Plerixafor in Treating Patients With Multiple Myeloma Previously Treated With Lenalidomide and Planning to Undergo Autologous Stem Cell Transplant

• Sponsor: Mayo Clinic (Other)
• Overall Status: Completed
• CT.gov ID: NCT00998049
• Collaborator: (none)
• Enrollment: 40
• Locations: 2
• Arm: 1
• Duration (Months): 64
• Patients Per Site: 20
• Patients Per Site Per Month: 0.3

Study Details

Study Description

Brief Summary

Rationale: 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. Purpose: This phase II trial is studying how well plerixafor works in patients with multiple myeloma previously treated with lenalidomide and planning to undergo autologous stem cell transplant.

Condition or Disease	Intervention/Treatment	Phase
Multiple Myeloma; Refractory Multiple Myeloma; Stage I Multiple Myeloma; Stage II Multiple Myeloma; Stage III Multiple Myeloma	Drug: plerixafor; Drug: filgrastim	Phase 2

Detailed Description

Primary Objective: I. To determine the proportion of patients reaching a stem cell yield of 3 million CD34 cells/kg by second day of apheresis with intravenously administered AMD3100 among patients receiving primary therapy for myeloma with lenalidomide. Secondary Objectives:

1. Safety and tolerability of intravenously administered AMD3100. II. Rate of failure to mobilize. Outline: Patients receive plerixafor IV on days 5-8 and filgrastim subcutaneously on days 1-8 in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed at 30 days.

Study Design

• Study Type: Interventional
• Actual Enrollment: 40 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Phase II Trial of Intravenously Administered AMD3100 (Plerixafor) for Stem Cell Mobilization in Patients With Multiple Myeloma Undergoing Autologous Stem Cell Transplantation Following a Lenalidomide Based Initial Therapy
• Study Start Date: Dec 1, 2009
• Actual Primary Completion Date: Nov 1, 2011
• Actual Study Completion Date: Apr 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Plerixafor Plerixafor 160mg/kg/dose by IV on days 5-8 Filgrastim (G-CSF) 10 mg/kg/dose subcutaneously on days 1-8.	Drug: plerixafor; Plerixafor 160mg/kg/dose by IV on days 5-8; Other Names: AMD 3100 LM-3100 Mozobil ; Drug: filgrastim; Filgrastim (G-CSF) 10 mg/kg/dose subcutaneously on days 1-8.; Other Names: G-CSF granulocyte colony-stimulating factor Neupogen r-metHuG-CSF Recombinant Methionyl Human Granulocyte Colony Stimulating Factor

Outcome Measures

Primary Outcome Measures

1. Number of Patients Achieving 3 Million CD34 Cells/kg After 2 Days of Apheresis [After 2 days of apheresis]

   Number of CD34 cells/kg collected on days 1-2. Apheresis is the process when blood is taken out through a catheter in a vein in one arm, blood is sent through a machine that takes out the stem cells and the rest of the blood is then returned through a vein in your other arm.

Secondary Outcome Measures

1. CD34 Yield on Day 1 [Day 1]

   Number of CD34 cells/kg collected on day 1.

2. CD34 Yield Day 2 [Day 2]

   Number of CD34 cells/kg collected on day 2

3. Median Number of Days of Apheresis [Duration of apheresis (up to 7 days)]

4. Time to Reach 6 Million CD34 Cells [Duration of apheresis (up to 7 days)]

   Number (median and 95% confidence interval) of days to reach 6 million CD34 cells/kg was estimated using the Kaplan Meier method. Participants were lower than 6 million CD34 cells/kg at time of last follow-up will be censored at that date.

