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A Phase II Trial With VELCADE® (PS-341), Cytoxan (Cyclophosphamide), Dexamethasone and Thalomid® (VEL-CTD) in Previously Untreated Multiple Myeloma Patients

Phase 2
18 Years
Open (Enrolling)
Multiple Myeloma and Plasma Cell Neoplasm

Thank you

Trial Information

A Phase II Trial With VELCADE® (PS-341), Cytoxan (Cyclophosphamide), Dexamethasone and Thalomid® (VEL-CTD) in Previously Untreated Multiple Myeloma Patients



- Determine the response rate in patients with newly diagnosed, previously untreated
multiple myeloma treated with bortezomib, cyclophosphamide, dexamethasone, and


- Determine the safety and tolerability of this regimen in these patients.

OUTLINE: This is an open-label, multicenter study.

Patients receive bortezomib IV on days 1, 4, 8, and 11; cyclophosphamide IV on days 1 and 8
of courses 1-3; oral thalidomide once daily on days 1-21 beginning in course 4; and
dexamethasone IV or orally once daily on days 1, 2, 4, 5, 8, 9, 11, and 12. Treatment
repeats every 21 days for up to 6 courses in the absence of disease progression or
unacceptable toxicity.

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

PROJECTED ACCRUAL: A total of 43 patients will be accrued for this study.

Inclusion Criteria


- Diagnosis of multiple myeloma meeting 1 of the following criteria:

- Monoclonal immunoglobulin spike on serum electrophoresis (IgG > 3.5 g/dL or IgA
> 2.0 g/dL) and kappa or lambda light chain excretion > 1 g/day by 24-hour urine
protein electrophoresis AND meets any of the following criteria:

- Bone marrow plasmacytosis (10-30% plasma cells)

- Lytic bone lesions

- Monoclonal immunoglobulin of lesser magnitude present and bone marrow
plasmacytosis (10-30% plasma cells) AND meets any of the following criteria:

- Lytic bone lesions

- IgM < 50 mg/dL, IgA < 100 mg/dL, or IgG < 600 mg/dL

- Bone marrow plasmacytosis (> 30% plasma cells) or plasmacytoma on tissue biopsy
AND meets any of the following criteria:

- Monoclonal immunoglobulin of lesser magnitude present

- Lytic bone lesions

- IgM < 50 mg/dL, IgA < 100 mg/dL, or IgG < 600 mg/dL

- FreeLite testing abnormal and kappa:lambda light chain ratio abnormal

- Symptomatic disease requiring treatment

- Documented related organ or tissue involvement, if present

- Measurable disease, defined as 1 of the following:

- Monoclonal immunoglobulin spike on serum electrophoresis ≥ 1 g/dL and/or urine
monoclonal immunoglobulin spike ≥ 200 mg/day

- Abnormal FreeLite testing (for nonsecretors)

- Patients with nonsecretory disease must meet either of the following criteria
for measurability:

- Has measurable protein by FreeLite testing

- Untreated soft tissue plasmacytoma and/or evaluable disease in bone marrow

- Newly diagnosed, previously untreated disease

- No POEMS syndrome (i.e., plasma cell dyscrasia with polyneuropathy, organomegaly,
endocrinopathy, monoclonal protein [M-protein], and skin changes)

- No plasma cell leukemia


- Karnofsky performance status 50-100%

- Platelet count ≥ 100,000/mm³ (≥ 50,000/mm³ if bone marrow is extensively infiltrated)

- Extensive infiltration is defined as > 50% myeloma cells or plasma cells

- Hemoglobin ≥ 8.5 g/dL

- Absolute neutrophil count ≥ 1,500/mm³

- AST and ALT ≤ 2 times upper limit of normal (ULN)

- Bilirubin ≤ 1.5 times ULN (unless clearly related to the disease)

- Creatinine clearance ≥ 20 mL/min

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use 2 methods of effective contraception ≥ 4 weeks prior to
beginning treatment, during, and for ≥ 4 weeks after completion of study treatment

- No impaired kidney function requiring dialysis

- No uncontrolled infection

- No HIV positivity

- No known active hepatitis B or C

- No cardiovascular disease including, but not limited to, any of the following:

- Myocardial infarction within the past 6 months

- New York Heart Association class II-IV heart failure

- Uncontrolled angina

- Severe uncontrolled ventricular arrhythmias

- Clinically significant pericardial disease

- Acute ischemic or active conduction system abnormalities by EKG

- No history of allergic reactions to compounds containing mannitol, bortezomib, or

- No second malignancy requiring concurrent treatment

- No other serious medical or psychiatric illness that would preclude study compliance

- No peripheral neuropathy ≥ grade 1


- No prior chemotherapy, immunotherapy, vaccine therapy, therapeutic doses of steroids,
or other agents for the treatment of active myeloma

- Drugs given to prevent onset of myeloma allowed

- Bisphosphonates for hypercalcemia or short course corticosteroids for
hypercalcemia or cord compromise allowed

- Prior local radiotherapy with or without a brief exposure to steroids allowed

- More than 4 weeks since prior and no concurrent radiotherapy

- Spot radiotherapy to ≤ 3 vertebrae allowed

- No concurrent steroids at > 10 mg of prednisone daily (or the equivalent) for other
medical conditions (e.g., asthma, systemic lupus erythematosus, or rheumatoid

- No other concurrent chemotherapy or investigational agents

- Concurrent daily acetylsalicylic acid required during course 4-6 of study treatment

Type of Study:


Study Design:

Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Response rate

Safety Issue:


Principal Investigator

William I. Bensinger, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Fred Hutchinson Cancer Research Center


United States: Federal Government

Study ID:




Start Date:

August 2006

Completion Date:

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



Fred Hutchinson Cancer Research CenterSeattle, Washington  98109
Sutter Cancer CenterSacramento, California  95816
St. Vincent's Comprehensive Cancer Center - ManhattanNew York, New York  10011
Samuel Oschin Comprehensive Cancer Institute at Cedars-Sinai Medical CenterLos Angeles, California  90048-1865
Alta Bates Summit Comprehensive Cancer CenterBerkeley, California  94704
Seattle Cancer Care AllianceSeattle, Washington  98109
Desert Regional Medical Center Comprehensive Cancer CenterPalm Springs, California  92262
Oregon Health and Science University Cancer InstitutePortland, Oregon  97239-3098
Eugene M. and Christine E. Lynn Cancer Institute at Boca Raton Community Hospital - Main CampusBoca Raton, Florida  33486
Lone Star Oncology - AustinAustin, Texas  78759