Trial Outcomes & Findings for Rituximab and Combination Chemotherapy in Treating Patients With Newly Diagnosed Waldenstrom's Macroglobulinemia (NCT NCT00060346)
NCT ID: NCT00060346
Last Updated: 2023-06-29
Results Overview
Objective response assessed using standard myeloma response criteria. Objective response is defined as a \> 50% reduction in the quantitative IgM or M-Spike levels from baseline levels. Response must be documented by two measurements separated by at least 3 weeks.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
16 participants
Primary outcome timeframe
Every 3 months if patient is < 2 years from study entry, every 6 months if patient is 2-5 years from study entry, every 12 months if patient is 6-10 years from study entry
Results posted on
2023-06-29
Participant Flow
The study was activated on June 15, 2004, accrued its first patient on October 5, 2004, and closed due to slow accrual on April 26, 2007. Sixteen patients were accrued in this trial from Eastern Cooperative Oncology Group (ECOG) and Southwest Oncology Group (SWOG) institutions.
Participant milestones
| Measure |
Rituximab + CHOP
Rituximab 375 mg/m2 day 1 of a 21-day cycle, followed by:
Cyclophosphamide 750 mg/m2 Doxorubicin 50 mg/m2 Vincristine 1.4 mg/m2 and Prednisone 100 mg/m2 daily
|
|---|---|
|
Overall Study
STARTED
|
16
|
|
Overall Study
Eligible and Treated
|
16
|
|
Overall Study
COMPLETED
|
16
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Rituximab and Combination Chemotherapy in Treating Patients With Newly Diagnosed Waldenstrom's Macroglobulinemia
Baseline characteristics by cohort
| Measure |
Rituximab + CHOP
n=16 Participants
Rituximab 375 mg/m2 day 1 of a 21-day cycle, followed by:
Cyclophosphamide 750 mg/m2 Doxorubicin 50 mg/m2 Vincristine 1.4 mg/m2 and Prednisone 100 mg/m2 daily
|
|---|---|
|
Age, Continuous
|
59.5 years
n=93 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=93 Participants
|
PRIMARY outcome
Timeframe: Every 3 months if patient is < 2 years from study entry, every 6 months if patient is 2-5 years from study entry, every 12 months if patient is 6-10 years from study entryPopulation: All eligible and treated patients are included in this analysis.
Objective response assessed using standard myeloma response criteria. Objective response is defined as a \> 50% reduction in the quantitative IgM or M-Spike levels from baseline levels. Response must be documented by two measurements separated by at least 3 weeks.
Outcome measures
| Measure |
Rituximab + CHOP
n=16 Participants
Rituximab 375 mg/m2 day 1 of a 21-day cycle, followed by:
Cyclophosphamide 750 mg/m2 Doxorubicin 50 mg/m2 Vincristine 1.4 mg/m2 and Prednisone 100 mg/m2 daily
|
|---|---|
|
Objective Response to Treatment
|
0.938 proportion of participants
Interval 0.736 to 0.997
|
Adverse Events
Rituximab + CHOP
Serious events: 16 serious events
Other events: 16 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Rituximab + CHOP
n=16 participants at risk
Rituximab 375 mg/m2 day 1 of a 21-day cycle, followed by:
Cyclophosphamide 750 mg/m2 Doxorubicin 50 mg/m2 Vincristine 1.4 mg/m2 and Prednisone 100 mg/m2 daily
|
|---|---|
|
Immune system disorders
Allergic reaction
|
6.2%
1/16 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment.
|
|
Blood and lymphatic system disorders
Anemia
|
6.2%
1/16 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment.
|
|
Investigations
Leukopenia
|
50.0%
8/16 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment.
|
|
Investigations
Lymphopenia
|
50.0%
8/16 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment.
|
|
Investigations
Neutropenia
|
81.2%
13/16 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment.
|
|
Cardiac disorders
Cardiac-Left Ventricular Function
|
6.2%
1/16 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment.
|
|
General disorders
Edema
|
6.2%
1/16 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment.
|
|
Vascular disorders
Hypotension
|
12.5%
2/16 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment.
|
|
Blood and lymphatic system disorders
Thrombosis/Embolism
|
6.2%
1/16 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment.
|
|
General disorders
Fatigue
|
6.2%
1/16 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment.
|
|
Gastrointestinal disorders
Nausea
|
6.2%
1/16 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment.
|
|
Gastrointestinal disorders
Stomatitis
|
6.2%
1/16 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
12.5%
2/16 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment.
|
|
Infections and infestations
Infection w/ Gr3-4 neutropenia
|
18.8%
3/16 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment.
|
|
Infections and infestations
Infection w/o neutropenia
|
6.2%
1/16 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment.
|
|
Psychiatric disorders
Insomnia
|
6.2%
1/16 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment.
|
|
Nervous system disorders
Neuropathy-motor
|
6.2%
1/16 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment.
|
|
Nervous system disorders
Neuropathy-sensory
|
12.5%
2/16 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment.
