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Trial of Three Stem Cell Mobilization Regimens for Multiple Myeloma

Primary Purpose

Multiple Myeloma

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
bortezomib (Velcade)
cyclophosphamide
G-CSF
Plerixafor
Sponsored by
Weill Medical College of Cornell University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Multiple Myeloma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Voluntary written informed consent
  • Confirmed diagnosis of multiple myeloma
  • Age > than 18 years at the time of signing the informed consent form.
  • Karnofsky performance status above 60%
  • Patients must be within 30 days of completing induction therapy.
  • Female subject is either post-menopausal or surgically sterilized or willing to use an acceptable method of birth control .
  • Male subject agrees to use an acceptable method for contraception for the duration of the study.
  • Life expectancy > 12 weeks.
  • Subjects must have a MUGA scan or echo with LVEF >50%

  • Subjects must meet the following laboratory parameters:

    1. Absolute neutrophil count (ANC) ≥1500 cells/mm3
    2. Platelets count ≥ 50,000/mm3
    3. Hemoglobin > 9.0 g/dL
    4. Serum SGOT/AST <3.0 x upper limits of normal (ULN)
    5. Serum SGPT/ALT <3.0 x upper limits of normal (ULN)
    6. Serum creatinine < 2.5 mg/dL or creatinine clearance > 40ml/min
    7. Serum total bilirubin < 1.5 x ULN

Exclusion Criteria:

  • Patients with (no measurable monoclonal protein, free light chains, and/or M-spike in blood or urine) unless measurable disease is available with imaging techniques such as MRI and PET scan.
  • History of allergic reactions to compounds containing boron, mannitol, VELCADE
  • Prior history of other malignancies (except for basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the cervix or breast) unless disease free for > = 5 years.
  • NYHA Class III or IV heart disease. History of active unstable angina, congestive heart disease, severe uncontrolled cardiac arrhythmia, electrocardiographic evidence of acute ischemia, active conduction system abnormalities or myocardial infarction within 6 months prior to enrollment. Prior to study entry, any ECG abnormality at Screening has to be documented by the investigator as not medically relevant.
  • Female patients who are pregnant or breastfeeding. Women of childbearing potential and men must agree to use adequate contraception prior to study entry and for the duration of study participation.
  • Known HIV or hepatitis A, B, or C positivity---ONLY IF ACTIVE
  • Active viral or bacterial infections or any coexisting medical problem that would significantly increase the risks of this treatment program.
  • Any concurrent, uncontrolled medical condition, laboratory abnormality, or psychiatric illness which could place him/her at unacceptable risk
  • Patient has > = Grade 2 peripheral neuropathy within 14 days before enrollment.
  • Patient has received other investigational drugs with 14 days before enrollment
  • Diagnosed or treated for another malignancy within 3 years of enrollment, with the exception of complete resection of basal cell carcinoma or squamous cell carcinoma of the skin, an in situ malignancy, or low-risk prostate cancer after curative therapy.

Sites / Locations

  • Emory University
  • New York University Cancer Institute
  • Columbia Presbyterian Medical Center):
  • Memorial Sloan-Kettering Cancer Center):
  • Weill Cornell Medical College

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

Arm A: VELCADE, CYCLOPHOSPHAMIDE, & G-CSF

Arm B: VELCADE & G-CSF

Arm C: CYCLOPHOSPHAMIDE & G-CSF

Arm D: PLERIXAFOR & G-CSF

Arm E: PLERIXAFOR, VELCADE, & G-CSF

Arm Description

VELCADE at 1.3 mg/m2 IVP on days 1, 4, 8 and 11 in combination with high-dose cyclophosphamide at 2.0 g/m2 on day 4. G-CSF is given for ten (+/- two) consecutive days starting on day 9 at a dose of 10 micrograms/kg/day. Pheresis will commence once ANC of 1.5 is reached.

