Multiple MyelomaPhase 1/2NCT00361088
A Combination of Zarnestra With Velcade for Patients With Relapsed Multiple Myeloma
A Phase 1/2 study testing PS-341 and R11577 in people with Multiple Myeloma, run by H. Lee Moffitt Cancer Center and Research Institute at 1 site in United States.
Trial summary
In Phase I, patients will receive a combination of PS-341 (Velcade) and R115777 (Zarnestra) to determine the dose limiting toxicity (DLT). Once DLT is determined, patients in Phase II will be receive the maximum tolerated dose (MTD) to complete 8 cycles of therapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Myeloma
- What is being tested?
- PS-341 and R11577
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2005to Jun 2007
- Phase
- Phase 1/2
- 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
- Voluntary written informed consent
- Female subject is either post-menopausal/surgically sterilized or willing to use an acceptable method of birth control for the duration of the study.
- Male subject agrees to use an acceptable method for contraception for the duration of the study.
- Diagnosis of stage II or III multiple myeloma and have relapsed after at least one prior therapies confirmed by the presence of:
- A new lytic lesion
- A 25% increase in urine or serum monoclonal protein
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- Patient can have received PS-341 (Velcade) previously and does not require a previous response.
- Patients must have measurable disease. One or more of the following must be present to qualify for this study:
- Serum M-component greater than or equal to 1.0 gm/dl (10.0 g/L) by serum protein electrophoresis
- Urine M-protein excretion > 200 mg/24 (0.2 g/24h) hours, by urine protein electrophoresis
- Abnormal serum free light chain ratio with elevated Kappa or Lambda light chains in serum
- Baseline measurements must be done within 21 days of study entry.
- Karnofsky Performance Status Scale > 60.
- Greater than or equal to 18 years of age.
- Expected survival of greater than 8 weeks.
- Swallow intact study medication tablets.
- Can follow directions or has a caregiver who will be responsible for administering study medication.
Who cannot join
- Previously treated with R115777 (Zarnestra).
- Undergone an allogeneic bone marrow transplant.
- A platelet count of <100,000 x 10 to the 9 power/L within 14 days before enrollment.
- Absolute neutrophil count of <1.0 x 10 to the 9 power/L within 14 days before enrollment.
- Measured creatinine > 1.5 X the upper limits of normal within 14 days before enrollment.
- Greater than or equal to Grade 2 peripheral neuropathy within 14 days before enrollment.
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- Hypersensitivity to bortezomib, boron, mannitol or imidazole compounds
- Female subject is pregnant or breast-feeding. Confirmation that the subject is not pregnant must be established by a negative serum beta-human chorionic gonadotropin (beta-hCG) pregnancy test result obtained during screening.
- Received other investigational drugs within 14 days of enrollment or immunotherapy within 30 days of enrollment.
- Serious medical or psychiatric illness likely to interfere with participation in this clinical study.
- Ongoing radiation therapy or radiation therapy within 14 days prior to first treatment.
- Cytotoxic chemotherapy within 30 days prior to first treatment.
- Therapy with high-dose corticosteroids within 14 days prior to first treatment.
- Presence of any of the following excludes a patient from entering the study until such condition is resolved (determined within 14 days prior to the first treatment):
- Elevated total bilirubin > 2mg/dl, or direct bilirubin > 2 times the ULN.
- Serum glutamic oxaloacetic transaminase (AST, formerly SGOT) or serum glutamic pyruvic transaminase (ALT, formerly SGPT) > 2 times the ULN
- Serum calcium > 12 mg/dL.
- Concurrent serious infection.
- Life-threatening illness (unrelated to tumor).
- History of any other ACTIVE and INVASIVE cancer other than the present condition (except non-melanoma skin cancer), unless in complete remission and off of all therapy for that disease for a minimum of 3 years.
- Prohibited/allowable medications or precautions:
- Enzyme-inducing anti-epileptic medications (e.g. phenytoin, phenobarbital, carbamazepine) are not allowed.
- Non-enzyme anti-epileptic medications will be allowed.
Trial locations and contacts
1 site in 1 country.
