Ignite Creation Date:
2024-05-05 @ 11:42 AM
Last Modification Date:
2024-10-26 @ 9:12 AM
Study NCT ID:
NCT00116961
Status:
COMPLETED
Last Update Posted:
2012-02-07
First Post:
2005-06-30
Brief Title:
Velcade Doxil and Dexamethasone VDd as First Line Therapy for Multiple Myeloma
Sponsor:
University of Michigan Rogel Cancer Center
Organization:
University of Michigan Rogel Cancer Center
Study Overview
Official Title:
A Phase II Study of Combination of Velcade Doxil and Dexamethasone VDd as First Line Therapy for Multiple Myeloma
Status:
COMPLETED
Status Verified Date:
2012-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a research study for patients with newly diagnosed multiple myeloma Multiple myeloma remains a non-curable disease however newer medications and their combinations appear to provide higher response rates and higher complete response rates than current treatment options One of the new medications in multiple myeloma is Velcade Preliminary results from a study using a combination of Velcade with Doxil have shown high response rates disease reduction Preliminary results also show that an addition of dexamethasone to Velcade in patients not responding to Velcade alone showed improved response rates This study involves treatment with a new combination of three standard medications Velcade Doxil and dexamethasone VDd combination The proposed combination of all three drugs may improve efficacy and response
Velcade is approved by the Food and Drug Administration FDA for treatment in multiple myeloma patients who have received at least two prior therapies and have demonstrated disease progression on the last therapy Velcade is still currently under investigation for other indications Doxil is not approved for use in multiple myeloma but is an approved drug for use in patients with some other cancers Several published clinical trials provide evidence that Doxil is an active agent in multiple myeloma and it is used in treatment combinations for multiple myeloma in general practice Dexamethasone is a standard therapy for multiple myeloma but is not approved by the FDA for that use The combination of all three drugs is experimental not FDA approved
The goals of this study are to determine if this new combination therapy with Velcade Doxil and dexamethasone is an effective treatment and also to determine the side effects that occur when this combination treatment is given
Velcade is approved by the Food and Drug Administration FDA for treatment in multiple myeloma patients who have received at least two prior therapies and have demonstrated disease progression on the last therapy Velcade is still currently under investigation for other indications Doxil is not approved for use in multiple myeloma but is an approved drug for use in patients with some other cancers Several published clinical trials provide evidence that Doxil is an active agent in multiple myeloma and it is used in treatment combinations for multiple myeloma in general practice Dexamethasone is a standard therapy for multiple myeloma but is not approved by the FDA for that use The combination of all three drugs is experimental not FDA approved
The goals of this study are to determine if this new combination therapy with Velcade Doxil and dexamethasone is an effective treatment and also to determine the side effects that occur when this combination treatment is given
Detailed Description:
Multiple myeloma remains a non-curable disease Initial therapy with one of the commonly used regimens such as thalidomide with dexamethasone VAD dexamethasone pulses and melphalan with prednisone results in at least partial response PR in approximately 50-75 of patients Complete responses CRs with any of these regimens are uncommon A proportion of patients will have further improvement of response after autologous stem cell transplant which usually follows initial therapy However virtually all patients will eventually relapse and will require re-treatment Emerging data suggests that achieving CR or near CR after transplantation will result in a more durable remission and longer survival It is not clear whether CR in response to initial therapy and prior to transplant may have similar impacts on overall outcomes
Newer agents and their combinations appear to provide higher response rates and higher CR rates One of the new active agents in multiple myeloma is Velcade bortezomib formerly known as PS-341 This molecule has a novel mechanism of action by specifically inhibiting the proteasome In a reported phase II trial Velcade as a single agent induced at least minimal responses MR in 35 of patients and CR in 4 of patients and at least a stabilization of the disease in 59 of patients with heavily pretreated relapsedrefractory multiple myeloma using strict SWOG criteria Velcade alone is superior than dexamethasone pulses in a phase III randomized study in patients with at least one but no more than 3 lines of therapy Preliminary reports indicate that combinations of Velcade with other active anti-myeloma agents appear to provide superior outcomes than Velcade alone An additional 18 of patients responded when dexamethasone was combined with Velcade in a patient population refractory to Velcade alone Velcade with Doxil was shown to produce high response rates in a phase I study with 60 PR rate and 20 CR rate and acceptable toxicity in patients with relapsedrefractory multiple myeloma There is only limited data on the outcomes of treatment of newly diagnosed patients with myeloma with Velcade or its combinations Velcade as a single agent has been shown to have impressive response rate in newly diagnosed patients with 55 percent of patients achieving at least PR and 77 of patients achieving at least MR as per preliminary report from a phase II study Treatment with Velcade did not appear to affect stem cell collection
Considering the high activity of Velcade alone in untreated patients and the superior activity of combinations of Velcade with either Doxil or dexamethasone we propose combining all three agents as a VDd combination ie Velcade Doxil and dexamethasone We hypothesize that this combination will have similar or better efficacy compared to other commonly used combinations for initial therapy ie thalidomide with dexamethasone dexamethasone pulses VAD or melphalan and prednisone or Velcade alone and higher than these treatment regimens CR rate with acceptable toxicity
Newer agents and their combinations appear to provide higher response rates and higher CR rates One of the new active agents in multiple myeloma is Velcade bortezomib formerly known as PS-341 This molecule has a novel mechanism of action by specifically inhibiting the proteasome In a reported phase II trial Velcade as a single agent induced at least minimal responses MR in 35 of patients and CR in 4 of patients and at least a stabilization of the disease in 59 of patients with heavily pretreated relapsedrefractory multiple myeloma using strict SWOG criteria Velcade alone is superior than dexamethasone pulses in a phase III randomized study in patients with at least one but no more than 3 lines of therapy Preliminary reports indicate that combinations of Velcade with other active anti-myeloma agents appear to provide superior outcomes than Velcade alone An additional 18 of patients responded when dexamethasone was combined with Velcade in a patient population refractory to Velcade alone Velcade with Doxil was shown to produce high response rates in a phase I study with 60 PR rate and 20 CR rate and acceptable toxicity in patients with relapsedrefractory multiple myeloma There is only limited data on the outcomes of treatment of newly diagnosed patients with myeloma with Velcade or its combinations Velcade as a single agent has been shown to have impressive response rate in newly diagnosed patients with 55 percent of patients achieving at least PR and 77 of patients achieving at least MR as per preliminary report from a phase II study Treatment with Velcade did not appear to affect stem cell collection
Considering the high activity of Velcade alone in untreated patients and the superior activity of combinations of Velcade with either Doxil or dexamethasone we propose combining all three agents as a VDd combination ie Velcade Doxil and dexamethasone We hypothesize that this combination will have similar or better efficacy compared to other commonly used combinations for initial therapy ie thalidomide with dexamethasone dexamethasone pulses VAD or melphalan and prednisone or Velcade alone and higher than these treatment regimens CR rate with acceptable toxicity
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None