VELCADE at 1.3 mg/m2 IVP on days 1, 4, 8 and 11. G-CSF is given for ten (+/- two) consecutive days starting on day 9 at a dose of 10 micrograms/kg/day. Day 12 start pheresis collection

High-dose cyclophosphamide at 2.0 g/m2 on day 1. G-CSF is given for ten (+/- two) consecutive days starting on day 2 at a dose of 10 micrograms/kg/day. Pheresis will commence once ANC of 1.5 is reached.

G-CSF is given for ten (+/- two) consecutive days starting on day 1 at a dose of 10 micrograms/kg/day. Plerixafor is given on day 4, approximately 11 hours prior to stem cell collection attempt on Day 5. Both G-CSF and plerixafor are continued daily until collection is complete. Pheresis will commence for everyone on Day 5 regardless of ANC status.

Bortezomib at 1.3 mg/m2 IVP on days 1, 4, 8 and 11. G-CSF is given for ten (+/- wo) consecutive days starting on day 9 at a dose of 10 micrograms/kg/day. Plerixafor is given on day 12, approximately 11 hours prior to stem cell collection attempt and is continued daily until collection is complete. Pheresis will commence for everyone on Day 13 regardless of ANC status.

Outcomes

Primary Outcome Measures

Number of Patients Able to Collect >=6 x 106 CD34+ Cells/kg in <= 2 Collections.
The primary endpoint in all five treatment arms is the percentage of patients who are able to achieve greater than 6 x 106 CD34+ stems cells/kg harvested (defined as effectiveness). Note that no patients were enrolled Arm D and Arm E.

Secondary Outcome Measures

Number of Patients Who Achieved Neutrophil Recovery After Melphalan 200 Based Transplant
Number of patients who achieved neutrophil recovery after Melphalan 200 based transplant in 20 days or fewer. Neutrophil recovery is defined as an absolute neutrophil count of greater than 0.5 k/uL for three consecutive days.
Number of Patients Who Achieved Platelet Recovery After Melphalan 200 Based Transplant
Number of patients who achieved platelet recovery after Melphalan 200 based transplant in 20 days or fewer. Platelet recovery is defined as a platelet count of greater than 20,000, untransfused, for three consecutive days.

Full Information

First Posted
June 16, 2010
Last Updated
December 18, 2019
Sponsor
Weill Medical College of Cornell University
Collaborators
Millennium Pharmaceuticals, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT01146834
Brief Title
Trial of Three Stem Cell Mobilization Regimens for Multiple Myeloma
Official Title
A Prospective Randomized Trial Comparing Three Different Peripheral Stem Cell Mobilization Regimens in Patients With Symptomatic Multiple Myeloma or Lymphoma
Study Type
Interventional

2. Study Status

Record Verification Date
December 2019
Overall Recruitment Status
Completed
Study Start Date
March 2011 (Actual)
Primary Completion Date
February 4, 2019 (Actual)
Study Completion Date
February 4, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Weill Medical College of Cornell University
Collaborators
Millennium Pharmaceuticals, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This phase III randomized trial compares three different peripheral stem cell mobilization regimens for patients with multiple myeloma who have received primary induction therapy or other therapies. Up to 180 patients will be enrolled. Patients eligible for treatment will be randomized to one of the three following mobilization regimens: Arm A = VELCADE, CYCLOPHOSPHAMIDE, & G-CSF Arm B = VELCADE & G-CSF Arm C = CYCLOPHOSPHAMIDE & G-CSF Arm D = PLERIXAFOR & G-CSF Arm E = PLERIXAFOR, VELCADE, & G-CSF
Detailed Description
PRIMARY STUDY OBJECTIVES • To compare the efficacy of the following peripheral stem cell mobilization regimens for MM: i. High dose cyclophosphamide, VELCADE, and G-CSF ii. VELCADE and G-CSF iii. High dose cyclophosphamide and G-CSF SECONDARY STUDY OBJECTIVES • To evaluate biomarkers as surrogate markers of mobilization in each arm To evaluate changes in tumor mass as defined by standard response parameters. To evaluate the safety of each of the arms. This phase III randomized trial compares three different peripheral stem cell mobilization regimens for patients with multiple myeloma who have received primary induction therapy Primary Endpoints a) Percentage of patients able to collect >6 x 106 CD34+ cells/kg in < 2 collections. Secondary Endpoints Engrafting: Neutrophil recovery (ANC >0.5 of <12 days), Plt recovery (>20K untransfused <20 days)) after mel 200 based transplant. Toxicities

