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NCT01212952 · REGISTRY CONDITION SEARCH

Pomalidomide, Bortezomib, and Dexamethasone in Treating Patients With Relapsed or 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
2020-04-17

RATIONALE: Pomalidomide and bortezomib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Bortezomib may also stop the growth of tumor cells by blocking blood flow to the tumor. Drugs used in chemotherapy, such as dexamethasone, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving pomalidomide and bortezomib together with dexamethasone may kill more tumor cells. PURPOSE: This phase I/II trial is studying the side effects and best dose of bortezomib when given together with pomalidomide and dexamethasone and to see how well it works in treating patients with relapsed or refractory multiple myeloma.

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

Find Maximum Tolerated Dose (MTD) of Bortezomib in Combination With Pomalidomide and Dexamethasone Out to 2.5 Years, by Count of Patients With Dose Limiting Toxicities.

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outcome · POSTED

Number of Participants With a Hematologic Response (PR, VGPR, or CR)

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outcome · POSTED

Progression Free Survival

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outcome · POSTED

Number of Participants With Adverse Events

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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: * Serum Creatinine =\< 3 mg/dL * Absolute neutrophil count \>= 1000/uL * Platelet count \>= 75,000/uL * Measurable disease of multiple myeloma as defined by at least ONE of the following: * serum monoclonal protein \>= 1.0 g/dL * \> 200 mg of monoclonal protein in the urine on 24 hour electrophoresis * serum immunoglobulin free light chain \>= 10 mg/dL AND abnormal serum immunoglobulin kappa to lambda free light chain ratio * monoclonal bone marrow plasmacytosis \>= 30% (evaluable disease) * measurable plasmacytoma that has not been radiated * ECOG Performance status (PS) 0, 1, or 2 * Previously treated relapsed or refractory multiple myeloma * Patients must have received at least one prior therapy but no more than 4 therapies. * one or more of the prior regimens must have included lenalidomide and it has been determined the patient is refractory, resistant, or relapsed this therapy * prior bortezomib not required but if prior exposure, patients should not be refractory (Refractory means progression on therapy or within 60 days from the last dose of bortezomib.) * Provide informed written consent * Females of childbearing potential (FCBP) must have a negative serum or urine pregnancy test with a sensitivity of at least 50 mIU/mL within 10 - 14 days prior to and again within 24 hours of starting pomalidomide and must either commit to continued abstinence from heterosexual intercourse or begin TWO acceptable methods of birth control, one highly effective method and one additional effective method AT THE SAME TIME, at least 28 days before she starts taking pomalidomide; FCBP must also agree to ongoing pregnancy testing * Men must agree to use a latex condom during sexual contact with a FCBP even if they have had a vasectomy * All patients must be counseled at a minimum of every 28 days about pregnancy precautions and risks of fetal exposure * Willing and able to take aspirin or alternate prophylactic anticoagulation * All previous cancer therapy, including chemotherapy, high dose corticosteroids, immune modulatory drugs or proteosome inhibitors must have been discontinued \>= 2 weeks prior to study registration * Any prior treatment with investigational agents must be discontinued \>= 28 days prior to study registration * Willing to abstain from donating blood during study participation and for 28 days after discontinuation of study drug * Men must agree to abstain from donating semen or sperm during study participation and for 28 days after discontinuation of study drug * Willingness to return to enrolling institution for follow-up Exclusion Criteria: * Concomitant high dose corticosteroids (concurrent use of corticosteroids); EXCEPTION: Patients may be on chronic steroids (maximum dose 20 mg/day prednisone equivalent) if they are being given for disorders other than myeloma, i.e., adrenal insufficiency, rheumatoid arthritis, etc * Another malignancy undergoing active treatment with the exception of non melanoma skin cancer or in situ cervical or breast cancer * 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 * Other co-morbidity which would interfere with patient's ability to participate in trial, e.g. uncontrolled infection, uncompensated heart or lung disease * Other concurrent chemotherapy, radiotherapy, or any ancillary therapy considered investigational: NOTE: Bisphosphonates are considered to be supportive care rather than therapy, and are thus allowed while on protocol treatment * Active DVT or PE that has not been therapeutically anticoagulated * Known positive for HIV or active hepatitis infection * Any condition, including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data from the study * Known hypersensitivity to thalidomide or lenalidomide including development of erythema nodosum if characterized by a desquamating rash * \> grade 2 peripheral neuropathy * Any prior use of pomalidomide
healthy Volunteers
false
minimum Age
18 Years
sex
ALL
std Ages
  1. ADULT
  2. OLDER_ADULT
Treatment arms and interventions
arm Groups
  1. description
    Patients receive oral pomalidomide on days 1-21; bortezomib IV on days 1, 8, 15, 22; and oral dexamethasone on days 1, 8, 15, 22. Treatment repeats every 28 days for 8 courses. Patients then receive maintenance therapy comprising oral pomalidomide on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
    intervention Names
    1. Drug: pomalidomide
