Clinical trial · Interventional
Study of Bortezomib and Revlimid™ for Patients Relapsing or Progressing on Total Therapy II
UARK 2003-35, A Phase III Study of Bortezomib Versus Bortezomib in Two Doses in Combination With Revlimid™ for Patients Relapsing or Progressing on Total Therapy II (UARK 98-026)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Multiple Myeloma | Multiple Myeloma | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| bortezomib | Drug | Bortezomib | ALIAS |
| CC-5013 (Revlimid™) | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- To find out the effects (good and bad) of treating patients with two new chemotherapy drugs (BORTEZOMIB and REVLIMID).
- timeFrame
- 24 months
Secondary outcomes (1)
- measure
- 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).
- timeFrame
- 24 months
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 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 Exclusion Criteria: * 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. * Known hypersensitivity to thalidomide.
References
Publications (0)
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