Neoplasms

Heart and Blood Diseases

Blood and Lymph Conditions

Immune System Diseases

All Conditions

Rare Diseases

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

Anti-Infective Agents

Dexamethasone

Lenalidomide

Dexamethasone acetate

Clarithromycin

Glucocorticoids

Hormones

Hormone Antagonists

Antineoplastic Agents, Hormonal

Immunologic Factors

Angiogenesis Inhibitors

Growth Inhibitors

Anti-Bacterial Agents

Enzyme Inhibitors

Cytochrome P-450 CYP3A Inhibitors

Cytochrome P-450 Enzyme Inhibitors

Clarithromycin 500mg，po，bid，d1-21; Lenalidomide 25mg，po，daily，d1-21 (dose according to creatinine clearance rate); Dexamethasone 20mg，po，daily，d1-2, 8-9,15-16, 22-23

Clarithromycin Lenalidomide Dexamethasone (BiRd) Regimen

Fengyan Jin, professor

Fengyan Jin, Professor

BiRd regimen consisting of clarithromycin and Rd is safe and effective in NDMM. It can significantly increase ORR (up to 90.3%) , relief depth (≥VGPR), and prolong PFS to 43 months. In our previous study, thirty RRMM patients treated with BiRd regimen in 6 centers in China benefited.It suggested that BiRd regimen may not only improve overall efficacy of RRMM , especially long-term benefits, but also reverse Rd resistance in patients who fail to achieve any remission after multiline therapy.The study is a Prospective, Multicenter, Single Arm, Phase II Clinical Trial, which intend to recruit first relapse MM patients over 18 years old. Once included, patients will receive the treatment of Clarithromycin Lenalidomide Dexamethasone (BiRd) Regimen. (Clarithromycin 500mg，po，bid，d1-21; Lenalidomide 25mg，po，daily，d1-21 (dose according to creatinine clearance rate); Dexamethasone 20mg，po，daily，d1-2, 8-9,15-16, 22-23) And we will evaluate efficacy and adverse events of the BiRd regimen at a point of time predetermined.

Clinical Trial of Clarithromycin, Lenalidomide and Dexamethasone in the Treatment of the First Relapsed Multiple Myeloma

A Prospective, Multicenter, Single Arm, Phase II Clinical Trial of Clarithromycin, Lenalidomide and Dexamethasone (BiRd Regimen) in the Treatment of the First Relapsed Multiple Myeloma

According to the data of SF-36 Quality of Life Questionnaire Survey

PFS were calculated from the enrollment to the first instance of disease progression, relapse, or death

OS were calculated from the time of enrollment to death or the last follow-up

the time from the first assessment of CR (complete response) or PR (partial response) to the first PD (Progressive Disease) or any cause of death

The First Hospital of Jilin University

MD, PHD, Physician in Charge of Hematology Department

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Clinical Trial of Clarithromycin, Lenalidomide and Dexamethasone in the Treatment of the First Relapsed Multiple Myeloma	NCT04063189	Multiple Myelom...	Clarithromycin ...	18 Years -	The First Hospital of Jilin University
Clinical Trial of Clarithromycin, Lenalidomide and Dexamethasone in the Treatment of the First Relapsed Multiple Myeloma	NCT04063189	Multiple Myelom...	Clarithromycin ...	18 Years -	The First Hospital of Jilin University

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