    2. Drug: bortezomib
    3. Drug: dexamethasone
    4. Other: laboratory biomarker analysis
    5. Other: gene expression analysis
    label
    Arm I
    type
    EXPERIMENTAL
interventions
  1. arm Group Labels
    1. Arm I
    description
    Given orally
    name
    pomalidomide
    other Names
    1. CC-4047
    type
    DRUG
  2. arm Group Labels
    1. Arm I
    description
    Given IV
    name
    bortezomib
    other Names
    1. LDP 341
    2. MLN341
    3. PS-341
    4. VELCADE
    type
    DRUG
  3. arm Group Labels
    1. Arm I
    description
    Given orally
    name
    dexamethasone
    other Names
    1. Aeroseb-Dex
    2. Decaderm
    3. Decadron
    4. Decaspray
    5. DM
    6. DXM
    type
    DRUG
  4. arm Group Labels
    1. Arm I
    description
    Optional correlative studies
    name
    laboratory biomarker analysis
    type
    OTHER
  5. arm Group Labels
    1. Arm I
    description
    Optional correlative studies
    name
    gene expression analysis
    type
    OTHER
Study design
allocation
NA
intervention Model
SINGLE_GROUP
masking Info
masking
NONE
primary Purpose
TREATMENT
Enrollment
count
50
type
ACTUAL
Registered outcome plans (not posted results)
primary Outcomes
  1. description
    MTD is defined as the dose level below the lowest dose that induces dose-limiting toxicity in at least one-third of patients (at least 2 of a maximum of 6 new patients).
    measure
    Find Maximum Tolerated Dose (MTD) of Bortezomib in Combination With Pomalidomide and Dexamethasone Out to 2.5 Years, by Count of Patients With Dose Limiting Toxicities.
    time Frame
    2.5 years
  2. description
    The number of participants who achieve PR, VGPR, or CR as defined by The International Myeloma Working Group uniform response criteria(2011). sCR: CR as defined below plus normal FLC ratio and absence of clonal cells in bone marrow by immunohistochemistry or immunofluorescence. CR: Negative immunofixation on the serum and urine and disappearance of any soft tissue plasmacytomas and \< 5% plasma cells in bone marrow. VGPR: Serum and urine M-protein detectable by immunofixation but not on electrophoresis or \> 90% reduction in serum M-protein plus urine M-protein level \< 100 mg/24 h. PR: \> 50% reduction of serum M-protein and reduction in 24 hours urinary M-protein by \>90% or to \< 200 mg/24 h. MR: NA. SD: Not meeting criteria for CR, VGPR, PR, or progressive disease. PD: Increase of \> 25% from lowest response value in any one or more of the following: Serum M-component and/or (the absolute increase must be \> 0.5 g/dL), Urine M-component and/or (the absolute increase must be \> 200 mg/24 h)
    measure
    Number of Participants With a Hematologic Response (PR, VGPR, or CR)
    time Frame
    2.5 years
secondary Outcomes
  1. description
    The progression-free survival (PFS) time is defined as the time from registration to progression or death due to any cause. The distribution of progression-free survival will be estimated using the method of Kaplan-Meier. PD: Increase of \> 25% from lowest response value in any one or more of the following: Serum M-component and/or (the absolute increase must be \> 0.5 g/dL), Urine M-component and/or (the absolute increase must be \> 200 mg/24 h)
    measure
    Progression Free Survival
    time Frame
    2.5 years
  2. description
    Reported in Adverse Events section of the results
    measure
    Number of Participants With Adverse Events
    time Frame
    2.5 years
Full study description
brief Summary
RATIONALE: Pomalidomide and bortezomib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Bortezomib may also stop the growth of tumor cells by blocking blood flow to the tumor. Drugs used in chemotherapy, such as dexamethasone, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving pomalidomide and bortezomib together with dexamethasone may kill more tumor cells. PURPOSE: This phase I/II trial is studying the side effects and best dose of bortezomib when given together with pomalidomide and dexamethasone and to see how well it works in treating patients with relapsed or refractory multiple myeloma.
detailed Description
PRIMARY OBJECTIVES: I. Determine the maximum tolerated dose (MTD) of bortezomib in combination with pomalidomide and dexamethasone. II. To evaluate the hematologic response rate (PR, VGPR, or CR) of pomalidomide, bortezomib and dexamethasone in patients with relapsed or refractory myeloma. SECONDARY OBJECTIVES: I. Time to progression. II. To assess the toxicity of pomalidomide, bortezomib and dexamethasone in this patient population. OUTLINE : This is a phase I, dose-escalation study of bortezomib followed by a phase II study. Patients receive oral pomalidomide on days 1-21; bortezomib IV on days 1, 8,15, 22; and oral dexamethasone on days 1, 8, 15, 22 . Treatment repeats every 28 days for 8 courses. Patients then receive maintenance therapy comprising oral pomalidomide on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up every 6 months.
Source references
references
  1. citation
    Paludo J, Mikhael JR, LaPlant BR, Halvorson AE, Kumar S, Gertz MA, Hayman SR, Buadi FK, Dispenzieri A, Lust JA, Kapoor P, Leung N, Russell SJ, Dingli D, Go RS, Lin Y, Gonsalves WI, Fonseca R, Bergsagel PL, Roy V, Sher T, Chanan-Khan AA, Ailawadhi S, Stewart AK, Reeder CB, Richardson PG, Rajkumar SV, Lacy MQ. Pomalidomide, bortezomib, and dexamethasone for patients with relapsed lenalidomide-refractory multiple myeloma. Blood. 2017 Sep 7;130(10):1198-1204. doi: 10.1182/blood-2017-05-782961. Epub 2017 Jul 6.
    pmid
    28684537
    type
    DERIVED
Source notices and limitations
    Discovery and provenance
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      query disease state id
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      source file
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    Preserved source evidence · Not medical advice