Multiple Myeloma and Plasma Cell NeoplasmPhase 2NCT00618345
Everolimus in Treating Patients With Relapsed or Refractory Multiple Myeloma
A Phase 2 study testing everolimus, DNA analysis and protein analysis in people with Multiple Myeloma and Plasma Cell Neoplasm, run by Mayo Clinic.
Trial summary
RATIONALE: Everolimus 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. PURPOSE: This phase II trial is studying how well everolimus works in treating patients with relapsed or refractory multiple myeloma. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Myeloma and Plasma Cell Neoplasm
- What is being tested?
- everolimus, DNA analysis and protein analysis
- Type of treatment
- Surgery or procedure
- How many people
- 35 participants
- Where
- No sites listed yet
- Study dates
- Mar 2005to Aug 2008
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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
DISEASE CHARACTERISTICS:
- Diagnosis of multiple myeloma, meeting 1 of the following criteria:
- Monoclonal protein in the serum of ≥ 1 g/dL
- Monoclonal light chain in the urine protein electrophoresis of ≥ 200 mg/24 hours
- Measurable light chains by free light chain assay of ≥ 10 mg/dL
- Measurable plasmacytoma
- Must have received prior therapy and have relapsed or refractory disease
PATIENT CHARACTERISTICS:
- ECOG performance status 0-2
- Life expectancy ≥ 12 weeks
- ANC ≥ 1,000/mm³
- Platelet count ≥ 75,000/mm³
- Hemoglobin ≥ 8.0 g/dL
- Total bilirubin ≤ 2.0 mg/dL (if total bilirubin is elevated, direct bilirubin must be normal)
- AST ≤ 3 times upper limit of normal (ULN)
- Creatinine ≤ 1.5 times ULN
- Calcium < 11 mg/dL
- No uncontrolled infection
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No HIV positivity
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- At least 3 weeks since prior cytotoxic chemotherapy
- At least 2 weeks since prior biologic therapy or radiotherapy
- At least 2 weeks since prior corticosteroids
- Concurrent chronic corticosteroids allowed for treatment of disorders other than myeloma
- No other concurrent chemotherapy, immunotherapy, radiotherapy, or any ancillary therapy considered investigational
About this study
Official title: Phase II Trial of RAD001 in Relapsed/Refractory Multiple Myeloma
RATIONALE: Everolimus 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.
PURPOSE: This phase II trial is studying how well everolimus works in treating patients with relapsed or refractory multiple myeloma.
Read the detailed description
OBJECTIVES:
Primary
- To assess the response rate in patients with relapsed or refractory multiple myeloma treated with everolimus.
Secondary
- To evaluate the toxicity of everolimus in patients with multiple myeloma.
- To study the tumor cells and blood from patients entering this trial for laboratory correlates.
OUTLINE: Patients receive oral everolimus once daily on days 1-28. Treatment repeats every 4 weeks for up to 12 courses in the absence of disease progression or unacceptable toxicity.
Patients undergo bone marrow aspirate, biopsy, and blood sample collections periodically. Samples are assessed for the following: cyclin D1, phospho-AKT, phospho-p70 S6 kinase, and phospho-S6 by western blot; checkpoint regulators PTEN, p53, pRB, and p27 by immunoblotting; p53, Rb, p16, PTEN, p27, and cyclin D1 by DNA analysis; caspases 3 and 9 by immunoblotting and Annexin/PI by flow cytometry; unknown molecular markers by protein profiling; and microvessel density.
After completion of study treatment, patients are followed every 3-6 months for up to 2 years.
- Being tested
- everolimus, DNA analysis, protein analysis, western blotting, flow cytometry
- Keywords
- refractory multiple myeloma
- Medical subject headings
- Multiple Myeloma, Neoplasms, Plasma Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
everolimusDrug
DNA analysisGenetic
protein analysisGenetic
western blottingGenetic
flow cytometryOther
laboratory biomarker analysisOther
biopsyProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Confirmed response (complete response, very good partial response, partial response, or minimal response) of serum and urine monoclonal protein
Secondary outcomes (1)
Toxicity
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2008 (estimated)
- Study startMar 2005
- Primary completionOct 2006
- Study completionAug 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple Myeloma and Plasma Cell NeoplasmStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe 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
- Masking
- None (open label)
- Enrolment
- 35 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Investigators
- Thomas E. Witzig, MD, Study chair, Mayo ClinicRafael Fonseca, MD, Principal investigator, Mayo ClinicRoy Vivek, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00618345
- Sponsor's protocol ID
- CDR0000582257
- Other IDs
- P30CA015083, MC048E, 96-05
- Status last verified
- May 2011
- First submitted
- 19 Feb 2008
- Last updated
- 16 May 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Trial of RAD001 in Relapsed/Refractory Multiple Myeloma
- ClinicalTrials.gov ID
- NCT00618345
- Acronym / sponsor ID
- CDR0000582257
- Keywords
- refractory multiple myeloma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (estimated)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Mar 2005
- Primary completion
- Oct 2006 (actual)
- Study completion
- Aug 2008 (actual)
- First posted
- 20 Feb 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
RATIONALE: Everolimus 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.
PURPOSE: This phase II trial is studying how well everolimus works in treating patients with relapsed or refractory multiple myeloma.
Detailed description
OBJECTIVES:
Primary
- To assess the response rate in patients with relapsed or refractory multiple myeloma treated with everolimus.
Secondary
- To evaluate the toxicity of everolimus in patients with multiple myeloma.
- To study the tumor cells and blood from patients entering this trial for laboratory correlates.
OUTLINE: Patients receive oral everolimus once daily on days 1-28. Treatment repeats every 4 weeks for up to 12 courses in the absence of disease progression or unacceptable toxicity.
Patients undergo bone marrow aspirate, biopsy, and blood sample collections periodically. Samples are assessed for the following: cyclin D1, phospho-AKT, phospho-p70 S6 kinase, and phospho-S6 by western blot; checkpoint regulators PTEN, p53, pRB, and p27 by immunoblotting; p53, Rb, p16, PTEN, p27, and cyclin D1 by DNA analysis; caspases 3 and 9 by immunoblotting and Annexin/PI by flow cytometry; unknown molecular markers by protein profiling; and microvessel density.
After completion of study treatment, patients are followed every 3-6 months for up to 2 years.
Study design
- Primary purpose
- Treatment
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| everolimus | Drug | – |
| DNA analysis | Genetic | – |
| protein analysis | Genetic | – |
| western blotting | Genetic | – |
| flow cytometry | Other | – |
| laboratory biomarker analysis | Other | – |
| biopsy | Procedure or surgery | – |
Primary outcome
Confirmed response (complete response, very good partial response, partial response, or minimal response) of serum and urine monoclonal protein
1 secondary outcome
Toxicity
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2011.
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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.
Thomas E. Witzig, MD study chair
Mayo Clinic
Rafael Fonseca, MD principal investigator
Mayo Clinic
Roy Vivek, MD principal investigator
Mayo Clinic
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing everolimus, DNA analysis and protein analysis in people with Multiple Myeloma and Plasma Cell Neoplasm, run by Mayo Clinic.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 16 May 2011. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Confirmed response (complete response, very good partial response, partial response, or minimal response) of serum and urine monoclonal protein. 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 16 May 2011.