Sunitinib in Treating Patients With Relapsed Multiple Myeloma
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Purpose
This phase II trial is studying how well sunitinib works in treating patients with relapsed multiple myeloma. Sunitinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the cancer
| Condition | Intervention | Phase |
|---|---|---|
|
Refractory Multiple Myeloma Stage I Multiple Myeloma Stage II Multiple Myeloma Stage III Multiple Myeloma |
Drug: sunitinib malate |
Phase 2 |
| Study Type: | Interventional |
| 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.
| Enrollment: | 13 |
| Study Start Date: | September 2007 |
| Study Completion Date: | April 2009 |
| Primary Completion Date: | March 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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).
Other Names:
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Detailed Description:
PRIMARY OBJECTIVES:
I. To assess the number of responses in patients with relapsed multiple myeloma treated with sunitinib (sunitinib malate).
SECONDARY OBJECTIVES:
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.
OUTLINE:
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Diagnosis of relapsed multiple myeloma
Measurable disease as defined by at least one of the following:
- Serum monoclonal protein ≥ 1.0 g by protein electrophoresis
- Urine monoclonal protein > 200 mg by 24-hour electrophoresis
- Serum immunoglobulin free light chain ≥ 10 mg/dL AND abnormal serum immunoglobulin kappa to lambda free light chain ratio
- Monoclonal bone marrow plasmacytosis ≥ 30%
- Not a candidate for stem cell transplantation OR have undergone prior stem cell collection
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2
- Life expectancy ≥ 3 months
- Absolute neutrophil count ≥ 1,000/microliter (mcL)
- Platelets ≥ 75,000/mcL
- Hemoglobin ≥ 8 g/dL
- Total serum bilirubin normal
- aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 x upper limit of normal
- Creatinine < 2.5 mg/dL
- Negative pregnancy test for women of childbearing potential
No more than 4 prior therapies
- Stem cell transplantation and preceding induction therapy will be considered 1 therapy
- Prior anthracycline exposure or central thoracic radiotherapy that included the heart in the radiotherapy port allowed provided patient has a New York Heart Association (NYHA) class II or better cardiac function on baseline ECHO or multiple gated acquisition scan (MUGA)
- Concurrent bisphosphonates allowed
- At least 7 days since prior and no concurrent cytochrome P450 3A4 (CYP3A4) inhibitors
- At least 12 days since prior and no concurrent CYP3A4 inducers
Exclusion Criteria:
- Pregnant or nursing women
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to sunitinib malate
- History of serious ventricular arrhythmia or corrected QT interval (QTc) prolongation
- Poorly controlled hypertension
- Any condition that impairs the ability to swallow and retain sunitinib malate tablets
- Patients with a preexisting thyroid abnormality who are unable to maintain thyroid function in the normal range with medication
- Other active malignancy except nonmelanoma skin cancer or carcinoma in situ of the cervix or breast
- Concurrent uncontrolled illness including, but not limited to, ongoing or active infections or psychiatric illness/social situations that would limit compliance with study requirements
- Patients who have not recovered from adverse events of prior therapy
- Chemotherapy or radiotherapy ≤ 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to study entry
- Any major surgery ≤ 4 weeks prior to study entry
- Nonmyelosuppressive agents ≤ 2 weeks prior to study entry
- Any other prior antiangiogenic agents
Concurrent high-dose corticosteroids
- Concurrent chronic steroids (up to 20 mg/day prednisone equivalent) allowed for disorders other than amyloid; NOTE: Bisphosphonates are considered to be supportive care rather than therapy, and are thus allowed while on protocol treatment
- Concurrent therapeutic doses of coumarin-derivative anticoagulants
- Concurrent agents with proarrhythmic potential
- Concurrent combination antiretroviral therapy for HIV-positive patients
- Any other concurrent investigational agents or anticancer therapy
Contacts and Locations More Information
No publications provided
| Responsible Party: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00514137 History of Changes |
| Other Study ID Numbers: | NCI-2009-00208, MC058F, CDR0000560703, N01CM62205 |
| Study First Received: | August 8, 2007 |
| Results First Received: | January 30, 2013 |
| Last Updated: | March 22, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Multiple Myeloma Neoplasms, Plasma Cell Neoplasms by Histologic Type Neoplasms Hemostatic Disorders Vascular Diseases Cardiovascular Diseases Paraproteinemias Blood Protein Disorders Hematologic Diseases Hemorrhagic Disorders Lymphoproliferative Disorders |
Immunoproliferative Disorders Immune System Diseases Sunitinib Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Angiogenesis Inhibitors Angiogenesis Modulating Agents Growth Substances Physiological Effects of Drugs Growth Inhibitors |
ClinicalTrials.gov processed this record on May 22, 2013