Refractory Multiple MyelomaPhase 2NCT00047203
Flavopiridol in Treating Patients With Relapsed or Refractory Multiple Myeloma
A Phase 2 study testing alvocidib 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
Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Phase II trial to study the effectiveness of flavopiridol in treating patients who have relapsed or refractory multiple myeloma 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?
- alvocidib
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2002to Sep 2006
- 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
Who may be able to join
- Diagnosis of relapsed or refractory multiple myeloma (MM) requiring treatment
- Durie-Salmon stage I or greater at diagnosis
- Patients with non-secretory or oligo-secretory MM (defined as maximum urinary M-spike less than 200 mg/24 hours and a maximum serum M-spike less than 0.5 g/dL during entire disease course) must have at least 30% bone marrow plasma cells
- Patients with secretory MM must have measurable disease defined as serum monoclonal protein of at least 1 g/dL or urinary M-spike of at least 200 mg/24 hours
- Must have received at least 1, but no more than 5 prior therapy regimens
- Patients who have had 4 or 5 regimens are allowed provided corticosteroids and/or thalidomide are part of the regimens
Show all 35Show fewer
- No more than 5 prior chemotherapy regimens (as long as 2 contained dexamethasone or thalidomide)
- Prior autologous peripheral blood stem cell transplantation is considered 1 prior regimen
- Performance status - ECOG 0-2
- Performance status - ECOG 0-3 if secondary to neuropathy or acute bone event (e.g., vertebral compression or rib fracture)
- Absolute neutrophil count at least 750/mm^3
- Bilirubin no greater than 1.5 times upper limit of normal (ULN)
- Alkaline phosphatase no greater than 2.5 times ULN
- AST no greater than 2.5 times ULN
- Creatinine no greater than 3 mg/dL
- No myocardial infarction within the past 6 months
- Peripheral neuropathy secondary to prior drug therapy or myeloma-associated neuropathy allowed
- No other uncontrolled serious medical condition
- No uncontrolled infection
- No other active malignancy
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- See Disease Characteristics
- No prior allogeneic stem cell transplantation
- At least 10 days since prior thalidomide
- No concurrent biologic therapy
- See Disease Characteristics
- At least 2 weeks since prior myelosuppressive chemotherapy
- No other concurrent chemotherapy
- See Disease Characteristics
- No concurrent corticosteroids (including as antiemetics) except chronic corticosteroids for disorders other than myeloma (e.g., rheumatoid arthritis or adrenal insufficiency)
- Maximum dose allowed for prednisone is no more than 10 mg/day or hydrocortisone no more than 40 mg/day
- At least 10 days since prior bortezomib or tipifarnib
- Concurrent bisphosphonates allowed if on stable dose before study entry
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase II Study of Flavopiridol in Patients With Relapsed and Refractory Multiple Myeloma
Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Phase II trial to study the effectiveness of flavopiridol in treating patients who have relapsed or refractory multiple myeloma
Read the detailed description
PRIMARY OBJECTIVES:
- Determine the response rate in patients with relapsed or refractory multiple myeloma treated with flavopiridol.
II. Determine the disease-free survival and overall survival of patients treated with this drug.
III. Correlate disease response with t(11;14)(q13;q32) rearrangement, p16 methylation status, and BCRP expression in patients treated with this drug.
IV. Correlate disease response and drug treatment with cell cycle status and effects on apoptosis and apoptosis regulatory proteins in these patients.
OUTLINE: This is a multicenter study.
Patients receive flavopiridol IV over 1 hour on days 1-3. Courses repeat every 21 days for up to 12 months in the absence of disease progression or unacceptable toxicity. After 12 months, patients achieving at least a partial response may continue treatment in the absence of disease progression or unacceptable toxicity.
Patients are followed every 6 months for 1 year.
- Conditions
- Refractory Multiple Myeloma, Stage I Multiple Myeloma, Stage II Multiple Myeloma, Stage III Multiple Myeloma
- Being tested
- alvocidib
- Medical subject headings
- Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
alvocidibDrug
Also called FLAVO, flavopiridol, HMR 1275, L-868275
Given IV
| Study group | Role | What they receive |
|---|---|---|
| Treatment (flavopiridol) | Experimental | Patients receive flavopiridol IV over 1 hour on days 1-3. Courses repeat every 21 days for up to 12 months in the absence of disease progression or unacceptable toxicity. After 12 months, patients achieving at least a partial response may continue treatment in the absence of disease progression or unacceptable toxicity. Receives: Drug: alvocidib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Confirmed response (CR, VGPR, or PR) defined as a patient who has achieved response and maintained it on two consecutive evaluations at least 4 weeks apart.
