Sunitinib in Treating Patients With Relapsed Multiple Myeloma
Refractory Multiple Myeloma
Stage I Multiple Myeloma
Stage II Multiple Myeloma
Stage III Multiple Myeloma
Drug: sunitinib malate
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase II Trial of Sunitinib (SU11248) in Multiple Myeloma|
- The Number of Confirmed Responses (Complete Response [CR], Very Good Partial Response [VGPR], or Partial Response [PR]) [ Time Frame: Every 6 weeks from the first initiation of therapy up to 72 weeks ] [ Designated as safety issue: No ]
A confirmed response is defined as a patient who has achieved response and maintained it on two consecutive evaluations at least 2 weeks apart.
A Complete Response (CR) is defined as the complete disappearance of an M-protein and fewer than 5% bone marrow plasmacytosis.
A Hematologic Very good partial response (VGPR) is defined as having a ≥ 90% reduction of M-protein from serum, a Urine M-spike to be ≤ 100 mg/24 hours, and a disappearance of soft tissue plasmacytomas.
A Partial Response (PR) is defined as having a 50-89% reduction in the level of the serum monoclonal protein, a reduction in 24-hour urinary light chain excretion either by ≥90% or to <200 mg, and a ≥ 50% reduction in size of soft tissue plasmacytoma.
- Event-free Survival [ Time Frame: Time from registration to progression or death due to any cause, assessed up to 3 years ] [ Designated as safety issue: No ]The distribution of progression-free survival will be estimated using the method of Kaplan-Meier.
- Duration of Response [ Time Frame: From the documentation of response until the date of progression ] [ Designated as safety issue: No ]The distribution of duration of response will be estimated using the method of Kaplan-Meier.
- Toxicity [ Time Frame: From the time of first treatment to up to 30 days after the last day of study drug treatment ] [ Designated as safety issue: Yes ]Assessed per National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 3.0. Included are the toxicities at least possibly related to the study drug.
|Study Start Date:||September 2007|
|Study Completion Date:||August 2010|
|Primary Completion Date:||March 2009 (Final data collection date for primary outcome measure)|
Experimental: Treatment (kinase inhibitor therapy)
Patients receive 37.5 mg oral sunitinib malate once daily on days 1-42. Treatment repeats every 42 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
Drug: sunitinib malate
Oral 37.5 mg each day of the 6-week cycle (continuous dosing).
I. To assess the number of responses in patients with relapsed multiple myeloma treated with sunitinib (sunitinib malate).
I. To assess the toxicity of sunitinib malate in patients with relapsed multiple myeloma.
II. To assess time to progression after initial response to sunitinib malate.
Patients receive oral sunitinib malate once daily on days 1-42. Treatment repeats every 42 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed every 3-6 months for up to 3 years.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00514137
|United States, Minnesota|
|Mayo Clinic Cancer Research Consortium|
|Rochester, Minnesota, United States, 55905|
|Principal Investigator:||Shaji Kumar||Mayo Clinic|