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Comparison of Plerixafor and G-CSF Versus G-CSF Alone for Stem Cell Mobilization in Patients With Multiple Myeloma Previously Treated With Lenalidomide


Phase 3
19 Years
N/A
Open (Enrolling)
Both
Refractory Multiple Myeloma

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Trial Information

Comparison of Plerixafor and G-CSF Versus G-CSF Alone for Stem Cell Mobilization in Patients With Multiple Myeloma Previously Treated With Lenalidomide


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.


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

- At time of transplant: white blood cell count >/= 2.5 x 10^9/L

- At time of transplant: absolute neutrophil count >/= 1.2 x 10^9/L

- At time of transplant: platelet count >/=100 x 10^9/L

- At time of transplant: 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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Ability to reach target collection of 5 x 10^6 CD34+ cells/kg

Outcome Time Frame:

In =< 2 days of leukaphereses

Safety Issue:

No

Principal Investigator

Hien Duong

Investigator Role:

Principal Investigator

Investigator Affiliation:

Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center

Authority:

United States: Federal Government

Study ID:

CASE3A10

NCT ID:

NCT01301963

Start Date:

July 2011

Completion Date:

Related Keywords:

  • Refractory Multiple Myeloma
  • Multiple Myeloma
  • Neoplasms, Plasma Cell

Name

Location

Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer CenterCleveland, Ohio  44106-5065
Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer CenterCleveland, Ohio  44195