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NCT00903968 · REGISTRY CONDITION SEARCH

Combination Plerixafor (AMD3100)and Bortezomib in Relapsed or Relapsed/Refractory 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
PHASE1, PHASE2
Status at capture
COMPLETED
Registry last update
2020-06-02

The purpose of this research study is to determine the safety of plerixafor and bortezomib, and the highest dose that can be given to people safely. Plerixafor appears to stop myeloma cells from attaching to bone marrow and has been used in other phase I studies for mobilization of stem cells for patients with myeloma and lymphoma. We have shown that the combination of plerixafor and bortezomib is very effective in killing myeloma cells in the laboratory more than the effect of each drug alone.

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

Plerixafor Maximum Tolerated Dose (MTD) [Phase I]

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outcome · POSTED

Bortezomib Maximum Tolerated Dose (MTD) [Phase I]

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outcome · POSTED

Number of Participants With Dose Limiting Toxicity (DLT) [Phase I]

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outcome · POSTED

Response Rate of Plerixafor, Bortezomib, and Dexamethasone in Relapsed or Relapsed/ Refractory Multiple Myeloma (ORR) [Phase I and Phase II]

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outcome · POSTED

Time to Progression (TTP) [Phase II]

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outcome · POSTED

Duration of Response (DOR) [Phase II]

