Neoplasms

Heart and Blood Diseases

Blood and Lymph Conditions

Immune System Diseases

All Conditions

Rare Diseases

Multiple Myeloma

Neoplasms, Plasma Cell

Leukemia

Leukemia, Plasma Cell

Neoplasms by Histologic Type

Hematologic Diseases

Hemostatic Disorders

Blood Coagulation Disorders

Vascular Diseases

Paraproteinemias

Blood Protein Disorders

Hemorrhagic Disorders

Lymphoproliferative Disorders

Immunoproliferative Disorders

Plasma Cell Leukemia

Anti-Inflammatory Agents

Antineoplastic Agents

Antiemetics

Gastrointestinal Agents

All Drugs and Chemicals

Anti-Infective Agents

Dexamethasone

Doxorubicin

Liposomal doxorubicin

Bortezomib

Dexamethasone acetate

BB 1101

Thalidomide

Interferons

Immunoglobulin A

Glucocorticoids

Hormones

Hormone Antagonists

Antineoplastic Agents, Hormonal

Anti-Bacterial Agents

Antibiotics, Antitubercular

Enzyme Inhibitors

INDUCTION THERAPY: V-DD induction therapy for 6 cycles，28 Days per Cycle. Bortezomib - 1.3 mg/m2 IV, Days 1, 4, 8 , 11 of every treatment; Liposomal Doxorubicin - 30 mg/m2 IV, Day 4 of every treatment; Dexamethasone - 40 mg/d IV, Days 1 - 4 of every treatment.

Maintenance treatment for 4 cycles,28 Days per Cycle. Thalidomide - 100mg Qn ; Bortezomib - 1.3 mg/m2 IV ,Days 1, 4, 8 and 11 of every treatment; Dexamethasone - 40 mg/d IV ,Days 1 - 4; Interferon - 300 u Qod,（Specially for IgA type）. Interval between every two cycles for 6 months, until progression or unacceptable toxicity develops.

INDUCTION THERAPY: 1.3 mg/m2, IV (in the vein) on day 1， 4， 8， 11 of each 28 day cycle. 6 Cycles: until progression or unacceptable toxicity develops.

MAINTENANCE THERAPY: 1.3 mg/m2, IV (in the vein) on day 1， 4， 8， 11 of each 28 day cycle. 4 Cycles: interval between every two cycles for 6 months, until progression or unacceptable toxicity develops.

INDUCTION THERAPY: 30 mg/m2, IV (in the vein) on day 4 of each 28 day cycle. 6 Cycles: until progression or unacceptable toxicity develops.

Liposome doxorubicin

INDUCTION THERAPY: 40 mg/d, IV (in the vein) on day 1- 4 of each 28 day cycle. 6 Cycles: until progression or unacceptable toxicity develops.

MAINTENANCE THERAPY: 40 mg/d, IV (in the vein) on day 1- 4 of each 28 day cycle. 4 Cycles: interval between every two cycles for 6 months, until progression or unacceptable toxicity develops.

zhao wang, M.D

zhao wang, Master

Bortezomib/Liposomal doxorubicin (V-DD) is preferred to bortezomib single agent in salvage therapy for Multiple Myeloma (MM).

The present study is designed to assessment the efficacy and safety study of Bortezomib in combination with Liposomal Doxorubicin and Dexamethasone in treatment of Plasma Cell Leukemia (PCL).

Primary study endpoint is the overall response rate (sCR+CR+VGPR+PR). Secondary endpoints is the rate of complete response (sCR+CR), partial remission rate (VGPR + PR), duration of response (DOR), overall survival (OS).

Patient with Plasma Cell Leukemia(PCL ) and multiple myeloma (MM); KPS ≥ 60scores

Bortezomib in Combination With Liposomal Doxorubicin and Dexamethasone to Treat Plasma Cell Leukemia

The overall response rate of V-DD in patients with PCL assessed by International Myeloma Working Group(IMWG) criteria

The complete response rate of V-DD in patients with PCL assessed by International Myeloma Working Group(IMWG) criteria.