United States1 site
H. Lee Moffitt Cancer Center & Research Institute
Tampa, Florida, 33612
About this study
Official title: A Dose Escalation of Zarnestra (R115777) Combined With Velcade® (PS-341) in Patients With Relapsed Multiple Myeloma
In Phase I, patients will receive a combination of PS-341 (Velcade) and R115777 (Zarnestra) to determine the dose limiting toxicity (DLT). Once DLT is determined, patients in Phase II will be receive the maximum tolerated dose (MTD) to complete 8 cycles of therapy. Treatment will continue if there is evidence of continued response for 8 cycles. Patients will receive follow up to include normal laboratory evaluations at least every 3 months and a skeletal survey will be performed at least every 6 months.
Read the detailed description
In Phase I, patients will receive intravenous PS-341 (Velcade) and 3 different dose levels of oral R115777 (Zarnestra). Dose Limiting Toxicity (DLT) will be determined over a period of one cycle and dose escalation to the next level will not occur until all patients projected at each level complete one cycle of therapy. Once DLT is determined, patients in Phase I and all patients enrolled for the phase II component will be treated at the maximum tolerated dose (MTD) to complete 8 cycles of therapy. Treatment will continue beyond 8 cycles if there is evidence of continued response. The study regimen will consist of two weeks of treatment followed by one week off for a total cycle duration of three weeks. If disease stabilization occurs (noted on 2 consecutive cycles) after the standard 8 cycles are given, treatment will be discontinued.
Patients are to be monitored for adverse events throughout the treatment phases and for a minimum of 30 days after their last dose of drugs. Follow up will include history and physical exam with laboratory evaluation at least every 3 months. Laboratories will include CMP, CBC, SPEP, UPEP, and quantitative immunoglobulins. A skeletal survey will be performed at least every 6 months.
- Conditions
- Multiple Myeloma
- Being tested
- PS-341, R11577
- Keywords
- Velcade (PS-341), Bortezomib, Zarnestra (R115777), Tipifarnib
- Medical subject headings
- Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PS-341Drug
Also called bortezomib, Velcade®
Phase I and II: 1.3mg/m2 iv days 1,4,8,11
R11577Drug
Also called Zarnestra
Phase I: 100mg po BID days 1014 for Cohort 1, 200mg po BID days 1014 for Cohort 2, 300mg po BID days 1014 for Cohort 3.
Phase II: Maximum Tolerated Dose (MTD)
| Study group | Role | What they receive |
|---|---|---|
| Phase I | Experimental | Not described Receives: Drug: PS-341; Drug: R11577 |
| Phase II | Experimental | Not described Receives: Drug: PS-341; Drug: R11577 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose Limiting Toxicity (DLT)
Determine the dose limiting toxicity at 3 weeks post treatment
Measured: Average of 6 months
Maximum Tolerated Dose
Determine the maximum tolerated dose
Measured: Average of 6 months
Response Rates
Determine response rates after 8 cycles of treatment
Measured: Average of 6 months
Toxicity
Determine toxicity profiles
Measured: Average of 6 months
Secondary outcomes (1)
Progression Free Survival
Determine progression free survival
Measured: Average of 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2006 (estimated)
- Study startAug 2005
- Primary completionJun 2007
- Study completionJun 2007
Why it stopped: Initial Principal Investigator left Moffitt
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple MyelomaStudies of the same condition, open and under way.
- More trials run by H. Lee Moffitt Cancer Center and Research InstituteThe 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 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Millennium Pharmaceuticals, Inc., National Cancer Institute (NCI)
- Investigators
- Melissa Alsina, M.D., Principal investigator, H. Lee Moffitt Cancer Center and Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00361088
- Sponsor's protocol ID
- MCC-13971
- Other IDs
- 7032
- Status last verified
- May 2011
- First submitted
- 3 Aug 2006
- Last updated
- 25 Nov 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Dose Escalation of Zarnestra (R115777) Combined With Velcade® (PS-341) in Patients With Relapsed Multiple Myeloma
- ClinicalTrials.gov ID
- NCT00361088
- Acronym / sponsor ID
- MCC-13971
- Conditions
- Multiple Myeloma
- Keywords
- Velcade (PS-341), Bortezomib, Zarnestra (R115777), Tipifarnib
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Initial Principal Investigator left Moffitt
- Enrolment
- 42 participants (actual)
- Lead sponsor
- H. Lee Moffitt Cancer Center and Research InstituteUniversity, hospital or other
- Collaborators
- Millennium Pharmaceuticals, Inc., National Cancer Institute (NCI)
- Study start
- Aug 2005
- Primary completion
- Jun 2007 (actual)
- Study completion
- Jun 2007 (actual)
- First posted
- 7 Aug 2006 (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.
