Neoplasms

Blood and Lymph Conditions

All Conditions

Rare Diseases

Leukemia

Leukemia, Myeloid

Leukemia, Myeloid, Acute

Sarcoma

Sarcoma, Myeloid

Neoplasms by Histologic Type

Hematologic Diseases

Myeloid Leukemia

Acute Myeloid Leukemia

Acute Non Lymphoblastic Leukemia

Soft Tissue Sarcoma

Acute Graft Versus Host Disease

Myeloid Sarcoma

chart review, analysis and reporting outcomes

retrospective data analysis

Patients with extramedullary leukemia were identified over 10 years (January 2003 to September 2019). Clinicopathological,genetic-molecular features were identified and survival outcomes were studied and analyzed.

We retrospectively collected patients demographics ,including clinicopathological and genetic-molecular parameters in patients with extramedullary leukemia between January 2003 till September 2019 from King Hussein cancer center(KHCC) electronic medical records. All potential prognostic factors were identified and compared with worldwide data published previously. Treatment and survival outcomes were studies and analyzed.

Primary endpoint : Overall survival (OS).

Secondary endpoint :

* Progression Free Survival (PFS).
* incidence of extramedullary leukemia.

Extramedullary Acute Myeloid Leukemia (eAML): Retrospective Single Center Cohort Study, Clinicopathological, Molecular Analysis and Survival Outcomes

To calculate the median and estimated 4-year overall survival

To calculate the median and estimated 4-year PFS

King Hussein Cancer Center

Consultant, Medical Oncologist-BMT consultant

Heart and Blood Diseases

Immune System Diseases

Multiple Myeloma

Neoplasms, Plasma Cell

Hemostatic Disorders

Blood Coagulation Disorders

Vascular Diseases

Paraproteinemias

Blood Protein Disorders

Hemorrhagic Disorders

Lymphoproliferative Disorders

Immunoproliferative Disorders

Anti-Inflammatory Agents

Antineoplastic Agents

Antiemetics

Gastrointestinal Agents

All Drugs and Chemicals

Dexamethasone

Lenalidomide

Bortezomib

Dexamethasone acetate

Glucocorticoids

Hormones

Hormone Antagonists

Antineoplastic Agents, Hormonal

Immunologic Factors

Angiogenesis Inhibitors

Growth Inhibitors

Selinexor 60 mg/day, orally on d1,8,15,22

Selinexor

Bortezomib 1.3mg/m2 intravenously on d1,8,15,22

Lenalidomide 25 mg/d (the dose will be adjusted according to creatinine clearance)

Dexamethasone 20 mg/day orally on d1-2, d8-9,d15-16,d22-23

Yuanyuan Jin, Doctor

Lijuan Chen, Doctor

Xuzhang Lu, doctor

Xuezhong Zhang, master

Yuanyuan Jin, doctor

Hongming Huang, Doctor

Jianfeng Zhu, doctor

Yuexin Cheng, master

Lijuan Chen

The purpose of this study is to evaluate the efficacy and safety of SVRd in NDMM patients presenting with extramedullary disease.

Study Design:

This protocol corresponds to a multicenter, open-label, single arm, exploratory study designed to determine the safety of the combination of selinexor combined with VRd in NDMM patients presenting with EMD. The patients who respond to this combination treatment will undergo allogeneic hematopoietic stem cell transplantation or no ASCT and followed by consolidation and maintenance treatment.

All patients will receive 4 courses of SVRd induction therapy, each cycle of treatment will compromise 4 weeks of Selinexor 60mg QW treatment. Transplantation could be performed after 2 courses of VRd consolidation therapy. If not receive transplantation will give 4 cycles of SVRd consolidation therapy. Maintenance treatment will continued for a maximum of 2 years.

Study design allows 35 patients. Induction treatment will consist of Selinexor 60 mg/day orally on d1,8,15,22, Bortezomib 1.3mg/m2 intravenously on d1,8,15,22, Lenalidomide 25 mg/d ( the dose will be adjusted according to creatinine clearance), orally on days 1 to14, Dexamethasone 20 mg/day orally on d1-2, d8-9,d15-16,d22-23

SVRd for the Treatment of Newly Diagnosed Multiple Myeloma Patients Presenting With Extramedullary Disease

An Open Label, Single Arm, Multi-Center Exploratory Study to Evaluate the Efficacy and Safety of SVRd for the Treatment of Newly Diagnosed Multiple Myeloma Patients Presenting With Extramedullary Disease.

ORR: defined as the proportion of patients who will achieve PR or better, as per IMWG criteria.

CR: defined as the proportion of patients who will achieve CR, as per IMWG criteria.

DOR: defined as time, in months, from initial response (PR or better) until the date of a disease progression event

PFS: was calculated from the time of informed consent to the date of recurrence or death, whichever occurred first. Patients were censored at the date of the last follow-up visit if they were alive without relapse.

OS was calculated from the date of informed consent to the date of death. Patients still alive at the end of follow-up were censored at the last date of follow-up.

Adverse events are evaluated with CTCAE V5.0.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Extramedullary Acute Myeloid Leukemia (eAML): Retrospective Single Center Cohort Study, Clinicopathological, Molecular Analysis and Survival Outcomes	NCT05057299	Acute Myeloid L...	retrospective d...	18 Years -	King Hussein Cancer Center
SVRd for the Treatment of Newly Diagnosed Multiple Myeloma Patients Presenting With Extramedullary Disease	NCT05900882	Multiple Myelom...	Selinexor Bortezomib Lenalidomide Dexamethasone	18 Years - 75 Years	The First Affiliated Hospital with Nanjing Medical University

Spots Global Cancer Trial Database for extramedullary disease