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NCT02547662 · REGISTRY CONDITION SEARCH

Pomalidomide, Ixazomib Citrate, and Dexamethasone in Treating Patients With Previously Treated Multiple Myeloma or Plasma Cell Leukemia

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

Phase
PHASE2
Status at capture
COMPLETED
Registry last update
2023-10-30

This phase II trial studies how well pomalidomide, ixazomib citrate, and dexamethasone work in treating patients with previously treated multiple myeloma or plasma cell leukemia. Biological therapies, such as pomalidomide and dexamethasone, use substances made from living organisms that may stimulate or suppress the immune system in different ways and stop cancer cells from growing. Ixazomib citrate may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving pomalidomide, ixazomib citrate, and dexamethasone together may be more effective in treating 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

Confirmed Response Rate

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outcome · POSTED

Biochemical Response Rate

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outcome · POSTED

Extramedullary Response Rate

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outcome · POSTED

Incidence of Adverse Events Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0

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outcome · POSTED

Progression-free Survival

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outcome · NOT POSTED

Proportion of Patients Who Achieve Minimal Residual Disease (MRD) Negative Status

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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: * Previously treated myeloma, currently with extramedullary disease (defined as plasmacytoma outside bone marrow that is not contiguous with a bone lesion) with at least one lesion that has a single diameter of \>= 2 cm or plasma cell leukemia (defined as circulating plasma cells exceeding 5% of peripheral blood leukocytes or 0.5 X 10\^9/L or 200 cells/150000 events by flow cytometry) * Calculated creatinine clearance (using Cockcroft-Gault equation) \>= 30 mL/min * Absolute neutrophil count (ANC) \>= 1000/mm\^3 * Platelet count \>= 50,000/mm\^3 * Hemoglobin \>= 8.0 g/dL * Patients with measurable disease defined as at least one of the following: * For patients with extramedullary disease (EMD) measurable disease by computed tomography (CT) or magnetic resonance imaging (MRI) or the CT portion of the positron emission tomography (PET)/CT: must have at least one lesion that has a single diameter of \>= 2 cm; skin lesions can be used if the area is \>= 2 cm in at least one diameter and measured with a ruler * Plasma cell count \>= 0.5 X 10\^9/L or 5 percent of the peripheral blood white cells * Plasma cell count if determined by flow cytometry, \>= 200/150,000 events * Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0, 1 or 2 * Provide informed written consent * Negative pregnancy test done =\< 7 days prior to registration, for women of childbearing potential only * All study participants must be registered into the mandatory pomalidomide (POMALYST) Risk Evaluation and Mitigation Strategy (REMS) program, and be willing and able to comply with the requirements of the POMALYST REMS program * Willing to return to enrolling institution for follow-up (during the active monitoring phase of the study) * Willing to provide bone marrow and blood samples for correlative research purposes Exclusion Criteria: * Other malignancy requiring active therapy * EXCEPTIONS: Non-melanoma skin cancer, ductal breast carcinoma in situ (DCIS) or carcinoma-in-situ of the cervix * NOTE: If there is a history or prior malignancy, they must not be receiving other specific treatment for their cancer * Females of childbearing potential (FCBP)\* must have a negative serum pregnancy test with a sensitivity of at least 50 mIU/mL within 10-14 days prior to and again within 24 hours prior to prescribing pomalidomide for cycle 1 (prescriptions must be filled within 7 days as required by RevAssist \[lenalidomide REMS program\]), 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 successful vasectomy; patient must follow pregnancy testing requirements as outlined in the POMALYST REMS program * A female of childbearing potential is a sexually mature woman who: 1) has not undergone a hysterectomy or bilateral oophorectomy; or 2) has not been naturally postmenopausal for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months) * Nursing women * Men or women of childbearing potential who are unwilling to employ adequate contraception * 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 * Patient has \>= grade 3 peripheral neuropathy, or grade 2 with pain on clinical examination during the screening period * Major surgery =\< 14 days before study registration * Systemic treatment with strong CYP3A4 inducers (e.g. rifampin, rifapentine, rifabutin, carbamazepine, phenytoin, phenobarbital, gingko biloba, St. John's wort) within 7 days before registration * Evidence of current uncontrolled cardiovascular conditions, including cardiac arrhythmias, congestive heart failure, angina, or myocardial infarction within the past 6 months; Note: prior to study entry, any electrocardiogram (ECG) abnormality at screening must be documented by the investigator as not medically relevant * Corrected QT Interval (QTc) \> 470 milliseconds (msec) on a 12-lead ECG obtained during the screening period * Note: If a machine reading is above this value, the ECG should be reviewed by a qualified reader and confirmed on a subsequent ECG * Known human immunodeficiency virus (HIV) positive * Known hepatitis B surface antigen-positive status, or known or suspected active hepatitis C infection * Any serious medical or psychiatric illness that could, in the investigator's opinion, potentially interfere with the completion of treatment according to this protocol * Known allergy to any of the study medications, their analogues or excipients in the various formulations * Known gastrointestinal (GI) disease or GI procedure that could interfere with the oral absorption or tolerance of ixazomib including difficulty swallowing * Diarrhea \> grade 1, based on the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) grading, in the absence of antidiarrheals