5. Rate of Failure to Mobilize [Duration of apheresis (up to 7 days)]

   The rate of failure to mobilize will be estimated by dividing the number of patients that fail to mobilize by the total number of evaluable patients. A patient is considered a failure if they never achieve 2.5 million CD34 cells/kg.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion - Absolute neutrophil count >= 1000/uL - Platelet >= 75000/uL - Hemoglobin >= 8.0 g/dL - Serum aspartate aminotransferase (AST)/serum glutamic oxaloacetic transaminase (SGOT), serum alanine aminotransferase (ALT)/serum glutamic pyruvic transaminase (SGPT) and total bilirubin < 2 x upper limit of normal (ULN) - Confirmed diagnosis of multiple myeloma, requiring therapy - Initial treatment for symptomatic myeloma using a lenalidomide based treatment regimen, started =< 12 months prior to registration - Received at least 2 cycles of treatment with the lenalidomide regimen - Last dose of lenalidomide > 2 weeks prior to registration - Eligible to undergo autologous transplantation - ECOG performance status (PS) 0 or 1 - Willingness to return for follow-up - Provide informed written consent

• Adequate cardiopulmonary function: ejection fraction >= 45%, corrected pulmonary diffusion capacity of >= 50%, FEV1 >= 50%, FVC >= 50% - Negative serum or urine pregnancy test done =< 7 days prior to registration, for women of childbearing potential only Exclusion - A co-morbid condition which, in the view of the Investigators, renders the patient at high risk from treatment complications - Active malignancy with the exception of non melanoma skin cancer or in situ cervical or breast cancer - Other co-morbidity which would interfere with patient's ability to participate in the trial, e.g. uncontrolled infection, uncompensated heart or lung disease - Other concurrent chemotherapy, radiotherapy, or any ancillary therapy considered investigational - Use of cyclophosphamide as part of stem cell mobilization - Use of more than one regimen for treatment of symptomatic myeloma - Dialysis dependent renal failure - Pregnant women or women of reproductive ability who are unwilling to use effective contraception - Nursing women - Men who are unwilling to use a condom (even if they have undergone a prior vasectomy) while having intercourse with any woman, while taking the drug and for 4 weeks after stopping treatment - Acute infection, active HIV infection

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Mayo Clinic in Arizona	Scottsdale	Arizona	United States	85259
2	Mayo Clinic	Rochester	Minnesota	United States	55905

Sponsors and Collaborators

• Mayo Clinic

Investigators

• Study Chair: Shaji Kumar, M.D., Mayo Clinic
• Principal Investigator: Joseph R. Mikhael, M.D., Mayo Clinic

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Mayo Clinic
• ClinicalTrials.gov Identifier: NCT00998049
• Other Study ID Numbers: MC0889; NCI-2009-01328; MC0889; 08-005644
• First Posted: Oct 20, 2009
• Last Update Posted: May 14, 2015
• Last Verified: Apr 1, 2015

• Additional relevant MeSH terms: Multiple Myeloma; Neoplasms, Plasma Cell; Plerixafor; Lenograstim

Study Results

Participant Flow

Recruitment Details	Forty (40) participants were recruited at Mayo Clinic (Rochester, Florida and Arizona) between December 2009 and October 2011.
Pre-assignment Detail	One participant was deemed ineligible and is excluded from all analyses per study design.

Arm/Group Title	Plerixafor
Arm/Group Description	Plerixafor 160mg/kg/dose by IV on days 5-8 Filgrastim (G-CSF) 10 mg/kg/dose subcutaneously on days 1-8.
Period Title: Overall Study
STARTED	39
COMPLETED	39
NOT COMPLETED	0

Baseline Characteristics

Arm/Group Title	Plerixafor
Arm/Group Description	Plerixafor 160mg/kg/dose by IV on days 5-8 Filgrastim (G-CSF) 10 mg/kg/dose subcutaneously on days 1-8.
Overall Participants	39
Age (years) [Median (Full Range) ]
Median (Full Range) [years]	60
Sex: Female, Male (Count of Participants)
Female	14 35.9%
Male	25 64.1%
Region of Enrollment (participants) [Number]
United States	39 100%

Outcome Measures

1. Primary Outcome

Title	Number of Patients Achieving 3 Million CD34 Cells/kg After 2 Days of Apheresis
Description	Number of CD34 cells/kg collected on days 1-2. Apheresis is the process when blood is taken out through a catheter in a vein in one arm, blood is sent through a machine that takes out the stem cells and the rest of the blood is then returned through a vein in your other arm.
Time Frame	After 2 days of apheresis

