Skip to content
Triangle logo TriangleGet started
← Study library

NCT01754402 · REGISTRY CONDITION SEARCH

Bendamustine + Pomalidomide + Dex in R/R 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
UNKNOWN
Registry last update
2024-02-20

This study is designed as a phase I-II, open label, dose finding study. Study treatment will be as follows, in 28 day cycles: * Pomalidomide: once daily orally (PO) dosing on days 1-21, every 28 days * Bendamustine: once intravenously (IV) dosing on day 1, every 28 days * Dexamethasone: weekly PO or IV dosing on days 1, 8, 15, and 22. After completing 6 cycles of treatment, dexamethasone may be decreased to 20mg per investigator discretion. After completing 12 cycles of treatment, patients will proceed to the maintenance phase of the study. Patients will receive Pomalidomide on day 1-21, every 28 days and dexamethasone on days 1, 8, 15, and 22 every 28 days until time of progression.

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

→

baseline

Baseline characteristics

→

outcome · POSTED

Maximum Tolerated Dose of Pomalidomide and Bendamustine

→

outcome · POSTED

Initial Response Rate

→

outcome · NOT POSTED

Overall Response Rate

→

outcome · NOT POSTED

Time to Progression

→

outcome · NOT POSTED

Time to Next Therapy

→

outcome · NOT POSTED

Progression Free Survival

→

adverse events

Adverse events

→

more info

Limitations, agreements, and source contact

→
Who could take part
eligibility Criteria
INCLUSION CRITERIA: Patients must meet all of the following inclusion criteria to be eligible to enroll in this study. 1. Cytopathologically or histologically confirmed diagnosis of multiple myeloma 2. Relapsed or refractory to most recent therapy (i.e. \< 25% response, progression during therapy or within 60 days after completion). 3. Refractory to prior lenalidomide therapy (i.e. history of progression on therapy using full or maximally tolerated dose of lenalidomide for \>/= two cycles). 4. Measurable disease: * Serum M protein \> 0.5 g/dL or * Urine Bence Jones protein \>200 mg/24 hr or * Elevated Free Light Chain per International Myeloma Working Group (IMWG) criteria, and abnormal ratio 5. Evidence of progression/relapse 6. Over 18 7. Life expectancy of more than 3 months 8. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-2 9. Total bilirubin \< 2 times the upper limit of normal (ULN), and aspartate aminotransferase (AST) and alanine aminotransferase (ALT) \< 3 times ULN 10. Serum creatinine \<3 mg/dL 11. • Absolute neutrophil count (ANC) \>1.0 x 109/L or \<1.0 x 109/L but \> 0.75 due to \>30%\* marrow involvement (without granulocyte and granulocyte/macrophage colony stimulating factor (GCSF and GMCSF) for \>1 week and of pegylated GCSF for \>2 weeks) * Hemoglobin \>8 g/dL * Platelet count \>75.0 x 109/L or \< 75.0 x 109/L but \>50.0 x 109/L due to \>30%\* marrow involvement (without platelet transfusions for \>1 week) * Transfusions allowed if clinically indicated 12. Agree to take enteric coated aspirin 81 mg daily 13. Consent 14. Females of childbearing potential (FCBP) must have a negative serum or urine pregnancy test and abstain from sex or begin TWO acceptable methods of birth control \>28 days before pomalidomide dose, and agree to ongoing pregnancy testing. 15. Male patients must abstain from sex or use a latex condom and not donate sperm while taking pomalidomide and for 1 week after stopping drug. 16. Register with POMALYST REMS™ and comply with their requirements. EXCLUSION CRITERIA: 1. Patients with known sensitivity to immunomodulatory drugs (IMiDs) 2. Use of experimental drugs or therapy within 21 days of study-related drug therapy. 3. Exposure to chemotherapy or steroids within 14 days of study-related drug therapy. 4. Prior use of pomalidomide. 5. Radiation therapy within 14 days of screening. 6. POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes). 7. Plasma cell leukemia. 8. Waldenström's macroglobulinemia. 9. Major surgery within 21 days prior to first dose. 10. Pregnant or lactating females. 11. Congestive heart failure, symptomatic ischemia, conduction abnormalities uncontrolled or myocardial infarction in the last six months. 12. Uncontrolled hypertension 13. Acute active infection requiring systemic antibiotics, antivirals, or antifungals within 14 days prior to first dose. 14. Active treatment or intervention for other malignancy or need active treatment within 8 months of starting study treatment. 15. Serious psychiatric or medical conditions that interfere with treatment 16. Significant neuropathy (Grade 3, Grade 4) at first dose and/or within 14 days before enrollment 17. Contraindication to required concomitant drugs 18. Patients with primary systemic amyloidosis
