Multiple MyelomaPhase 2NCT00375791
Efficacy of Perifosine Alone and in Combination With Dexamethasone for Patients With Multiple Myeloma
A Phase 2 study testing perifosine and dexamethasone in people with Multiple Myeloma, run by AEterna Zentaris at 7 sites in United States.
Trial summary
This is a phase 2 study of perifosine in patients with multiple myeloma. Patients will receive perifosine 150 mg at bedtime (qhs) daily. Patients will be assessed by serum and/or urine-electrophoresis at least every 3 weeks. 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?
- perifosine and dexamethasone
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 67 participants
- Where
- 7 sitesUnited States
- Study dates
- Dec 2005to Oct 2011
- 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
- Major criteria:
- Plasmacytomas on tissue biopsy.
- Bone marrow plasmacytosis (> 30% plasma cells).
- Monoclonal immunoglobulin spike on serum electrophoresis immunoglobulin G (IgG) > 3.5 g/dL or immunoglobulin A (IgA) > 2.0 g/dL; kappa or lambda light chain excretion > 1 g/day on 24 hour urine protein electrophoresis.
- Minor criteria:
- Bone marrow plasmacytosis (10 to 30% plasma cells)
Show all 14Show fewer
- Monoclonal immunoglobulin present but of lesser magnitude than given under major criteria
- Lytic bone lesions
- Normal immunoglobulin M (IgM) < 50 mg/dL, IgA < 100 mg/dL or IgG < 600 mg/dL.
- Any of the following sets of criteria will confirm the diagnosis of multiple myeloma:
- Any two of the major criteria.
- Major criterion 1 plus minor criterion b, c or d.
- Major criterion 3 plus minor criterion a or c.
- Minor criteria a, b and c or a, b and d.
Who cannot join
- Renal insufficiency (serum creatinine levels > 3 mg/dL).
- Patients who present with either ALT or AST ≥ 2.5 X upper limit of normal.
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to perifosine (miltefosine or edelfosine).
- Concomitant therapy medications that include corticosteroids (except as indicated for other medical conditions, or up to 100 mgs of hydrocortisone as premedication for administration of certain medications or blood products) or other chemotherapy that is or may be active against myeloma, or therapy with chemotherapy within 3 weeks prior to Day 1. Nitrosoureas must be discontinued 6 weeks prior to Day 1.
- Subjects with a hemoglobin < 8.0 g/dL.
- Any condition, including laboratory abnormalities, that in the opinion of the Investigator, places the subject at unacceptable risk if he/she were to participate in the study.
- Women of childbearing potential (WCBP) who are pregnant, or breast-feeding or men and women who are not using adequate contraception are excluded.
- Plasma cell leukemia.
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
Investigative Site
Ann Arbor, Michigan, 48103
Investigative Site
Atlanta, Georgia, 30322
Investigative Site
Berkeley, California, 94704
Investigative Site
Boston, Massachusetts, 02115
Investigative Site
Charlottesville, Virginia, 22908
Investigative Site
Chicago, Illinois, 60611
Investigative Site
Duarte, California, 91010
About this study
Official title: An Open-Label Phase II Study of the Safety and Efficacy of Perifosine Alone and in Combination With Dexamethasone for Patients With Relapsed or Relapsed/Refractory Multiple Myeloma
This is a phase 2 study of perifosine in patients with multiple myeloma. Patients will receive perifosine 150 mg at bedtime (qhs) daily. Patients will be assessed by serum and/or urine-electrophoresis at least every 3 weeks.
Read the detailed description
Treatment: Patients will take three 50 mg tablets of perifosine qhs daily with food. All patients should continue therapy unless disease progression is documented on two occasions at least 1 week apart. Progressing patients will have dexamethasone 20 mg twice per week added to the perifosine. Patients who experience toxicity may continue on treatment with doses delayed or reduced.
Evaluations: Serum and/or urine-electrophoresis will be evaluated for progression or response at 3 week intervals.
This study will enroll a total of up to 64 patients.
- Conditions
- Multiple Myeloma
- Being tested
- perifosine, dexamethasone
- Keywords
- Relapsed Multiple Myeloma, Refractory Multiple Myeloma
- Medical subject headings
- Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
perifosineDrug
Also called D-21266, KRX-0401
100 - 150 mg daily
dexamethasoneDrug
Also called decadron
20 mg twice weekly
| Study group | Role | What they receive |
|---|---|---|
| Perifosine daily | Experimental | Patients will take three 50 mg tablets of perifosine daily at bedtime with food. Patients will be examined every three weeks. If patients have no progression it is allowed to receive 8 cycles of perifosine Receives: Drug: perifosine |
| Perifosine daily + Dexa twice per week | Experimental | Patients will take three 50 mg tablets of perifosine daily at bedtime with food until progression. If progressive disease is confirmed by a second measurement at least one week later the patient will receive a combination of 20 mg twice per week dexamethasone (dexa) and 150 mg perifosine daily at bedtime. Receives: Drug: perifosine; Drug: dexamethasone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Response rate (the combined CR + PR + MR) with treatment perifosine
To determine the response rate (the combined Complete Response (CR) + Partial Response (PR) + Minor Response (MR) following treatment with perifosine in patients with multiple myeloma who have relapsed following Initial front-line therapy and are refractory to their most recent therapy.
Measured: Every 3 weeks
Secondary outcomes (3)
Response rate (CR + PR + MR) with combination therapy
To determine the response rate (CR + PR + MR) following treatment with combination therapy with perifosine plus dexamethasone in patients with multiple myeloma who have relapsed or were refractory to their most recent therapy before study enrollment, and failed to respond to or have relapsed following treatment with perifosine alone.
