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NCT01421186 · REGISTRY CONDITION SEARCH

A Phase 1/2a Study of Human Anti-CD 38 Antibody MOR03087 (MOR202) in 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
COMPLETED
Registry last update
2021-11-16

This is an open-label, multicentre, dose escalation study to characterize the safety and preliminary efficacy of the human anti-CD38 antibody MOR03087 (MOR202), in adult subjects with relapsed/refractory multiple myeloma, as monotherapy and in adult subjects with relapsed/refractory multiple myeloma in combination with standard therapy.

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

Determination of Maximum Tolerated Dose and / or Recommended Dose and Dosing Regimen of MOR03087

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outcome · POSTED

Number of Participants Who Develop Anti-MOR03087 Antibodies

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outcome · POSTED

Overall Response Rate

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outcome · POSTED

Time to Progression

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outcome · POSTED

Progression-free Survival

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outcome · POSTED

Duration of Response

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outcome · POSTED

Pharmacokinetics: Cmax - Maximum Observed Serum Concentration for MOR202

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outcome · POSTED

Pharmacokinetics: AUC Cycle 1+2 - Area Under the Time/Concentration Curve for MOR202

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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: 1. Male or female subjects 18 years and older 2. Relapsed or refractory multiple myeloma defined as: Parts A, B and C: (i) Failure of at least 2 previous therapies which must have included an immunomodulatory agent and a proteasome inhibitor (either together or part of different therapies) (ii) All subjects must have documented progression during or after their last prior therapy for multiple myeloma Part D: (i) At least 2 previous therapies including lenalidomide and a proteasome inhibitor (ii) All subjects must have documented progression during or within 60 days after their last prior therapy for multiple myeloma Part E: (i) Received at least one previous therapy (ii) All subjects must have documented progression during or after their last prior therapy for multiple myeloma 3. Presence of serum M-protein ≥ 0.5 g per 100 mL (≥ 5 g/L) and / or urine M-protein ≥ 200 mg per 24-hour period 4. Absolute neutrophil count (ANC) ≥ 1,000 / mm3 5. Haemoglobin ≥ 8 g/dL 6. Ability to comply with all study related procedures, medication use and evaluations Exclusion Criteria: 1. Primary refractory multiple myeloma 2. History of significant cerebrovascular disease or sensory or motor neuropathy of toxicity grade 3 or higher 3. Treatment with systemic investigational agent within 28 days prior to first study treatment 4. Solitary plasmacytoma or plasma cell leukaemia 5. Previous allogenic stem cell transplant (SCT) 6. Prior therapy with other monoclonal antibodies targeting the CD38 antigen or prior therapy with other IgG monoclonal antibodies within 3 months prior to first study treatment, or IgM monoclonal antibodies within 1 month prior to first study treatment 7. Active systemic infection 8. Systemic disease preventing study treatment 9. Multiple myeloma with central nervous system (CNS) involvement 10. Previous treatment with cytotoxic chemotherapy or large field radiotherapy or other myeloma specific therapy within 28 days prior to first study treatment (radiation to a single site as concurrent therapy is allowed) 11. Significant uncontrolled cardiovascular disease or cardiac insufficiency (New York Heart Association \[NYHA\] classes III, IV)
healthy Volunteers
false
minimum Age
18 Years
sex
ALL
std Ages
  1. ADULT
  2. OLDER_ADULT
Treatment arms and interventions
arm Groups
  1. description
    Part A: MOR03087 dose escalation; biweekly treatment Part B: MOR03087 dose escalation; weekly treatment Part C: MOR03087 dose escalation (weekly treatment) + dexamethasone Part D: MOR03087 weekly treatment in combination with pomalidomide + dexamethasone Part E: MOR03087 weekly treatment in combination with lenalidomide + dexamethasone For all parts, patients will be treated until disease progression (PD) or until a maximum of 3 years after first treatment.
    intervention Names
    1. Drug: MOR03087 phase 1 dose escalation
    2. Drug: Dexamethasone
    3. Drug: Pomalidomide
    4. Drug: Lenalidomide
    label
    Phase 1 dose escalation
    type
    EXPERIMENTAL
  2. description
    Confirmatory cohorts of MOR03087 monotherapy (plus or minus dexamethasone), in combination with pomalidomide plus dexamethasone, and in combination with lenalidomide plus dexamethasone. Following completion of Parts A, B, and C (dose escalation of MOR03087 biweekly and weekly schedules), the Maximum Tolerated Dose (MTD) or recommended dose and dosing regimen will be confirmed in a minimum of 6 subjects. Following completion of Parts D (dose escalation of MOR03087 in combination with pomalidomide + dexamethasone) and E (dose escalation of MOR03087 in combination with lenalidomide + dexamethasone), the MTD and/or recommended dose in each part will be confirmed in a minimum of 6 subjects. For all parts, patients will be treated until PD or until a maximum of 3 years after first treatment.
    intervention Names
    1. Drug: MOR03087
    2. Drug: Dexamethasone
    3. Drug: Pomalidomide
    4. Drug: Lenalidomide
    label
    Phase 2a confirmatory cohorts
    type
    EXPERIMENTAL
interventions
  1. arm Group Labels
    1. Phase 1 dose escalation
    description