Occurrence of adverse events throughout the study using CTCAE ctriteria version 4.0.

Harbin Hematology and Oncology Institute

Shanghai Changzheng Hospital

Chinese PLA General Hospital

307 Hospital of PLA

Wuhan Union Hospital, China

Beijing Chao Yang Hospital

Henan Provincial People's Hospital

Peking University Third Hospital

Clinical Service, China

Beijing Friendship Hospital

Behaviors and Mental Disorders

Skin and Connective Tissue Diseases

Fibromatosis, Aggressive

Aggression

Fibroma

Neoplasms, Fibrous Tissue

Neoplasms, Connective Tissue

Neoplasms, Connective and Soft Tissue

Desmoid Tumor

Pharmaceutical Solutions

Liposome doxorubicin (50mg/m2) with a treatment cycle of once every 28 days

Liposome doxorubicin (50mg/m2) or intravenous placebo with a treatment cycle of once every 28 days

Saline Solution

Jin Wang, M.D.

Huaiyuan Xu, M.D.

Jin WANG, MD

The aim of this study was to evaluate the efficacy and safety of liposomal doxorubicin in the treatment of desmoid tumors. Unless the subject withdraws from the trial voluntarily, or the researcher considers that the subject is not suitable for further trial, each subject will be treated until the disease progresses or the toxic and side effects caused by the drug are intolerable, and then enter the survival follow-up period

A randomized, double-blind, placebo-controlled study designed to compare (PFS) differences in progression-free survival in patients treated with liposome doxorubicin or placebo. PFS is defined as the time from randomization to the first occurrence of disease progression or death caused by any cause. If the disease is stable, PFS will be calculated at the time of the last follow-up in the study. Patients who have reached the maximum follow-up period and have no progress will be reviewed on the date of the last disease assessment. The crossover data of the patients were analyzed and summarized separately from the data of the main treatment process.In this study, 72 patients were expected to be enrolled in the group for 12 months and followed up for 24 months.Patients will be randomized to receive liposome adriamycin (50mg/m2) or intravenous placebo for a treatment cycle of once every 28 days.Duration of medication: a total of 6 cycles, or to the progression of the disease, tolerable toxicity, whichever occurs first.As the disease progresses, patients treated with placebo will be allowed to enter the unblinded liposome adriamycin group.

A Randomized, Double-blind,Phase Ⅲ Study of Liposome Doxorubicin in Desmoid Tumor

A Randomized, Double-blind, Phase Ⅲ Study of Liposomal Doxorubicin in Desmoid Tumor

Patient Reported Outcomes-Common Terminology Criteria in Adverse Events version 5.0 was used to evaluate the toxicity. The evaluation time is 2 years. The data of patients who crossover or receive surgical or radiotherapy intervention will be summarized independently of their main research and treatment processes.

Sun Yat-sen University

Chief Physician Professor

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Bortezomib in Combination With Liposomal Doxorubicin and Dexamethasone to Treat Plasma Cell Leukemia	NCT01328236	Plasma Cell Leu... Multiple Myelom...	Bortezomib Liposome doxoru... Dexamethasone	18 Years - 75 Years	Clinical Service, China
A Randomized, Double-blind,Phase Ⅲ Study of Liposome Doxorubicin in Desmoid Tumor	NCT05561036	Desmoid Tumor	Liposome doxoru... Saline Solution	1 Year -	Sun Yat-sen University
Bortezomib in Combination With Liposomal Doxorubicin and Dexamethasone to Treat Plasma Cell Leukemia	NCT01328236	Plasma Cell Leu... Multiple Myelom...	Bortezomib Liposome doxoru... Dexamethasone	18 Years - 75 Years	Clinical Service, China
A Randomized, Double-blind,Phase Ⅲ Study of Liposome Doxorubicin in Desmoid Tumor	NCT05561036	Desmoid Tumor	Liposome doxoru... Saline Solution	1 Year -	Sun Yat-sen University

Spots Global Cancer Trial Database for liposome doxorubicin