Ninety percent confidence intervals for the true success proportion will be calculated assuming a binomial distribution.
Measured: First 3 months of treatment
Secondary outcomes (2)
Overall survival time
The distribution of survival time will be estimated using the method of Kaplan-Meier.
Measured: Time from registration to death due to any cause, assessed up to 1 year
Time to disease progression
The distribution of time to progression will be estimated using the method of Kaplan-Meier.
Measured: Time from registration to documentation of disease progression, assessed up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2003 (estimated)
- Study startSep 2002
- Primary completionSep 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Angela Dispenzieri, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00047203
- Sponsor's protocol ID
- NCI-2012-02496
- Other IDs
- MC018B, N01CM17104, CDR0000257567
- Status last verified
- Jan 2013
- First submitted
- 3 Oct 2002
- Last updated
- 16 Jan 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study of Flavopiridol in Patients With Relapsed and Refractory Multiple Myeloma
- ClinicalTrials.gov ID
- NCT00047203
- Acronym / sponsor ID
- NCI-2012-02496
- 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
- 35 participants (actual)
- Lead sponsor
- National Cancer Institute (NCI)US National Institutes of Health
- Study start
- Sep 2002
- Primary completion
- Sep 2006 (actual)
- First posted
- 27 Jan 2003 (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.
Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Phase II trial to study the effectiveness of flavopiridol in treating patients who have relapsed or refractory multiple myeloma
Detailed description
PRIMARY OBJECTIVES:
- Determine the response rate in patients with relapsed or refractory multiple myeloma treated with flavopiridol.
II. Determine the disease-free survival and overall survival of patients treated with this drug.
III. Correlate disease response with t(11;14)(q13;q32) rearrangement, p16 methylation status, and BCRP expression in patients treated with this drug.
IV. Correlate disease response and drug treatment with cell cycle status and effects on apoptosis and apoptosis regulatory proteins in these patients.
OUTLINE: This is a multicenter study.
Patients receive flavopiridol IV over 1 hour on days 1-3. Courses repeat every 21 days for up to 12 months in the absence of disease progression or unacceptable toxicity. After 12 months, patients achieving at least a partial response may continue treatment in the absence of disease progression or unacceptable toxicity.
Patients are followed every 6 months for 1 year.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment (flavopiridol) | Experimental | Drug: alvocidibPatients receive flavopiridol IV over 1 hour on days 1-3. Courses repeat every 21 days for up to 12 months in the absence of disease progression or unacceptable toxicity. After 12 months, patients achieving at least a partial response may continue treatment 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 (35 listed)
- Diagnosis of relapsed or refractory multiple myeloma (MM) requiring treatment
- Must have received at least 1, but no more than 5 prior therapy regimens
- Performance status - ECOG 0-2
- Performance status - ECOG 0-3 if secondary to neuropathy or acute bone event (e.g., vertebral compression or rib fracture)
- Absolute neutrophil count at least 750/mm^3
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| alvocidibAlso: FLAVO, flavopiridol, HMR 1275, L-868275Given IV | Drug | Treatment (flavopiridol) |
Primary outcome
Confirmed response (CR, VGPR, or PR) defined as a patient who has achieved response and maintained it on two consecutive evaluations at least 4 weeks apart.
Time frame: First 3 months of treatment
Ninety percent confidence intervals for the true success proportion will be calculated assuming a binomial distribution.
2 secondary outcomes
Overall survival time
Time frame: Time from registration to death due to any cause, assessed up to 1 year
Time to disease progression
Time frame: Time from registration to documentation of disease progression, assessed up to 1 year
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 Jan 2013.
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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.
Angela Dispenzieri 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 alvocidib 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 35 inclusion and 0 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 16 Jan 2013. 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?
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 (CR, VGPR, or PR) defined as a patient who has achieved response and maintained it on two consecutive evaluations at least 4 weeks apart. (time frame: First 3 months of treatment). 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 Jan 2013.