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Study of Combination PS-341 and Thalidomide in Multiple Myeloma

This study has been completed.
Sponsor:
Information provided by:
University of Arkansas
ClinicalTrials.gov Identifier:
NCT00083460
First received: May 24, 2004
Last updated: July 30, 2010
Last verified: July 2010

May 24, 2004
July 30, 2010
December 2001
November 2007   (final data collection date for primary outcome measure)
Assess the toxicity of PS-341 combined with one of four doses of thalidomide in patients with refractory multiple myeloma [ Time Frame: until pt progresses or unexceptible toxicity ] [ Designated as safety issue: Yes ]
Assess the toxicity of PS-341 combined with one of four doses of thalidomide in patients with refractory multiple myeloma
Complete list of historical versions of study NCT00083460 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
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Study of Combination PS-341 and Thalidomide in Multiple Myeloma
UARK 2001-37, A Phase I Exploratory Study of Combination PS-341 and Thalidomide in Refractory Multiple Myeloma

The purpose of this study is to assess the toxicity of PS-341 combined with one of four doses of thalidomide in patients with refractory multiple myeloma, and to find the most appropriate doses of PS-341 and thalidomide in the combination.

Patients will be enrolled in groups of 6-10 patients, each receiving a low dose of PS-341 (1.0 mg/m2) and different dose levels of thalidomide (50, 100, 150, and 200 mg). The first six patients in each group will receive PS-341 alone for the first cycle, and thalidomide will be added on day 22. If the combination is found to be safe in these first 6 patients, the remaining patients in each group will be enrolled. Initially, these patients will receive PS-341 alone and thalidomide will be added subsequently, if deemed safe based on the first 6 patients in each thalidomide dose cohort.

Interventional
Phase 1
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Multiple Myeloma
  • Drug: PS-341
    Arm 1 a dose of 1.0mg/m2. Arm 2 a dose of 1.3mg/m2
  • Drug: Thalidomide
    In cohort 1, a dose of 50mg for cycles 2-8. Cohort 2, 100mg for cycles 2-8. Cohort 3, 150mg for cycles 2-8. Cohort 4, 200mg for cycles 2-8.
  • Drug: Dexamethasone
    A dose of 20mg for cylces 3-8.
  • Active Comparator: 1
    Interventions:
    • Drug: PS-341
    • Drug: Thalidomide
    • Drug: Dexamethasone
  • Active Comparator: 2
    Interventions:
    • Drug: PS-341
    • Drug: Thalidomide
    • Drug: Dexamethasone
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
86
November 2007
November 2007   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • History of histologically documented multiple myeloma with relapsed or resistant disease, defined as previously treated with/without autologous stem cell transplantation and is either relapsing or is resistant after > 1 line of prior therapy for myeloma
  • Patients can not be eligible for MTRC phase III protocols of higher priority
  • Performance status of greater than or equal to 2 as per SWOG scale
  • Patients must have an absolute neutrophil count > 750/mm3, and a platelet count greater than or equal to 25,000/mm3
  • No prior malignancy is allowed except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or other cancer for which the patient has been disease free for at least three years. Prior malignancy is acceptable provided there has been no evidence of disease within the three-year interval
  • Pregnant or nursing women may not participate. Women of childbearing potential must have a negative pregnancy documented within one week of registration. Women/men 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.
  • Signed written informed consent and willingness to meet follow-up schedule and study procedure obligations

Exclusion Criteria:

  • Chemotherapy or radiotherapy received within the previous 2 weeks
  • Prior Treatment of PS-341
  • Significant neurotoxicity, defined as grade greater than or equal to 2 neurotoxicity per NCI Common Toxicity Criteria
  • POEMS Syndrome
  • Non-secretory multiple myeloma
  • Active infection requiring antibiotics
  • Clinically significant hepatic dysfunction in the absence of liver metastases 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
  • Poorly controlled hypertension, diabetes mellitus, or other serious or psychiatric illness that could potentially interfere with the completion of treatment according to this protocol
  • Severe renal dysfunction defined as a creatinine clearance < 20 cc/min.
  • Absolute neutrophil count < 750/mm3, and a platelet count < 25,000/mm3
  • Pregnant or potential for pregnancy
  • Breast-feeding
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00083460
UARK 2001-37
Yes
Brooke Carter, CRA, University_Of_Arkansas
University of Arkansas
Not Provided
Principal Investigator: Barlogie Barthel, M.D. Ph.D University of Arkanas for Medical Sciences website
University of Arkansas
July 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP