Refractory Multiple Myeloma
Conditions
Brief summary
This clinical trial studies filgrastim (G-CSF) with or without plerixafor in treating patients with multiple myeloma (MM) previously treated with lenalidomide. Giving colony-stimulating factors, such as G-CSF, and plerixafor helps stem cells move from the patient's bone marrow to the blood so they can be collected and stored
Detailed description
PRIMARY OBJECTIVES: I. Ability to reach target collection of 5 x 10\^6 CD34+ cells/Kg with =\< 2 days of leukaphereses using one of two mobilization regimens. SECONDARY OBJECTIVES: I. Percentage of patients achieving target goal CD34+ cell dose (as above) in =\< 5 days of leukaphereses. II. Compare collections between different mobilization regimens in those patients who are crossed over from one mobilization regimen to the other. III. Compare days of apheresis, need for hospitalization during mobilization, and need for remobilization between mobilizing groups. OUTLINE: Patients are randomized to 1 of 2 treatment arms. ARM I: Patients receive G-CSF subcutaneously (SC) once daily (QD) on days 1-8. ARM II: Patients receive G-CSF SC QD on days 1-7 and plerixafor SC QD on days 4-7. After completion of study treatment, patients are followed up at 14 days.
Interventions
DRUGplerixafor
Given SC
BIOLOGICALfilgrastim
Given SC
Sponsors
National Cancer Institute (NCI)
Case Comprehensive Cancer Center
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Diagnosis of MM by International Myeloma Working Group Criteria * In first or second complete or partial remission or stable refractory but not actively progressing myeloma according to the classifications provided by The Center for International Blood & Marrow Transplant Research * Received at least 2 cycles of lenalidomide therapy * Patients with MM scheduled to undergo stem cell harvest for possible allogeneic stem cell transplant (ASCT) * At least 2 weeks since last exposure to lenalidomide * Eastern Cooperative Oncology Group performance status of 0 or 1 * Prior to the start of mobilization: * white blood cell count \>/= 2.5 x 10\^9/L * absolute neutrophil count \>/= 1.2 x 10\^9/L * platelet count \>/=100 x 10\^9/L * creatinine clearance \>/= 30mL/minute * If childbearing potential, must either agree to complete abstinence from heterosexual intercourse or effective means of contraception during stem cell mobilization; female patients will undergo pregnancy test prior to stem cell mobilization therapy
Exclusion criteria
* Had prior autologous or allogeneic transplantation * Received pegfilgrastim within 3 weeks or G-CSF within 14 days of first dose of G-CSF for mobilization * Failed previous hematopoietic stem cell collections or collection attempts * Received radiation therapy to the pelvic area * Received lenalidomide within 2 weeks of first dose of G-CSF for mobilization * Had received experimental therapy within 4 weeks of enrolling in study * Current or prior history of other malignancies, excluding basal cell carcinoma of the skin
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Ability to Reach Target Collection of 5 x 10^6 CD34+ Cells/kg | In =< 2 days of leukaphereses |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Patients Achieving Target Goal CD34+ Cells Dose | In =< 5 days of leukaphereses | — |
| Compare Hematopoietic Stem Cells/kg Collections Between Different Mobilization Regimens in Those Patients Who Are Crossed Over From One Mobilization Regimen to the Other | By day 1 | Patients will be randomized to receive either G-CSF or Plerixafor with G-CSF. All patients will undergo at least 2 days of leukopheresis. Cells/kg between these 2 arms will be compared. For those patients that do not reach the target goal will undergo a wash-out period and cross over to the other study arm. |
| Compare Days of Apheresis Between Mobilization Groups | Day 1 | Using the Wilcoxon Rand Sum Test |
| Compare Need for Hospitalization During Mobilization Between Mobilization Groups | Day 1 | — |
| Compare Need for Remobilization Between Mobilization Groups | Day 1 | Using the Chi-square test or Fisher's exact test, as appropriate. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Arm I Patients receive G-CSF SC QD on days 1-4.
filgrastim: Given SC | 5 |
| Arm II Patients receive G-CSF SC QD on days 1-4 and plerixafor SC QD on days 4-8.
plerixafor: Given SC
filgrastim: Given SC | 4 |
| Total | 9 |
Baseline characteristics
| Characteristic | Arm I | Arm II | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 1 Participants | 1 Participants |
| Age, Categorical Between 18 and 65 years | 5 Participants | 3 Participants | 8 Participants |
| Age, Continuous | 52.40 years STANDARD_DEVIATION 4.16 | 56.25 years STANDARD_DEVIATION 8.18 | 53.00 years STANDARD_DEVIATION 6.15 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 5 Participants | 4 Participants | 9 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants | 0 Participants | 2 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 | 3 Participants | 4 Participants | 7 Participants |
| Region of Enrollment United States | 5 participants | 4 participants | 9 participants |
| Sex: Female, Male Female | 2 Participants | 1 Participants | 3 Participants |
| Sex: Female, Male Male | 3 Participants | 3 Participants | 6 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 5 | 0 / 4 |
| serious Total, serious adverse events | 0 / 5 | 0 / 4 |
Outcome results
Primary
Ability to Reach Target Collection of 5 x 10^6 CD34+ Cells/kg
Time frame: In =< 2 days of leukaphereses
Population: due to low enrollment (10% of anticipated participants), no analysis is being done on data collected in this study
Secondary
Compare Days of Apheresis Between Mobilization Groups
Using the Wilcoxon Rand Sum Test
Time frame: Day 1
Secondary
Compare Hematopoietic Stem Cells/kg Collections Between Different Mobilization Regimens in Those Patients Who Are Crossed Over From One Mobilization Regimen to the Other
Patients will be randomized to receive either G-CSF or Plerixafor with G-CSF. All patients will undergo at least 2 days of leukopheresis. Cells/kg between these 2 arms will be compared. For those patients that do not reach the target goal will undergo a wash-out period and cross over to the other study arm.
Time frame: By day 1
Secondary
Compare Need for Hospitalization During Mobilization Between Mobilization Groups
Time frame: Day 1
Secondary
Compare Need for Remobilization Between Mobilization Groups
Using the Chi-square test or Fisher's exact test, as appropriate.
Time frame: Day 1
Secondary
Percentage of Patients Achieving Target Goal CD34+ Cells Dose
Time frame: In =< 5 days of leukaphereses
Population: Due to low enrollment (10% of anticipated participants), no analysis is being done on data collected in this study