Sunitinib in Treating Patients With Relapsed Multiple Myeloma
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00514137|
Recruitment Status : Completed
First Posted : August 9, 2007
Results First Posted : March 6, 2013
Last Update Posted : May 28, 2014
|Condition or disease||Intervention/treatment||Phase|
|Refractory Multiple Myeloma Stage I Multiple Myeloma Stage II Multiple Myeloma Stage III Multiple Myeloma||Drug: sunitinib malate||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||13 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Trial of Sunitinib (SU11248) in Multiple Myeloma|
|Study Start Date :||September 2007|
|Primary Completion Date :||March 2009|
|Study Completion Date :||August 2010|
U.S. FDA Resources
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).
- 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 ]
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 ]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 ]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 ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00514137
|United States, Minnesota|
|Mayo Clinic Cancer Research Consortium|
|Rochester, Minnesota, United States, 55905|
|Principal Investigator:||Shaji Kumar||Mayo Clinic|