Sunitinib in Treating Patients With Relapsed Multiple Myeloma

NCT00514137 | Completed Phase 2 Results DMC

• 4 other identifiers: NCI-2009-00208MC058FCDR0000560703N01CM62205
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Refractory Multiple Myeloma; Stage I Multiple Myeloma; Stage II Multiple Myeloma; Stage III Multiple Myeloma

Outcome Measures

Primary Outcomes (1)

• The Number of Confirmed Responses (Complete Response [CR], Very Good Partial Response [VGPR], or Partial Response [PR])

  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.

  Every 6 weeks from the first initiation of therapy up to 72 weeks

Secondary Outcomes (3)

• Event-free Survival

  Time from registration to progression or death due to any cause, assessed up to 3 years

• Duration of Response

  From the documentation of response until the date of progression

• Toxicity

  From the time of first treatment to up to 30 days after the last day of study drug treatment

Study Arms (1)

Treatment (kinase inhibitor therapy)

EXPERIMENTAL

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

Interventions

sunitinib malate DRUG

Oral 37.5 mg each day of the 6-week cycle (continuous dosing).

Also known as: SU11248, sunitinib, Sutent

Treatment (kinase inhibitor therapy)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (1)

Mayo Clinic Cancer Research Consortium

Rochester, Minnesota, 55905, United States

Location

MeSH Terms

Conditions

Multiple Myeloma

Interventions

Sunitinib

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Results Point of Contact

• Title: Shaji Kumar, M.D.
• Organization: Mayo Clinic Cancer Center

kumar.shaji@mayo.edu

Study Officials

• Shaji Kumar

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 8, 2007
• First Posted: August 9, 2007
• Study Start: September 1, 2007
• Primary Completion: March 1, 2009
• Study Completion: August 1, 2010
• Last Updated: May 28, 2014
• Results First Posted: March 6, 2013

Record last verified: 2013-03

Locations

US (1)