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Phase 1/2 Study of VELCADE® (Bortezomib), Dexamethasone, and Revlimid® (Lenalidomide) Versus VELCADE, Dexamethasone, Cyclophosphamide, and Revlimid Versus VELCADE, Dexamethasone and Cyclophosphamide in Subjects With Previously Untreated Multiple Myeloma


Phase 1/Phase 2
18 Years
N/A
Not Enrolling
Both
Multiple Myeloma

Thank you

Trial Information

Phase 1/2 Study of VELCADE® (Bortezomib), Dexamethasone, and Revlimid® (Lenalidomide) Versus VELCADE, Dexamethasone, Cyclophosphamide, and Revlimid Versus VELCADE, Dexamethasone and Cyclophosphamide in Subjects With Previously Untreated Multiple Myeloma


Inclusion Criteria:



- Voluntary written informed consent

- Male or female subject 18 years of age or older

- A Karnofsky Performance Status score of ≥50% (Eastern Cooperative Oncology Group
Performance Status score ≤2)

- Subjects must have symptomatic myeloma or asymptomatic myeloma with myeloma-related
organ damage

- Diagnosed Multiple myeloma

- Subjects must have measurable disease requiring systemic therapy

- Subjects must not have been treated previously with any systemic therapy for multiple
myeloma

- Two weeks must have elapsed since the date of the last radiotherapy treatment

- Women of childbearing potential must have a negative serum or urine pregnancy test
with a sensitivity of at least 50 mIU/mL within 10 to 14 days prior to therapy and
repeated within 24 hours before starting study drug. They must commit to continued
abstinence from heterosexual intercourse or begin 2 acceptable methods of birth
control (1 highly effective method and 1 additional effective method) used at the
same time, beginning at least 4 weeks before initiation of Revlimid treatment. Women
must also agree to ongoing pregnancy testing

- Men must agree to not father a child and agree to use a latex condom during therapy
and for 4 weeks after the last dose of study drug, even if they have had a successful
vasectomy, if their partner is of childbearing potential

- All subjects must agree to comply with the requirements of the RevAssistSM program

Exclusion Criteria:

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

- ≥Grade 2 peripheral neuropathy on clinical examination

- Myocardial infarction within 6 months prior to enrollment or New York Heart
Association Class III or IV heart failure, uncontrolled angina, severe uncontrolled
ventricular arrhythmias, or electrocardiographic evidence of acute ischemia or
clinically significant conduction system abnormalities.

- Female subject who is pregnant or breast-feeding

- Clinically relevant active infection or serious comorbid medical conditions

- 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 or psychiatric illness
likely to interfere with participation in this clinical study

- Active prior malignancy diagnosed or treated within the last 3 years

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Number of Patients With Combined Complete Response and Very Good Partial Response

Outcome Description:

Complete response requires negative immunofixation on the serum and urine and disappearance of any soft tissue plasmacytomas and < 5% plasma cells in bone marrow. Very good partial response requires serum and urine M-protein detectable by immunofixation but not on electrophoresis or 90% or greater reduction in serum M-protein plus urine M-protein level < 100 mg per 24 h

Outcome Time Frame:

Up to 48 weeks or until disease progression

Safety Issue:

No

Principal Investigator

Medical Monitor

Investigator Role:

Study Director

Investigator Affiliation:

Millennium Pharmaceuticals, Inc.

Authority:

United States: Food and Drug Administration

Study ID:

C05008

NCT ID:

NCT00507442

Start Date:

August 2007

Completion Date:

November 2010

Related Keywords:

  • Multiple Myeloma
  • Treatment for patients with multiple myeloma
  • who have received no prior treatment
  • Multiple Myeloma
  • Neoplasms, Plasma Cell

Name

Location

Mayo ClinicRochester, Minnesota  55905
Rocky Mountain Cancer CenterDenver, Colorado  80218