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Myeloma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
47 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm A: VELCADE, CYCLOPHOSPHAMIDE, & G-CSF
Arm Type
Experimental
Arm Description
VELCADE at 1.3 mg/m2 IVP on days 1, 4, 8 and 11 in combination with high-dose cyclophosphamide at 2.0 g/m2 on day 4. G-CSF is given for ten (+/- two) consecutive days starting on day 9 at a dose of 10 micrograms/kg/day. Pheresis will commence once ANC of 1.5 is reached.
Arm Title
Arm B: VELCADE & G-CSF
Arm Type
Experimental
Arm Description
VELCADE at 1.3 mg/m2 IVP on days 1, 4, 8 and 11. G-CSF is given for ten (+/- two) consecutive days starting on day 9 at a dose of 10 micrograms/kg/day. Day 12 start pheresis collection
Arm Title
Arm C: CYCLOPHOSPHAMIDE & G-CSF
Arm Type
Experimental
Arm Description
High-dose cyclophosphamide at 2.0 g/m2 on day 1. G-CSF is given for ten (+/- two) consecutive days starting on day 2 at a dose of 10 micrograms/kg/day. Pheresis will commence once ANC of 1.5 is reached.
Arm Title
Arm D: PLERIXAFOR & G-CSF
Arm Type
Experimental
Arm Description
G-CSF is given for ten (+/- two) consecutive days starting on day 1 at a dose of 10 micrograms/kg/day. Plerixafor is given on day 4, approximately 11 hours prior to stem cell collection attempt on Day 5. Both G-CSF and plerixafor are continued daily until collection is complete. Pheresis will commence for everyone on Day 5 regardless of ANC status.
Arm Title
Arm E: PLERIXAFOR, VELCADE, & G-CSF
Arm Type
Experimental
Arm Description
Bortezomib at 1.3 mg/m2 IVP on days 1, 4, 8 and 11. G-CSF is given for ten (+/- wo) consecutive days starting on day 9 at a dose of 10 micrograms/kg/day. Plerixafor is given on day 12, approximately 11 hours prior to stem cell collection attempt and is continued daily until collection is complete. Pheresis will commence for everyone on Day 13 regardless of ANC status.
Intervention Type
Drug
Intervention Name(s)
bortezomib (Velcade)
Other Intervention Name(s)
Velcade
Intervention Description
1.3 mg/m2 IVP on days 1, 4, 8 and 11
Intervention Type
Drug
Intervention Name(s)
cyclophosphamide
Other Intervention Name(s)
Cytoxan
Intervention Description
2.0 g/m2 (day 4 for Arm A and day 1 for Arm C)
Intervention Type
Drug
Intervention Name(s)
G-CSF
Other Intervention Name(s)
Filgrastim, Neupogen
Intervention Description
given for ten (+/- two) consecutive days starting on day 9 at a dose of 10 micrograms/kg/day (start on day 2 for Arm C and start on Day 1 for Arm D)
Intervention Type
Drug
Intervention Name(s)
Plerixafor
Other Intervention Name(s)
Mozobil
Intervention Description
plerixafor is given on day 4, approximately 11 hours prior to stem cell collection attempt on Day 5, plerixafor daily until stem cell collection is complete (Arm D), start on Day 12, approximately 11 hours prior to stem cell collection attempt and plerixafor daily until collection if complete (Arm E)
Primary Outcome Measure Information:
Title
Number of Patients Able to Collect >=6 x 106 CD34+ Cells/kg in <= 2 Collections.
Description
The primary endpoint in all five treatment arms is the percentage of patients who are able to achieve greater than 6 x 106 CD34+ stems cells/kg harvested (defined as effectiveness). Note that no patients were enrolled Arm D and Arm E.
Time Frame
36 months
Secondary Outcome Measure Information:
Title
Number of Patients Who Achieved Neutrophil Recovery After Melphalan 200 Based Transplant
Description
Number of patients who achieved neutrophil recovery after Melphalan 200 based transplant in 20 days or fewer. Neutrophil recovery is defined as an absolute neutrophil count of greater than 0.5 k/uL for three consecutive days.
Time Frame
20 days post-transplant
Title
Number of Patients Who Achieved Platelet Recovery After Melphalan 200 Based Transplant
Description
Number of patients who achieved platelet recovery after Melphalan 200 based transplant in 20 days or fewer. Platelet recovery is defined as a platelet count of greater than 20,000, untransfused, for three consecutive days.
Time Frame
20 days post-transplant

