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Trial record 74 of 107 for:    "Vascular Hemostatic Disease" | "Doxorubicin"

Tandem Transplantation in Multiple Myeloma (MM) Patients With <12 Months of Prior Treatment

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ClinicalTrials.gov Identifier: NCT00670631
Recruitment Status : Completed
First Posted : May 2, 2008
Results First Posted : August 31, 2017
Last Update Posted : August 31, 2017
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Guido Tricot, University of Iowa

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Multiple Myeloma
Intervention Combination Product: tandem autologous transplantation
Enrollment 46
Recruitment Details  
Pre-assignment Details Data not available. Study conducted at University of Utah. Upon PI leaving Utah and coming to the University of Iowa, record NCT00670631 was transferred to Iowa by ClinicalTrials.gov staff. No research activities under NCT00670631 were conducted at Iowa. PRS staff at Iowa and Utah have corresponded and neither party (including PI) have the data.
Arm/Group Title Tandem Autologous Stem Cell Transplant
Hide Arm/Group Description

Induction: DPACE chemotherapy plus stem cell collection. Additional stem cell collection and/or chemotherapy may be required.

After collection, participants will receive dexamethasone x 4 days every 14 days.

Period Title: Overall Study
Started 0
Completed 0
Not Completed 0
Arm/Group Title Tandem Autologous Stem Cell Transplant
Hide Arm/Group Description

Induction: DPACE(dexamethasone,cisplatin,doxorubicin,cyclophosphamide,etoposide) chemotherapy plus stem cell collection. Additional stem cell collection and/or chemotherapy may be required.

After collection, participants will receive dexamethasone x 4 days every 14 days.

Overall Number of Baseline Participants 0
Hide Baseline Analysis Population Description
Data not available. Study conducted at University of Utah. Upon PI leaving Utah and coming to the University of Iowa, record NCT00670631 was transferred to Iowa by ClinicalTrials.gov staff. No research activities under NCT00670631 were conducted at Iowa. PRS staff at Iowa and Utah have corresponded and neither party (including PI) have the data.
Age, Categorical  
Number Analyzed 0 participants
<=18 years
Between 18 and 65 years
>=65 years
Sex: Female, Male  
Number Analyzed 0 participants
Female
Male
Region of Enrollment  
Unit of measure:  Participants
United States Number Analyzed 0 participants
1.Primary Outcome
Title To Determine Whether, in Comparison to TT II, the Median EFS Can be Increased From 4.8 Years to 6.2 Years, Which Represents an Increase in Median EFS of Approximately 30%
Hide Description [Not Specified]
Time Frame After enrollment of 204 subjects is completed
Hide Outcome Measure Data
Hide Analysis Population Description
Data not available. Study conducted at University of Utah. Upon PI leaving Utah and coming to the University of Iowa, record NCT00670631 was transferred to Iowa by ClinicalTrials.gov staff. No research activities under NCT00670631 were conducted at Iowa. PRS staff at Iowa and Utah have corresponded and neither party (including PI) have the data.
Arm/Group Title Tandem Autologous Stem Cell Transplant
Hide Arm/Group Description:

Induction: DPACE(dexamethasone,cisplatin,doxorubicin,cyclophosphamide,etoposide) chemotherapy plus stem cell collection. Additional stem cell collection and/or chemotherapy may be required.

After collection, participants will receive dexamethasone x 4 days every 14 days.

Transplant 1: The transplant preparative regimen will be bortezomib/thalidomide/dexamethasone/melphalan.

Once recovered, participants start thalidomide daily & dexamethasone x 4 days every 21 days.

Consolidation (if administered): VDT-PACE(bortezomib,dexamethasone,thalidomide,cisplatin,doxorubicin,cyclophosphamide, etoposide) Transplant 2: 8 weeks to 6 months after the first transplant, participants will have the second transplant Maintenance: Year 1- VTD (bortezomib, thalidomide, dexamethasone) cycles. Year 2 - VCD (bortezomib, cyclophosphamide, dexamethasone)cycles.

tandem autologous transplantation: DPACE: dexamethasone 20 mg days 1-4 and 8-11, cisplatin 10 mg/m2 days 1-4, Adriamycin 10 mg/m2 days

Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
2.Primary Outcome
Title In Assessing Patient Safety, we Will Examine Treatment Toxicity Related Mortality and SAEs. Historical Study Results Indicate That a Mortality Rate of Greater Than 10% is Not Acceptable in This Population, Nor is an SAE Rate of Greater Than 15%.
Hide Description [Not Specified]
Time Frame Interim analyses for safety will be performed after 20, 100, 200, and 300 patients have been enrolled.
Hide Outcome Measure Data
Hide Analysis Population Description
Data not available. Study conducted at University of Utah. Upon PI leaving Utah and coming to the University of Iowa, record NCT00670631 was transferred to Iowa by ClinicalTrials.gov staff. No research activities under NCT00670631 were conducted at Iowa. PRS staff at Iowa and Utah have corresponded and neither party (including PI) have the data.
Arm/Group Title Tandem Autologous Stem Cell Transplant
Hide Arm/Group Description:

Induction: DPACE(dexamethasone,cisplatin,doxorubicin,cyclophosphamide,etoposide) chemotherapy plus stem cell collection. Additional stem cell collection and/or chemotherapy may be required.

