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Trial record 68 of 2511 for:    "Plasma Cell Neoplasm"

Rituximab and Cyclophosphamide in Treating Patients With High Risk, Refractory, or Relapsed Multiple Myeloma

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ClinicalTrials.gov Identifier: NCT00258206
Recruitment Status : Completed
First Posted : November 24, 2005
Results First Posted : June 11, 2015
Last Update Posted : December 6, 2017
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Multiple Myeloma and Plasma Cell Neoplasm
Interventions Biological: rituximab
Drug: cyclophosphamide
Enrollment 21
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Rituximab + Cyclophosphamide
Hide Arm/Group Description Rituximab 375 mg/m^2 on Days -10 and -7; Cyclophosphamide 50 mg/kg on days -3, -2, -1, and 0; Rituximab 375 mg/m^2 weekly x4 after platelet counts recover; For patients achieving at least stable disease, rituximab maintenance 375 mg/m^2 once each during months 3, 6, 9, and 12
Period Title: Overall Study
Started 21
Completed 21
Not Completed 0
Arm/Group Title Rituximab + Cyclophosphamide
Hide Arm/Group Description Rituximab 375 mg/m^2 on Days -10 and -7; Cyclophosphamide 50 mg/kg on days -3, -2, -1, and 0; Rituximab 375 mg/m^2 weekly x4 after platelet counts recover; For patients achieving at least stable disease, rituximab maintenance 375 mg/m^2 once each during months 3, 6, 9, and 12
Overall Number of Baseline Participants 21
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 21 participants
<=18 years
0
   0.0%
Between 18 and 65 years
17
  81.0%
>=65 years
4
  19.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 21 participants
Female
14
  66.7%
Male
7
  33.3%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 21 participants
American Indian or Alaska Native
0
   0.0%
Asian
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
6
  28.6%
White
15
  71.4%
More than one race
0
   0.0%
Unknown or Not Reported
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 21 participants
21
1.Primary Outcome
Title Event-free Survival
Hide Description Percentage of study participants who did not report that their multiple myeloma relapsed or progressed (got worse)
Time Frame 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Rituximab + Cyclophosphamide
Hide Arm/Group Description:
Rituximab 375 mg/m^2 on Days -10 and -7; Cyclophosphamide 50 mg/kg on days -3, -2, -1, and 0; Rituximab 375 mg/m^2 weekly x4 after platelet counts recover; For patients achieving at least stable disease, rituximab maintenance 375 mg/m^2 once each during months 3, 6, 9, and 12
Overall Number of Participants Analyzed 21
Measure Type: Number
Unit of Measure: percentage of participants
29
2.Primary Outcome
Title Safety of Maintenance Rituximab Following High Dose Cyclophosphamide
Hide Description [Not Specified]
Time Frame 2, 3, 6, 9, and 12 months
Outcome Measure Data Not Reported
3.Secondary Outcome
Title Safety and Toxicity
Hide Description [Not Specified]
Time Frame 2, 3, 6, 9, and 12 months
Outcome Measure Data Not Reported
4.Secondary Outcome
Title Complete Response (CR) Rate and Partial Response (PR) Rate
Hide Description [Not Specified]
Time Frame 1 year
Outcome Measure Data Not Reported
5.Secondary Outcome
Title Effect of Rituximab by Clonogenic Growth of Multiple Myeloma (MM) Progenitors and the Mechanisms by Which MM Stem Cells Are Inhibited
Hide Description [Not Specified]
Time Frame 2, 3, 6, 9, and 12 months
Outcome Measure Data Not Reported
6.Secondary Outcome
Title Overall Survival
Hide Description [Not Specified]
Time Frame 5 years
Outcome Measure Data Not Reported
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Rituximab + Cyclophosphamide
Hide Arm/Group Description Rituximab 375 mg/m^2 on Days -10 and -7; Cyclophosphamide 50 mg/kg on days -3, -2, -1, and 0; Rituximab 375 mg/m^2 weekly x4 after platelet counts recover; For patients achieving at least stable disease, rituximab maintenance 375 mg/m^2 once each during months 3, 6, 9, and 12
All-Cause Mortality
Rituximab + Cyclophosphamide
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Rituximab + Cyclophosphamide
Affected / at Risk (%)
Total   0/21 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Rituximab + Cyclophosphamide
Affected / at Risk (%)
Total   0/21 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Dr. Carol Ann Huff
Organization: Johns Hopkins University
Phone: 410-955-8842
Responsible Party: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
ClinicalTrials.gov Identifier: NCT00258206     History of Changes
Other Study ID Numbers: J0478 CDR0000441169
P30CA006973 ( U.S. NIH Grant/Contract )
JHOC-J0478 ( Other Identifier: Johns Hopkins SKCCC )
First Submitted: November 22, 2005
First Posted: November 24, 2005
Results First Submitted: May 28, 2015
Results First Posted: June 11, 2015
Last Update Posted: December 6, 2017