Neoplasms

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Multiple Myeloma

Neoplasms, Plasma Cell

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Leukemia, Plasma Cell

Neoplasms by Histologic Type

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All Drugs and Chemicals

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Antiemetics

Gastrointestinal Agents

Anti-Infective Agents

Etoposide

Cyclophosphamide

Dexamethasone

Melphalan

Cisplatin

Epirubicin

Lenalidomide

Bortezomib

Daratumumab

Dexamethasone acetate

BB 1101

Etoposide phosphate

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Alkylating Agents

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Pretrial induction chemotherapy (if required): bortezomib, cyclophosphamid, dexamethasone (VCD).

Induction Chemotherapy: Daratumumab, Carfilzomib,Lenalidomide, Dexamethasone, CisPlatin, epirubicin, Cyclophosphamide and Etoposide (Dara-KRd-PACE).

Autologous Stem Cell Transplant (ASCT) : Melphalan, ASCT.

Consolidation: Daratumumab, Carfilzomib, Lenalidomide, Dexamethasone (Dara-KRd).

Maintenance: Daratumumab, Carfilzomib, and Dexamethasone (Dara-Kd).

Given by vein: days 1 and 8 of each Induction cycle; days 1 and 15 of each Consolidation cycle; and day 1of each Maintenance cycle.

Given by vein: days 1,2,8 and 9 of each Induction cycle; days 1, 2, 8, 9,15, and 16 of each Consolidation cycle; days 1, 2,15, and 16 of each Maintenance cycle.

Carfilzomib

Given by mouth: days 1-7 of each Induction cycle; days 1-14 of each Consolidation cycle.

Given by mouth or by vein: days 1, 8, 15, and 22 of each Induction cycle; days 1, 8, 15, and 22 of each Consolidation cycle; and days 1 and 15 of every cycle during Maintenance

Given by vein: days 1-4 of each Induction cycle

epirubicin

ASCT

given by subcutaneous injection: days 1, 4, 8, and 11 of pretrial induction chemotherapy

bortezomib

Chunyan Sun, MD

Jian Xu, MD

This study will assess whether the combination of daratumumab and carfilzomib-based Induction/Consolidation/Maintenance Therapy with ASCT improves the outcome of patients with ultra high-risk, newly diagnosed multiple myeloma

Survival outcomes for patients with newly diagnosed multiple myeloma (MM) have improved substantially in the past decades, due to the introduction of novel therapeutic strategies. Unfortunately, patients with ultra-high-risk MM, including "double-hit" MM, extramedullary MM (EMM), and primary plasma cell leukemia (pPCL), have a significantly worse prognosis and benefit less from current therapeutic strategies. This study aims to investigate whether a treatment regimen combining daratumumab and carfilzomib-based Induction/Consolidation/Maintenance Therapy with autologous stem cell transplantation (ASCT) can improve the survival outcomes of newly diagnosed, transplant-eligible, ultra high-risk multiple myeloma patients. In the study, participants will receive induction therapy with 2-4 cycles of Dara-KRd-PACE, followed by ASCT, 4 cycles of Dara-KRd consolidation, and then maintenance with 12 cycles of Dara-Kd.

Study to Evaluate the Safety and Efficacy of Daratumumab and Carfilzomib-based Induction/Consolidation/Maintenance Therapy in Transplant-eligible, Ultra High-risk, Newly Diagnosed Multiple Myeloma

Clinical Study to Evaluate the Safety and Efficacy of Daratumumab and Carfilzomib-based Induction/Consolidation/Maintenance Therapy in Transplant-eligible, Ultra High-risk, Newly Diagnosed Multiple Myeloma

2-year Progression-free survival of participants as determined by investigator assessment.

progression-free survival of participants as determined by investigator assessment.

overall survival of participants as determined by investigator assessment.

Overall response rate as determined by the 2016 International Myeloma Working Group (IMWG) Response Criteria for Multiple Myeloma and 2013 IMWG Response Criteria for Plasma cell leukemia by Independent Review Committee (IRC) and investigator assessment.

Minimal Residual Disease (MRD) negativity rate as assessed by next generation sequencing.

complete response rate as determined by the 2016 International Myeloma Working Group (IMWG) Response Criteria for Multiple Myeloma and 2013 IMWG Response Criteria for Plasma cell leukemia by Independent Review Committee (IRC) and investigator assessment.

determined by the 2016 International Myeloma Working Group (IMWG) Response Criteria for Multiple Myeloma and 2013 IMWG Response Criteria for Plasma cell leukemia by Independent Review Committee (IRC) and investigator assessment.

graded according to the Common Terminology Criteria for Adverse Events v5

Spots Global Cancer Trial Database for double hit

Every month we try and update this database with for double hit cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for double hit

Every month we try and update this database with for double hit cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for double hit cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.