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A Sequential Phase II Trial of the Combination of Bortezomib (VELCADE), Dexamethasone (DECADRON) and Pegylated Liposomal Doxorubicin (DOXIL) Followed by High Dose Cyclophosphamide in Multiple Myeloma Patients


Phase 2
18 Years
N/A
Not Enrolling
Both
Multiple Myeloma

Thank you

Trial Information

A Sequential Phase II Trial of the Combination of Bortezomib (VELCADE), Dexamethasone (DECADRON) and Pegylated Liposomal Doxorubicin (DOXIL) Followed by High Dose Cyclophosphamide in Multiple Myeloma Patients


Inclusion Criteria:



- Subject must voluntarily sign and understand written informed consent.

- Confirmed diagnosis of multiple myeloma as specified by the SWOG criteria and is
detailed in Appendix I.

- Measurable disease as defined the following:

1. For patients post induction therapy, any measurable paraprotein in the serum or
urine and/or any plasmacytoma present on physical exam or imaging.

2. For patients with relapsed/refractory disease, > 0.5 g/dL serum monoclonal
protein, > 0.1 g/dL serum free light chains, > 0.2 g/24 hrs urinary M-protein
excretion, and/or measurable plasmacytoma(s).

- Age > or = than 18 years at the time of signing the informed consent form.

- Karnofsky performance status> or =70% (>60% if due to bony involvement of myeloma).

- Group A (post-induction therapy)- patients who have received only one prior treatment
regimen (eg VAD, Thal/Dex, BLT-D, MP, BiRD, or DVd) with at least 20 patients having
received a Revlimid based regimen or Group B(>1st line of therapy)- patients with
relapsed/refractory multiple myeloma who have received two or more prior treatment
regimens .

- If the patient is a woman of childbearing age, she must have a negative serum or
urine pregnancy test within 7 days of starting study and must use effective
contraception throughout the course of the study.

- Life expectancy > 12 weeks.

- Absolute neutrophil count (ANC)> or = 1500 cells/mm3 (> or = 1000 for patients with
bone marrow biopsy displaying > 50% involvement by myeloma)

- Platelets count > or = 50,000/mm3 (> or = 30,000 for patients with bone marrow biopsy
displaying > 50% involvement by myeloma)

- Hemoglobin > 9.0 g/dL

- Serum SGOT/AST <3.0 x upper limits of normal (ULN)

- Serum SGPT/ALT <3.0 x upper limits of normal (ULN)

- Serum creatinine < 2.5 mg/dL or creatinine clearance > 40ml/min

- Serum total bilirubin < 1.5 x ULN

- Patients must have a MUGA scan with LVEF >50%

Exclusion Criteria:

- Patients with non-secretory MM (no measurable monoclonal protein, free light chains,
and/or M-spike in blood or urine) unless measurable disease is available with imaging
techniques such as MRI and PET scan.

- Prior treatment with bortezomib.

- Peripheral neuropathy of > Grade 2 as defined by CTCAE Version 3.0 (see Appendix II)

- History of allergic reactions to compounds containing mannitol, bortezomib,
conventional formulation of doxorubicin HCL or the components of DOXIL.

- Prior history of other malignancies (except for basal cell or squamous cell carcinoma
of the skin or carcinoma in situ of the cervix or breast) unless disease free for ³ 5
years.

- NYHA Class III or IV heart disease. History of active unstable angina, congestive
heart disease, serious uncontrolled cardiac arrhythmia or myocardial infarction
within 6 months.

- Female patients who are pregnant or breastfeeding. Women of childbearing potential
and men must agree to use adequate contraception prior to study entry and for the
duration of study participation.

- Known HIV or hepatitis A, B, or C positivity

- Active viral or bacterial infections or any coexisting medical problem that would
significantly increase the risks of this treatment program.

- Any concurrent, uncontrolled medical condition, laboratory abnormality, or
psychiatric illness which could place him/her at unacceptable risk, including, but
not limited to, uncontrolled hypertension, uncontrolled diabetes, active uncontrolled
infection, and/or acute chronic liver disease (i.e., hepatitis, cirrhosis).

- No prior anti-myeloma therapy within 2 weeks of treatment initiation.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

efficacy of drug combination as therapy for myeloma

Outcome Time Frame:

duration of study

Safety Issue:

No

Principal Investigator

Ruben Niesvizky, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Weill Medical College of Cornell University

Authority:

United States: Institutional Review Board

Study ID:

0504007841

NCT ID:

NCT00148317

Start Date:

June 2005

Completion Date:

November 2012

Related Keywords:

  • Multiple Myeloma
  • Multiple Myeloma
  • Neoplasms, Plasma Cell

Name

Location

Weill Medical College of Cornell UniversityNew York, New York  10021