|
|
Gastrointestinal disorders
Abdominal Pain
|
6.2%
1/16 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
12.5%
2/16 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment.
|
Other adverse events
| Measure |
Rituximab + CHOP
n=16 participants at risk
Rituximab 375 mg/m2 day 1 of a 21-day cycle, followed by:
Cyclophosphamide 750 mg/m2 Doxorubicin 50 mg/m2 Vincristine 1.4 mg/m2 and Prednisone 100 mg/m2 daily
|
|---|---|
|
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis
|
6.2%
1/16 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment.
|
|
Blood and lymphatic system disorders
Anemia
|
87.5%
14/16 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment.
|
|
Investigations
Leukopenia
|
100.0%
16/16 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment.
|
|
Investigations
Lymphopenia
|
93.8%
15/16 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment.
|
|
Investigations
Neutropenia
|
93.8%
15/16 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment.
|
|
Investigations
Thrombocytopenia
|
50.0%
8/16 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment.
|
|
Cardiac disorders
Palpitations
|
6.2%
1/16 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment.
|
|
Cardiac disorders
Sinus tachycardia
|
6.2%
1/16 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment.
|
|
Cardiac disorders
Cardiac-Left Ventricular Function
|
6.2%
1/16 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment.
|
|
General disorders
Edema
|
18.8%
3/16 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment.
|
|
Vascular disorders
Hypotension
|
12.5%
2/16 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment.
|
|
General disorders
Fatigue
|
87.5%
14/16 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment.
|
|
General disorders
Fever
|
12.5%
2/16 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment.
|
|
General disorders
Rigors/chills
|
31.2%
5/16 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment.
|
|
Skin and subcutaneous tissue disorders
Sweating
|
12.5%
2/16 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment.
|
|
Investigations
Weight gain
|
6.2%
1/16 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment.
|
|
General disorders
Constitutional symptoms
|
6.2%
1/16 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
56.2%
9/16 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment.
|
|
Injury, poisoning and procedural complications
Bruising
|
6.2%
1/16 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment.
|
|
Vascular disorders
Flushing
|
12.5%
2/16 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
6.2%
1/16 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment.
|
|
Skin and subcutaneous tissue disorders
Rash/desquamation
|
12.5%
2/16 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment.
|
|
Skin and subcutaneous tissue disorders
Skin- Other
|
6.2%
1/16 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment.
|
|
Metabolism and nutrition disorders
Anorexia
|
25.0%
4/16 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment.
|
|
Gastrointestinal disorders
Constipation
|
12.5%
2/16 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment.
|
|
Gastrointestinal disorders
Dyspepsia
|
6.2%
1/16 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment.
|
|
Gastrointestinal disorders
Dysphagia
|
12.5%
2/16 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment.
|
|
Gastrointestinal disorders
Nausea
|
37.5%
6/16 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment.
|
|
Gastrointestinal disorders
Stomatitis
|
25.0%
4/16 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment.
|
|
Nervous system disorders
Taste disturbance
|
6.2%
1/16 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment.
|
|
Gastrointestinal disorders
Vomiting
|
25.0%
4/16 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment.
|
|
Gastrointestinal disorders
Diarrhea w/o prior colostomy
|
12.5%
2/16 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment.
|
|
Investigations
Alkaline phosphatase increased
|
12.5%
2/16 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment.
|
|
Investigations
Bilirubin increased
|
6.2%
1/16 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment.
|
|
Investigations
SGOT increased
|
31.2%
5/16 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment.
|
|
Infections and infestations
Infection w/o neutropenia
|
6.2%
1/16 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
56.2%
9/16 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment.
|
|
Nervous system disorders
Dizziness/Lightheadedness
|
18.8%
3/16 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment.
|
|
Psychiatric disorders
Insomnia
|
31.2%
5/16 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment.
|
|
Psychiatric disorders
Anxiety/Agitation
|
12.5%
2/16 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment.
|
|
Nervous system disorders
Neuropathy-motor
|
12.5%
2/16 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment.
|
|
Nervous system disorders
Neuropathy-sensory
|
68.8%
11/16 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment.
|
|
Gastrointestinal disorders
Abdominal Pain
|
6.2%
1/16 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
6.2%
1/16 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment.
|
|
Ear and labyrinth disorders
Earache
|
6.2%
1/16 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment.
|
|
Nervous system disorders
Headache
|
18.8%
3/16 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
18.8%
3/16 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment.
|
|
General disorders
Pain-other
|
6.2%
1/16 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
37.5%
6/16 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
12.5%
2/16 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment.
|
|
Investigations
Creatinine increased
|
25.0%
4/16 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment.
|
|
Renal and urinary disorders
Urinary Frequency/Urgency
|
6.2%
1/16 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment.
|
Additional Information
Study Statistician
ECOG Statistical Office
Phone: 617-632-3012
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place