Study of Bortezomib and Revlimid™ for Patients Relapsing or Progressing on Total Therapy II

NCT00093028 | Completed Phase 3

• 1 other identifier: UARK 2003-35
• Study Type: interventional
• Target: 315
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is

• to find out the effects of treating patients with two new chemotherapy drugs (bortezomib and Revlimid™),
• to study how many patients' myeloma responds to treatment on this study, and how many patients survive after this treatment,
• to learn if a patient's genetic makeup before and after treatment can predict which patients will respond to bortezomib and Revlimid™, and to learn more about how the body responds (gene array studies).

Conditions

Multiple Myeloma

Keywords

Myeloma; Revlimid; bortezomib; CC-5013; Dexamethasone

Outcome Measures

Primary Outcomes (1)

• To find out the effects (good and bad) of treating patients with two new chemotherapy drugs (BORTEZOMIB and REVLIMID).

  24 months

Secondary Outcomes (1)

• To learn if a patient's genetic makeup before and after treatment can predict which patients will respond to BORTEZOMIB and REVLIMID, and to learn more about how the body responds (gene array studies).

  24 months

Interventions

CC-5013 (Revlimid™) DRUG

N/A Study Complete

bortezomib DRUG

N/A Study Complete

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• History of histologically documented Multiple Myeloma (MM) previously enrolled on UARK 98-026 with relapsed or progressive disease after at least one autologous transplant.
• Patient has measurable disease in which to capture response, defined as: a. Serum M-protein level \> or =1.0 gm/dl (10.0 g/L) measured by serum protein electrophoresis or immunoglobulin electrophoresis b. Urinary M-protein excretion \> or =200 mg/24 hrs c. Bone marrow plasmacytosis of \> or =30% by bone marrow aspirate and/or biopsy d. Serum Free Light Chains (By the Freelite test) \> 2X normal.
• Performance status of \< or = 2 as per Zubrod scale, unless PS of 3 based solely on bone pain.
• Patients must have a platelet count \> or = 50,000/mm3, and an ANC of at least 1,000/μl.
• Patients must have adequate renal function defined as serum creatinine \< or =3.0 mg/dl.
• Patients must have adequate hepatic function defined as serum transaminases and direct bilirubin \< or =2 x the upper limit of normal.
• Pregnant or nursing women may not participate. Women of childbearing potential must have a negative pregnancy documented within one week of registration. Women of reproductive potential may not participate unless they have agreed to use an effective contraceptive method.
• Male or female adults of at least 18 years of age.
• Patients must have signed an IRB-approved written informed consent form and demonstrate willingness to meet follow-up schedule and study procedure obligations

You may not qualify if:

• Chemotherapy or radiotherapy received within the previous 2 weeks.
• Not previously enrolled on UARK 98-026.
• Has received either CC-5013 or bortezomib therapy after discontinuing from UARK 98-026.
• Significant neurotoxicity, defined as grade \> or = 2 neurotoxicity per NCI Common Toxicity Criteria.
• Platelet count \< 50,000/mm3, or ANC \< 1,000/μl
• POEMS Syndrome
• Clinically significant hepatic dysfunction as noted by bilirubin or AST \>3 times the upper normal limit or clinically significant concurrent hepatitis.
• New York Hospital Association (NYHA) Class III or Class IV heart failure
• Myocardial infarction within the last 6 months.
• Non-secretory MM, unless the patient has measurable lesions on CT, MRI and/or PET.
• Uncontrolled, active infection requiring IV antibiotics.
• Patients with a history of treatment for clinically significant ventricular cardiac arrhythmias.
• Poorly controlled hypertension, diabetes mellitus, or other serious or psychiatric illness that could potentially interfere with the completion of treatment according to this protocol.
• Pregnant or potential for pregnancy. Women of childbearing potential will have a pregnancy test at screening, and will be required to use a medically approved contraceptive method. Pregnancy testing will be performed prior to administration of each cycle of study drug.
• Breast-feeding women may not participate.

Sponsors & Collaborators

• University of Arkansas: lead

Study Sites (1)

University of Arkansas for Medical Sciences/MIRT

Little Rock, Arkansas, 72205, United States

Location

Related Links

• Myeloma Institute for Research \& Therapy website

MeSH Terms

Conditions

Multiple Myeloma; Neoplasms, Plasma Cell

Interventions

Lenalidomide; Bortezomib

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Phthalimides; Phthalic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Piperidones; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Isoindoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Boronic Acids; Acids, Noncarboxylic; Acids; Inorganic Chemicals; Boron Compounds; Pyrazines

Study Officials

• Bart Barlogie, M.D., Ph.D.

  UAMS Myeloma Institute for Research & Therapy

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 29, 2004
• First Posted: October 1, 2004
• Study Start: January 1, 2004
• Primary Completion: January 1, 2006
• Study Completion: January 1, 2006
• Last Updated: July 2, 2010

Record last verified: 2010-07

Locations

US (1)