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NCT02492750 · REGISTRY CONDITION SEARCH

Lenalidomide and Dexamethasone With or Without Anakinra in Treating Patients With Early Stage 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
Status at capture
COMPLETED
Registry last update
2020-03-25

This partially randomized phase I/II trial studies the side effects and best dose of anakinra when given together with lenalidomide and dexamethasone in treating patients with early stage multiple myeloma. Biological therapies, such as lenalidomide and anakinra, may stimulate or suppress the immune system in different ways and stop cancer cells from growing. Drugs used in chemotherapy, such as dexamethasone, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. It is not yet known whether lenalidomide and dexamethasone are more effective with or without anakinra in treating patients with 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

Number of Participants Experiencing a Dose-limiting Toxicity (DLT)

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outcome · POSTED

Number of Participants Who Experienced at Least One Grade 3+ Adverse Events Deemed at Least Possibly Related to Treatment, Graded According to NCI CTCAE Version 4.0

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outcome · POSTED

Best Response

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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: * Absolute neutrophil count (ANC) \>= 1700/mm\^3 * Platelet count \>= 100,000/mm\^3 * Hemoglobin \>= 8.0 g/dL * Serum glutamic oxaloacetic transaminase (SGOT) (aspartate aminotransferase \[AST\]) =\< 3 x upper limit of normal (ULN) * Creatinine clearance \>= 30 mL/min (as determined by Cockroft-Gault equation) * Diagnosis of multiple myeloma according to International Myeloma Working Group criteria and one of the following: * Smoldering multiple myeloma (SMM) * Indolent multiple myeloma (IMM) * Newly diagnosed multiple myeloma (MM) * Note: patients with lytic disease and anemia are eligible * High risk disease defined by all of the following: * \>= 10% bone marrow plasma cells AND * Abnormal serum free light chain (FLC) ratio (\< 0.26 or \> 1.65) by serum FLC assay AND * Monotypic plasma cell S-phase \>= 0.3% * Measurable level of M-protein \> 1 g/dL on serum protein electrophoresis or \> 200 mg of M-protein on a 24 hour urine protein electrophoresis * Negative tuberculosis (TB) testing (Quantiferon - TB blood test or skin test) =\< 7 days prior to registration * Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0, 1 or 2 * Provide signed informed consent * Negative (serum or urine) pregnancy test done =\< 7 days prior to registration, for women of childbearing potential only; NOTE: a second pregnancy test must be performed within 24 hours prior to the start of lenalidomide; the subject may not receive lenalidomide until the study doctor has verified that the results of these pregnancy tests are negative * Willing to return to enrolling institution for follow-up (during the active monitoring phase of the study) * Willing and able to comply with the requirements of the Revlimid Risk Evaluation and Mitigation Strategy (REMS) program * Females of childbearing potential must be willing to adhere to the scheduled pregnancy testing as required by the Revlimid REMS program Exclusion Criteria: * Prior treatment with any other agent that may affect M-protein =\< 30 days prior to registration * Acute/chronic infections, open wounds, or any active infection requiring intravenous antibiotic therapy =\< 12 weeks prior to registration * Other active malignancy (=\< 3 years) prior to registration; exceptions: basal cell skin cancer or carcinoma-in-situ of the cervix or low-risk prostate cancer after curative therapy * Any of the following: * Pregnant women * Nursing women * Men or women of childbearing potential who are unwilling to employ adequate contraception * New York Heart Association (NYHA) class 3 or 4 congestive heart failure (CHF) symptoms * Other concurrent chemotherapy, radiotherapy, or any ancillary therapy considered investigational; NOTE: bisphosphonates are allowed while on protocol treatment
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 lenalidomide PO on days 1-21 and dexamethasone PO on days 1, 8, 15, and 22. Patients also receive anakinra SC on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity
    intervention Names
    1. Biological: Anakinra
    2. Drug: Dexamethasone
    3. Other: Laboratory Biomarker Analysis
    4. Drug: Lenalidomide
    label
    Arm A (lenalidomide, dexamethasone, anakinra)
    type
    EXPERIMENTAL
  2. description
    Patients receive lenalidomide and dexamethasone as in Arm A. Patients also receive placebo SC on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
    intervention Names
    1. Drug: Dexamethasone
    2. Other: Laboratory Biomarker Analysis
    3. Drug: Lenalidomide
    4. Other: Placebo
    label
    Arm B (lenalidomide, dexamethasone, placebo)
    type
    ACTIVE_COMPARATOR
interventions
  1. arm Group Labels
    1. Arm A (lenalidomide, dexamethasone, anakinra)
    description
    Given SC
    name
    Anakinra
    other Names
    1. Kinaret
    2. Kineret
    3. rIL-1ra
    4. rIL1RN
    type
    BIOLOGICAL
  2. arm Group Labels
    1. Arm A (lenalidomide, dexamethasone, anakinra)