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 ixazomib citrate PO on days 1, 8, and 15, pomalidomide PO on days 1-21, and dexamethasone PO on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
    intervention Names
    1. Drug: Dexamethasone
    2. Drug: Ixazomib Citrate
    3. Other: Laboratory Biomarker Analysis
    4. Drug: Pomalidomide
    label
    Treatment (ixazomib citrate, pomalidomide, dexamethasone)
    type
    EXPERIMENTAL
interventions
  1. arm Group Labels
    1. Treatment (ixazomib citrate, pomalidomide, dexamethasone)
    description
    Given PO
    name
    Dexamethasone
    other Names
    1. Aacidexam
    2. Adexone
    3. Aknichthol Dexa
    4. Alba-Dex
    5. Alin
    6. Alin Depot
    7. Alin Oftalmico
    8. Amplidermis
    9. Anemul mono
    10. Auricularum
    11. Auxiloson
    12. Baycuten
    type
    DRUG
  2. arm Group Labels
    1. Treatment (ixazomib citrate, pomalidomide, dexamethasone)
    description
    Given PO
    name
    Ixazomib Citrate
    other Names
    1. MLN-9708
    2. MLN9708
    3. Ninlaro
    type
    DRUG
  3. arm Group Labels
    1. Treatment (ixazomib citrate, pomalidomide, dexamethasone)
    description
    Correlative studies
    name
    Laboratory Biomarker Analysis
    type
    OTHER
  4. arm Group Labels
    1. Treatment (ixazomib citrate, pomalidomide, dexamethasone)
    description
    Given PO
    name
    Pomalidomide
    other Names
    1. 4-Aminothalidomide
    2. Actimid
    3. CC-4047
    4. Imnovid
    5. Pomalyst
    type
    DRUG
Study design
allocation
NA
intervention Model
SINGLE_GROUP
masking Info
masking
NONE
primary Purpose
TREATMENT
Enrollment
count
17
type
ACTUAL
Registered outcome plans (not posted results)
other Outcomes
  1. description
    The proportion of patients who achieve MRD negative status will be estimated by the number of patients who are MRD negative divided by the total number of evaluable patients who achieve a sCR or CR. Exact binomial 95% confidence intervals for the true MRD negative rate will be calculated.
    measure
    Proportion of Patients Who Achieve Minimal Residual Disease (MRD) Negative Status
    time Frame
    Up to 5 years
primary Outcomes
  1. description
    A confirmed response is defined as a patient who has achieved a stringent complete response (sCR), complete response (CR), very good partial response (PR), or PR on two consecutive evaluations. The proportion of successes will be estimated by the number of successes divided by the total number of evaluable patients. Ninety-five percent confidence intervals for the true success proportion will be calculated according to the approach of Duffy and Santner. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
    measure
    Confirmed Response Rate
    time Frame
    4 years
secondary Outcomes
  1. description
    The biochemical response rate will be estimated by the number of responders(patients that achieved partial or complete response) divided by the number of evaluable patients who have measurable disease by serum M-protein, urine M-protein, or serum FLC assay at baseline. Exact binomial confidence intervals will be calculated.
    measure
    Biochemical Response Rate
    time Frame
    4 years
  2. description
    Extramedullary response, defined as a response by extramedullary plasmacytoma or plasma cell count parameters. The extramedullary response rate will be estimated by the number of responders(patients that achieved a partial or complete response) divided by the number of evaluable patients. Exact binomial confidence intervals will be calculated.
    measure
    Extramedullary Response Rate
    time Frame
    4 years
  3. description
    Number of patients with adverse events is reported here, the full list of those adverse events and their frequency is reported in the adverse event section.
    measure
    Incidence of Adverse Events Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0
    time Frame
    4 years 1 month
  4. description
    The distribution of progression-free survival will be estimated using the method of Kaplan-Meier.
    measure
    Progression-free Survival
    time Frame
    4 years 8 months
Full study description
brief Summary
This phase II trial studies how well pomalidomide, ixazomib citrate, and dexamethasone work in treating patients with previously treated multiple myeloma or plasma cell leukemia. Biological therapies, such as pomalidomide and dexamethasone, use substances made from living organisms that may stimulate or suppress the immune system in different ways and stop cancer cells from growing. Ixazomib citrate may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving pomalidomide, ixazomib citrate, and dexamethasone together may be more effective in treating multiple myeloma.
detailed Description
PRIMARY OBJECTIVES: I. To determine the confirmed response rate (\>= partial response \[PR\]) of ixazomib citrate (ixazomib), used in combination with pomalidomide and dexamethasone in patients with previously treated multiple myeloma (MM) with extramedullary disease. SECONDARY OBJECTIVES: I. To determine the toxicities associated with ixazomib in combination with pomalidomide and dexamethasone in patients with previously treated MM with extramedullary disease. II. To determine the differential response rates (biochemical versus extramedullary disease) with ixazomib in combination with pomalidomide and dexamethasone in patients with previously treated MM with extramedullary disease. III. To determine the progression free survival following treatment with ixazomib in combination with pomalidomide and dexamethasone in patients with previously treated MM with extramedullary disease. TERTIARY OBJECTIVES: I. To assess the proportion of patients achieving minimal residual disease (MRD) negative status. OUTLINE: Patients receive ixazomib citrate orally (PO) on days 1, 8, and 15, pomalidomide PO on days 1-21, and dexamethasone PO on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up every 3 or 6 months for up to 3 years.
Source references
Source notices and limitations
    Discovery and provenance
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    Preserved source evidence · Not medical advice