Lymphoma
Conditions
Keywords
contiguous stage II mantle cell lymphoma, noncontiguous stage II mantle cell lymphoma, stage III mantle cell lymphoma, stage IV mantle cell lymphoma
Brief summary
RATIONALE: Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving rituximab together with combination chemotherapy and bortezomib may kill more cancer cells. Giving bortezomib as maintenance therapy may keep the cancer from progressing. PURPOSE: This phase II trial is studying how well giving rituximab together with combination chemotherapy and bortezomib followed by bortezomib alone works in treating patients with newly diagnosed mantle cell lymphoma.
Detailed description
OBJECTIVES: Primary * Determine the 2-year progression-free survival rate in patients with newly diagnosed mantle cell lymphoma treated with induction therapy comprising rituximab, cyclophosphamide, doxorubicin hydrochloride, vincristine, prednisone, and bortezomib followed by bortezomib maintenance (VM) therapy. Secondary * Determine the response rate (complete, complete unconfirmed, and partial responses) in patients treated with this regimen. * Determine the toxicity of VM in these patients. OUTLINE: This is a multicenter study. * Induction therapy: Patients receive R-CHOP-V induction therapy comprising rituximab IV over ≤ 6 hours, cyclophosphamide IV over 15-45 minutes, doxorubicin hydrochloride IV over 5-20 minutes, and vincristine IV over 5-15 minutes on day 1; oral prednisone once daily on days 1-5; and bortezomib IV over 30-90 minutes on days 1 and 4. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. After completion of 6 courses, patients with stable disease or better proceed to bortezomib maintenance therapy. * Maintenance therapy: Beginning 3 months after completion of R-CHOP-V induction therapy, patients receive bortezomib IV on days 1, 4, 8, and 11. Treatment repeats every 3 months for up to 8 courses in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed periodically for 4 years and then annually for 3 years. PROJECTED ACCRUAL: A total of 60 patients will be accrued for this study.
Interventions
BIOLOGICALrituximab
375 mg/m\^2 on day 1 for cycles 1-6.
DRUGbortezomib
1.3 mg/m\^2 on days 1, 4 of cycles 1-6 and on days 1, 4, 8, 11 of cycles 7-14.
DRUGcyclophosphamide
750 mg/m\^2 on day 1 of cycles 1-6.
DRUGdoxorubicin hydrochloride
50 mg/m\^2 on day 1 of cycles 1-6.
DRUGprednisone
100 mg on days 1-5 of cycles 1-6.
DRUGvincristine sulfate
1.4 mg/m\^2 on day 1 of cycles 1-6.
Sponsors
National Cancer Institute (NCI)
SWOG Cancer Research Network
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 120 Years
Healthy volunteers
No
Inclusion criteria
DISEASE CHARACTERISTICS: * Histologically confirmed mantle cell lymphoma (MCL) meeting the following criteria: * Stage III-IV or bulky stage II disease * Confirmation of positivity for the following phenotypes by immunohistochemistry or flow cytometry: * Cluster of differentiation antigen 19 (CD19) (or CD20) * Cyclin D1 OR evidence of t(11;14) translocation by cytogenetic analysis or fluorescent in situ hybridization * Newly diagnosed, previously untreated disease * Bidimensionally measurable disease by conventional techniques * No nonmeasurable disease only * Adequate tumor tissue from original diagnostic specimen available * Tissue obtained by needle aspiration or cytology not allowed * No clinical evidence of central nervous system (CNS) involvement by lymphoma * Co-registration on protocols SWOG-8947 and SWOG-8819 is strongly encouraged PATIENT CHARACTERISTICS: * Zubrod performance status 0-2 * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * No peripheral neuropathy ≥ grade 2 * No hypersensitivity to bortezomib, boron, or mannitol * No other prior malignancy except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated stage I or II cancer for which the patient is currently in complete remission, or any other cancer for which the patient has been disease free for the past 5 years * HIV negative PRIOR CONCURRENT THERAPY: * No prior chemotherapy, radiotherapy, or antibody therapy for lymphoma * More than 14 days since prior investigational drugs
