Institution - 118

Dallas, Texas, 75390, United States

Location

University of Texas Southwestern Medical Center

Dallas, Texas, 75390, United States

Location

Huntsman Cancer Institute at the University of Utah

Salt Lake City, Utah, 84112-5550, United States

Location

Local Institution - 119

Salt Lake City, Utah, 84112-5550, United States

Location

Local Institution - 126

Seattle, Washington, 98109, United States

Location

Local Institution - 132

Tacoma, Washington, 98405, United States

Location

Local Institution - 854

Adelaide, South Australia, 5000, Australia

Location

Local Institution - 852

Box Hill, Victoria, 3128, Australia

Location

Local Institution - 904

Calgary, Alberta, T2N 4N2, Canada

Location

Tom Baker Cancer Centre

Calgary, Alberta, T2N 4N2, Canada

Location

Local Institution - 901

Vancouver, British Columbia, V5Z 1M9, Canada

Location

Vancouver General Hospital

Vancouver, British Columbia, V5Z 1M9, Canada

Location

Local Institution - 902

Halifax, Nova Scotia, B3H 1V7, Canada

Location

Queen Elizabeth II Health Sciences Centre

Halifax, Nova Scotia, B3H 1V7, Canada

Location

Local Institution - 903

Montreal, Quebec, H4A 3J1, Canada

Location

McGill University Health Center - Royal Victoria Hospital

Montreal, Quebec, H4A 3J1, Canada

Location

CHRU Hopital Claude Huriez

Lile Cedax, 59037, France

Location

Local Institution - 704

Lile Cedax, 59037, France

Location

CHU Bordeaux

Pessac, 33604, France

Location

Local Institution - 701

Pessac, 33604, France

Location

Centre Hospitalier Lyon Sud

Pierre-Bénite, 69495, France

Location

Local Institution - 703

Pierre-Bénite, 69495, France

Location

CHU La Miletrie

Poitiers, 86021, France

Location

Local Institution - 702

Poitiers, 86021, France

Location

Local Institution - 605

Dresden, 01307, Germany

Location

Medizinische Kinik und Poliklinik I

Dresden, 01307, Germany

Location

Local Institution - 603

Düsseldorf, 40225, Germany

Location

Universitaetsklinikum Duesseldorf

Düsseldorf, 40225, Germany

Location

Local Institution - 604

Hamburg, 20246, Germany

Location

Universitaetsklinik Hamburg - Eppendorf

Hamburg, 20246, Germany

Location

Local Institution - 602

Heidelberg, 69120, Germany

Location

Universitaetsklinikum Heidelberg

Heidelberg, 69120, Germany

Location

Local Institution - 601

Tübingen, 72076, Germany

Location

UKT Universitaetsklinikum Tuebingen

Tübingen, 72076, Germany

Location

Local Institution - 606

Würzburg, 97080, Germany

Location

Universitaets-klinikum Wuerzburg

Würzburg, 97080, Germany

Location

Local Institution - 751

Jerusalem, Jerusalem, 91031, Israel

Location

Local Institution - 755

Tel Aviv, 64239, Israel

Location

Local Institution - 754

Tel Litwinsky, 52620, Israel

Location

Local Institution - 307

Meldola, 47014, Italy

Location

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

Pavia, 27100, Italy

Location

Local Institution - 305

Pavia, 27100, Italy

Location

Azienda Ospedaliera di Reggio Emilia - Arcispedale Santa Maria Nuova

Reggio Emilia, 42100, Italy

Location

Local Institution - 302

Reggio Emilia, 42100, Italy

Location

Local Institution - 303

Rome, 00161, Italy

Location

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

Rome, 00161, Italy

Location

Local Institution - 301

Torino, 10126, Italy

Location

Osp. S.Giovanni Battista Le Molinette

Torino, 10126, Italy

Location

Local Institution - 808

Matsuyama, Ehime, 790-8524, Japan

Location

Aomori Prefectural Central Hospital

Aomori, 030-8553, Japan

Location

Local Institution - 805

Aomori, 030-8553, Japan

Location

Hiroshima Red Cross Hospital & Atomic-bomb Survivors Hospital

Hiroshima, 730-8619, Japan

Location

Local Institution - 813

Hiroshima, 730-8619, Japan

Location

Local Institution - 812

Isehara City, Kanagawa, 259-1193, Japan

Location

Tokai University Hospital

Isehara City, Kanagawa, 259-1193, Japan

Location

Kameda Medical Center

Kamogawa, 296-8602, Japan

Location

Local Institution - 809

Kamogawa, 296-8602, Japan

Location

Local Institution - 802

Kyoto, 602-8566, Japan

Location

University Hospital, Kyoto Prefectural University of Medicine

Kyoto, 602-8566, Japan

Location

Matsuyama Red Cross Hospital

Matsuyama, 790-8524, Japan

Location

Japanese Red Cross Nagasaki Genbaku Hospital

Nagasaki, 8528511, Japan

Location

Local Institution - 811

Nagasaki, 8528511, Japan

Location

Aichi Cancer Center

Nagoya, 464-8681, Japan

Location

Local Institution - 810

Nagoya, 464-8681, Japan

Location

Local Institution - 801

Nagoya, 467-8602, Japan

Location

Nagoya City University Hospital

Nagoya, 467-8602, Japan

Location

Local Institution - 804

Osaka, 545-8586, Japan

Location

Osaka City University Hospital

Osaka, 545-8586, Japan