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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: * 18 years of age or older * Must have received prior 1-5 therapies for their myeloma and have relapsed or refractory multiple myeloma. Prior therapy with bortezomib is allowed as long as they were not refractory to bortezomib * Monoclonal protein serum of 1gm/dL or greater or monoclonal light chain in the urine protein electrophoresis of 200 mg/24 hours or greater, or measurable light chains by free light chain assay of 10 mg/dL or greater, or measurable plasmacytoma * ECOG Performance Status 0, 1, or 2 * Laboratory values as outlined in the protocol Exclusion Criteria: * Uncontrolled infection * Cytotoxic chemotherapy \< 3 weeks, or biologic or targeted novel therapy \< 2 weeks, or corticosteroids \< 2 weeks prior to registration. Patients may be receiving chronic corticosteroids if they are being given for disorders other than myeloma * Pregnant women * Nursing women * Men or women of child-bearing potential who are unwilling to employ adequate contraception * Other concurrent chemotherapy, immunotherapy, radiotherapy, or any ancillary therapy considered investigational * Known to be HIV positive * Radiation therapy \< 2 weeks prior to registration
healthy Volunteers
false
minimum Age
18 Years
sex
ALL
std Ages
  1. ADULT
  2. OLDER_ADULT
Treatment arms and interventions
arm Groups
  1. description
    Phase I Dose Level 1 patients received plerixafor 160ug/kg by injection on days 1-6 and bortezomib 1.0 mg/m2 intravenously days 3, 6, 10, and 13 of each 21 day cycle until disease progression or unacceptable toxicity.
    intervention Names
    1. Drug: Plerixafor
    2. Drug: bortezomib
    label
    Phase I Dose Level 1
    type
    EXPERIMENTAL
  2. description
    Phase I Dose Level 2 patients received plerixafor 160ug/kg by injection on days 1-6 and bortezomib 1.3 mg/m2 intravenously days 3, 6, 10, and 13 of each 21 day cycle until disease progression or unacceptable toxicity.
    intervention Names
    1. Drug: Plerixafor
    2. Drug: bortezomib
    label
    Phase I Dose Level 2
    type
    EXPERIMENTAL
  3. description
    Phase I Dose Level 3 patients received plerixafor 240ug/kg by injection on days 1-6 and bortezomib 1.0 mg/m2 intravenously days 3, 6, 10, and 13 of each 21 day cycle until disease progression or unacceptable toxicity.
    intervention Names
    1. Drug: Plerixafor
    2. Drug: bortezomib
    label
    Phase I Dose Level 3
    type
    EXPERIMENTAL
  4. description
    Phase I Dose Level 4 patients received plerixafor 240ug/kg by injection on days 1-6 and bortezomib 1.3 mg/m2 intravenously days 3, 6, 10, and 13 of each 21 day cycle until disease progression or unacceptable toxicity.
    intervention Names
    1. Drug: Plerixafor
    2. Drug: bortezomib
    label
    Phase I Dose Level 4
    type
    EXPERIMENTAL
  5. description
    Phase I Dose Level 5 patients received plerixafor 320ug/kg by injection on days 1-6 and bortezomib 1.3 mg/m2 intravenously days 3, 6, 10, and 13 of each 21 day cycle until disease progression or unacceptable toxicity.
    intervention Names
    1. Drug: Plerixafor
    2. Drug: bortezomib
    label
    Phase I Dose Level 5
    type
    EXPERIMENTAL
  6. description
    Phase I Dose Level 5B patients received plerixafor 320ug/kg by injection on days 1, 2, 3, 6, 10, and 13 and bortezomib 1.3 mg/m2 intravenously days 3, 6, 10, and 13 of each 21 day cycle until disease progression or unacceptable toxicity.
    intervention Names
    1. Drug: Plerixafor
    2. Drug: bortezomib
    label
    Phase I Dose Level 5B
    type
    EXPERIMENTAL
  7. description
    Phase I Dose Level 6 patients received plerixafor 400ug/kg by injection on days 1, 2, 3, 6, 10, and 13 and bortezomib 1.3 mg/m2 intravenously days 3, 6, 10, and 13 of each 21 day cycle until disease progression or unacceptable toxicity.
    intervention Names
    1. Drug: Plerixafor
    2. Drug: bortezomib
    label
    Phase I Dose Level 6
    type
    EXPERIMENTAL
  8. description
    All Phase I participants received plerixafor by injection and bortezomib intravenously according to the established dose escalation schedule. Participants were treated until disease progression or unacceptable toxicity.
    intervention Names
    1. Drug: Plerixafor
    2. Drug: bortezomib
    label
    All Phase I Participants
    type
    EXPERIMENTAL
  9. description
    All Phase I participants received plerixafor 320ug/kg by injection on days 1, 2, 3, 6, 10, and 13, bortezomib 1.3 mg/m2 intravenously or subcutaneously days 3, 6, 10, and 13, and dexamethasone 40mg orally days 3, 6, 10, and 13 of each 21 day cycle during induction. In maintenance, participants received plerixafor, bortezomib, and dexamethasone days 1, 8, 15, and 22 of each 35 day cycle. Participants were treated until disease progression or unacceptable toxicity.
    intervention Names
    1. Drug: Plerixafor
    2. Drug: bortezomib
    3. Drug: Dexamethasone
    label
    All Phase II Participants
    type
    EXPERIMENTAL
interventions
  1. arm Group Labels
    1. All Phase I Participants
    2. All Phase II Participants
    3. Phase I Dose Level 1
    4. Phase I Dose Level 2
    5. Phase I Dose Level 3
    6. Phase I Dose Level 4
    7. Phase I Dose Level 5
    8. Phase I Dose Level 5B
    9. Phase I Dose Level 6
    name
    Plerixafor
    other Names
    1. AMD3100
    type
    DRUG
  2. arm Group Labels
    1. All Phase I Participants
    2. All Phase II Participants
    3. Phase I Dose Level 1
    4. Phase I Dose Level 2
    5. Phase I Dose Level 3
    6. Phase I Dose Level 4
    7. Phase I Dose Level 5
    8. Phase I Dose Level 5B
    9. Phase I Dose Level 6
    name
    bortezomib
    other Names
    1. velcade
    type
    DRUG
  3. arm Group Labels
    1. All Phase II Participants
    name
    Dexamethasone
    other Names
    1. Decadron
    type
    DRUG
Study design
allocation
NON_RANDOMIZED
intervention Model
SINGLE_GROUP
masking Info
masking
NONE
primary Purpose
TREATMENT
Enrollment
count
58
type
ACTUAL
Registered outcome plans (not posted results)
primary Outcomes
  1. description