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 2-year Progression-free Survival in Patients Treated With Rituximab-CHOP-bortezomib Induction Therapy (RCHOP-V) Followed by Bortezomib Maintenance Therapy (VM) | 0-2 years | Measured from date of registration to date of first observation of relapsed or progressive disease, or death due to any cause. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Response Rate in Patients Treated With Rituximab-CHOPbortezomib Induction Therapy (R-CHOP-V) Followed by Bortezomib Maintenance Therapy(VM). | At the time of restaging (between Cycles 6 and 7), every 6 months during Cycles 7-14, and at the end of protocol treatment | Complete Response(CR) is a complete disappearance of all disease with the exception of nodes. No new lesions. previously enlarged organs must have regressed and not be palpable. Bone marrow(BM) must be negative if positive at baseline. Normalization of markers. CR Unconfirmed (CRU) does not qualify for CR above, due to a residual nodal mass or an indeterminate BM. Partial Response(PR) is a 50% decrease in the sum of products of greatest diameters (SPD) for up to 6 identified dominant lesions, including spleenic and hepatic nodules from baseline. No new lesions and no increase in the size of liver, spleen or other nodes. |
| 2-year Overall Survival in Patients Treated With Rituximab-CHOP-bortezomib Induction Therapy (RCHOP-V) Followed by Bortezomib Maintenance Therapy (VM) | 0-2 years | Measured from date of registration to date of death due to any cause or last contact |
| Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Assessed prior to each cycle (for Cycles 2-6), at restaging (between Cycle 6 and 7), every 3 months ( for Cycle 7-14), and at the end of protocol treatment. | Adverse Events (AEs) are reported by the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0. For each patient, worst grade of each event type is reported. Grade 3 = Severe, Grade 4 = Life-threatening, Grade 5 = Fatal. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Rituximab-CHOP-Bortezomib (R-CHOP-V) R-CHOP-V will be administered for 6 cycles (one cycle is defined as a single 21-day course of treatment). | 65 |
| Total | 65 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Initial Registration | Adverse Event | 1 | 0 |
| Initial Registration | Ineligible | 3 | 0 |
| Initial Registration | Progression/relapse | 1 | 0 |
| Initial Registration | Refusal Unrelated to Adverse Event | 2 | 0 |
| Maintenance | Adverse Event | 0 | 1 |
| Maintenance | Ineligible | 0 | 3 |
| Maintenance | Progression/relapse | 0 | 18 |
| Maintenance | Refusal Unrelated to Adverse Event | 0 | 1 |
Baseline characteristics
| Characteristic | Rituximab-CHOP-Bortezomib (R-CHOP-V) |
|---|---|
| Age, Continuous | 61 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 51 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 13 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 61 Participants |
| Sex: Female, Male Female | 13 Participants |
| Sex: Female, Male Male | 52 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 64 / 65 | 43 / 47 |
| serious Total, serious adverse events | 1 / 65 | 0 / 47 |
Outcome results
Primary
2-year Progression-free Survival in Patients Treated With Rituximab-CHOP-bortezomib Induction Therapy (RCHOP-V) Followed by Bortezomib Maintenance Therapy (VM)
Measured from date of registration to date of first observation of relapsed or progressive disease, or death due to any cause.
Time frame: 0-2 years
Population: All eligible patients who started treatment were included in the analysis
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| R-CHOP-V Followed by VM | 2-year Progression-free Survival in Patients Treated With Rituximab-CHOP-bortezomib Induction Therapy (RCHOP-V) Followed by Bortezomib Maintenance Therapy (VM) | 62 percentage of participants |
Secondary
2-year Overall Survival in Patients Treated With Rituximab-CHOP-bortezomib Induction Therapy (RCHOP-V) Followed by Bortezomib Maintenance Therapy (VM)
Measured from date of registration to date of death due to any cause or last contact
Time frame: 0-2 years
Population: All eligible patients who started treatment were included in the analysis.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| R-CHOP-V Followed by VM | 2-year Overall Survival in Patients Treated With Rituximab-CHOP-bortezomib Induction Therapy (RCHOP-V) Followed by Bortezomib Maintenance Therapy (VM) | 85 percentage of participants |
Secondary
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Adverse Events (AEs) are reported by the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0. For each patient, worst grade of each event type is reported. Grade 3 = Severe, Grade 4 = Life-threatening, Grade 5 = Fatal.