    2. Arm B (lenalidomide, dexamethasone, placebo)
    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
  3. arm Group Labels
    1. Arm A (lenalidomide, dexamethasone, anakinra)
    2. Arm B (lenalidomide, dexamethasone, placebo)
    description
    Correlative studies
    name
    Laboratory Biomarker Analysis
    type
    OTHER
  4. arm Group Labels
    1. Arm A (lenalidomide, dexamethasone, anakinra)
    2. Arm B (lenalidomide, dexamethasone, placebo)
    description
    Given PO
    name
    Lenalidomide
    other Names
    1. CC-5013
    2. CC5013
    3. CDC 501
    4. Revlimid
    type
    DRUG
  5. arm Group Labels
    1. Arm B (lenalidomide, dexamethasone, placebo)
    description
    Given SC
    name
    Placebo
    other Names
    1. placebo therapy
    2. PLCB
    3. sham therapy
    type
    OTHER
Study design
allocation
RANDOMIZED
intervention Model
PARALLEL
masking Info
masking
DOUBLE
who Masked
  1. PARTICIPANT
  2. INVESTIGATOR
primary Purpose
TREATMENT
Enrollment
count
14
type
ACTUAL
Registered outcome plans (not posted results)
primary Outcomes
  1. description
    Number of participants experiencing a dose-limiting toxicity (DLT) is reported below. Dose-limiting toxicity is graded by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.
    measure
    Number of Participants Experiencing a Dose-limiting Toxicity (DLT)
    time Frame
    28 days
  2. description
    The number of participants who experienced at least one grade 3+ adverse events deemed at least possibly related to treatment, graded according to NCI CTCAE version 4.0, is reported below.
    measure
    Number of Participants Who Experienced at Least One Grade 3+ Adverse Events Deemed at Least Possibly Related to Treatment, Graded According to NCI CTCAE Version 4.0
    time Frame
    Up to 41 months
  3. description
    The following response terms will be used: stringent Complete Response (sCR), complete response (CR), very good partial response (VGPR), partial response (PR), Minimal Response (MR), stable disease (SD), and progressive disease (PD). The International Myeloma Working Group (IMWG) uniform response criteria (Rajkumar et al, 2011) will be used to assess response to therapy. PR defined as: ≥50% reduction of serum M-protein and reduction in 24-hour urinary M-protein by ≥90% or to \<200 mg/24hrs; ≥ 50% reduction in the size of soft tissue plasmacytomas. MR defined as: ≥25% but ≤ 49% reduction of serum M protein and reduction in 24-hour urine M-protein by 50-89% which still exceeds 200mg/24 hours; 25-49% reduction in the size of soft tissue plasmacytoma and No increase in the size or number of lytic bone lesions. VGPR defined as: Serum and urine M-protein detectable by immunofixation but not on electrophoresis or ≥90% reduction in serum M-protein and urine M-protein \<100 mg/24 h
    measure
    Best Response
    time Frame
    Up to 41 months
Full study description
brief Summary
This partially randomized phase I/II trial studies the side effects and best dose of anakinra when given together with lenalidomide and dexamethasone in treating patients with early stage multiple myeloma. Biological therapies, such as lenalidomide and anakinra, may stimulate or suppress the immune system in different ways and stop cancer cells from growing. Drugs used in chemotherapy, such as dexamethasone, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. It is not yet known whether lenalidomide and dexamethasone are more effective with or without anakinra in treating patients with multiple myeloma.
detailed Description
PRIMARY OBJECTIVES: I. To determine the maximum tolerated dose (MTD)/maximum allowable dose (MAD) of anakinra that can be combined with lenalidomide and dexamethasone. (Phase I) II. To compare the time to progression of the standard treatment arm (lenalidomide/dexamethasone) to the experimental arm (lenalidomide/dexamethasone + anakinra). (Phase II) SECONDARY OBJECTIVES: I. To compare the response rate of the standard treatment arm (lenalidomide/dexamethasone) to the experimental arm (lenalidomide/dexamethasone + anakinra). II. To compare the toxicity of the standard treatment arm (lenalidomide/dexamethasone) to the experimental arm (lenalidomide/dexamethasone + anakinra). III. To compare the overall survival of the standard treatment arm (lenalidomide/dexamethasone) to the experimental arm (lenalidomide/dexamethasone + anakinra). OUTLINE: This is a phase I, dose-escalation study of anakinra followed by a phase II study. PHASE I: Patients receive lenalidomide orally (PO) on days 1-21 and dexamethasone PO on days 1, 8, 15, and 22. Patients also receive anakinra subcutaneously (SC) on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. PHASE II: Patients are randomized to 1 of 2 treatment arms. ARM A: Patients receive lenalidomide PO on days 1-21 and dexamethasone PO on days 1, 8, 15, and 22. Patients also receive anakinra SC on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. ARM B: Patients receive lenalidomide and dexamethasone as in Arm A. Patients also receive placebo SC on days 1-28. 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 months.
Source references
Source notices and limitations
    Discovery and provenance
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    Preserved source evidence · Not medical advice