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Trial record 14 of 31 for:    "Plasma Cell Leukemia"

Stem Cell Transplantation To Treat High Risk Multiple Myeloma With Reduced Toxicity Myeloablative Conditioning Regimen

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ClinicalTrials.gov Identifier: NCT00615589
Recruitment Status : Terminated (Low accrual)
First Posted : February 14, 2008
Results First Posted : December 11, 2014
Last Update Posted : April 4, 2016
Sponsor:
Collaborator:
Otsuka Pharmaceutical Development & Commercialization, Inc.
Information provided by (Responsible Party):
University of Michigan Rogel Cancer Center

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Multiple Myeloma
Plasma Cell Leukemia
Interventions Drug: Fludarabine/Busulfan x 4 days
Procedure: stem cell transplant
Enrollment 22
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Flu-Bu4
Hide Arm/Group Description

Fludarabine Busulfan chemotherapy regimen (Flu-Bu4), followed by allogeneic stem cell transplant from best available, matched donor.

Fludarabine/Busulfan x 4 days:

Fludarabine: 40 mg/m2/day, administered IV over 30 minutes on days –5, -4, -3, and –2 pre-transplant.

Busulfan: 3.2 mg/kg IV daily over 4 hours on days –5, –4, -3, and –2.

The Fludarabine shall be administered prior to the Busulfan each day.

Period Title: Overall Study
Started 22
Completed 22
Not Completed 0
Arm/Group Title Flu-Bu4
Hide Arm/Group Description

Fludarabine Busulfan chemotherapy regimen(Flu-Bu4), followed by allogeneic stem cell transplant from best available, matched donor.

Fludarabine/Busulfan x 4 days:

Fludarabine: 40 mg/m2/day in NS, administered IV over 30 minutes on days –5, -4, -3, and –2 pre-transplant.

Busulfan: 3.2 mg/kg IV daily in NS over 4 hours on days –5, –4, -3, and –2.

The Fludarabine shall be administered prior to the Busulfan each day.

Overall Number of Baseline Participants 22
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 22 participants
54
(45 to 70)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 22 participants
Female
8
  36.4%
Male
14
  63.6%
1.Primary Outcome
Title The Percentage of Patients Alive 1 Year Post Transplant
Hide Description The primary objective is overall survival, one year from the time of transplant.
Time Frame 1 Year
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Hide Analysis Population Description
[Not Specified]
Arm/Group Title Flu-Bu4
Hide Arm/Group Description:

Fludarabine Busulfan chemotherapy regimen(Flu-Bu4), followed by allogeneic stem cell transplant from best available, matched donor.

Fludarabine/Busulfan x 4 days:

Fludarabine: 40 mg/m2/day in NS, administered IV over 30 minutes on days –5, -4, -3, and –2 pre-transplant.

Busulfan: 3.2 mg/kg IV daily in NS over 4 hours on days –5, –4, -3, and –2.

The Fludarabine shall be administered prior to the Busulfan each day.

Overall Number of Participants Analyzed 22
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of patients
61
(43 to 87)
2.Secondary Outcome
Title The Percentage of Patients Free From Progression at 1 Year
Hide Description

One of the secondary outcomes that will be measured is progression free survival at 1 Year.

Progressive Disease (PD) is defined as a >25% increase in serum monoclonal paraprotein, a >25% increase in 24-hour urinary light chain excretion, a >25% increase in plasma cells in bone marrow aspirate, an increase in the size or the development of new bone lesions/soft tissue plasmacytomas, or the development of hypercalcemia.

Time Frame 1 Year
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Flu-Bu4
Hide Arm/Group Description:

Fludarabine Busulfan chemotherapy regimen(Flu-Bu4), followed by allogeneic stem cell transplant from best available, matched donor.

Fludarabine/Busulfan x 4 days:

Fludarabine: 40 mg/m2/day in NS, administered IV over 30 minutes on days –5, -4, -3, and –2 pre-transplant.

Busulfan: 3.2 mg/kg IV daily in NS over 4 hours on days –5, –4, -3, and –2.

The Fludarabine shall be administered prior to the Busulfan each day.

Overall Number of Participants Analyzed 22
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of patients
40
(23 to 67)
3.Secondary Outcome
Title Percentage of Patients With Treatment Related Mortality (TRM)
Hide Description [Not Specified]
Time Frame 100 days, one-year
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Flu-Bu4
Hide Arm/Group Description:

Fludarabine Busulfan chemotherapy regimen(Flu-Bu4), followed by allogeneic stem cell transplant from best available, matched donor.

Fludarabine/Busulfan x 4 days:

Fludarabine: 40 mg/m2/day in NS, administered IV over 30 minutes on days –5, -4, -3, and –2 pre-transplant.

Busulfan: 3.2 mg/kg IV daily in NS over 4 hours on days –5, –4, -3, and –2.

The Fludarabine shall be administered prior to the Busulfan each day.

