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Phase II Study of VDT (VELCADE, Doxil® and Thalidomide) as Frontline Therapy for Patients With Previously Untreated Multiple Myeloma (MM)


Phase 2
18 Years
N/A
Not Enrolling
Both
Multiple Myeloma and Plasma Cell Neoplasm

Thank you

Trial Information

Phase II Study of VDT (VELCADE, Doxil® and Thalidomide) as Frontline Therapy for Patients With Previously Untreated Multiple Myeloma (MM)


OBJECTIVES:

Primary

- To determine the overall response rate (complete response and partial response) in
patients previously untreated stage I, II, or III multiple myeloma.

Secondary

- To evaluate the complete response rate in patients treated with this regimen.

- To determine the time to disease progression from the start of this therapy in patients
treated with this regimen.

OUTLINE: Patients receive low-dose oral thalidomide once a day on days 1-28, bortezomib IV
on days 1, 4, 15, and 18, and doxorubicin hydrochloride liposome IV over 60-90 minutes on
days 1 and 15. Treatment repeats every 4 weeks for 6 courses in the absence of disease
progression or unacceptable toxicity. Patients with residual disease who continue to show
response after completion of 6 courses may receive 2 additional courses for a total of 8
courses.

After completion of study treatment, patients are followed every 3 months.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Diagnosis of stage I, II, or III multiple myeloma requiring therapy

- No prior systemic therapy for multiple myeloma

- Patients who have received steroids or radiotherapy for cord compression or
spinal cord disease are eligible for this study

- Patients who have received 1 prior course of antimyeloma therapy may be enrolled
at the investigator's discretion provided disease progression is not noted

PATIENT CHARACTERISTICS:

Inclusion criteria:

- Karnofsky performance status 60-100%

- Platelet count ≥ 75,000 cells/mm^3 (< 75,000 cells/mm^3 secondary to extensive bone
marrow disease allowed at the PI's discretion with appropriate transfusion support)

- ANC ≥ 1,000 cells/mm^3

- Hemoglobin ≥ 8.0 g/dL (< 8 g/dL secondary to extensive bone marrow disease allowed at
the PI's discretion with appropriate transfusion support)

- Creatinine clearance > 20 mL/min

- AST and ALT ≤ 2 times upper limit of normal (ULN) OR ≤ 3 times ULN (in the presence
of liver metastases)

- Alkaline phosphatase ≤ 2 times ULN OR ≤ 3 times ULN (in the presence of liver
metastases)

- Total bilirubin ≤ 2 times ULN OR ≤ 3 times ULN (in the presence of liver metastases)

- Ejection fraction ≥ 50% by MUGA or 2-D echocardiogram

- Negative pregnancy test

- Fertile patients must use at least 1 highly effective and 1 additional effective
contraception method 4 weeks prior to, during, and 3 months after completion of study
therapy

- HIV-negative

- Must have sufficient mental capacity to understand the explanation of the study and
to provide informed consent

- Willingness and ability to comply with the FDA-mandated S.T.E.P.S. program

Exclusion criteria:

- Pregnant or lactating

- Active, serious infections uncontrolled by antibiotics

- Any medical condition or reason that, in the investigator's opinion, makes the
patient unsuitable to participate in this clinical trial

- History of hypersensitivity reactions attributed to a conventional formulation of
doxorubicin hydrochloride or the components of doxorubicin hydrochloride liposome or
bortezomib, boron, or mannitol

- Any of the following conditions:

- History of uncontrolled New York Heart Association class II-IV heart disease or
clinical evidence of congestive heart failure

- Myocardial infarction within the past 6 months

- Uncontrolled angina

- Severe uncontrolled ventricular arrhythmias, ECG evidence of acute ischemia, or
active conduction system abnormalities

- Peripheral neuropathy ≥ grade 2

PRIOR CONCURRENT THERAPY:

- See Disease Characteristics

Type of Study:

Interventional

Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Overall response rate (complete and partial)

Outcome Time Frame:

Every 3 months

Safety Issue:

No

Principal Investigator

Kelvin Lee, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Roswell Park Cancer Institute

Authority:

United States: Food and Drug Administration

Study ID:

CDR0000563183

NCT ID:

NCT00523848

Start Date:

June 2006

Completion Date:

October 2012

Related Keywords:

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

Name

Location

Roswell Park Cancer Institute Buffalo, New York  14263