After collection, participants will receive dexamethasone x 4 days every 14 days.

Transplant 1: The transplant preparative regimen will be bortezomib/thalidomide/dexamethasone/melphalan.

Once recovered, participants start thalidomide daily and dexamethasone x 4 days every 21 days.

Consolidation (if administered): VDT-PACE(bortezomib,dexamethasone,thalidomide,cisplatin,doxorubicin,cyclophosphamide, etoposide) Transplant 2: 8 weeks to 6 months after the first transplant, participants will have the second transplant Maintenance: Year 1- VTD (bortezomib, thalidomide, dexamethasone) cycles. Year 2 - VCD (bortezomib, cyclophosphamide, dexamethasone)cycles.

Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
3.Secondary Outcome
Title Overall Survival Will be Compared to a Historical Control (UARK 98-026, TT2)as a Secondary Outcome.
Hide Description [Not Specified]
Time Frame After 204 patients have been enrolled
Hide Outcome Measure Data
Hide Analysis Population Description
Data not available. Study conducted at University of Utah. Upon PI leaving Utah and coming to the University of Iowa, record NCT00670631 was transferred to Iowa by ClinicalTrials.gov staff. No research activities under NCT00670631 were conducted at Iowa. PRS staff at Iowa and Utah have corresponded and neither party (including PI) have the data.
Arm/Group Title Tandem Autologous Stem Cell Transplant
Hide Arm/Group Description:

Induction: DPACE(dexamethasone,cisplatin,doxorubicin,cyclophosphamide,etoposide) chemotherapy plus stem cell collection. Additional stem cell collection and/or chemotherapy may be required.

After collection, participants will receive dexamethasone x 4 days every 14 days.

Transplant 1: The transplant preparative regimen will be bortezomib/thalidomide/dexamethasone/melphalan.

Once recovered, participants start thalidomide daily and dexamethasone x 4 days every 21 days.

Consolidation (if administered): VDT-PACE(bortezomib,dexamethasone,thalidomide,cisplatin,doxorubicin,cyclophosphamide, etoposide) Transplant 2: 8 weeks to 6 months after the first transplant, participants will have the second transplant Maintenance: Year 1- VTD (bortezomib, thalidomide, dexamethasone) cycles. Year 2 - VCD (bortezomib, cyclophosphamide, dexamethasone)cycles.

Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame [Not Specified]
Adverse Event Reporting Description Data not available. Study conducted at University of Utah. Upon PI leaving Utah and coming to the University of Iowa, record NCT00670631 was transferred to Iowa by ClinicalTrials.gov staff. No research activities under NCT00670631 were conducted at Iowa. PRS staff at Iowa and Utah have corresponded and neither party (including PI) have the data.
 
Arm/Group Title Tandem Autologous Stem Cell Transplant
Hide Arm/Group Description

Induction: DPACE chemotherapy plus stem cell collection. Additional stem cell collection and/or chemotherapy may be required.

After collection, participants will receive dexamethasone x 4 days every 14 days.

All-Cause Mortality
Tandem Autologous Stem Cell Transplant
Affected / at Risk (%)
Total   0/0 
Show Serious Adverse Events Hide Serious Adverse Events
Tandem Autologous Stem Cell Transplant
Affected / at Risk (%)
Total   0/0 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Tandem Autologous Stem Cell Transplant
Affected / at Risk (%)
Total   0/0 
Data not available. Study conducted at Utah. Upon PI leaving & coming to Iowa, record was transferred to IA by ClinicalTrials.gov. No research activities under NCT00670631 were conducted at IA. PRS staff have corresponded and neither party have data.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Guido Tricot, MD, PhD
Organization: University of Iowa
Responsible Party: Guido Tricot, University of Iowa
ClinicalTrials.gov Identifier: NCT00670631     History of Changes
Other Study ID Numbers: 25009
7R01CA115399 ( U.S. NIH Grant/Contract )
First Submitted: April 3, 2008
First Posted: May 2, 2008
Results First Submitted: August 29, 2017
Results First Posted: August 31, 2017
Last Update Posted: August 31, 2017