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NCT02548962 · REGISTRY CONDITION SEARCH

Study of Ibrutinib in Combination With Pomalidomide and Dexamethasone in Subjects With 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
TERMINATED
Registry last update
2019-11-21

Phase 1 is an open-label, dose finding, multicenter study of ibrutinib in combination with pomalidomide and dexamethasone in subjects with relapsed/refractory multiple myeloma. Phase 2b is a randomized, double-blind, multicenter study of ibrutinib or placebo, in combination with pomalidomide and dexamethasone in subjects with relapsed/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

Overall Response Rate (ORR) According to the IMWG Response Criteria Per Investigator Assessment

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outcome · POSTED

Clinical Benefit Response (CBR)

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outcome · POSTED

Duration of Response (DOR)

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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: * Subjects with relapsed/refractory MM who have received at least two prior lines of therapy including lenalidomide and either bortezomib or carfilzomib and have demonstrated disease progression on or within 60 days of the completion of the most recent treatment regimen. * Measurable disease defined by at least ONE of the following: 1. Serum monoclonal protein (SPEP) ≥1 g/dL. 2. Urine monoclonal protein (UPEP) ≥200 mg by 24 hour urine. * Adequate hematologic, hepatic, and renal function * ECOG performance status of ≤ 2 Exclusion Criteria: * Subject must not have primary refractory disease * Plasma cell leukemia, primary amyloidosis or POEMS syndrome * Unable to swallow capsules or disease significantly affecting gastrointestinal function * Requires treatment with strong CYP3A inhibitors * Women who are pregnant or breast feeding.
healthy Volunteers
false
maximum Age
100 Years
minimum Age
18 Years
sex
ALL
std Ages
  1. ADULT
  2. OLDER_ADULT
Treatment arms and interventions
arm Groups
  1. description
    Ibrutinib PO+ Pomalidomide PO+ Dexamethasone PO
    intervention Names
    1. Drug: Ibrutinib
    2. Drug: Pomalidomide
    3. Drug: Dexamethasone
    label
    Phase 1: Dose Finding
    type
    EXPERIMENTAL
  2. description
    Ibrutinib PO+ Pomalidomide PO+ Dexamethasone PO
    intervention Names
    1. Drug: Ibrutinib
    2. Drug: Pomalidomide
    3. Drug: Dexamethasone
    label
    Phase 2: Treatment Arm A
    type
    EXPERIMENTAL
  3. description
    Placebo PO+ Pomalidomide PO+ Dexamethasone PO
    intervention Names
    1. Drug: Pomalidomide
    2. Drug: Dexamethasone
    3. Drug: Placebo
    label
    Phase 2: Treatment Arm B
    type
    EXPERIMENTAL
interventions
  1. arm Group Labels
    1. Phase 1: Dose Finding
    2. Phase 2: Treatment Arm A
    name
    Ibrutinib
    type
    DRUG
  2. arm Group Labels
    1. Phase 1: Dose Finding
    2. Phase 2: Treatment Arm A
    3. Phase 2: Treatment Arm B
    name
    Pomalidomide
    type
    DRUG
  3. arm Group Labels
    1. Phase 1: Dose Finding
    2. Phase 2: Treatment Arm A
    3. Phase 2: Treatment Arm B
    name
    Dexamethasone
    type
    DRUG
  4. arm Group Labels
    1. Phase 2: Treatment Arm B
    name
    Placebo
    type
    DRUG
Study design
allocation
NON_RANDOMIZED
intervention Model
PARALLEL
masking Info
masking
QUADRUPLE
who Masked
  1. PARTICIPANT
  2. CARE_PROVIDER
  3. INVESTIGATOR
  4. OUTCOMES_ASSESSOR
primary Purpose
TREATMENT
Enrollment
count
11
type
ACTUAL
Registered outcome plans (not posted results)
primary Outcomes
  1. description
    The overall response rate, defined as the proportion of subjects achieving a best overall response of PR or better per investigator assessment per IMWG at or prior to initiation of subsequent anticancer therapy
    measure
    Overall Response Rate (ORR) According to the IMWG Response Criteria Per Investigator Assessment
    time Frame
    14 Months
secondary Outcomes
  1. description
    The clinical benefit response, defined as the proportion of subjects achieving a best overall response of MR or better per investigator assessment per IMWG at or prior to initiation of subsequent anticancer therapy.
    measure
    Clinical Benefit Response (CBR)
    time Frame
    14 Months
  2. description
    The time interval between the date of initial documentation of a response and the date of first documented evidence of progressive disease, death, or date of censoring for the subjects not progressed/died. The censoring date is the last adequate tumor assessment date.
    measure
    Duration of Response (DOR)
    time Frame
    14 Months
Full study description
brief Summary
Phase 1 is an open-label, dose finding, multicenter study of ibrutinib in combination with pomalidomide and dexamethasone in subjects with relapsed/refractory multiple myeloma. Phase 2b is a randomized, double-blind, multicenter study of ibrutinib or placebo, in combination with pomalidomide and dexamethasone in subjects with relapsed/refractory multiple myeloma.
detailed Description
Bruton's tyrosine kinase (Btk) is an enzyme that is present in hematopoietic cells other than T cells and is necessary for downstream signal transduction from various hematopoietic receptors including the B cell receptor as well as some Fc, chemokine, and adhesion receptors, and is crucial for both B cell development and osteoclastogenesis. Although down-regulated in normal plasma cells, Btk is highly expressed in the malignant cells from many myeloma patients and some cell lines. Ibrutinib is a potent and specific inhibitor of Btk currently in Phase 2 and 3 clinical trials. The current study is designed and intended to determine the safety and efficacy of ibrutinib in combination with pomalidomide and dexamethasone in subjects with relapsed/refractory multiple myeloma.
Source references
Source notices and limitations
    Discovery and provenance
    1. release id
      ctgov-registry-1336d216cbd1bbff780dac70
      edge id
      nct-edge-ba9454712070ecb72fcd
      requested nct id
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      primary nct id
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      source kind
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      source record id
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      source file sha256
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      payload sha256
      91e14d3d60e5b0581b20da3e399e23d764430138f46bb67063e2b425ebfa9b31
      payload
      clinical indication matching status
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      end exclusive
      true
      id
      nct-edge-ba9454712070ecb72fcd
      link basis
      returned_by_explicit_condition_and_posted_results_filter_query
      nct id
      NCT02548962
      occurrences
      1. context exact
        NCT02548962
        end
        11
        exact text
        NCT02548962
        start
        0
      offset unit
      unicode_code_points
      query cond
      Plasma Cell Neoplasms
      query disease state id
      ds-plasma-cell-neoplasms
      source file
      /Users/arunverma/Documents/ChatGPT/Cancer Statistics Website/research-data/2026-09-10/clinicaltrials-condition/round-0000/raw/cond-plasma-cell-neoplasms-001.json
      source file sha256
      f61b5b8281f834a98709317598003056a2aa82c9b92a292e3623f400c9c3291b
      source json pointer
      /studies/27/protocolSection/identificationModule/nctId
      source kind
      ctgov_condition_query
      source record id
      Source null
      source string basis
      parsed_JSON_string_unmodified
      source string sha256
      7b0e3424704cc9666119dbd225f4448afbed64198273d0fadf36b416ca86ae6b

    Preserved source evidence · Not medical advice