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Plerixafor
Arm/Group Description	Plerixafor 160mg/kg/dose by IV on days 5-8 Filgrastim (G-CSF) 10 mg/kg/dose subcutaneously on days 1-8.
Measure Participants	39
Number [participants]	38 97.4%

2. Secondary Outcome

Title	CD34 Yield on Day 1
Description	Number of CD34 cells/kg collected on day 1.
Time Frame	Day 1

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Plerixafor
Arm/Group Description	Plerixafor 160mg/kg/dose by IV on days 5-8 Filgrastim (G-CSF) 10 mg/kg/dose subcutaneously on days 1-8.
Measure Participants	39
Median (Full Range) [cells/kg]	3870000

3. Secondary Outcome

Title	CD34 Yield Day 2
Description	Number of CD34 cells/kg collected on day 2
Time Frame	Day 2

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Plerixafor
Arm/Group Description	Plerixafor 160mg/kg/dose by IV on days 5-8 Filgrastim (G-CSF) 10 mg/kg/dose subcutaneously on days 1-8.
Measure Participants	39
Median (Full Range) [cells/kg]	3550000

4. Secondary Outcome

Title	Median Number of Days of Apheresis
Time Frame	Duration of apheresis (up to 7 days)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Plerixafor
Arm/Group Description	Plerixafor 160mg/kg/dose by IV on days 5-8 Filgrastim (G-CSF) 10 mg/kg/dose subcutaneously on days 1-8.
Measure Participants	39
Median (Full Range) [days]	4

5. Secondary Outcome

Title	Time to Reach 6 Million CD34 Cells
Description	Number (median and 95% confidence interval) of days to reach 6 million CD34 cells/kg was estimated using the Kaplan Meier method. Participants were lower than 6 million CD34 cells/kg at time of last follow-up will be censored at that date.
Time Frame	Duration of apheresis (up to 7 days)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Plerixafor
Arm/Group Description	Plerixafor 160mg/kg/dose by IV on days 5-8 Filgrastim (G-CSF) 10 mg/kg/dose subcutaneously on days 1-8.
Measure Participants	39
Median (95% Confidence Interval) [days]	5

6. Secondary Outcome

Title	Rate of Failure to Mobilize
Description	The rate of failure to mobilize will be estimated by dividing the number of patients that fail to mobilize by the total number of evaluable patients. A patient is considered a failure if they never achieve 2.5 million CD34 cells/kg.
Time Frame	Duration of apheresis (up to 7 days)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Plerixafor
Arm/Group Description	Plerixafor 160mg/kg/dose by IV on days 5-8 Filgrastim (G-CSF) 10 mg/kg/dose subcutaneously on days 1-8.
Measure Participants	39
Number (95% Confidence Interval) [percentage of participants]	3 7.7%

Adverse Events

Arm/Group Title	Plerixafor
Arm/Group Description	Plerixafor 160mg/kg/dose by IV on days 5-8 Filgrastim (G-CSF) 10 mg/kg/dose subcutaneously on days 1-8.
All Cause Mortality
	Plerixafor
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Plerixafor
	Affected / at Risk (%)	# Events
Total	0/39 (0%)
Other (Not Including Serious) Adverse Events
	Plerixafor
	Affected / at Risk (%)	# Events
Total	25/39 (64.1%)
Blood and lymphatic system disorders
Anemia	1/39 (2.6%)	1
Gastrointestinal disorders
Abdominal pain	7/39 (17.9%)	7
Bloating	1/39 (2.6%)	1
Diarrhea	10/39 (25.6%)	10
Nausea	17/39 (43.6%)	17
General disorders
Injection site reaction	2/39 (5.1%)	2
Investigations
Platelet count decreased	2/39 (5.1%)	2
Nervous system disorders
Dizziness	8/39 (20.5%)	8
Headache	8/39 (20.5%)	8

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.