Neoplasms

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Blood and Lymph Conditions

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All Conditions

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Multiple Myeloma

Neoplasms, Plasma Cell

Neoplasms by Histologic Type

Hemostatic Disorders

Blood Coagulation Disorders

Vascular Diseases

Paraproteinemias

Blood Protein Disorders

Hematologic Diseases

Hemorrhagic Disorders

Lymphoproliferative Disorders

Immunoproliferative Disorders

Anti-Inflammatory Agents

Antineoplastic Agents

Antiemetics

Gastrointestinal Agents

All Drugs and Chemicals

Dexamethasone

Bortezomib

Daratumumab

Dexamethasone acetate

Glucocorticoids

Hormones

Hormone Antagonists

Antineoplastic Agents, Hormonal

Participants will receive oral iberdomide, subcutaneous daratumumab and oral dexamethasone.

Participants will receive subcutaneous daratumumab, bortezomib and oral dexamethasone

Oral dexamethasone 40mg on days 1, 8, 15, 22 of a 28-day cycle

Subcutaneous Daratumumab 1800mg on Days 1, 8, 15 and 22 for Cycles 1 to 2, on Days 1 and 15 for Cycles 3 to 6, and then on Day 1 for Cycle 7 of a 28-day cycle

Subcutaneous Bortezomib 1.3 mg/m2 on Days 1, 4, 8 and 11 of each 21-day cycle for a total of 8 cycles.

Oral Iberdomide 1.0mg on Days 1 to 21 of a 28-day cycle

Iberdomide

Oral Iberdomide 1.3mg on Days 1 to 21 of a 28-day cycle

Oral Iberdomide 1.6mg on Days 1 to 21 of a 28-day cycle

BMS Study Connect Contact Center www.BMSStudyConnect.com

First line of the email MUST contain NCT # and Site #.

Stephen Divers, Site 035

Site 683

Janet Pan, Site 681

Eduardo Fernandez-Hernandez, Site 047

Site 684

Terri Parker, Site 033

Maxim Norkin, Site 049

Andrew Schneider, Site 045

Sagar Lonial, Site 018

Site 040

Hafez Halawani, Site 041

Site 682

Ralph Boccia, Site 014

Site 010

Muthalagu Ramanathan, Site 009

Suman Kambhampati, Site 031

Patrick Cobb, Site 046

Site 042

Cristina Gasparetto, Site 039

Saulius Girnius, Site 038

Tamila Kindwall-Keller, Site 037

Faiz Anwer, Site 008

Yvonne Efebera, Site 036

Caleb Scheckel, Site 680

Rebecca Silbermann, Site 043

Seema Naik, Site 048

Bertrand Anz III, Site 030

Jesus Berdeja, Site 021

Timothy Schmidt, Site 025

Site 080

Site 083

Site 813

Joel Wight, Site 812

Noemi Horvath, Site 803

Douglas Coghlan, Site 806

Michael Low, Site 802

Henry Prince, Site 809

Andrew Spencer, Site 801

Hasib Sidiqi, Site 811

Maan Alwan, Site 807

Phoebe Joy Ho, Site 804

Hang Quach, Site 800

Edwin Lee, Site 808

Peter Neumeister, Site 155

Irene Strassl, Site 154

Richard Greil, Site 153

Martin Wiesholzer, Site 156

Maria Krauth, Site 150

Site 151

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Jan Van Droogenbroeck, Site 172

Marie-Christiane Vekemans, Site 174

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Jesse Shustik, Site 112

Debra Bergstrom, Site 110

Darrell White, Site 101

Marc Lalancette, Site 108

Xin Li, Site 141

Fei Li, Site 129

Site 143

Weijun Fu, Site 142

Liangming Ma, Site 145

Songfu Jiang, Site 144

Kai Hu, Site 140

Hongmei Jing, Site 139

Junling Zhuang, Site 138

Sujun Gao, Site 126

Wenming Chen, Site 121

Jianyu Weng, Site 135

Zhongjun Xia, Site 136

Jie Jin, Site 128

Zhen Cai, Site 120

Tiejun Gong, Site 127

Xiaoyan Qu, Site 134

Jianqing Mi, Site 132

Peng Liu, Site 130

Zhuogang Liu, Site 131

Chengcheng Fu, Site 124

Yan Xu, Site 133

Chunrui Li, Site 137

Guangxun Gao, Site 125

Baijun Fang, Site 123

Bristol-Myers Squibb

This is a multicenter, two-stage, randomized, controlled, open-label, Phase 3 study comparing the efficacy and safety of iberdomide in combination with dexamethasone and daratumumab (IberDd) versus daratumumab, bortezomib, and dexamethasone (DVd) in participants with relapsed or refractory multiple myeloma (RRMM).

