A Phase 2 interventional study of perifosine and dexamethasone in Multiple Myeloma, sponsored by AEterna Zentaris. Completed at 7 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-02-28.
Sponsored by AEterna Zentaris · Phase 2, Interventional, and Treatment
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.
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.
3,632 studies on the registry are indexed under Multiple Myeloma; 745 are open to participants now.
This study's enrollment of 67 is above the median of 41 across 2,907 interventional studies indexed under Multiple Myeloma.
Browse Multiple Myeloma studies →AEterna Zentaris is the lead sponsor of 34 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Major criteria:
Minor criteria:
Any of the following sets of criteria will confirm the diagnosis of multiple myeloma:
Exclusion Criteria:
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
Drug: perifosine
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.
Drug: perifosine · Drug: dexamethasone
100 - 150 mg daily
Also known as: D-21266, KRX-0401
20 mg twice weekly
Also known as: decadron
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.
Time frame: Every 3 weeks
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.
Time frame: 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.
Time frame: 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.
Time frame: Every 3 weeks
This study is completed, as verified in Feb 2012. You cannot join it, but the record below documents what was studied.
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AEterna Zentaris