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

Anti-Infective Agents

Etoposide

Cytarabine

Melphalan

Bortezomib

Etoposide phosphate

Carmustine

Enzyme Inhibitors

Antimetabolites

Antiviral Agents

Immunosuppressive Agents

Immunologic Factors

Antineoplastic Agents, Alkylating

Alkylating Agents

Bortezomib IV or SC (1.3mg/m2) on Days -6, -3, +1 and +4 Carmustine IV (300mg/m2) on Day -7 Etoposide IV twice daily (100 mg/m2) on Days -6, -5, -4, and -3 Cytarabine IV twice daily (100 mg/m2) on Days -6, -5, -4, and -3 Melphalan IV (140 mg/m2) on Day-2 Stem cell infusion on Day 0

Stem cell infusion

Ravi Vij, M.D.

BEAM regimen (BCNU, etoposide, cytarabine, and melphalan) is the most commonly used conditioning regimen for relapsed/refractory lymphoma patients needing autologous stem cell transplantation. Since these components are all effective in myeloma and bortezomib has shown promising results in the transplant setting, here the investigators propose a phase II study to investigate the combination of bortezomib and BEAM as a new conditioning regimen for patients who relapse or progress after the first autologous transplantation and for whom a second autologous transplant is considered.

Phase II Study of V-BEAM Conditioning Regimen Prior to Second Autologous Stem Cell Transplantation

A Phase II Study of V-BEAM (Bortezomib, Carmustine, Etoposide, Cytarabine, and Melphalan) as Conditioning Regimen Prior to Second Autologous Stem Cell Transplantation for Multiple Myeloma

Defined by the International Myeloma Working Group (IMWG) criteria

PFS is defined as the duration from transplant to time of first progression, death, relapse after CR, or the date the patient was last known to be in remission.

Response will be assessed per the International Myeloma Working Group (IMWG) Response Criteria.

ORR includes Partial Response (PR) + Very Good Partial Response (VGPR) + Complete Response (CR)

Response will be assessed per the International Myeloma Working Group (IMWG) Response Criteria.

Response will be assessed per the International Myeloma Working Group (IMWG) Response Criteria.

Graded per the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.

Patients are evaluated from first receiving study treatment until a 30-day follow-up after the conclusion of treatment for adverse events not resulting in death. Adverse events resulting in death will be evaluated through Day +100.

This outcomes measures the common toxicities observed. Please refer to the Serious Adverse Event and Other Adverse Event sections of the results for further details.

Time to neutrophil engraftment is defined as duration between Day 0 to the first day of ANC \> 0.5x109/L post transplant when it is sustained for more than three consecutive days.

OS is defined as the duration from the time of transplant to death or last follow-up.

Time to platelet engraftment is defined as the duration between Day 0 to the first day of platelet count sustained at \> 20x109/L without transfusion. The median time to neutrophil and platelet engraftment will be reported.

Washington University School of Medicine

V-BEAM + Stem Cell Infusion

Age, Continuous

Sex: Female, Male

United States

Region of Enrollment

Stage I

Stage IIA

Stage IIIA

STAGE I

* Hemoglobin \>10g/dL
* Serum calcium normal or \<10.5mg/dL
* Bone x-ray, normal bone structure (scale 0), or solitary bone plasmacytoma only
* Low M-component production rates IgG value \<5g/dL; IgA value \<3g/dL
* Urine light chain M-component on electrophoresis \<4g/24h

STAGE II -Neither Stage I or Stage III

STAGE III

* Hemoglobin \<8.5g/dL
* Serum calcium \>12mg/dL
* Advanced lytic bone lesions (scale 3) -High M-component production rates IgG value \>7g/dL IgA value \>5g/dL- Bence Jones protein \>12g/24h

SUBCLASS

-A: relatively normal renal function (serum creatinine) \<2.0 mg/dL

Durie-Salmon Stage of Myeloma on Diagnosis

Stage II

Stage III

Unknown

STAGE I

-Serum beta-2 microglobulin is less than 3.5 (mg/L) and the albumin level is above 3.5 (g/L)

STAGE II -Neither stage I or III

STAGE III

-Serum beta-2 microglobulin is greater than 5.5

International Staging System (ISS) Stage of Myeloma on Diagnosis

Light chain only

Antibodies typically consist of 2 heavy chains and 2 light chains. There are 5 kinds of heavy chains termed IgG, IgA, IgM, IgD, and IgE; and 2 distinct types of light chain, termed kappa and lambda. In myeloma, all the abnormal plasma cells make the same antibody. Therefore the myeloma can be classified by the type of light and heavy chains produced, such as IgG kappa, IgG lambda, IgA kappa, or IgA lambda, etc.

Occasionally, the malignant plasma cells make only the light chain component of the antibody. These patients are said to have "light chain myeloma."

Monoclonal Protein Type

Time to Progression from First Transplant

Time from Diagnosis to V-BEAM transplant

Number of Prior Therapies (including prior transplant)

2 early deaths caused a concern for safety and resulted in suspension of enrollment in May 2013. After a review of the data, the investigators determined that this regimen had unexpected toxicity \& the trial was closed to enrollment in June 2013.

Two participants without evaluable responses due to early mortality were not included in this analysis.

Spots Global Cancer Trial Database for Phase II Study of V-BEAM Conditioning Regimen Prior to Second Autologous Stem Cell Transplantation

Trial Identification

Conditions

Interventions

Study Description

Keywords

Eligibility

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