healthy Volunteers
false
minimum Age
18 Years
sex
ALL
std Ages
  1. ADULT
  2. OLDER_ADULT
Treatment arms and interventions
arm Groups
  1. description
    * Pomalidomide: once daily oral (PO) dosing on days 1-21, every 28 days * Bendamustine: once intravenous (IV) dosing on day 1, every 28 days * Dexamethasone: weekly PO or IV dosing on days 1, 8, 15, and 22 every 28 days
    intervention Names
    1. Drug: Bendamustine
    2. Drug: Pomalidomide
    3. Drug: Dexamethasone
    label
    Cohort 1: benda 120mg + pom 3mg
    type
    EXPERIMENTAL
  2. description
    * Pomalidomide: once daily oral (PO) dosing on days 1-21, every 28 days * Bendamustine: once intravenous (IV) dosing on day 1, every 28 days * Dexamethasone: weekly PO or IV dosing on days 1, 8, 15, and 22 every 28 days
    intervention Names
    1. Drug: Bendamustine
    2. Drug: Pomalidomide
    3. Drug: Dexamethasone
    label
    Cohort 2: benda 120mg + pom 4mg
    type
    EXPERIMENTAL
  3. description
    * Pomalidomide 3mg: once daily oral (PO) dosing on days 1-21, every 28 days * Bendamustine 120 mg: once intravenous (IV) dosing on day 1, every 28 days * Dexamethasone: weekly PO or IV dosing on days 1, 8, 15, and 22 every 28 days
    intervention Names
    1. Drug: Bendamustine
    2. Drug: Pomalidomide
    3. Drug: Dexamethasone
    label
    Expansion
    type
    EXPERIMENTAL
interventions
  1. arm Group Labels
    1. Cohort 1: benda 120mg + pom 3mg
    2. Cohort 2: benda 120mg + pom 4mg
    3. Expansion
    description
    Bendamustine will be administered intravenously over 1 hour (if using Treanda) or over 10 minutes (if using Bendeka) on day 1, every 28 days for 12 cycles.
    name
    Bendamustine
    other Names
    1. Treanda
    2. Bendeka
    type
    DRUG
  2. arm Group Labels
    1. Cohort 1: benda 120mg + pom 3mg
    2. Cohort 2: benda 120mg + pom 4mg
    3. Expansion
    description
    Pomalidomide will be administered once daily orally (PO) on days 1-21, every 28 days until disease progression or death.
    name
    Pomalidomide
    other Names
    1. CC-4047
    2. Pomalyst
    type
    DRUG
  3. arm Group Labels
    1. Cohort 1: benda 120mg + pom 3mg
    2. Cohort 2: benda 120mg + pom 4mg
    3. Expansion
    description
    Dexamethasone will be administered weekly orally or intravenously on days 1, 8, 15, and 22 every 28 days until disease progression or death. After 6 cycles of treatment, the dose may be reduced to 20mg at investigator's discretion. For subjects ≥ 75 years of age, the starting dose of dexamethasone is 20 mg/day on Days 1, 8, 15 and 22 of each 28-day treatment cycle.
    name
    Dexamethasone
    type
    DRUG
Study design
allocation
NON_RANDOMIZED
intervention Model
SEQUENTIAL
intervention Model Description
Dose escalation with 3+3 cohort design plus Dose expansion at the Maximum tolerated dose.
masking Info
masking
NONE
primary Purpose
TREATMENT
Enrollment
count
56
type
ACTUAL
Registered outcome plans (not posted results)
primary Outcomes
  1. description
    In the phase I dose escalation portion, patients will be sequentially enrolled in 4 cohorts at dose levels in a standard 3+3 design until the maximum tolerated dose (MTD) is reached. Cohort 1 (bendamustine 120mg/m2 + pomalidomide 3mg); Cohort 2 (bendamustine 120mg/m2 + pomalidomide 4mg); Cohort 3 (bendamustine 150mg/m2 + pomalidomide 4mg); Cohort 4 (bendamustine 180mg/m2 + pomalidomide 4mg) If dose limiting toxicity (DLT) is observed in 2 or more of the six patients at the same dosing level while DLT is observed in only 1 or none of the 6 patients at the dosing level immediately below it, then the lower dosing level will be defined as the maximum tolerated dose (MTD).