Time frame: Assessed prior to each cycle (for Cycles 2-6), at restaging (between Cycle 6 and 7), every 3 months ( for Cycle 7-14), and at the end of protocol treatment.
Population: Eligible patients who had received any treatment were included in the adverse event summaries. Any CTCAE 3.0 event of Grade 3 (severe), Grade 4 (life threatening), or Grade 5 (fatal) which deemed to be related to protocol treatment are included.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| R-CHOP-V Followed by VM | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Albumin, serum-low (hypoalbuminemia) | 1 Participants |
| R-CHOP-V Followed by VM | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Anorexia | 1 Participants |
| R-CHOP-V Followed by VM | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Calcium, serum-low (hypocalcemia) | 1 Participants |
| R-CHOP-V Followed by VM | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Constipation | 1 Participants |
| R-CHOP-V Followed by VM | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Dehydration | 1 Participants |
| R-CHOP-V Followed by VM | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Diarrhea | 3 Participants |
| R-CHOP-V Followed by VM | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Dizziness | 1 Participants |
| R-CHOP-V Followed by VM | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Dyspnea (shortness of breath) | 1 Participants |
| R-CHOP-V Followed by VM | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Edema: limb | 1 Participants |
| R-CHOP-V Followed by VM | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Fatigue (asthenia, lethargy, malaise) | 6 Participants |
| R-CHOP-V Followed by VM | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Febrile neutropenia | 12 Participants |
| R-CHOP-V Followed by VM | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | GGT (gamma-glutamyl transpeptidase) | 1 Participants |
| R-CHOP-V Followed by VM | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Glucose, serum-high (hyperglycemia) | 3 Participants |
| R-CHOP-V Followed by VM | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Hemoglobin | 3 Participants |
| R-CHOP-V Followed by VM | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Hypoxia | 1 Participants |
| R-CHOP-V Followed by VM | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Inf (clin/microbio) w/Gr 3-4 neuts - Lung | 3 Participants |
| R-CHOP-V Followed by VM | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Inf (clin/microbio) w/Gr 3-4 neuts - Oral cav-gums | 1 Participants |
| R-CHOP-V Followed by VM | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Inf (clin/microbio) w/Gr 3-4 neuts - Sinus | 1 Participants |
| R-CHOP-V Followed by VM | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Inf w/normal ANC or Gr 1-2 neutrophils - Ext ear | 1 Participants |
| R-CHOP-V Followed by VM | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Inf w/normal ANC or Gr 1-2 neutrophils - Lung | 1 Participants |
| R-CHOP-V Followed by VM | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Inf w/normal ANC or Gr 1-2 neutrophils - Oral cav | 1 Participants |
| R-CHOP-V Followed by VM | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Inf w/normal ANC or Gr 1-2 neutrophils - Sinus | 0 Participants |
| R-CHOP-V Followed by VM | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Inf w/normal ANC or Gr 1-2 neutrophils -Nerve-peri | 1 Participants |
| R-CHOP-V Followed by VM | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Infection-Other (Specify) | 1 Participants |
| R-CHOP-V Followed by VM | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Leukocytes (total WBC) | 26 Participants |
| R-CHOP-V Followed by VM | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Lymphopenia | 15 Participants |
| R-CHOP-V Followed by VM | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Mucositis/stomatitis (functional/symp) - Oral cav | 1 Participants |
| R-CHOP-V Followed by VM | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Muscle weakness, not d/t neuropathy - body/general | 1 Participants |
| R-CHOP-V Followed by VM | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Nausea | 2 Participants |
| R-CHOP-V Followed by VM | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Neuropathy: CN V Motor-jaw muscles; Sensory-facial | 1 Participants |
| R-CHOP-V Followed by VM | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Neuropathy: motor | 2 Participants |
| R-CHOP-V Followed by VM | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Neuropathy: sensory | 2 Participants |
| R-CHOP-V Followed by VM | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Neutrophils/granulocytes (ANC/AGC) | 34 Participants |
| R-CHOP-V Followed by VM | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Pain - Head/headache | 0 Participants |
