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A Phase II Study of Maintenance Treatment With Sequential Bortezomib, Thalidomide and Dexamethasone Following Autologous Peripheral Blood Stem Cell Transplant in Patients With Multiple Myeloma


Phase 2
N/A
70 Years
Open (Enrolling)
Both
Multiple Myeloma and Plasma Cell Neoplasm, Neurotoxicity

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Trial Information

A Phase II Study of Maintenance Treatment With Sequential Bortezomib, Thalidomide and Dexamethasone Following Autologous Peripheral Blood Stem Cell Transplant in Patients With Multiple Myeloma


OBJECTIVES:

Primary

- To assess the feasibility and toxicities of maintenance therapy with sequential
bortezomib, thalidomide, and dexamethasone after high-dose melphalan and autologous
peripheral blood stem cell transplantation in patients with multiple myeloma.

- To assess whether administration of sequential bortezomib, thalidomide, and
dexamethasone can improve progression-free survival of these patients.

Secondary

- To assess whether administration of sequential bortezomib, thalidomide, and
dexamethasone can increase complete remission rate and duration of response in these
patients.

- To assess the impact of maintenance therapy with sequential bortezomib, thalidomide,
and dexamethasone after transplantation on overall survival of these patients.

- To evaluate the influence of cytogenetic abnormalities (e.g., chromosome 13 deletion,
14 q32 abnormality, t [4;14], chromosome 1 q21 amplification, and chromosome 17
deletion) on outcome by performing conventional cytogenetic study and fluorescence in
situ hybridization (FISH) studies on baseline and post-transplant bone marrow
specimens.

OUTLINE:

- High-dose melphalan and autologous peripheral blood stem cell transplantation (PBSCT):
Patients receive high-dose melphalan IV over 30 minutes on days -2 and -1 and undergo
autologous PBSCT on day 0. Patients receive filgrastim (G-CSF) IV or subcutaneously
beginning on day 5 and continuing until blood counts recover.

- Maintenance therapy: Beginning 4-8 weeks after transplantation, patients receive
bortezomib IV on days 1, 8, and 15. Treatment repeats every 28 days for 6 courses in
the absence of disease progression or unacceptable toxicity. Patients also receive oral
dexamethasone on days 1-4; treatment with dexamethasone repeats every month for 12
months in the absence of disease progression or unacceptable toxicity. Beginning 2
weeks after completion of bortezomib, patients receive oral thalidomide once daily
until disease progression.

Patients complete the FACT-GOG neurotoxicity questionnaire periodically. Bone marrow samples
are collected at baseline and post-transplant for cytogenetic analysis by FISH.


Inclusion Criteria:



- Multiple Myeloma patients with symptomatic disease, stage II or III at diagnosis or
progressive stage I requiring chemotherapy and/or radiation therapy (by Salmon-Durie
classification), who are not eligible for tandem transplant study using TMI; because
of previous radiation or eligibility criteria; documentation of disease staging by
both Salmon-Durie classification and International Staging System (ISS) is required

- Patients with non-secretory myeloma should have measurable serum free-light chain
protein by the Free-lite test or measurable disease such as a soft tissue myeloma

- A minimum of 4 x 10^6 of CD 34 Positive cell/kg has been harvested

- A Karnofsky performance status (KPS) of >= 70% is required unless the KPS is impaired
due to bone disease

- No contraindication to the collection of a minimum of 4 x 10^6 CD34+ cells/kg by
apheresis

- All patients must have signed a voluntary, informed consent in accordance with
institutional and federal guidelines

- Bilirubin =< 1.5 mg/dl

- Serum glutamic oxaloacetic transaminase (SGOT) and serum glutamic pyruvate
transaminase (SGPT) < 2.5 x upper limits of normal

- Creatinine clearance of >= 40cc/min

- Absolute neutrophil count of > 1000/ul

- Platelet count of > 100,000/ul

- Cardiac ejection fraction >= 45% by multigated acquisition (MUGA) scan and/or by
echocardiogram

- Diffusing capacity of the lung for carbon monoxide (DLCO) >= 50% of predicted lower
limit

- Human immunodeficiency virus (HIV) antibody tests negative

- No other medical, or psychosocial problems which in the opinion of the primary
physician or principal investigator would place the patient at unacceptably high risk
from this treatment regimen

Exclusion Criteria:

- Presence of peripheral neuropathy >= grade II

- Patients with evidence of disease progression (with >= 25% increase in M protein) on
bortezomib and or thalidomide therapy prior to transplant

- Pregnant or nursing women, as well as women of child bearing age, who are unwilling
to use a dual method of contraception and men who are unwilling to use condom

- Patients with history of hypersensitivity to bortezomib, boron or mannitol

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Feasibility and toxicities of maintenance therapy

Outcome Time Frame:

After 4 months of maintenance therapy

Safety Issue:

Yes

Principal Investigator

Firoozeh Sahebi, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

City of Hope Medical Center

Authority:

United States: Institutional Review Board

Study ID:

06143

NCT ID:

NCT00792142

Start Date:

January 2008

Completion Date:

Related Keywords:

  • Multiple Myeloma and Plasma Cell Neoplasm
  • Neurotoxicity
  • neurotoxicity
  • stage I multiple myeloma
  • stage II multiple myeloma
  • stage III multiple myeloma
  • Neoplasms
  • Multiple Myeloma
  • Neoplasms, Plasma Cell
  • Plasmacytoma
  • Neurotoxicity Syndromes

Name

Location

City of Hope Medical CenterDuarte, California  91010