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NCT02100657 · REGISTRY CONDITION SEARCH

Study of Plitidepsin (Aplidin®) in Combination With Bortezomib and Dexamethasone in Patients With 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
2020-10-12

Study of Plitidepsin (Aplidin®) to determine the recommended dose (RD) of plitidepsin in Combination with Bortezomib and Dexamethasone in Patients with Relapsed and/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

Recommended Dose of Plitidepsin in Combination With Bortezomib and Dexamethasone

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outcome · POSTED

Recommended Dose of Bortezomib in Combination With Plitidepsin and Dexamethasone

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outcome · POSTED

Recommended Dose of Dexamethasone in Combination With Plitidepsin and Bortezomib

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outcome · POSTED

Number of Participants Who Experienced Dose-Limiting Toxicities (DLTs)

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outcome · POSTED

Response According to International Myeloma Working Group Criteria

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outcome · POSTED

Overall Response Rate

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outcome · POSTED

Duration of Response

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outcome · POSTED

Time to Progression

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outcome · POSTED

Time to Progression Rates

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outcome · POSTED

Progression-free Survival

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outcome · POSTED

Progression-free Survival Rates

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outcome · POSTED

Event-free Survival

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outcome · POSTED

Event-free Survival Rates

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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: * Age ≥ 18 years. * Prior autologous transplantation (HSCT) patients are allowed. * Patients must have received at least one previous treatment line of induction, chemotherapy, chemotherapy and transplantation or previous treatment with bortezomib or another proteasome drug Exclusion Criteria: * Previous treatment with plitidepsin. * Active or metastatic primary malignancy other than MM. * Serious concomitant systemic disorders * History of hypersensitivity reactions to bortezomib, polyoxyl 35 castor oil or mannitol * Neuropathy * Pregnant and/or lactating women * HIV infection * Active hepatitis B or C virus infection. * Treatment with any Investigational Medicinal Product (IMP) in the 30 days before inclusion in the study * Plasma cell leukemia at the time of study entry * Contraindication for the use of steroids
healthy Volunteers
false
minimum Age
18 Years
sex
ALL
std Ages
  1. ADULT
  2. OLDER_ADULT
Treatment arms and interventions
arm Groups
  1. description
    Plitidepsin will be administered as a 3-hour (h) intravenous (i.v.) infusion on Day (D) 1 and 15, every four weeks (q4wk). Bortezomib will be administered as a subcutaneous (s.c.) injection on D1, 4, 8 and 11, q4wk, for a maximum of eight cycles. Dexamethasone will be taken orally on D1, 8, 15 and 22, q4wk
    intervention Names
    1. Drug: Plitidepsin
    2. Drug: Bortezomib
    3. Drug: Dexamethasone
    label
    plitidepsin + bortezomib + dexamethasone
    type
    EXPERIMENTAL
interventions
  1. arm Group Labels
    1. plitidepsin + bortezomib + dexamethasone
    name
    Plitidepsin
    type
    DRUG
  2. arm Group Labels
    1. plitidepsin + bortezomib + dexamethasone
    name
    Bortezomib
    type
    DRUG
  3. arm Group Labels
    1. plitidepsin + bortezomib + dexamethasone
    name
    Dexamethasone
    type
    DRUG
Study design
allocation
NA
intervention Model
SINGLE_GROUP
masking Info
masking
NONE
primary Purpose
OTHER
Enrollment
count
39
type
ACTUAL
Registered outcome plans (not posted results)
primary Outcomes
  1. description
    To determine the recommended dose (RD) of plitidepsin in combination with bortezomib and dexamethasone in patients with relapsed and/or refractory multiple myeloma (MM). To define the RD, patients will be evaluated for DLTs during the first 28-day cycle. The RD will be the highest DL at which fewer than two out of six (33%) of evaluable patients experience a DLT during the first 28-day cycle.
    measure
    Recommended Dose of Plitidepsin in Combination With Bortezomib and Dexamethasone
    time Frame
    After 28-day cycle
  2. description
    To determine the recommended dose (RD) of plitidepsin in combination with bortezomib and dexamethasone in patients with relapsed and/or refractory multiple myeloma (MM). To define the RD, patients will be evaluated for DLTs during the first 28-day cycle. The RD will be the highest DL at which fewer than two out of six (33%) of evaluable patients experience a DLT during the first 28-day cycle.
    measure
    Recommended Dose of Bortezomib in Combination With Plitidepsin and Dexamethasone
    time Frame
    After 28-day cycle
  3. description
    To determine the recommended dose (RD) of plitidepsin in combination with bortezomib and dexamethasone in patients with relapsed and/or refractory multiple myeloma (MM). To define the RD, patients will be evaluated for DLTs during the first 28-day cycle. The RD will be the highest DL at which fewer than two out of six (33%) of evaluable patients experience a DLT during the first 28-day cycle.
    measure
    Recommended Dose of Dexamethasone in Combination With Plitidepsin and Bortezomib
    time Frame
    After 28-day cycle
  4. description
