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Randomized Phase 3b Study of Three Treatment Regimens in Subjects With Previously Untreated Multiple Myeloma Who Are Not Considered Candidates for High-Dose Chemotherapy and Autologous Stem Cell Transplantation: VELCADE,Thalidomide, and Dexamethasone Versus VELCADE and Dexamethasone Versus VELCADE, Melphalan, and Prednisone

Phase 3
18 Years
Open (Enrolling)
Multiple Myeloma

Thank you

Trial Information

Randomized Phase 3b Study of Three Treatment Regimens in Subjects With Previously Untreated Multiple Myeloma Who Are Not Considered Candidates for High-Dose Chemotherapy and Autologous Stem Cell Transplantation: VELCADE,Thalidomide, and Dexamethasone Versus VELCADE and Dexamethasone Versus VELCADE, Melphalan, and Prednisone

Inclusion Criteria:

- Male or female subjects 18 years of age or older

- Subject is not a candidate for high-dose chemotherapy and stem cell
transplantation(HDT/SCT) due to age, presence of important comorbid condition(s)
likely to have a negative impact on tolerability of HDT-SCT, or subject preference.

- A Karnofsky Performance Status score of ≥50%

- Symptomatic multiple myeloma or asymptomatic multiple myeloma with related organ or
tissue damage.

- Asymptomatic multiple myeloma-related organ or tissue damage can include presence of
an asymptomatic lytic bone lesion or plasmacytoma, the presence of anemia(hemoglobin
<10 g/dL), renal function impairment (serum creatinine > upper limit of normal [ULN])
or hypercalcemia (serum calcium >ULN).

- Subject must have measurable disease requiring systemic therapy. Measurable disease
is defined by at least 1 of the following criteria:

- quantifiable serum M-protein value (>1 g/dL of IgG or IgM M-protein, >0.5g/dL of IgA
M-protein, >0.5 g/dL of IgD M-protein)

- urine light-chain excretion ≥200 mg/24 hours

- Voluntary written informed consent must be given before performance of any study
related procedure not part of normal medical care, with the understanding that
consent may be withdrawn by the subject at any time without prejudice to future
medical care.

Exclusion Criteria:

- Diagnosis of smoldering multiple myeloma or MGUS. Smoldering multiple myeloma is
defined as asymptomatic multiple myeloma with absence of lytic bone lesions. MGUS is
defined by presence of serum monoclonal protein <3 g/dL; absence of lytic bone
lesions, anemia, hypercalcemia, and renal insufficiency related to the monoclonal
protein; and (if determined) proportion of plasma cells in the bone marrow of 10% or

- Diagnosis of Waldenström's disease or other conditions in which IgM M-protein is
present in the absence of a clonal plasma cell infiltration or lytic bone lesions.

- Previously or currently treated with any systemic therapy for multiple myeloma. Prior
treatment of hypercalcemia or spinal cord compression with corticosteroids or
radiation therapy, respectively, does not disqualify the subject (the dose of
corticosteroids should not exceed the equivalent of 160 mg of dexamethasone in 2-week

- Radiation therapy within 2 weeks before randomization. Enrollment of subjects who
require concurrent radiotherapy (which must be localized in its field size) should be
deferred until the radiotherapy is completed and 2 weeks have elapsed since the last
date of therapy.

- Major surgery within 30 days before randomization (Kyphoplasty is not considered
major surgery)

- History of allergy to any of the study medications, their analogues, or excipients in
the various formulations

- ≥Grade 2 peripheral neuropathy on clinical examination within 21 days before

- Any of the following clinical laboratory values within 21 days prior to enrollment:

- Absolute neutrophil count (ANC) <1000 cells/mm3

- Platelets <100,000 × 109/L, or <70 × 109/L if thrombocytopenia is considered by the
investigator to be due to myeloma infiltration of bone marrow

- Aspartate aminotransferase (AST [SGOT]) or alanine aminotransferase (ALT [SGPT]) >2×
the ULN

- Serum creatinine >2 mg/dL (>176.8µmol/L); if the rise in creatinine is related to
myeloma and there has been demonstrated a response to hydration, the subject may be

- Myocardial infarction within 6 months prior to enrollment or New York Hospital
Association Class III or IV heart failure, uncontrolled angina, severe uncontrolled
ventricular arrhythmias, or electrocardiographic evidence of acute ischemia or
significant conduction system abnormalities in the opinion of the investigator. Prior
to study entry, any abnormality on electrocardiogram at screening must be determined
and documented by the investigator as not medically relevant.

- Any condition, including laboratory abnormalities, that in the opinion of the
Investigator places the subject at unacceptable risk if he/she were to participate in
the study. This includes but is not limited to serious medical conditions or
psychiatric illness likely to interfere with participation in this clinical study.

- Prior malignancy except for adequately treated basal cell or squamous cell skin
cancer, in situ cervical cancer, in situ breast cancer, in situ prostate cancer, or
other cancer for which the subject has been disease-free for at least 3 years.

- Female subject who is pregnant or breastfeeding. Female subjects of childbearing
potential must have a negative pregnancy test with a sensitivity of at least 50
mIU/mL during Screening.

- Use of any investigational drugs within 30 days before randomization.

Type of Study:


Study Design:

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Progression Free Survival.

Outcome Time Frame:

Up to 3 years after treatment is completed

Safety Issue:


Principal Investigator

Medical Monitor

Investigator Role:

Study Director

Investigator Affiliation:

Millennium Pharmaceuticals, Inc.


United States: Institutional Review Board

Study ID:




Start Date:

June 2007

Completion Date:

May 2013

Related Keywords:

  • Multiple Myeloma
  • Multiple Myeloma
  • Neoplasms, Plasma Cell



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