    measure
    Maximum Tolerated Dose of Pomalidomide and Bendamustine
    time Frame
    2 cycles (approximately 2 months)
  2. description
    The number of patients achieving a complete response (CR) or partial response (PR). Response is defined by the International Myeloma Working Group as: CR- Negative immunofixation on serum and urine and disappearance of soft tissue plasmacytomas and \< 5% plasma cells in bone marrow PR- \> 50% reduction of serum M-protein and urine M-protein by \>90% or to \< 200 mg/24 h In addition, if present at baseline, a \> 50% reduction in the size of soft tissue plasmacytomas is also required VGPR - Serum and urine M-protein detectable by immunofixation but n
    measure
    Initial Response Rate
    time Frame
    2 cycles (approximately 2 months)
secondary Outcomes
  1. description
    The number of patients achieving stable disease (SD), partial response (PR), very good partial response (VGPR), complete response (CR) or stringent complete response (sCR) sCR = CR as defined in Primary Outcome measure 2 plus normal free light chain ratio and absence of clonal cells in bone marrow by immunohistochemistry or immunofluorescence 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 SD = Not meeting criteria for CR, VGPR, PR, or progressive disease
    measure
    Overall Response Rate
    time Frame
    2 years after last dose of study drug
  2. description
    Time to progression - defined as time elapsed in patients between achievement of response and disease progression
    measure
    Time to Progression
    time Frame
    2 years after last dose of study drug
  3. description
    Time to next Therapy - defined as the time elapsed for patients from initiation of study therapy until initiation of next therapy
    measure
    Time to Next Therapy
    time Frame
    2 years after last dose of study drug
  4. description
    The time elapsed for patients between initiation of study therapy and either disease progression or death
    measure
    Progression Free Survival
    time Frame
    2 years after last dose of study drug
Full study description
brief Summary
This study is designed as a phase I-II, open label, dose finding study. Study treatment will be as follows, in 28 day cycles: * Pomalidomide: once daily orally (PO) dosing on days 1-21, every 28 days * Bendamustine: once intravenously (IV) dosing on day 1, every 28 days * Dexamethasone: weekly PO or IV dosing on days 1, 8, 15, and 22. After completing 6 cycles of treatment, dexamethasone may be decreased to 20mg per investigator discretion. After completing 12 cycles of treatment, patients will proceed to the maintenance phase of the study. Patients will receive Pomalidomide on day 1-21, every 28 days and dexamethasone on days 1, 8, 15, and 22 every 28 days until time of progression.
detailed Description
PRIMARY ENDPOINTS: Phase I • Determination of the MTD of the combination therapy Phase II: • Response rate (CR+PR) SECONDARY ENDPOINTS: * Overall Response Rate (ORR) * Progression Free Survival (PFS) * Time to Progression (TTP) * Time to next therapy A total of 56 patients may be enrolled in this study: Dose escalation phase: Up to 24 subjects; Dose expansion phase: Up to a maximum of 38 patients treated at the maximum tolerated dose (MTD). Study treatment will be administered starting at Cohort 1 for up to four sequential cohorts, with 3-6 patients in each cohort. A standard 3+ 3 dose escalation schedule will be used. A minimum of 3 patients will be entered within each cohort, to be expanded to 6 patients if dose limiting toxicities (DLTs) are observed, to determine the MTD. Once the MTD is reached, any additional patients will be enrolled at the MTD level. Dose Escalation * Cohort -1: bendamustine 120 mg/m2; pomalidomide 2mg; dexamethasone 40mg\*\* * Cohort 1 (initial dose): bendamustine 120/mg/m2; pomalidomide 3 mg; dexamethasone 40 mg\*\* * Cohort 2: bendamustine 120 mg/m2; pomalidomide 4 mg; dexamethasone 40 mg\*\* * Cohort 3: bendamustine 150 mg/m2; pomalidomide 4 mg; dexamethasone 40 mg\*\* * Cohort 4: bendamustine 180 mg/m2; pomalidomide 