Refractory Multiple MyelomaPhase 2NCT00514137
Sunitinib in Treating Patients With Relapsed Multiple Myeloma
A Phase 2 study testing sunitinib malate in people with Refractory Multiple Myeloma and Stage I Multiple Myeloma, run by National Cancer Institute (NCI) at 1 site in United States.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Refractory Multiple Myeloma, Stage I Multiple Myeloma, Stage II Multiple Myeloma
- What is being tested?
- sunitinib malate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2007to Aug 2010
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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%
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Mayo Clinic Cancer Research Consortium
Rochester, Minnesota, 55905
About this study
Official title: A Phase II Trial of Sunitinib (SU11248) in Multiple Myeloma
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
Read the detailed description
PRIMARY OBJECTIVES:
- To assess the number of responses in patients with relapsed multiple myeloma treated with sunitinib (sunitinib malate).
SECONDARY OBJECTIVES:
- 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.
- Conditions
- Refractory Multiple Myeloma, Stage I Multiple Myeloma, Stage II Multiple Myeloma, Stage III Multiple Myeloma
- Being tested
- sunitinib malate
- Medical subject headings
- Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sunitinib malateDrug
Also called SU11248, sunitinib, Sutent
Oral 37.5 mg each day of the 6-week cycle (continuous dosing).
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: sunitinib malate |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Every 6 weeks from the first initiation of therapy up to 72 weeks
Secondary outcomes (3)
Event-free Survival
The distribution of progression-free survival will be estimated using the method of Kaplan-Meier.
Measured: Time from registration to progression or death due to any cause, assessed up to 3 years
Duration of Response
The distribution of duration of response will be estimated using the method of Kaplan-Meier.
Measured: From the documentation of response until the date of progression
Toxicity
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.
Measured: From the time of first treatment to up to 30 days after the last day of study drug treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2007 (estimated)
- Study startSep 2007
- Primary completionMar 2009
- Study completionAug 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Refractory Multiple MyelomaStudies of the same condition, open and under way.
- More trials run by National Cancer Institute (NCI)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Shaji Kumar, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00514137
- Sponsor's protocol ID
- NCI-2009-00208
- Other IDs
- MC058F, CDR0000560703, N01CM62205
- Status last verified
- Mar 2013
- First submitted
- 8 Aug 2007
- Last updated
- 28 May 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Trial of Sunitinib (SU11248) in Multiple Myeloma
- ClinicalTrials.gov ID
- NCT00514137
- Acronym / sponsor ID
- NCI-2009-00208
- Conditions
- Refractory Multiple Myeloma, Stage I Multiple Myeloma, Stage II Multiple Myeloma, Stage III Multiple Myeloma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- National Cancer Institute (NCI)US National Institutes of Health
- Study start
- Sep 2007
- Primary completion
- Mar 2009 (actual)
- Study completion
- Aug 2010 (actual)
- First posted
- 9 Aug 2007 (estimated)
- Results
- Posted 6 Mar 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- To assess the number of responses in patients with relapsed multiple myeloma treated with sunitinib (sunitinib malate).
SECONDARY OBJECTIVES:
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment (kinase inhibitor therapy) | Experimental | Drug: sunitinib malatePatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (22 listed)
- Diagnosis of relapsed multiple myeloma
- Measurable disease as defined by at least one of the following:
- 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
Key exclusion criteria (19 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| sunitinib malateAlso: SU11248, sunitinib, SutentOral 37.5 mg each day of the 6-week cycle (continuous dosing). | Drug | Treatment (kinase inhibitor therapy) |
Primary outcome
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.
3 secondary outcomes
Event-free Survival
Time frame: Time from registration to progression or death due to any cause, assessed up to 3 years
Duration of Response
Time frame: From the documentation of response until the date of progression
Toxicity
Time frame: From the time of first treatment to up to 30 days after the last day of study drug treatment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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A Study to Evaluate Mezigdomide, Bortezomib and Dexamethasone (MEZIVd) Versus Pomalidomide, Bortezomib and Dexamethasone (PVd) in Participants With Relapsed or Refractory Multiple Myeloma (RRMM)
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Radioimmunotherapy (111Indium/225Actinium-DOTA-daratumumab) for the Treatment of Relapsed/Refractory Multiple Myeloma
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shaji Kumar principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing sunitinib malate in people with Refractory Multiple Myeloma and Stage I Multiple Myeloma, run by National Cancer Institute (NCI) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 22 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 May 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 6 Mar 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 May 2014.