In Phase I, patients will receive a combination of PS-341 (Velcade) and R115777 (Zarnestra) to determine the dose limiting toxicity (DLT). Once DLT is determined, patients in Phase II will be receive the maximum tolerated dose (MTD) to complete 8 cycles of therapy. Treatment will continue if there is evidence of continued response for 8 cycles. Patients will receive follow up to include normal laboratory evaluations at least every 3 months and a skeletal survey will be performed at least every 6 months.
Detailed description
In Phase I, patients will receive intravenous PS-341 (Velcade) and 3 different dose levels of oral R115777 (Zarnestra). Dose Limiting Toxicity (DLT) will be determined over a period of one cycle and dose escalation to the next level will not occur until all patients projected at each level complete one cycle of therapy. Once DLT is determined, patients in Phase I and all patients enrolled for the phase II component will be treated at the maximum tolerated dose (MTD) to complete 8 cycles of therapy. Treatment will continue beyond 8 cycles if there is evidence of continued response. The study regimen will consist of two weeks of treatment followed by one week off for a total cycle duration of three weeks. If disease stabilization occurs (noted on 2 consecutive cycles) after the standard 8 cycles are given, treatment will be discontinued.
Patients are to be monitored for adverse events throughout the treatment phases and for a minimum of 30 days after their last dose of drugs. Follow up will include history and physical exam with laboratory evaluation at least every 3 months. Laboratories will include CMP, CBC, SPEP, UPEP, and quantitative immunoglobulins. A skeletal survey will be performed at least every 6 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Phase I | Experimental | Drug: PS-341, Drug: R11577 |
| Phase II | Experimental | Drug: PS-341, Drug: R11577 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- Voluntary written informed consent
- Female subject is either post-menopausal/surgically sterilized or willing to use an acceptable method of birth control for the duration of the study.
- Male subject agrees to use an acceptable method for contraception for the duration of the study.
- Diagnosis of stage II or III multiple myeloma and have relapsed after at least one prior therapies confirmed by the presence of:
- Patient can have received PS-341 (Velcade) previously and does not require a previous response.
Key exclusion criteria (23 listed)
- Previously treated with R115777 (Zarnestra).
- Undergone an allogeneic bone marrow transplant.
- A platelet count of <100,000 x 10 to the 9 power/L within 14 days before enrollment.
- Absolute neutrophil count of <1.0 x 10 to the 9 power/L within 14 days before enrollment.
- Measured creatinine > 1.5 X the upper limits of normal within 14 days before enrollment.
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 |
|---|---|---|
| PS-341Also: bortezomib, Velcade®Phase I and II: 1.3mg/m2 iv days 1,4,8,11 | Drug | Phase I, Phase II |
| R11577Also: ZarnestraPhase I: 100mg po BID days 1014 for Cohort 1, 200mg po BID days 1014 for Cohort 2, 300mg po BID days 1014 for Cohort 3. Phase II: Maximum Tolerated Dose (MTD) | Drug | Phase I, Phase II |
Primary outcome
Dose Limiting Toxicity (DLT)
Time frame: Average of 6 months
Determine the dose limiting toxicity at 3 weeks post treatment
Maximum Tolerated Dose
Time frame: Average of 6 months
Determine the maximum tolerated dose
Response Rates
Time frame: Average of 6 months
Determine response rates after 8 cycles of treatment
Toxicity
Time frame: Average of 6 months
Determine toxicity profiles
1 secondary outcome
Progression Free Survival
Time frame: Average of 12 months
Results and safety
The study was stopped early (reason given: Initial Principal Investigator left Moffitt). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Nov 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.
Melissa Alsina, M.D. principal investigator
H. Lee Moffitt Cancer Center and Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing PS-341 and R11577 in people with Multiple Myeloma, run by H. Lee Moffitt Cancer Center and Research Institute 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 17 inclusion and 23 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: stopped early, as of the sponsor's last update on 25 Nov 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 was stopped early (reason given: Initial Principal Investigator left Moffitt). Results are not available in the source record.
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?
Dose Limiting Toxicity (DLT) (time frame: Average of 6 months). The study lists 4 primary outcomes in all. 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 25 Nov 2013.