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NCT01146834 · REGISTRY CONDITION SEARCH

Trial of Three Stem Cell Mobilization Regimens for Multiple Myeloma

Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.

Phase
PHASE3
Status at capture
COMPLETED
Registry last update
2019-12-27

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

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

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baseline

Baseline characteristics

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outcome · POSTED

Number of Patients Able to Collect >=6 x 106 CD34+ Cells/kg in <= 2 Collections.

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outcome · POSTED

Number of Patients Who Achieved Neutrophil Recovery After Melphalan 200 Based Transplant

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outcome · POSTED

Number of Patients Who Achieved Platelet Recovery After Melphalan 200 Based Transplant

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adverse events

Adverse events

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more info

Limitations, agreements, and source contact

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Who could take part
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: 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.
healthy Volunteers
false
minimum Age
18 Years
sex
ALL
std Ages
  1. ADULT
  2. OLDER_ADULT
Treatment arms and interventions
arm Groups
  1. 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.
    intervention Names
    1. Drug: bortezomib (Velcade)
    2. Drug: cyclophosphamide
    3. Drug: G-CSF
    label
    Arm A: VELCADE, CYCLOPHOSPHAMIDE, & G-CSF
    type
    EXPERIMENTAL
  2. 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
    intervention Names
    1. Drug: bortezomib (Velcade)
    2. Drug: G-CSF
    label
    Arm B: VELCADE & G-CSF
    type
    EXPERIMENTAL
  3. 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.
    intervention Names
    1. Drug: cyclophosphamide
    2. Drug: G-CSF
    label
    Arm C: CYCLOPHOSPHAMIDE & G-CSF
    type
    EXPERIMENTAL
  4. 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.
    intervention Names
    1. Drug: G-CSF
    2. Drug: Plerixafor
    label
    Arm D: PLERIXAFOR & G-CSF
    type
    EXPERIMENTAL
  5. 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 Names
    1. Drug: bortezomib (Velcade)
    2. Drug: G-CSF
    3. Drug: Plerixafor
    label
    Arm E: PLERIXAFOR, VELCADE, & G-CSF
    type
    EXPERIMENTAL
interventions
  1. arm Group Labels
    1. Arm A: VELCADE, CYCLOPHOSPHAMIDE, & G-CSF
    2. Arm B: VELCADE & G-CSF
    3. Arm E: PLERIXAFOR, VELCADE, & G-CSF
    description
    1.3 mg/m2 IVP on days 1, 4, 8 and 11
    name
    bortezomib (Velcade)
    other Names
    1. Velcade
    type
    DRUG
  2. arm Group Labels
    1. Arm A: VELCADE, CYCLOPHOSPHAMIDE, & G-CSF
    2. Arm C: CYCLOPHOSPHAMIDE & G-CSF
    description
    2.0 g/m2 (day 4 for Arm A and day 1 for Arm C)
    name
    cyclophosphamide
    other Names
    1. Cytoxan
    type
    DRUG
  3. arm Group Labels
    1. Arm A: VELCADE, CYCLOPHOSPHAMIDE, & G-CSF
    2. Arm B: VELCADE & G-CSF
    3. Arm C: CYCLOPHOSPHAMIDE & G-CSF
    4. Arm D: PLERIXAFOR & G-CSF
    5. Arm E: PLERIXAFOR, VELCADE, & G-CSF
    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)
    name
    G-CSF
    other Names
    1. Filgrastim
    2. Neupogen
    type
    DRUG
  4. arm Group Labels
    1. Arm D: PLERIXAFOR & G-CSF
    2. Arm E: PLERIXAFOR, VELCADE, & G-CSF
    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)
    name
    Plerixafor
    other Names
    1. Mozobil
    type
    DRUG
Study design
allocation
RANDOMIZED
intervention Model
PARALLEL
masking Info
masking
NONE
primary Purpose
TREATMENT
Enrollment
count
47
type
ACTUAL
Registered outcome plans (not posted results)
primary Outcomes
  1. 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.
    measure
    Number of Patients Able to Collect >=6 x 106 CD34+ Cells/kg in <= 2 Collections.
    time Frame
    36 months
secondary Outcomes
  1. 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.
    measure
    Number of Patients Who Achieved Neutrophil Recovery After Melphalan 200 Based Transplant
    time Frame
    20 days post-transplant
  2. 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.
    measure
    Number of Patients Who Achieved Platelet Recovery After Melphalan 200 Based Transplant
    time Frame
    20 days post-transplant
Full 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 1. Engrafting: Neutrophil recovery (ANC \>0.5 of \<12 days), Plt recovery (\>20K untransfused \<20 days)) after mel 200 based transplant. 2. Toxicities
Source references
Source notices and limitations
    Discovery and provenance
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    Preserved source evidence · Not medical advice