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Voluntary written informed consent Confirmed diagnosis of multiple myeloma Age > than 18 years at the time of signing the informed consent form. Karnofsky performance status above 60% Patients must be within 30 days of completing induction therapy. Female subject is either post-menopausal or surgically sterilized or willing to use an acceptable method of birth control . Male subject agrees to use an acceptable method for contraception for the duration of the study. Life expectancy > 12 weeks. Subjects must have a MUGA scan or echo with LVEF >50% Subjects must meet the following laboratory parameters: Absolute neutrophil count (ANC) ≥1500 cells/mm3 Platelets count ≥ 50,000/mm3 Hemoglobin > 9.0 g/dL Serum SGOT/AST <3.0 x upper limits of normal (ULN) Serum SGPT/ALT <3.0 x upper limits of normal (ULN) Serum creatinine < 2.5 mg/dL or creatinine clearance > 40ml/min Serum total bilirubin < 1.5 x ULN Exclusion Criteria: Patients with (no measurable monoclonal protein, free light chains, and/or M-spike in blood or urine) unless measurable disease is available with imaging techniques such as MRI and PET scan. History of allergic reactions to compounds containing boron, mannitol, VELCADE Prior history of other malignancies (except for basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the cervix or breast) unless disease free for > = 5 years. NYHA Class III or IV heart disease. History of active unstable angina, congestive heart disease, severe uncontrolled cardiac arrhythmia, electrocardiographic evidence of acute ischemia, active conduction system abnormalities or myocardial infarction within 6 months prior to enrollment. Prior to study entry, any ECG abnormality at Screening has to be documented by the investigator as not medically relevant. Female patients who are pregnant or breastfeeding. Women of childbearing potential and men must agree to use adequate contraception prior to study entry and for the duration of study participation. Known HIV or hepatitis A, B, or C positivity---ONLY IF ACTIVE Active viral or bacterial infections or any coexisting medical problem that would significantly increase the risks of this treatment program. Any concurrent, uncontrolled medical condition, laboratory abnormality, or psychiatric illness which could place him/her at unacceptable risk Patient has > = Grade 2 peripheral neuropathy within 14 days before enrollment. Patient has received other investigational drugs with 14 days before enrollment Diagnosed or treated for another malignancy within 3 years of enrollment, with the exception of complete resection of basal cell carcinoma or squamous cell carcinoma of the skin, an in situ malignancy, or low-risk prostate cancer after curative therapy.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ruben Niesvizky, MD
Organizational Affiliation
Weill Medical College of Cornell University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Emory University
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
New York University Cancer Institute
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
Columbia Presbyterian Medical Center):
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
Memorial Sloan-Kettering Cancer Center):
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Facility Name
Weill Cornell Medical College
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Trial of Three Stem Cell Mobilization Regimens for Multiple Myeloma

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