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

Antineoplastic Agents

All Drugs and Chemicals

Amino Acids

Fludarabine

Fludarabine phosphate

Melphalan

Bortezomib

Mechlorethamine

Antimetabolites

Immunosuppressive Agents

Immunologic Factors

Antineoplastic Agents, Alkylating

Alkylating Agents

Phenylalanine

* Fludarabine will be administered at a dose of 30/mg/m2 IV daily for 4 days starting on transplant day -5.
* Melphalan will be administered at a dose of 140 mg/m2 on transplant day-2
* Bortezomib will be administered by rapid IV push at a dose of 1.6mg/m2 on days-4 and -1. The bortezomib should be given at least 20 hours after the melphalan.

Fludarabine monophosphate, melphalan, Bortezomib

The hypothesis for this study is that the regimen consisting of fludarabine, melphalan and bortezomib improves the progression free survival and the response rate compared to historical controls of fludarabine and melphalan alone.

Multiple myeloma is the second most prevalent blood cancer (10%) after non-hodgkin's lymphoma. It represents approximately 1% of all cancers and 2% of all cancer deaths. Although the peak age of onset of multiple myeloma is 70 years of age, recent statistics indicate both increasing incidence and earlier age of onset.

The historical control 2-year progression-free survival (PFS) is assumed to be 35%. The proposed therapy of fludarabine, melphalan and bortezomib is expected to improve the PFS by 20%.

Allogeneic Hematopoietic Stem Cell Transplantation for Multiple Myeloma

A Phase II Study of Allogeneic Hematopoietic Stem Cell Transplantation for Multiple Myeloma Using a Conditioning Regimen of Fludarabine, Melphalan, and Bortezomib

The main primary endpoint of this study is two-year progression free survival. Patients are considered a failure with respect to PFS if they die or experience disease progression or relapse. The time to this event is the time from transplantation to relapse/progression, initiation of non-protocol anti-myeloma therapy, or death from any cause. Subjects alive without confirmed disease progression will be censored at the time of last disease evaluation. Deaths without progression are treated as failures no matter when they occur.

Overall survival (OS): Defined as time from the first dose of administration to death from any cause

Overall response rate: Defined as the composite endpoint of response to treatment which includes Complete Response (CR), Partial Response (PR), stable disease (SD) as defined in International Response Criteria.

International Myeloma Working Group Response Criteria for Multiple Myeloma:

CR: Negative immunofixation on the serum and urine and disappearance of any soft tissue plasmacytomas and \< 5% plasma cells in bone marrow PR: \> 50% reduction of serum M-protein and reduction in 24 hours urinary M-protein by \>90% or to \< 200 mg/24 h SD: Not meeting criteria for CR, VGPR, PR, or progressive disease

Hackensack Meridian Health

Fludarabine monophosphate, melphalan, Bortezomib: •Fludarabine will be administered at a dose of 30/mg/m2 IV daily for 4 days starting on transplant day -5.

* Melphalan will be administered at a dose of 140 mg/m2 on transplant day-2
* Bortezomib will be administered by rapid IV push at a dose of 1.6mg/m2 on days-4 and -1. The bortezomib should be given at least 20 hours after the melphalan.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Allogeneic Hematopoietic Stem Cell Transplantation for Multiple Myeloma	NCT01453101	Multiple Myelom...	Fludarabine mon...	18 Years - 69 Years	Hackensack Meridian Health
Allogeneic Hematopoietic Stem Cell Transplantation for Multiple Myeloma	NCT01453101	Multiple Myelom...	Fludarabine mon...	18 Years - 69 Years	Hackensack Meridian Health
Allogeneic Hematopoietic Stem Cell Transplantation for Multiple Myeloma	NCT01453101	Multiple Myelom...	Fludarabine mon...	18 Years - 69 Years	Hackensack Meridian Health

Spots Global Cancer Trial Database for fludarabine monophosphate, melphalan, bortezomib