NCT00514137 · REGISTRY CONDITION SEARCH

Sunitinib in Treating Patients With Relapsed Multiple Myeloma

Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.

Phase: PHASE2
Status at capture: COMPLETED
Registry last update: 2014-05-28

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

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

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baseline

Baseline characteristics

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outcome · POSTED

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

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outcome · POSTED

Event-free Survival

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outcome · POSTED

Duration of Response

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outcome · POSTED

Toxicity

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adverse events

Adverse events

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more info

Limitations, agreements, and source contact

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Who could take part

eligibility Criteria: 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
healthy Volunteers: false
minimum Age: 18 Years
sex: ALL
std Ages: ADULT
OLDER_ADULT

Treatment arms and interventions

arm Groups

description
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.
intervention Names
Drug: sunitinib malate
label
Treatment (kinase inhibitor therapy)
type
EXPERIMENTAL

interventions

arm Group Labels
Treatment (kinase inhibitor therapy)
description
Oral 37.5 mg each day of the 6-week cycle (continuous dosing).
name
sunitinib malate
other Names
SU11248
sunitinib
Sutent
type
DRUG

Study design

allocation

intervention Model

SINGLE_GROUP

masking Info

masking: NONE

primary Purpose

TREATMENT

Enrollment

count: 13
type: ACTUAL

Registered outcome plans (not posted results)

primary Outcomes

description
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.
measure
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

secondary Outcomes

description
The distribution of progression-free survival will be estimated using the method of Kaplan-Meier.
measure
Event-free Survival
time Frame
Time from registration to progression or death due to any cause, assessed up to 3 years
description
The distribution of duration of response will be estimated using the method of Kaplan-Meier.
measure
Duration of Response
time Frame
From the documentation of response until the date of progression
description
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.
measure
Toxicity
time Frame
From the time of first treatment to up to 30 days after the last day of study drug treatment

Full study description

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
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.

Source references

Source notices and limitations

Discovery and provenance

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requested nct id
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primary nct id
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source kind
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source url
https://clinicaltrials.gov/api/v2/studies?query.cond=Plasma+Cell+Neoplasms&filter.advanced=AREA%5BHasResults%5Dtrue&pageSize=1000&format=json&countTotal=true
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query cond
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query disease state id
ds-plasma-cell-neoplasms
source file
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source kind
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source record id
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source string sha256
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source url
https://clinicaltrials.gov/api/v2/studies?query.cond=Plasma+Cell+Neoplasms&filter.advanced=AREA%5BHasResults%5Dtrue&pageSize=1000&format=json&countTotal=true

Preserved source evidence · Not medical advice