4 mg; dexamethasone 40 mg\*\* EVALUATION: * For toxicity: 1 cycle (All patients will be considered evaluable for toxicity unless they cannot complete the first cycle of therapy due to withdrawal of consent or disease progression.) * For efficacy: 2 cycles Intended treatment duration: Patients will continue on protocol as long as they are receiving clinical benefit and will be removed for disease progression (at the investigator's discretion the patient may be treated up to one cycle after progression noted to confirm progression), adverse event/unacceptable toxicity or side effect, or withdrawal of consent. A DLT is defined as any of the following occurring during the first treatment cycle (28 days) that are judged by the investigator to be at least possibly related to the study therapy: Hematologic: * Febrile neutropenia (ANC \<1.0x109/L) with fever of 38.5 C. Subjects who enter the study with lower counts (ANC \<1.0x109/L) due to \>5030%\* marrow involvement will not be evaluated for this portion of the DLT definition. * Grade 4 neutropenia (ANC \< 0.5x109/L) for more than 7 days despite GCSF support. Subjects who enter the study with lower counts (ANC \<1.0x109/L) due to \>5030%\* marrow involvement will not be evaluated for this portion of the DLT definition. * Grade 4 thrombocytopenia (platelets count \<25.0x109/L) lasting \>7 days despite dose delay. Subjects who enter the study with lower counts (platelets \<50.0x109/L) due to \>5030%\* marrow involvement will not be evaluated for this portion of the DLT definition. * Grade 3-4 thrombocytopenia associated with bleeding * Any hematologic toxicity requiring a dose reduction within Cycle 1 * Inability to receive Day 1 dose of Cycle 2 due to drug related toxicity persisting from Cycle 1 greater than 14 days Non-hematologic: * Any \> Grade 3 toxicity determined by the Investigator to be related to pomalidomide or bendamustine (with the exception of thrombotic events and as noted below). * \> Grade 3 nausea, vomiting, or diarrhea, despite the use of maximal antiemetic/antidiarrheal therapy * \> Grade 3 neuropathy with pain * \>Grade 3 venous thromboembolic events. * Any Grade 4 rash related to the agents will be considered a DLT. * A Grade 3 rash related to the agents that has not resolved to \< Grade 2 within a 10 day period despite steroids therapy will be considered a DLT. * If an event is attributed to progressive disease, it will not be counted as a DLT. * Any non-hematologic toxicity requiring a dose reduction within Cycle 1 * Delay in ability to receive Day 1 dose of Cycle 2 due to drug related toxicity persisting from Cycle 1 greater than 14 days
Source references
Source notices and limitations
    Discovery and provenance
    1. release id
      ctgov-registry-1336d216cbd1bbff780dac70
      edge id
      nct-edge-250eb0aca2ad0dc0a9ef
      requested nct id
      NCT01754402
      primary nct id
      NCT01754402
      source kind
      ctgov_condition_query
      source record id
      Source null
      source file sha256
      2314ce01316b2d7044d298c6d25eda12e99cc5f44273bc75efed6cd5e03a8c14
      payload sha256
      72a78cb27806ae802205ccbd81078ad54fb4cc2a33bd3b1c1f4cc606c20d8360
      payload
      clinical indication matching status
      condition_index_match_asserted_by_registry_not_reviewed
      end exclusive
      true
      id
      nct-edge-250eb0aca2ad0dc0a9ef
      link basis
      returned_by_explicit_condition_and_posted_results_filter_query
      nct id
      NCT01754402
      occurrences
      1. context exact
        NCT01754402
        end
        11
        exact text
        NCT01754402
        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-000.json
      source file sha256
      2314ce01316b2d7044d298c6d25eda12e99cc5f44273bc75efed6cd5e03a8c14
      source json pointer
      /studies/751/protocolSection/identificationModule/nctId
      source kind
      ctgov_condition_query
      source record id
      Source null
      source string basis
      parsed_JSON_string_unmodified
      source string sha256
      528b6ea783acaea2e3581dbefeb9cdea6cd037d6511ce2cf84973305006b2fa4

    Preserved source evidence · Not medical advice