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UARK 2001-37, A Phase I Exploratory Study of Combination PS-341 and Thalidomide in Refractory Multiple Myeloma

Phase 1
18 Years
Not Enrolling
Multiple Myeloma

Thank you

Trial Information

UARK 2001-37, A Phase I Exploratory Study of Combination PS-341 and Thalidomide in Refractory Multiple Myeloma

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.

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

Type of Study:


Study Design:

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

Outcome Measure:

Assess the toxicity of PS-341 combined with one of four doses of thalidomide in patients with refractory multiple myeloma

Outcome Time Frame:

until pt progresses or unexceptible toxicity

Safety Issue:


Principal Investigator

Barlogie Barthel, M.D. Ph.D

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Arkanas for Medical Sciences website


United States: Food and Drug Administration

Study ID:

UARK 2001-37



Start Date:

December 2001

Completion Date:

November 2007

Related Keywords:

  • Multiple Myeloma
  • Multiple Myeloma
  • Thalidomide
  • Velcade
  • PS-341
  • Refractory
  • Bortezomid
  • Multiple Myeloma
  • Neoplasms, Plasma Cell



University of Arkansas for Medical Sciences/MIRT Little Rock, Arkansas  72205