    Treatment cycles will be 28 days. Initial MOR03087 doses will be 0.01 mg/kg in part A, 4 mg/kg in parts B and C and 8 mg/kg in parts D and E; in all parts MOR03087 doses will be escalated to a maximum of 16 mg/kg. In part A, patients will receive a biweekly intravenous infusion of MOR03087 which will be administered on days 1 and 15 of the cycle. In parts B to E patients will receive a weekly intravenous infusion of MOR03087 which will be administered on days 1, 8, 15, and 22 of the cycle. In all parts a loading dose of MOR03087 will be additionally administered on day 4 of cycle 1.
    name
    MOR03087 phase 1 dose escalation
    type
    DRUG
  2. arm Group Labels
    1. Phase 2a confirmatory cohorts
    description
    MOR03087 will be administered according to the Maximum Tolerated Dose (MTD) or recommended dose and dosing regimen for MOR03087 from parts A-E of the phase I dose escalation. The biweekly MOR03087 regimen as described in part A; the weekly regimen as described for parts B-E.
    name
    MOR03087
    type
    DRUG
  3. arm Group Labels
    1. Phase 1 dose escalation
    2. Phase 2a confirmatory cohorts
    description
    Dexamethasone will be administered to patients orally; 40 mg (≤ 75 years old) or 20 mg (\> 75 years old) on days 1, 8, 15, and 22 of the 28-day cycle. An additional dose will be administered in cycle 1 on day 4.
    name
    Dexamethasone
    type
    DRUG
  4. arm Group Labels
    1. Phase 1 dose escalation
    2. Phase 2a confirmatory cohorts
    description
    Pomalidomide will be administered to patients orally 4 mg on days 1-21 of the 28-day cycle.
    name
    Pomalidomide
    type
    DRUG
  5. arm Group Labels
    1. Phase 1 dose escalation
    2. Phase 2a confirmatory cohorts
    description
    Lenalidomide will be administered to patients orally 25 mg on days 1-21 of the 28-day cycle.
    name
    Lenalidomide
    type
    DRUG
Study design
allocation
NON_RANDOMIZED
intervention Model
SINGLE_GROUP
masking Info
masking
NONE
primary Purpose
TREATMENT
Enrollment
count
91
type
ACTUAL
Registered outcome plans (not posted results)
primary Outcomes
  1. description
    1. as monotherapy 2. in combination with dexamethasone 3. in combination with pomalidomide + dexamethasone 4. in combination with lenalidomide + dexamethasone
    measure
    Determination of Maximum Tolerated Dose and / or Recommended Dose and Dosing Regimen of MOR03087
    time Frame
    First cycle of treatment
  2. description
    Number of participants who develop anti-MOR03087 antibodies, a measure of immunogenicity
    measure
    Number of Participants Who Develop Anti-MOR03087 Antibodies
    time Frame
    during treatment period, maximum 3 years after 1st dose
secondary Outcomes
  1. description
    number (#) of patients responding (# stringent complete response + # complete response + # very good partial response + # partial response)
    measure
    Overall Response Rate
    time Frame
    maximum 3 years after 1st dose
  2. description
    Time to Progression (Kaplan Meier estimate)
    measure
    Time to Progression
    time Frame
    patients were observed for up to 36 months
  3. description
    Progression-free survival (Kaplan Meier estimates)
    measure
    Progression-free Survival
    time Frame
    patients were observed up to 36 months
  4. description
    Duration of response (Kaplan Meier estimates)
    measure
    Duration of Response
    time Frame
    patients were observed up to 36 months
  5. description
    PK analysis for MOR202 4, 8 and 16 mg/kg IV once weekly dose groups only, since serum concentrations of MOR202 were substantially affected by target mediated drug disposition effects for remaining dose groups
    measure
    Pharmacokinetics: Cmax - Maximum Observed Serum Concentration for MOR202
    time Frame
    up to 7 days after last MOR202 dose
  6. description
    PK analysis for MOR202 4, 8 and 16 mg/kg IV once weekly dose groups only, since serum concentrations of MOR202 were substantially affected by target mediated drug disposition effects for remaining dose groups
    measure
    Pharmacokinetics: AUC Cycle 1+2 - Area Under the Time/Concentration Curve for MOR202
    time Frame
    56 days
Full study description
brief Summary
This is an open-label, multicentre, dose escalation study to characterize the safety and preliminary efficacy of the human anti-CD38 antibody MOR03087 (MOR202), in adult subjects with relapsed/refractory multiple myeloma, as monotherapy and in adult subjects with relapsed/refractory multiple myeloma in combination with standard therapy.
detailed Description
The study enrolled patients aged 18 years or older with relapsed or refractory multiple myeloma and Karnofsky performance status of 60% or higher. Patients were assigned to the different treatment regimens with MOR202 ranging between 0·01 mg/kg and 16 mg/kg in a 3 + 3 design. Dose-escalation and expansion was done either with MOR202 intravenous infusions alone (MOR202 q2w \[twice a week\] and q1w \[weekly\] groups) or in combination with dexamethasone (MOR202 with dexamethasone group), with dexamethasone plus pomalidomide (MOR202 with dexamethasone plus pomalidomide group) or plus lenalidomide (MOR202 with dexamethasone plus lenalidomide group). Primary endpoints were safety, MOR202 maximum tolerated dose (or recommended dose) and regimen, and immunogenicity.
Source references
references
  1. citation
    Raab MS, Engelhardt M, Blank A, Goldschmidt H, Agis H, Blau IW, Einsele H, Ferstl B, Schub N, Rollig C, Weisel K, Winderlich M, Griese J, Hartle S, Weirather J, Jarutat T, Peschel C, Chatterjee M. MOR202, a novel anti-CD38 monoclonal antibody, in patients with relapsed or refractory multiple myeloma: a first-in-human, multicentre, phase 1-2a trial. Lancet Haematol. 2020 May;7(5):e381-e394. doi: 10.1016/S2352-3026(19)30249-2. Epub 2020 Mar 11.
    pmid
    32171061
    type
    DERIVED
Source notices and limitations
    Discovery and provenance
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    Preserved source evidence · Not medical advice