Location

Local Institution - 815

Ōgaki, 503-8502, Japan

Location

Ogaki Municipal Hospital

Ōgaki, 503-8502, Japan

Location

Local Institution - 803

Sendai, 980-8574, Japan

Location

Tohoku University Hospital

Sendai, 980-8574, Japan

Location

Local Institution - 806

Shinagawa-ku, Tokyo, 141-8625, Japan

Location

NTT Medical Center Tokyo

Shinagawa-ku, Tokyo, 141-8625, Japan

Location

Local Institution - 814

Sunto-gun, 411-8777, Japan

Location

Shizuoka Cancer Center

Sunto-gun, 411-8777, Japan

Location

Local Institution - 807

Toyohashi, 441-8570, Japan

Location

Toyohashi Municipal Hospital

Toyohashi, 441-8570, Japan

Location

Local Institution - 503

Amsterdam, North Holland, 1081 HV, Netherlands

Location

VU University Medical Center

Amsterdam, 1081 HV, Netherlands

Location

Local Institution - 504

Maastrich, 6202 AZ, Netherlands

Location

Maastricht University Medical Center

Maastrich, 6202 AZ, Netherlands

Location

Erasmus Medical Center

Rotterdam, 3075 EA, Netherlands

Location

Local Institution - 501

Rotterdam, 3075 EA, Netherlands

Location

Local Institution - 502

Utrecht, 3584 CX, Netherlands

Location

University Medical Center Utrecht

Utrecht, 3584 CX, Netherlands

Location

Hospital Universitari Germans Trias i Pujol Can Ruti

Badalona (Barcelona), 08916, Spain

Location

Local Institution - 404

Badalona (Barcelona), 08916, Spain

Location

Hospital Val d'Hebron

Barcelona, 08035, Spain

Location

Local Institution - 401

Barcelona, 08035, Spain

Location

Instituto Catalan de Oncologia-Hospital Duran i Reynals

Barcelona, 08908, Spain

Location

Local Institution - 405

Barcelona, 08908, Spain

Location

Hospital Gregorio Maranon

Madrid, 28007, Spain

Location

Local Institution - 408

Madrid, 28007, Spain

Location

Hospital Universitario Ramon y Cajal

Madrid, 28034, Spain

Location

Local Institution - 407

Madrid, 28034, Spain

Location

Clinica Universidad de Navarra

Pamplona, 31008, Spain

Location

Local Institution - 402

Pamplona, 31008, Spain

Location

Hospital Universitario Dr. Pesset

Valencia, 46017, Spain

Location

Local Institution - 406

Valencia, 46017, Spain

Location

Local Institution - 205

Birmingham, B15 2TH, United Kingdom

Location

University Hospitals Birmingham NHS Foundation Trust - Queen Elizabeth Hospital

Birmingham, B15 2TH, United Kingdom

Location

Local Institution - 202

Leeds, LS9 7TF, United Kingdom

Location

Saint James University Hospital

Leeds, LS9 7TF, United Kingdom

Location

Genesis Care

Oxford, OX4 6LB, United Kingdom

Location

Local Institution - 204

Oxford, OX4 6LB, United Kingdom

Location

Local Institution - 201

Sutton, SM2 5NG, United Kingdom

Location

The Institut of Cancer Research

Sutton, SM2 5NG, United Kingdom

Location

Local Institution - 203

Sutton, SM2 5PT, United Kingdom

Location

The Royal Marsden NHS Foundation Trust

Sutton, SM2 5PT, United Kingdom

Location

Related Publications (2)

• 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.

  PMID: 38776914 DERIVED

• 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.

  PMID: 36209764 DERIVED

Related Links

• BMS Clinical Trial Information
• BMS Clinical Trial Patient Recruiting

MeSH Terms

Conditions

Multiple Myeloma; Recurrence

Interventions

iberdomide; Dexamethasone; Calcium Dobesilate; daratumumab; Bortezomib; carfilzomib

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Benzenesulfonates; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Arylsulfonates; Arylsulfonic Acids; Sulfonic Acids; Sulfur Acids; Sulfur Compounds; Boronic Acids; Acids, Noncarboxylic; Acids; Inorganic Chemicals; Boron Compounds; Pyrazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Limitations and Caveats

Endpoints 8-10 were analyzed by cohort, not treatment (see protocol 9.6.3). Participant mortality in the flow differs from adverse events due to different collection periods: flow captures mortality until primary database lock, while adverse events track until study completion. Refer to the protocol for details. Any discrepancies in data between the two fields is due to data being cleaned and corrected.

Results Point of Contact

• Title: Bristol-Myers Squibb Study Director
• Organization: Bristol-Myers Squibb

Clinical.Trials@bms.com

Please Email

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 12, 2016
• First Posted: May 16, 2016
• Study Start: October 14, 2016
• Primary Completion: May 9, 2024
• Study Completion (Estimated): July 28, 2028
• Last Updated: March 20, 2026
• Results First Posted: March 20, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: See Plan Description
• Access Criteria: See Plan Description

Locations

IT (9); ES (14); NL (8); CA (8); AU (2); FR (8); DE (12); GB (10); IL (3); US (58); JP (30)