    DLTs were defined as: Hematological Toxicity * Grade 3/4 neutropenia associated with fever or lasting\>7 days related to the study treatment * Grade 3/4 thrombocytopenia accompanied by grade 3/4 hemorrhage * Extensive bone marrow (BM) infiltration, DLT was defined as grade 4 thrombocytopenia with grade 3/4 hemorrhage or grade 4 neutropenia lasting \>7 days or with fever Non-hematological Toxicity * Grade 3/4 nausea and vomiting refractory to antiemetic therapy * Grade≥3 muscular Adverse events (AE) (myalgia, muscular weakness, muscle cramps, myopathy) * Grade≥3 alanine aminotransferase (ALT)/Aspartate aminotransferase (AST) lasting more than 1 week * Grade≥3 bilirubin increase * Grade≥3 creatine phosphokinase (CPK) increase * Cardiac toxicity * Symptomatic or treatment-requiring grade ≥1 cardiac arrhythmia related to plitidepsin * Grade≥1 left ventricular systolic dysfunction related to plitidepsin * Neuropathic pain and peripheral sensory neuropathy related to BTZ
    measure
    Number of Participants Who Experienced Dose-Limiting Toxicities (DLTs)
    time Frame
    After 28-day cycle
secondary Outcomes
  1. description
    Stringent complete response (sCR) normal Free Light Chains (FLC) ratio. No clonal cells Complete response (CR) no serum/urine M-protein, no evidence of soft tissue plasmacytoma. \<5% clonal plasma cells Very good partial response (VGPR) serum and urine M-protein detectable but not electrophoresis or \>90% reduction in serum M-protein and urine M-protein \<100 mg/24h Partial response (PR) ≥50% reduction in serum M-protein and 90% reduction in 24h urine M-protein or to \<200 mg/24h. 50% reduction in size of any soft tissue plasmacytomas Minor response (MR) 25%-49% reduction of serum M-protein and 50-89% reduction of 24h urine M-protein. 25-49% reduction in size of soft tissue plasmacytomas. No increase in size or number of bone lesions Stable disease (SD) No sCR, CR, VGPR, PR, MR or PD Progressive disease (PD) 25% increase from the lowest value: serum M-protein, urine M-protein, BM plasma cell. Increase in size, new bone lesions, soft tissue plasmacytomas or serum calcium \>11.5 mg/dL
    measure
    Response According to International Myeloma Working Group Criteria
    time Frame
    Response or disease progression was assessed on Day 1 of each cycle, assessed up to 4 years
  2. description
    Overall response rate (ORR), including stringent complete response (sCR), complete response (CR), very good partial response (VGPR) and partial response (PR) according to the International Myeloma Working Group (IMWG) criteria
    measure
    Overall Response Rate
    time Frame
    Response or disease progression was assessed on Day 1 of each cycle, assessed up to 4 years
  3. description
    Duration of response (DR) was analyzed for all patients in whom a response had been observed and was calculated from the date of the first documentation of response to the date of PD or further therapy or death
    measure
    Duration of Response
    time Frame
    From the date of the first documentation of response to the date of PD or further therapy or death, up to 4 years
  4. description
    Time to progression (TTP) was calculated from the date of the first infusion to the date of documented PD or death due to PD.
    measure
    Time to Progression
    time Frame
    From the date of the first infusion to the date of documented PD or death due to PD, up to 4 years
  5. description
    Time to progression (TTP) was calculated from the date of the first infusion to the date of documented PD or death due to PD.
    measure
    Time to Progression Rates
    time Frame
    From the date of the first infusion to the date of documented PD or death due to PD, up to 4 years
  6. description
    Progression-free survival (PFS) was calculated from the date of the first infusion to the date of documented PD or death (regardless of the reason), whichever comes first
    measure
    Progression-free Survival
    time Frame
    from the date of the first infusion to the date of documented PD or death, up to 4 years
  7. description
    Progression-free survival (PFS) was calculated from the date of the first infusion to the date of documented PD or death (regardless of the reason), whichever comes first
    measure
    Progression-free Survival Rates
    time Frame
    From the date of the first infusion to the date of documented PD or death, up to 4 years
  8. description
    Event-free survival (EFS) was calculated from the date of first infusion to the date of documented PD or death, but could include additional events besides death and PD that were considered of importance
    measure
    Event-free Survival
    time Frame
    From the date of first infusion to the date of documented PD or death, up to 4 years
  9. description
    Event-free survival (EFS) was calculated from the date of first infusion to the date of documented PD or death, but could include additional events besides death and PD that were considered of importance
    measure
    Event-free Survival Rates
    time Frame
    from the date of first infusion to the date of documented PD or death, up to 4 years
Full study description
brief Summary
Study of Plitidepsin (Aplidin®) to determine the recommended dose (RD) of plitidepsin in Combination with Bortezomib and Dexamethasone in Patients with Relapsed and/or Refractory Multiple Myeloma.
detailed Description
Phase I Multicenter, Open-label, Dose-escalating Clinical and Pharmacokinetic Trial of Plitidepsin (Aplidin®) to determine the recommended dose (RD) of plitidepsin in combination with bortezomib and dexamethasone in patients with relapsed and/or refractory multiple myeloma (MM), to determine the efficacy of the combination plitidepsin/bortezomib/dexamethasone, to evaluate the safety and tolerability of the combination in patients with relapsing and/or refractory MM and to study the pharmacokinetics (PK) and pharmacodynamics (PDy) of plitidepsin in combination with bortezomib and dexamethasone.
Source references
Source notices and limitations
    Discovery and provenance
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    Preserved source evidence · Not medical advice