Ignite Creation Date:
2024-05-05 @ 11:47 AM
Last Modification Date:
2024-10-26 @ 9:13 AM
Study NCT ID:
NCT00135187
Status:
COMPLETED
Last Update Posted:
2012-02-07
First Post:
2005-08-23
Brief Title:
Study of Combination Therapy With VELCADE Doxil and Dexamethasone VDd in Multiple Myeloma
Sponsor:
University of Michigan Rogel Cancer Center
Organization:
University of Michigan Rogel Cancer Center
Study Overview
Official Title:
A Pilot Study of Combination Therapy With VELCADE Doxil and Dexamethasone VDd in 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:
Patients are being asked to take part in this research study because they have multiple myeloma which has relapsed after come back or is refractory to unaffected by initial therapy
For patients who have relapsed or are refractory to therapy there is no agreed upon standard treatment Treatment options include chemotherapy and for some patients bone marrow transplants None of the available treatments are curative and investigators are continually looking for more effective treatments This study involves treatment with a new combination of standard drugs VELCADE Doxil and Dexamethasone Preliminary results from a study using a combination of VELCADE with Doxil showed high response rates disease reduction Two other studies showed that an addition of Dexamethasone to VELCADE in patients not responding to VELCADE alone improved response rate The proposed combination of all three drugs may improve efficacy and response
VELCADE is approved by the Food and Drug Administration FDA for use in multiple myeloma 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 approved for use in multiple myeloma 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
For patients who have relapsed or are refractory to therapy there is no agreed upon standard treatment Treatment options include chemotherapy and for some patients bone marrow transplants None of the available treatments are curative and investigators are continually looking for more effective treatments This study involves treatment with a new combination of standard drugs VELCADE Doxil and Dexamethasone Preliminary results from a study using a combination of VELCADE with Doxil showed high response rates disease reduction Two other studies showed that an addition of Dexamethasone to VELCADE in patients not responding to VELCADE alone improved response rate The proposed combination of all three drugs may improve efficacy and response
VELCADE is approved by the Food and Drug Administration FDA for use in multiple myeloma 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 approved for use in multiple myeloma 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 Combination therapies such as VAD have been effective with partial response rates in 40-60 range and tolerable toxicity A recent study showed that substituting Doxil for Doxorubicin in a regimen similar to VAD DVd resulted in an improved toxicity profile and similar efficacy The most active agents in VAD and presumably in DVd are Doxorubicin or Doxil and Dexamethasone while Vincristine adds little if at all to the efficacy of these regimens One of the new active agents in multiple myeloma is VELCADE bortezomib formerly known as VELCADE This molecule has a novel mechanism of action by specifically inhibiting the proteasome A recently reported Phase II trial showed that VELCADE as a single agent induced at least minimal responses ie 25 reduction in monoclonal protein in 35 of patients and at least a stabilization of the disease in 59 of patients with relapsedrefractory multiple myeloma using strict SWOG criteria An additional 18 responded when Dexamethasone was added to VELCADE Pre-clinical observations showed that the addition of VELCADE to other chemotherapeutic agents such as doxorubicin enhances cytotoxicity of multiple myeloma cells Preliminary results from Phase I study of combination of VELCADE with Doxil showed 60 response rate ie partial response with acceptable toxicity In this study we propose to combine three active agents ie Doxil Dexamethasone two most active agents from DVd and VELCADE The ultimate goal is to show that this combination of drugs is more efficacious than VAD or VELCADE with either Dexamethasone or Doxil and without additional 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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| Legacy 2004-419 | OTHER | University of Michigan IRBMED | None |