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S0115, High-Dose Melphalan and Autologous Peripheral Stem Cell Transplantation in Treating Patients With Multiple Myeloma or Primary Systemic Amyloidosis

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00064337
First Posted: July 9, 2003
Last Update Posted: November 6, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Southwest Oncology Group
Results First Submitted: October 26, 2016  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions: Multiple Myeloma
Plasma Cell Myeloma
Interventions: Biological: filgrastim
Drug: cyclophosphamide
Drug: dexamethasone
Drug: melphalan
Drug: thalidomide
Procedure: peripheral blood stem cell transplantation

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Treatment

MM Induction: dexamethasone 20mg/d PO Days 1-4, 9-12 and 17-20 every 35 days for 2 cycles and thalidomide 200 mg/d PO Days 1-70.

Mobilization and SC Collection: MM, MM+AL, MM+LCD: cyclophosphamide 2.5 gm/m2 IV Day 1; mesna 800 mg/m2 IV Day 1 x 3 doses; G-CSF 10 mcg/kg/d SQ Day 2 through day prior to last leukapheresis.

Amyloid or LCDD-Only: G-CSF 16 mcg/kg/d SQ Days 1-3 (continued daily until the day prior to the last day of stem cell collection).

Conditioning/Transplant - Modified HighDose Melphalan (given for both transplants): melphalan 100 mg/m2/d IV over 20 mins Day -2; PBSC infusion >/= 3.5 x 10^6 CD34+ cells/kg IV Day 0.

Maintenance (MM only): dexamethasone 40 mg/d PO Days 1-4 every 28 days and thalidomide 100 mg/d PO daily - given for one year, followed by dexamethasone 40 mg/d PO Days 1-4 every 28 days and thalidomide 100 mg/d PO daily - given for one year.

filgrastim

cyclophosphamide

dexamethasone

melphalan

thalidomide

peripheral blood


Participant Flow for 3 periods

Period 1:   PBSCC or Induction/PBSCC
    Treatment
STARTED   93 [1] 
COMPLETED   73 
NOT COMPLETED   20 
Not protocol-specified                7 
Adverse Event                6 
Progression                3 
Patient Refusal                2 
Death                2 
[1] 104 patients were registered, 93 of whom were eligible and analyzable.

Period 2:   Transplant
    Treatment
STARTED   67 [1] 
COMPLETED   46 
NOT COMPLETED   21 
Adverse Event                9 
Not protocol-specified                5 
Death                3 
Patient Refusal                2 
Progression                2 
[1] 6 patients who completed PBSCC or Induction/PBSCC did not begin Transplant

Period 3:   Maintenance
    Treatment
STARTED   13 [1] 
COMPLETED   3 
NOT COMPLETED   10 
Adverse Event                3 
Progression                2 
On treatment at time of analysis                2 
Not protocol-specified                2 
Death                1 
[1] Only patients with High Risk MM or AL + MM were allowed to enroll to Maintenance treatment.



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Treatment

MM Induction: dexamethasone 20mg/d PO Days 1-4, 9-12 and 17-20 every 35 days for 2 cycles and thalidomide 200 mg/d PO Days 1-70.

Mobilization and SC Collection: MM, MM+AL, MM+LCD: cyclophosphamide 2.5 gm/m2 IV Day 1; mesna 800 mg/m2 IV Day 1 x 3 doses; G-CSF 10 mcg/kg/d SQ Day 2 through day prior to last leukapheresis.

Amyloid or LCDD-Only: G-CSF 16 mcg/kg/d SQ Days 1-3 (continued daily until the day prior to the last day of stem cell collection).

Conditioning/Transplant - Modified HighDose Melphalan (given for both transplants): melphalan 100 mg/m2/d IV over 20 mins Day -2; PBSC infusion >/= 3.5 x 10^6 CD34+ cells/kg IV Day 0.

Maintenance (MM only): dexamethasone 40 mg/d PO Days 1-4 every 28 days and thalidomide 100 mg/d PO daily - given for one year, followed by dexamethasone 40 mg/d PO Days 1-4 every 28 days and thalidomide 100 mg/d PO daily - given for one year.

filgrastim

cyclophosphamide

dexamethasone

melphalan

thalidomide

peripheral blood


Baseline Measures
   Treatment 
Overall Participants Analyzed 
[Units: Participants]
 93 
Age 
[Units: Years]
Median (Full Range)
 65 
 (33 to 80) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      35  37.6% 
Male      58  62.4% 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Overall Survival   [ Time Frame: 5 years from the date of the last patient registered ]

2.  Secondary:   Hematologic Response   [ Time Frame: Until off study ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS 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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Study Statistician
Organization: SWOG Statistical Center
phone: 206-667-4623



Responsible Party: Southwest Oncology Group
ClinicalTrials.gov Identifier: NCT00064337     History of Changes
Other Study ID Numbers: S0115
S0115 ( Other Identifier: SWOG )
U10CA032102 ( U.S. NIH Grant/Contract )
First Submitted: July 8, 2003
First Posted: July 9, 2003
Results First Submitted: October 26, 2016
Results First Posted: November 6, 2017
Last Update Posted: November 6, 2017