Multiple Myeloma
Conditions
Keywords
Multiple Myeloma, Revlimid
Brief summary
The purpose of this study to explore the combination of Revlimid®, oral cyclophosphamide and prednisone (RCP) in patients with newly diagnosed multiple myeloma.
Detailed description
This is a phase II single institution trial in patients with newly diagnosed multiple myeloma. Revlimid® 25 mg p.o. daily on days 1-21 of each 28-day cycle. Cyclophosphamide 50 mg p.o. BID daily on days 1-21 of each 28-day cycle. Prednisone 50 mg p.o. Q.O.D..
Interventions
25 mg p.o. daily on days 1-21 of each 28 day cycle
DRUGCyclophosphamide
50 mg p.o. BID daily on days 1-21 of each 28 day cycle
DRUGPrednisone
50 mg p.o. Q.O.D.
Sponsors
Celgene
Attaya Suvannasankha
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Patients with newly diagnosed, symptomatic multiple myeloma based on the following criteria: * Presence of an M-component in serum and/or urine plus clonal plasma cells in the bone marrow and/or a documented clonal plasmacytoma PLUS one or more of the following: * Calcium elevation (11.5 mg/dl) \[42.65 mmol/l\] * Renal insufficiency (1.5 x the ULN of serum creatinine) * Anemia (hemoglobin \<=10 g/dl or 2 g/dl \<= normal) * Bone disease (lytic lesions or osteopenia) Measurable disease is defined at least one of the following three measurements: * Serum M-protein \>=1 g/dl ( or 10 g/l) * Urine M-protein \>=200 mg/24 h * Serum FLC assay: Involved FLC level \>=10 mg/dl (\>=100 mg/l) provided serum FLC ratio is abnormal * Measurable plasmacytoma * NOTE: If a patient meets the criteria for symptomatic multiple myeloma but does not meet serum M-protein, urine M-protein or serum FLC levels stated above, percent plasma cells in bone marrow will be used to follow response. Laboratory test results within these ranges: * Absolute neutrophil count \>= 1.0 x 109/L * Platelet count \>= 50 x 10(9)/L * Hemoglobin \>= 9 gm/dl * Serum creatinine \<= 2.5mg/dL. * Total bilirubin \<=1.5 x upper limit of normal * AST (SGOT) and ALT (SGPT) \<= 3 x ULN
Exclusion criteria
* Known hypersensitivity to thalidomide * The development of erythema nodosum if characterized by a desquamating rash while taking thalidomide or similar drugs. * Patients with a solitary plasmacytoma * Patients with uncontrolled diabetes * Patients with ≥ Grade 3 sensory neuropathy * History of cardiac disease, with NYHA Class II or greater
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Response Rate (RR) After 6 Cycles of Therapy Using the Proposed International Myeloma Working Group Uniform Response Criteria | After 6 cycles | Evaluate the response rate of patients receiving therapy. Patients are considered as having a response if their overall response is Partial Response or better using the proposed International Myeloma Working Group uniform response criteria. The percentage of patients achieving this and the exact 95% confidence interval will be calculated. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Treatment Related Adverse Events Grade 3 or Higher | Beginning of treatment up to 5 years | Number of unique patients who had treatment related (possible, probable or definite) adverse events that were graded 3 or greater. |
| Quality of Life Using the FACT-G Data | baseline and after last cycle (up to 6 cycles) | Change from baseline FACT-G scores. The quality of life questionnaire (FACT-G) was given at various timepoints during the study. The values for change from baseline to endpoint are provided. Physical Well-Being (PWB; sum of 7 items, point range 0-28); Social/Family Well-Being (SWB, sum of 7-items, point range 0-28); Emotional Well-Being (EWB; sum of 6-items, point range 0-24); Functional Well-Being (FWB; sum of 7-items, point range 0-28) ; Fact-G score=sum of PWB, SWB, EWB, FWB, point range 0-108. Note: The higher the score, the better the outcome |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Original Study - Revlimid, Cyclophosphamide, Prednisone Original portion of the study where patients received Revlimid® 25 mg p.o. daily on days 1-21 of each 28-day cycle. Cyclophosphamide 50 mg p.o. BID daily on days 1-21 of each 28-day cycle. Prednisone 50 mg p.o. Q.O.D. | 48 |
| Extension - Revlimid, Cyclophosphamide, Prednisone Extension portion of the study where patients received Revlimid® 25 mg p.o. daily on days 1-21 of each 28-day cycle. Cyclophosphamide 50 mg p.o. BID daily on days 1-21 of each 28-day cycle. Prednisone 50 mg p.o. Q.O.D. | 22 |
| Total | 70 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 3 | 1 |
| Overall Study | Disease Progression | 3 | 1 |
| Overall Study | Noncomplilance | 1 | 0 |
| Overall Study | Physician Decision | 0 | 5 |
| Overall Study | Withdrawal by Subject | 2 | 2 |
Baseline characteristics
| Characteristic | Original Study - Revlimid, Cyclophosphamide, Prednisone | Extension - Revlimid, Cyclophosphamide, Prednisone | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 22 Participants | 5 Participants | 27 Participants |
| Age, Categorical Between 18 and 65 years | 26 Participants | 17 Participants | 43 Participants |
| Age, Continuous | 61.9 years STANDARD_DEVIATION 10.5 | 59.9 years STANDARD_DEVIATION 8 | 61.2 years STANDARD_DEVIATION 9.8 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 48 Participants | 22 Participants | 70 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 4 Participants | 0 Participants | 4 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 43 Participants | 21 Participants | 64 Participants |
| Sex: Female, Male Female | 18 Participants | 8 Participants | 26 Participants |
| Sex: Female, Male Male | 30 Participants | 14 Participants | 44 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 48 / 48 | 22 / 22 |
| serious Total, serious adverse events | 12 / 48 | 5 / 22 |
Outcome results
Primary
Response Rate (RR) After 6 Cycles of Therapy Using the Proposed International Myeloma Working Group Uniform Response Criteria
Evaluate the response rate of patients receiving therapy. Patients are considered as having a response if their overall response is Partial Response or better using the proposed International Myeloma Working Group uniform response criteria. The percentage of patients achieving this and the exact 95% confidence interval will be calculated.