| R-CHOP-V Followed by VM | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Phosphate, serum-low (hypophosphatemia) | 1 Participants |
| R-CHOP-V Followed by VM | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Platelets | 11 Participants |
| R-CHOP-V Followed by VM | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Pneumonitis/pulmonary infiltrates | 1 Participants |
| R-CHOP-V Followed by VM | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Potassium, serum-low (hypokalemia) | 2 Participants |
| R-CHOP-V Followed by VM | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Pruritus/itching | 1 Participants |
| R-CHOP-V Followed by VM | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Renal failure | 1 Participants |
| R-CHOP-V Followed by VM | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Syncope (fainting) | 2 Participants |
| R-CHOP-V Followed by VM | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Thrombosis/embolism (vascular access-related) | 1 Participants |
| R-CHOP-V Followed by VM | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Thrombosis/thrombus/embolism | 1 Participants |
| R-CHOP-V Followed by VM | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Uric acid, serum-high (hyperuricemia) | 1 Participants |
| R-CHOP-V Followed by VM | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Urticaria (hives, welts, wheals) | 0 Participants |
| Bortezomib Maintenance (VM) | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Inf w/normal ANC or Gr 1-2 neutrophils -Nerve-peri | 0 Participants |
| Bortezomib Maintenance (VM) | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Albumin, serum-low (hypoalbuminemia) | 0 Participants |
| Bortezomib Maintenance (VM) | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Renal failure | 0 Participants |
| Bortezomib Maintenance (VM) | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Anorexia | 0 Participants |
| Bortezomib Maintenance (VM) | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Infection-Other (Specify) | 0 Participants |
| Bortezomib Maintenance (VM) | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Calcium, serum-low (hypocalcemia) | 0 Participants |
| Bortezomib Maintenance (VM) | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Phosphate, serum-low (hypophosphatemia) | 0 Participants |
| Bortezomib Maintenance (VM) | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Constipation | 0 Participants |
| Bortezomib Maintenance (VM) | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Leukocytes (total WBC) | 0 Participants |
| Bortezomib Maintenance (VM) | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Dehydration | 0 Participants |
| Bortezomib Maintenance (VM) | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Thrombosis/thrombus/embolism | 0 Participants |
| Bortezomib Maintenance (VM) | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Diarrhea | 0 Participants |
| Bortezomib Maintenance (VM) | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Lymphopenia | 2 Participants |
| Bortezomib Maintenance (VM) | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Dizziness | 0 Participants |
| Bortezomib Maintenance (VM) | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Platelets | 0 Participants |
| Bortezomib Maintenance (VM) | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Dyspnea (shortness of breath) | 1 Participants |
| Bortezomib Maintenance (VM) | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Mucositis/stomatitis (functional/symp) - Oral cav | 0 Participants |
| Bortezomib Maintenance (VM) | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Edema: limb | 0 Participants |
| Bortezomib Maintenance (VM) | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Syncope (fainting) | 0 Participants |
| Bortezomib Maintenance (VM) | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Fatigue (asthenia, lethargy, malaise) | 1 Participants |
| Bortezomib Maintenance (VM) | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Muscle weakness, not d/t neuropathy - body/general | 0 Participants |
| Bortezomib Maintenance (VM) | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Febrile neutropenia | 0 Participants |
| Bortezomib Maintenance (VM) | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Pneumonitis/pulmonary infiltrates | 0 Participants |
| Bortezomib Maintenance (VM) | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | GGT (gamma-glutamyl transpeptidase) | 1 Participants |
| Bortezomib Maintenance (VM) | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Nausea | 0 Participants |
| Bortezomib Maintenance (VM) | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Glucose, serum-high (hyperglycemia) | 0 Participants |
| Bortezomib Maintenance (VM) | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Urticaria (hives, welts, wheals) | 1 Participants |