Measured: Every 3 weeks
Assess the safety and tolerability of perifosine alone and in combination
To assess the safety and tolerability of perifosine alone and in combination with dexamethasone in patients with multiple myeloma.
Measured: Every 3 weeks
Obtain correlative data in patients with multiple myeloma treated with perifosine and in combination
To obtain correlative data in patients with multiple myeloma treated with perifosine alone and in combination with dexamethasone.
Measured: Every 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2006 (estimated)
- Study startDec 2005
- Primary completionDec 2010
- Study completionOct 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Multiple MyelomaStudies of the same condition, open and under way.
- 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
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 67 participants (actual)
Sponsor and investigators
- Lead sponsor
- AEterna Zentaris
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Paul Richardson, M.D, Principal investigator, Dana-Farber Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00375791
- Sponsor's protocol ID
- Perifosine 212
- Status last verified
- Feb 2012
- First submitted
- 11 Sep 2006
- Last updated
- 28 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
Blood (ASH Annual Meeting Abstracts) 2007 110: Abstract 1164 © 2007 American Society of Hematology
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label Phase II Study of the Safety and Efficacy of Perifosine Alone and in Combination With Dexamethasone for Patients With Relapsed or Relapsed/Refractory Multiple Myeloma
- ClinicalTrials.gov ID
- NCT00375791
- Acronym / sponsor ID
- Perifosine 212
- Conditions
- Multiple Myeloma
- Keywords
- Relapsed Multiple Myeloma, Refractory Multiple Myeloma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 67 participants (actual)
- Lead sponsor
- AEterna ZentarisIndustry (pharma, biotech, devices)
- Study start
- Dec 2005
- Primary completion
- Dec 2010 (actual)
- Study completion
- Oct 2011 (actual)
- First posted
- 13 Sep 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.
This is a phase 2 study of perifosine in patients with multiple myeloma. Patients will receive perifosine 150 mg at bedtime (qhs) daily. Patients will be assessed by serum and/or urine-electrophoresis at least every 3 weeks.
Detailed description
Treatment: Patients will take three 50 mg tablets of perifosine qhs daily with food. All patients should continue therapy unless disease progression is documented on two occasions at least 1 week apart. Progressing patients will have dexamethasone 20 mg twice per week added to the perifosine. Patients who experience toxicity may continue on treatment with doses delayed or reduced.
Evaluations: Serum and/or urine-electrophoresis will be evaluated for progression or response at 3 week intervals.
This study will enroll a total of up to 64 patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Perifosine daily | Experimental | Drug: perifosinePatients will take three 50 mg tablets of perifosine daily at bedtime with food. Patients will be examined every three weeks. If patients have no progression it is allowed to receive 8 cycles of perifosine |
| Perifosine daily + Dexa twice per week | Experimental | Drug: perifosine, Drug: dexamethasonePatients will take three 50 mg tablets of perifosine daily at bedtime with food until progression. If progressive disease is confirmed by a second measurement at least one week later the patient will receive a combination of 20 mg twice per week dexamethasone (dexa) and 150 mg perifosine daily at bedtime. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Plasmacytomas on tissue biopsy.
- Bone marrow plasmacytosis (> 30% plasma cells).
- Monoclonal immunoglobulin spike on serum electrophoresis immunoglobulin G (IgG) > 3.5 g/dL or immunoglobulin A (IgA) > 2.0 g/dL; kappa or lambda light chain excretion > 1 g/day on 24 hour urine protein electrophoresis.
- Bone marrow plasmacytosis (10 to 30% plasma cells)
- Monoclonal immunoglobulin present but of lesser magnitude than given under major criteria
Key exclusion criteria (8 listed)
- Renal insufficiency (serum creatinine levels > 3 mg/dL).
- Patients who present with either ALT or AST ≥ 2.5 X upper limit of normal.
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to perifosine (miltefosine or edelfosine).
- Concomitant therapy medications that include corticosteroids (except as indicated for other medical conditions, or up to 100 mgs of hydrocortisone as premedication for administration of certain medications or blood products) or other chemotherapy that is or may be active against myeloma, or therapy with chemotherapy within 3 weeks prior to Day 1. Nitrosoureas must be discontinued 6 weeks prior to Day 1.
- Subjects with a hemoglobin < 8.0 g/dL.
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 |
|---|---|---|
| perifosineAlso: D-21266, KRX-0401100 - 150 mg daily | Drug | Perifosine daily, Perifosine daily + Dexa twice per week |
| dexamethasoneAlso: decadron20 mg twice weekly | Drug | Perifosine daily + Dexa twice per week |
Primary outcome
Response rate (the combined CR + PR + MR) with treatment perifosine
Time frame: Every 3 weeks
To determine the response rate (the combined Complete Response (CR) + Partial Response (PR) + Minor Response (MR) following treatment with perifosine in patients with multiple myeloma who have relapsed following Initial front-line therapy and are refractory to their most recent therapy.
3 secondary outcomes
Response rate (CR + PR + MR) with combination therapy
Time frame: Every 3 weeks
Assess the safety and tolerability of perifosine alone and in combination
Time frame: Every 3 weeks
Obtain correlative data in patients with multiple myeloma treated with perifosine and in combination
Time frame: Every 3 weeks
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 28 Feb 2018.
- Results publicationBlood (ASH Annual Meeting Abstracts) 2007 110: Abstract 1164 © 2007 American Society of Hematology
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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.
Paul Richardson, M.D principal investigator
Dana-Farber Cancer Institute
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing perifosine and dexamethasone in people with Multiple Myeloma, run by AEterna Zentaris at 7 sites 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 14 inclusion and 8 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 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites 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?
Response rate (the combined CR + PR + MR) with treatment perifosine (time frame: Every 3 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00375791, which also lists 1 linked publication.
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 Feb 2018.