Time frame: After 6 cycles
Population: All patients receiving at least one dose of study drug and having at least one post-baseline visit
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Original Study - Revlimid, Cyclophosphamide, Prednisone | Response Rate (RR) After 6 Cycles of Therapy Using the Proposed International Myeloma Working Group Uniform Response Criteria | 86.7 percentage of participants |
| Extension - Revlimid, Cyclophosphamide, Prednisone | Response Rate (RR) After 6 Cycles of Therapy Using the Proposed International Myeloma Working Group Uniform Response Criteria | 71.4 percentage of participants |
Secondary
Quality of Life Using the FACT-G Data
Change from baseline FACT-G scores. The quality of life questionnaire (FACT-G) was given at various timepoints during the study. The values for change from baseline to endpoint are provided. Physical Well-Being (PWB; sum of 7 items, point range 0-28); Social/Family Well-Being (SWB, sum of 7-items, point range 0-28); Emotional Well-Being (EWB; sum of 6-items, point range 0-24); Functional Well-Being (FWB; sum of 7-items, point range 0-28) ; Fact-G score=sum of PWB, SWB, EWB, FWB, point range 0-108. Note: The higher the score, the better the outcome
Time frame: baseline and after last cycle (up to 6 cycles)
Population: All patients enrolled and received treatment with a baseline and post-baseline measurement.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Original Study - Revlimid, Cyclophosphamide, Prednisone | Quality of Life Using the FACT-G Data | Social/Family Well-Being Change from Baseline | -0.03 scores on a scale | Standard Deviation 5.08 |
| Original Study - Revlimid, Cyclophosphamide, Prednisone | Quality of Life Using the FACT-G Data | Functional Well-Being Change from Baseline | 3.38 scores on a scale | Standard Deviation 5.33 |
| Original Study - Revlimid, Cyclophosphamide, Prednisone | Quality of Life Using the FACT-G Data | Emotional Well-Beling Change from Baseline | 2.52 scores on a scale | Standard Deviation 3.95 |
| Original Study - Revlimid, Cyclophosphamide, Prednisone | Quality of Life Using the FACT-G Data | FACT-G Change from Baseline | 7.44 scores on a scale | Standard Deviation 13.07 |
| Original Study - Revlimid, Cyclophosphamide, Prednisone | Quality of Life Using the FACT-G Data | Physical Well-Being Change from Baseline | 1.57 scores on a scale | Standard Deviation 6.2 |
| Extension - Revlimid, Cyclophosphamide, Prednisone | Quality of Life Using the FACT-G Data | FACT-G Change from Baseline | -3.61 scores on a scale | Standard Deviation 10.92 |
| Extension - Revlimid, Cyclophosphamide, Prednisone | Quality of Life Using the FACT-G Data | Physical Well-Being Change from Baseline | -2.81 scores on a scale | Standard Deviation 6.14 |
| Extension - Revlimid, Cyclophosphamide, Prednisone | Quality of Life Using the FACT-G Data | Social/Family Well-Being Change from Baseline | -0.23 scores on a scale | Standard Deviation 3.53 |
| Extension - Revlimid, Cyclophosphamide, Prednisone | Quality of Life Using the FACT-G Data | Emotional Well-Beling Change from Baseline | 0.60 scores on a scale | Standard Deviation 3.22 |
| Extension - Revlimid, Cyclophosphamide, Prednisone | Quality of Life Using the FACT-G Data | Functional Well-Being Change from Baseline | -1.17 scores on a scale | Standard Deviation 4.97 |
Secondary
Treatment Related Adverse Events Grade 3 or Higher
Number of unique patients who had treatment related (possible, probable or definite) adverse events that were graded 3 or greater.
Time frame: Beginning of treatment up to 5 years
Population: All patients enrolled and received treatment.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Original Study - Revlimid, Cyclophosphamide, Prednisone | Treatment Related Adverse Events Grade 3 or Higher | 21 participants |
| Extension - Revlimid, Cyclophosphamide, Prednisone | Treatment Related Adverse Events Grade 3 or Higher | 11 participants |