Overall Number of Participants Analyzed 22
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of patients
9
(2 to 33)
4.Secondary Outcome
Title Percentage of Patients With Acute and Chronic Graft Versus Host Disease (GVHD)
Hide Description

Incidence of acute (Stage II-IV and Stage III-IV) and chronic GVHD (any stage) were analyzed.

Acute GVHD Grading:

Stage II - Skin, 25-50% BSA (Body Surface Area); Liver, 3.1-6mg/dl bilirubin; Gut, 1000-1500ml/day diarrhea Stage III - Skin, generalized erythroderma; Liver, 6.1-15mg/dl bilirubin; Gut, >1500ml/day diarrhea Stage IV - Skin, bullae; Liver, >15mg/dl bilirubin; Gut, pain +/- ileus

Time Frame 100 days, 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Flu-Bu4
Hide Arm/Group Description:

Fludarabine Busulfan chemotherapy regimen(Flu-Bu4), followed by allogeneic stem cell transplant from best available, matched donor.

Fludarabine/Busulfan x 4 days:

Fludarabine: 40 mg/m2/day in NS, administered IV over 30 minutes on days –5, -4, -3, and –2 pre-transplant.

Busulfan: 3.2 mg/kg IV daily in NS over 4 hours on days –5, –4, -3, and –2.

The Fludarabine shall be administered prior to the Busulfan each day.

Overall Number of Participants Analyzed 22
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
Grade II-IV Acute GVHD
48
(29 to 72)
Grade III-IV Acute GVHD
23
(10 to 47)
Chronic GVHD
55
(34 to 78)
5.Secondary Outcome
Title Non Relapse Mortality (NRM) at 1 Year and 3 yearsThe Percentage of Deaths Not Attributable to Disease Relapse or Progression
Hide Description Non relapse mortality, defined as the percentage of deaths not attributable to disease relapse or progression at 1 year and at 3 years.
Time Frame 3 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Flu-Bu4
Hide Arm/Group Description:

Fludarabine Busulfan chemotherapy regimen (Flu-Bu4), followed by allogeneic stem cell transplant from best available, matched donor.

Fludarabine/Busulfan x 4 days:

Fludarabine: 40 mg/m2/day, administered IV over 30 minutes on days –5, -4, -3, and –2 pre-transplant.

Busulfan: 3.2 mg/kg IV daily over 4 hours on days –5, –4, -3, and –2.

The Fludarabine shall be administered prior to the Busulfan each day.

Overall Number of Participants Analyzed 22
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of deaths
NRM at 1 Year
19
(7 to 44)
NRM at 3 Years
29
(13 to 55)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Flu-Bu4
Hide Arm/Group Description

Fludarabine Busulfan chemotherapy regimen(Flu-Bu4), followed by allogeneic stem cell transplant from best available, matched donor.

Fludarabine/Busulfan x 4 days:

Fludarabine: 40 mg/m2/day in NS, administered IV over 30 minutes on days –5, -4, -3, and –2 pre-transplant.

Busulfan: 3.2 mg/kg IV daily in NS over 4 hours on days –5, –4, -3, and –2.

The Fludarabine shall be administered prior to the Busulfan each day.