This is a multicenter, two-stage, randomized, controlled, open-label, Phase 3 study comparing the efficacy and safety of iberdomide in combination with dexamethasone and daratumumab (IberDd) versus daratumumab, bortezomib, and dexamethasone (DVd) in participants with relapsed or refractory multiple myeloma (RRMM). Approximately 200 patients randomized in stage 1 to one of three iberdomide dose levels of 1, 1.3, or 1.6 mg in combination with daratumumab and dexamethasone (Treatment Arms A1, A2, or A3), or to the DVd comparator arm (Treatment Arm B).

In Stage 2 of the study, approximately 664 additional subjects will be randomized 1:1 between 2 treatment arms:

* Approximately 332 subjects will be randomized to receive Treatment Arm A (IberDd)
* Approximately 332 subjects will be randomized to receive Treatment Arm B (DVd)

Participants in both treatment arms will continue to receive treatment until confirmed progressive disease (PD), unacceptable toxicity or withdrawal of consent. To ensure accuracy and completeness of the primary endpoint assessment of progression-free survival (PFS), participants who permanently discontinue study treatment for any reason, other than confirmed PD or withdrawal of consent, will continue to be followed for disease assessment.

The study will be conducted in compliance with International Council for Harmonisation (ICH) and Good Clinical Practices (GCPs).

Open-label Study Comparing Iberdomide, Daratumumab and Dexamethasone (IberDd) Versus Daratumumab, Bortezomib, and Dexamethasone (DVd) in Participants With Relapsed or Refractory Multiple Myeloma (RRMM)

A Phase 3, Two-Stage, Randomized, Multicenter, Open-label Study Comparing Iberdomide, Daratumumab and Dexamethasone (IberDd) Versus Daratumumab, Bortezomib, and Dexamethasone (DVd) in Subjects With Relapsed or Refractory Multiple Myeloma (RRMM)

Information relating to our policy on data sharing and the process for requesting data can be found at the following link:

https://www.celgene.com/research-development/clinical-trials/clinical-trials-data-sharing/

To compare the efficacy of iberdomide, daratumumab, and dexamethasone (IberDd) to that of daratumumab, bortezomib, and dexamethasone (DVd) in terms of progression-free survival (PFS) in participants with relapsed or refractory multiple myeloma (RRMM).

To evaluate clinical efficacy in terms of overall survival (OS) in participants with relapsed or refractory multiple myeloma (RRMM) treated with iberdomide, daratumumab, and dexamethasone (IberDd) compared to daratumumab, bortezomib, and dexamethasone (DVd).

Proportion of participants who achieve complete response (CR) or better and are MRD negative (defined at a sensitivity of a minimum of 1 in 105 nucleated cells by next generation flow cytometry).

Calculated as percentage of participants who achieve best response of partial response (PR) or better according to the IMWG Uniform Response Criteria for multiple myeloma.

Time from randomization to the first documentation of response (PR or better).

Time from the first documentation of response (PR or better) to the first documentation of progressive disease (PD) or death due to any cause, whichever occurs first.

The time from randomization to the first documented disease progression.

Time from randomization to the start of the next antimyeloma treatment.

Time from randomization to progression on the next anti-myeloma treatment or death due to any cause, whichever occurs first.

Type, frequency, seriousness and severity of adverse events (AEs), and relationship of AEs to study treatment.

Mean changes from baseline in subscale scores in subject-reported health related quality of life outcomes and multiple myeloma-related symptoms as measured by the EORTC QLQ-C30.

EORTC QLQ-MY20 is a 20-item myeloma module intended for use among participants varying in disease stage and treatment modality. Mean changes from baseline in subscale scores in subject-reported health related quality of life outcomes and multiple myeloma-related symptoms as measured by the EORTC QLQ- MY20.

Celgene

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Open-label Study Comparing Iberdomide, Daratumumab and Dexamethasone (IberDd) Versus Daratumumab, Bortezomib, and Dexamethasone (DVd) in Participants With Relapsed or Refractory Multiple Myeloma (RRMM)	NCT04975997	Multiple Myelom...	Dexamethasone Daratumumab Bortezomib Iberdomide Iberdomide Iberdomide	18 Years -	Celgene
Open-label Study Comparing Iberdomide, Daratumumab and Dexamethasone (IberDd) Versus Daratumumab, Bortezomib, and Dexamethasone (DVd) in Participants With Relapsed or Refractory Multiple Myeloma (RRMM)	NCT04975997	Multiple Myelom...	Dexamethasone Daratumumab Bortezomib Iberdomide Iberdomide Iberdomide	18 Years -	Celgene

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