| Bortezomib Maintenance (VM) | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Hemoglobin | 0 Participants |
| Bortezomib Maintenance (VM) | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Neuropathy: CN V Motor-jaw muscles; Sensory-facial | 0 Participants |
| Bortezomib Maintenance (VM) | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Hypoxia | 0 Participants |
| Bortezomib Maintenance (VM) | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Potassium, serum-low (hypokalemia) | 0 Participants |
| Bortezomib Maintenance (VM) | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Inf (clin/microbio) w/Gr 3-4 neuts - Lung | 0 Participants |
| Bortezomib Maintenance (VM) | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Neuropathy: motor | 0 Participants |
| Bortezomib Maintenance (VM) | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Inf (clin/microbio) w/Gr 3-4 neuts - Oral cav-gums | 0 Participants |
| Bortezomib Maintenance (VM) | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Thrombosis/embolism (vascular access-related) | 0 Participants |
| Bortezomib Maintenance (VM) | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Inf (clin/microbio) w/Gr 3-4 neuts - Sinus | 0 Participants |
| Bortezomib Maintenance (VM) | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Neuropathy: sensory | 1 Participants |
| Bortezomib Maintenance (VM) | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Inf w/normal ANC or Gr 1-2 neutrophils - Ext ear | 0 Participants |
| Bortezomib Maintenance (VM) | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Pruritus/itching | 0 Participants |
| Bortezomib Maintenance (VM) | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Inf w/normal ANC or Gr 1-2 neutrophils - Lung | 0 Participants |
| Bortezomib Maintenance (VM) | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Neutrophils/granulocytes (ANC/AGC) | 0 Participants |
| Bortezomib Maintenance (VM) | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Inf w/normal ANC or Gr 1-2 neutrophils - Oral cav | 0 Participants |
| Bortezomib Maintenance (VM) | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Uric acid, serum-high (hyperuricemia) | 0 Participants |
| Bortezomib Maintenance (VM) | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Inf w/normal ANC or Gr 1-2 neutrophils - Sinus | 1 Participants |
| Bortezomib Maintenance (VM) | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Pain - Head/headache | 1 Participants |
Secondary
Response Rate in Patients Treated With Rituximab-CHOPbortezomib Induction Therapy (R-CHOP-V) Followed by Bortezomib Maintenance Therapy(VM).
Complete Response(CR) is a complete disappearance of all disease with the exception of nodes. No new lesions. previously enlarged organs must have regressed and not be palpable. Bone marrow(BM) must be negative if positive at baseline. Normalization of markers. CR Unconfirmed (CRU) does not qualify for CR above, due to a residual nodal mass or an indeterminate BM. Partial Response(PR) is a 50% decrease in the sum of products of greatest diameters (SPD) for up to 6 identified dominant lesions, including spleenic and hepatic nodules from baseline. No new lesions and no increase in the size of liver, spleen or other nodes.
Time frame: At the time of restaging (between Cycles 6 and 7), every 6 months during Cycles 7-14, and at the end of protocol treatment
Population: All eligible patients who started treatment were included in the analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| R-CHOP-V Followed by VM | Response Rate in Patients Treated With Rituximab-CHOPbortezomib Induction Therapy (R-CHOP-V) Followed by Bortezomib Maintenance Therapy(VM). | Complete Response | 17 participants |
| R-CHOP-V Followed by VM | Response Rate in Patients Treated With Rituximab-CHOPbortezomib Induction Therapy (R-CHOP-V) Followed by Bortezomib Maintenance Therapy(VM). | Partial Response | 16 participants |
| R-CHOP-V Followed by VM | Response Rate in Patients Treated With Rituximab-CHOPbortezomib Induction Therapy (R-CHOP-V) Followed by Bortezomib Maintenance Therapy(VM). | Unconfirmed Complete Response | 13 participants |
| R-CHOP-V Followed by VM | Response Rate in Patients Treated With Rituximab-CHOPbortezomib Induction Therapy (R-CHOP-V) Followed by Bortezomib Maintenance Therapy(VM). | Unconfirmed Partial Response | 1 participants |
| R-CHOP-V Followed by VM | Response Rate in Patients Treated With Rituximab-CHOPbortezomib Induction Therapy (R-CHOP-V) Followed by Bortezomib Maintenance Therapy(VM). | No Response | 4 participants |
| R-CHOP-V Followed by VM | Response Rate in Patients Treated With Rituximab-CHOPbortezomib Induction Therapy (R-CHOP-V) Followed by Bortezomib Maintenance Therapy(VM). | Assessment Inadequate | 14 participants |