All-Cause Mortality
Flu-Bu4
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Flu-Bu4
Affected / at Risk (%) # Events
Total   13/22 (59.09%)    
Blood and lymphatic system disorders   
Blood/Bone Marrow - Other  2/22 (9.09%)  2
Cardiac disorders   
Cardiac General - Other  1/22 (4.55%)  1
Hypotension  2/22 (9.09%)  2
Gastrointestinal disorders   
Diarrhea  2/22 (9.09%)  2
General disorders   
Fever  2/22 (9.09%)  2
Pain, headache  1/22 (4.55%)  1
Immune system disorders   
Allergy/Immunology - Other  1/22 (4.55%)  1
Infections and infestations   
Febrile neutropenia  1/22 (4.55%)  1
Infection with Grade 3 or 4 neutrophils  1/22 (4.55%)  1
Infection - Other  1/22 (4.55%)  1
Infection, blood  1/22 (4.55%)  1
Infection, lung  1/22 (4.55%)  1
Infection, upper airway  1/22 (4.55%)  1
Infection, UTI  1/22 (4.55%)  1
Musculoskeletal and connective tissue disorders   
Muscle weakness  1/22 (4.55%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Death, disease progression  1/22 (4.55%)  1
Nervous system disorders   
Somnolence/depressed level of consciousness  1/22 (4.55%)  1
Renal and urinary disorders   
Renal failure  2/22 (9.09%)  2
Respiratory, thoracic and mediastinal disorders   
Hypoxia  3/22 (13.64%)  3
Pulmonary/Upper Respiratory - Other  1/22 (4.55%)  1
Skin and subcutaneous tissue disorders   
Rash/desquamation  2/22 (9.09%)  2
Vascular disorders   
Hemorrhage, bladder  1/22 (4.55%)  1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Flu-Bu4
Affected / at Risk (%) # Events
Total   20/22 (90.91%)    
Blood and lymphatic system disorders   
Blood/Bone Marrow - Other  2/22 (9.09%)  2
Platelets  2/22 (9.09%)  2
Cardiac disorders   
Sinus bradycardia  2/22 (9.09%)  2
Sinus tachycardia  8/22 (36.36%)  9
Supraventricular extrasystoles  2/22 (9.09%)  2
Hypertension  2/22 (9.09%)  2
Hypotension  6/22 (27.27%)  6
Eye disorders   
Dry eye syndrome  2/22 (9.09%)  2
Vision-blurred vision  3/22 (13.64%)  3
Gastrointestinal disorders   
Diarrhea  3/22 (13.64%)  3
Dry mouth/salivary gland (xerostomia)  4/22 (18.18%)  4
Gastrointestinal - Other (Specify)  3/22 (13.64%)  3
Heartburn/dyspepsia  3/22 (13.64%)  3
Incontinence, anal  2/22 (9.09%)  2
Mucositis/stomatitis (clinical exam)  3/22 (13.64%)  3
Taste alteration (dysgeusia)  6/22 (27.27%)  7
Hemorrhage, GI  3/22 (13.64%)  3
Hemorrhage, GI  2/22 (9.09%)  2
General disorders   
Fatigue (asthenia, lethargy, malaise)  5/22 (22.73%)  5
Fever  2/22 (9.09%)  2
Edema: head and neck  2/22 (9.09%)  2
Edema: limb  5/22 (22.73%)  5
Edema: trunk/genital  2/22 (9.09%)  2
Pain - Other  4/22 (18.18%)  4
Syndromes - Other  2/22 (9.09%)  3
Infections and infestations   
Infection - Other (Specify)  5/22 (22.73%)  5
Infection with normal ANC or Grade 1 or 2 neutrophils  2/22 (9.09%)  2
Infection with normal ANC or Grade 1 or 2 neutrophils  3/22 (13.64%)  5
Investigations   
ALT, SGPT (serum glutamic pyruvic transaminase)  2/22 (9.09%)  2
Albumin, serum-low (hypoalbuminemia)  2/22 (9.09%)  2
Alkaline phosphatase  2/22 (9.09%)  2
Metabolism and nutrition disorders   
Weight gain  2/22 (9.09%)  2
Calcium, serum-low (hypocalcemia)  2/22 (9.09%)  2
Potassium, serum-high (hyperkalemia)  2/22 (9.09%)  2
Potassium, serum-low (hypokalemia)  2/22 (9.09%)  2
Sodium, serum-low (hyponatremia)  2/22 (9.09%)  2
Musculoskeletal and connective tissue disorders   
Pain, back  3/22 (13.64%)  3
Pain, bone  2/22 (9.09%)  2
Pain, neck  2/22 (9.09%)  2
Pain, pelvis  4/22 (18.18%)  4
Nervous system disorders   
Confusion  2/22 (9.09%)  2
Dizziness  6/22 (27.27%)  7
Neurology - Other  3/22 (13.64%)  4
Somnolence/depressed level of consciousness  2/22 (9.09%)  2
Tremor  7/22 (31.82%)  7
Pain, headache  5/22 (22.73%)  6
Psychiatric disorders   
Insomnia  4/22 (18.18%)  5
Mood alteration, anxiety  2/22 (9.09%)  2
Renal and urinary disorders   
Hemorrhage, GU  2/22 (9.09%)  3
Hemorrhage, GU  2/22 (9.09%)  2
Bladder spasms  2/22 (9.09%)  3
Renal failure  2/22 (9.09%)  2
Urinary frequency/urgency  2/22 (9.09%)  2
Urinary retention (including neurogenic bladder)  2/22 (9.09%)  2
Respiratory, thoracic and mediastinal disorders   
Hemorrhage, pulmonary/upper respiratory  3/22 (13.64%)  3
Cough  3/22 (13.64%)  4
Dyspnea (shortness of breath)  5/22 (22.73%)  5
Hypoxia  5/22 (22.73%)  9
Pulmonary/Upper Respiratory - Other  2/22 (9.09%)  2
Skin and subcutaneous tissue disorders   
Dermatology/Skin - Other  6/22 (27.27%)  8
Pruritus/itching  2/22 (9.09%)  2
Rash/desquamation  6/22 (27.27%)  8
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Dr. Attaphol Pawarode, M.D.
Organization: University of Michigan Comprehensive Cancer Center
Phone: 734-936-8785
Responsible Party: University of Michigan Rogel Cancer Center
ClinicalTrials.gov Identifier: NCT00615589     History of Changes
Other Study ID Numbers: umcc 2007.074
HUM00014029
First Submitted: January 22, 2008
First Posted: February 14, 2008
Results First Submitted: December 3, 2014
Results First Posted: December 11, 2014
Last Update Posted: April 4, 2016