    The MTD plerixafor in combination with bortezomib is determined by the number of patients who experience a dose limiting toxicity (DLT). See subsequent primary outcome measure for the DLT definition. The MTD is defined as highest dose level at which fewer than one-third of patients experience a DLT. The MTD was reached at dose level 5B. The maximum tolerated dose of plerixafor was given on days 1, 2, 3, 6, 10, 13 of 21 each cycle.
    measure
    Plerixafor Maximum Tolerated Dose (MTD) [Phase I]
    time Frame
    Participants were assessed every 3 weeks while on study; The observation period for MTD evaluation was the first 21 days of treatment.
  2. description
    The MTD plerixafor in combination with bortezomib is determined by the number of patients who experience a dose limiting toxicity (DLT). See subsequent primary outcome measure for the DLT definition. The MTD is defined as highest dose level at which fewer than one-third of patients experience a DLT. The MTD was reached at dose level 5B. The maximum tolerated dose of bortezomib was given on days 3, 6, 10, 13 of 21 each cycle.
    measure
    Bortezomib Maximum Tolerated Dose (MTD) [Phase I]
    time Frame
    Participants were assessed every 3 weeks while on study; The observation period for MTD evaluation was the first 21 days of treatment.
  3. description
    A DLT was defined as (a) grade 3 or greater non-hematologic toxicity, considered by the investigator to be related to plerixafor or bortezomib, with the exception of nausea, vomiting or diarrhea unless receiving maximal medical therapy, (b) grade 4 hematologic toxicity defined as: thrombocytopenia with platelets \<10,000 on more than one occasion within first cycle despite transfusion. Grade 4 neutropenia must occur for more than 5 days and/or result in neutropenic fever with elevated temperature (defined as \> 101 degrees F). (c) inability to receive Day 1 dose for Cycle 2 due to toxicity. All adverse events were graded according to the CTEP Common Toxicity Criteria (CTCAE v.3.0).
    measure
    Number of Participants With Dose Limiting Toxicity (DLT) [Phase I]
    time Frame
    Participants were assessed every 3 weeks while on study; The observation period for MTD evaluation was the first 21 days of treatment.
  4. description
    Overall response was established based on International Myeloma Working Group (IMWG) criteria with 6 potential categories: Complete Response (CR) which is a complete disappearance of monoclonal paraprotein based on negative immunofixation on the serum M-component and urine M-component and no evidence of myeloma in bone marrow, Very Good Partial Response (VGPR) defined as serum and urine M-component detectable by immunofixation but not on electrophoresis or ≥90% reduction in serum M-component plus urine M-component \<100 mg per 24 hours, Partial Response (PR) ≥50% reduction in serum M-component or ≥90% reduction urine M-component or urine M-component \<200 mg per 24 hours, Minimal Response (MR) ≥25% reduction in serum or urine M-component, Stable Disease (SD) defined as failure to meet any response criteria, and Progressive Disease (PD) ≥ 25% increase from lowest value reported in serum M-component (absolute ≥0.5 g/dL) and/or urine M-component (absolute ≥200 mg/24 hours).
    measure
    Response Rate of Plerixafor, Bortezomib, and Dexamethasone in Relapsed or Relapsed/ Refractory Multiple Myeloma (ORR) [Phase I and Phase II]
    time Frame
    Disease was assessed for response every cycle on treatment. The maximum number of cycles received was 25.
secondary Outcomes
  1. description
    TTP estimated using the Kaplan-Meier method is defined as the time from registration to progression based on IMWG criteria or date last known progression-free for those who have not progressed. \[Durie BG et al. Leukemia. 2006\] Progression (PD): ≥ 25% increase from lowest value reported in serum M-component (absolute increase ≥0.5 g/dL) and/or urine M-component (absolute increase ≥200 mg/24 hours); if appropriate, a ≥25% increase above the lowest level in the difference between involved and uninvolved FLC levels (absolute increase \>10 mg/dL); If none of these are measurable then ≥25% increase in bone marrow plasma cell percentage above the lowest response level (absolute ≥10%); Definite development of new bone lesions or soft tissue plasmacytomas OR increase in size of existing
    measure
    Time to Progression (TTP) [Phase II]
    time Frame
    DIsease was assessed to document progression every cycle on treatment and post-treatment every 12 weeks until progression.
  2. description
    DOR is defined as the time from response to disease progression or death, or date last known progression-free and alive for those who have not progressed or died. DOR was estimated using the Kaplan-Meier method.
    measure
    Duration of Response (DOR) [Phase II]
    time Frame
    DIsease was assessed to document response every cycle on treatment and post-treatment every 12 weeks until progression.
Full study description
brief Summary
The purpose of this research study is to determine the safety of plerixafor and bortezomib, and the highest dose that can be given to people safely. Plerixafor appears to stop myeloma cells from attaching to bone marrow and has been used in other phase I studies for mobilization of stem cells for patients with myeloma and lymphoma. We have shown that the combination of plerixafor and bortezomib is very effective in killing myeloma cells in the laboratory more than the effect of each drug alone.
Source references
references
  1. citation
    Ghobrial IM, Liu CJ, Zavidij O, Azab AK, Baz R, Laubach JP, Mishima Y, Armand P, Munshi NC, Basile F, Constantine M, Vredenburgh J, Boruchov A, Crilley P, Henrick PM, Hornburg KTV, Leblebjian H, Chuma S, Reyes K, Noonan K, Warren D, Schlossman R, Paba-Prada C, Anderson KC, Weller E, Trippa L, Shain K, Richardson PG. Phase I/II trial of the CXCR4 inhibitor plerixafor in combination with bortezomib as a chemosensitization strategy in relapsed/refractory multiple myeloma. Am J Hematol. 2019 Nov;94(11):1244-1253. doi: 10.1002/ajh.25627. Epub 2019 Oct 4.
    pmid
    31456261
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    DERIVED
Source notices and limitations
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    Preserved source evidence · Not medical advice