Bortezomib, Arsenic Trioxide, and Melphalan in Treating Patients Undergoing an Autologous Stem Cell Transplant For Multiple Myeloma

NCT00504101 | Withdrawn Phase 1 DMC

• 2 other identifiers: 20070104SCCC-2006071
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

RATIONALE: Bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as arsenic trioxide and melphalan, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving high-dose combination chemotherapy together with bortezomib may kill more cancer cells. PURPOSE: This phase I trial is studying the side effects and best dose of bortezomib when given together with arsenic trioxide and melphalan in treating patients undergoing an autologous stem cell transplant for multiple myeloma.

Conditions

Multiple Myeloma and Plasma Cell Neoplasm

Keywords

stage I multiple myeloma; stage II multiple myeloma; stage III multiple myeloma

Outcome Measures

Primary Outcomes (1)

• Evaluate toxicity of the conditioning treatment regimen.

  3 ¼ years

Secondary Outcomes (2)

• Evaluate response and overall survival (OS).

  3 ¼ years

• Determine what correlative laboratory and clinical parameters, if any, are associated with efficacy

  3 ¼ years

Interventions

Arsenic trioxide DRUG

Arsenic Trioxide will be given on day -6, -5, -4,-3,-2 (total of 5 doses). The dose of Arsenic trioxide (ATO) is 0.25 mg/m2.

Also known as: ATO (As2O3)

Bortezomib DRUG

Bortezomib will be given on day -6, -4, -2 (total 3 doses) beginning at a dose of 0.8 mg/m2 each day of therapy.

Also known as: Velcade, PS-341

Melphalan DRUG

Melphalan will be given at 200 mg/m2 on day -2 (1 dose only)

Also known as: L-PAM, L-phenylalanine mustard, L-sarcolysin, Alkeran

Autologous hematopoietic stem cell transplantation BIOLOGICAL

On day 0 a minimal of 2 x 106 CD 34 cells/kg will be infused by central catheter according to institutional standards.

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Confirmed diagnosis of multiple myeloma (M-protein by serum protein electrophoresis or urine protein electrophoresis) and either bone marrow biopsy and aspirate demonstrating a plasma cell count \> 10% or biopsy of a bone or soft tissue mass demonstrating a plasmacytoma
• Demonstration of an indication for therapy based on symptoms (e.g., boney pain), hypercalcemia, anemia, renal insufficiency, symptomatic plasmacytomas, multiple boney lytic lesions, etc
• Stable disease or has achieved a partial remission or complete remission to pre-transplant cyto-reductive therapy
• Primary refractory disease (no response to therapy but stable) is permitted
• Candidate for high-dose chemotherapy with autologous stem cell transplantation based on stabilization of disease with preparative chemotherapy (regardless of the specific agents)
• A minimum of 2 x 10\^6 CD34+ cells/kg must be collected prior to proceeding to transplant

You may not qualify if:

• Evidence of active plasma cell leukemia
• Relapsed refractory disease (patients who have achieved at least a partial response \[PR\] to previous therapy and are now refractory \[have not achieved a PR to subsequent therapy\])
• Progressive disease on their last therapy
• PATIENT CHARACTERISTICS:
• Karnofsky performance status 60-100%
• Creatinine \< 3.0 mg/dL
• AST and ALT \<2.5 times upper limit of normal
• Total bilirubin \< 3 mg/dL
• WBC ≥ 2,000/mm³
• Platelet count ≥ 50,000/mm³
• If abnormal hematologic function is attributable to bone marrow infiltration by multiple myeloma, the principal investigator will decide on a case-by-case basis if the patient's bone marrow reserve is appropriate for this study
• Females of childbearing potential must have a negative serum pregnancy test prior to enrollment on the study and must use an effective barrier method while on the study
• Ejection fraction \> 40% and no history of uncontrolled ischemic heart disease or congestive heart failure
• No evidence of cardiac amyloidosis by echocardiogram
• DLCO and FEV\_1 ≥ 50%

Sponsors & Collaborators

• University of Miami: lead

Study Sites (1)

University of Miami Sylvester Comprehensive Cancer Center - Miami

Miami, Florida, 33136, United States

Location

MeSH Terms

Conditions

Multiple Myeloma; Neoplasms, Plasma Cell

Interventions

Arsenic Trioxide; Bortezomib; Melphalan

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Arsenicals; Inorganic Chemicals; Oxides; Oxygen Compounds; Boronic Acids; Acids, Noncarboxylic; Acids; Boron Compounds; Organic Chemicals; Pyrazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Phenylalanine; Amino Acids, Aromatic; Amino Acids, Cyclic; Amino Acids; Amino Acids, Peptides, and Proteins

Study Officials

• Mark S. Goodman, MD

  University of Miami Sylvester Comprehensive Cancer Center

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 17, 2007
• First Posted: July 19, 2007
• Study Start: June 1, 2007
• Primary Completion: June 1, 2011
• Study Completion: June 1, 2011
• Last Updated: December 15, 2016

Record last verified: 2016-12

Locations

US (1)