Multiple MyelomaPhase 1/2NCT01421186
A Phase 1/2a Study of Human Anti-CD 38 Antibody MOR03087 (MOR202) in Relapsed/Refractory Multiple Myeloma
A Phase 1/2 study testing MOR03087 phase 1 dose escalation, MOR03087 and Dexamethasone in people with Multiple Myeloma, run by MorphoSys AG at 10 sites in 2 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Myeloma
- What is being tested?
- MOR03087 phase 1 dose escalation, MOR03087 and Dexamethasone
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 91 participants
- Where
- 10 sitesin 2 countries
- Study dates
- Jul 2011to Aug 2020
- Phase
- Phase 1/2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female subjects 18 years and older
- Relapsed or refractory multiple myeloma defined as:
- Parts A, B and C:
- 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:
- 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
Show all 12Show fewer
- Part E:
- Received at least one previous therapy (ii) All subjects must have documented progression during or after their last prior therapy for multiple myeloma
- 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
- Absolute neutrophil count (ANC) ≥ 1,000 / mm3
- Haemoglobin ≥ 8 g/dL
- Ability to comply with all study related procedures, medication use and evaluations
Who cannot join
- Primary refractory multiple myeloma
- History of significant cerebrovascular disease or sensory or motor neuropathy of toxicity grade 3 or higher
- Treatment with systemic investigational agent within 28 days prior to first study treatment
- Solitary plasmacytoma or plasma cell leukaemia
- Previous allogenic stem cell transplant (SCT)
- 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
Show all 11Show fewer
- Active systemic infection
- Systemic disease preventing study treatment
- Multiple myeloma with central nervous system (CNS) involvement
- 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)
- Significant uncontrolled cardiovascular disease or cardiac insufficiency (New York Heart Association [NYHA] classes III, IV)
Trial locations and contacts
10 sites in 2 countries.
10 sites in 2 countries
Germany9 sites
Charité - Universitätsmedizin Berlin, CBF: Campus Benjamin Franklin, CC 14: Tumormedizin, Medizinische Klinik mit Schwerpunkt Hämatologie, Onkologie
Berlin, 12200
Medizinische Klinik und Poliklinik I, Universitätsklinikum Carl Gustav Carus
Dresden, 01307
Medizinische Klinik 5 - Hämatologie und Internist. Onkologie, Universitätsklinikum Erlangen
Erlangen, 91054
Medizinische Universitätsklinik, Abt. Innere Medizin I
Freiburg im Breisgau, 79106
Universitäsklinikum Heidelberg, Klin.-Pharmakologisches Studienzentrum
Heidelberg, 69120
Sektion für Stammzell- und Immuntherapie, II. Medizinischen Klinik,
Kiel, 24105
Klinikum rechts der Isar/ Studien / III. Med. Klinik
Munich, 81675
Medizinische Klinik II, Abt. Hämatologie, Onkologie,
Tübingen, 7206
Universitätsklinikum Würzburg, Medizinische Klinik und Poliklinik II, Studienambulanz für Hämatologie/Onkologie und Infektiologie
Würzburg, 97080
Austria1 site
AKH (Allgemeines Krankenhaus der Stadt Wien), Abteilung für Klinische Onkologie, Universitätsklinik für Innere Medizin I
Vienna, 1090
About this study
Official title: A Phase 1/2a, Open-Label, Multicentre, Dose-Escalation Study to Evaluate the Safety and Preliminary Efficacy of the Human Anti-CD 38 Antibody MOR03087 as Monotherapy and in Combination With Standard Therapy in Subjects With Relapsed/Refractory Multiple Myeloma
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.
Read the 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.
- Conditions
- Multiple Myeloma
- Being tested
- MOR03087 phase 1 dose escalation, MOR03087, Dexamethasone, Pomalidomide, Lenalidomide
- Keywords
- Multiple Myeloma, MOR03087 (MOR202), Lenalidomide, Pomalidomide, CD38
- Medical subject headings
- Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MOR03087 phase 1 dose escalationDrug
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.
MOR03087Drug
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.
DexamethasoneDrug
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.
PomalidomideDrug
Pomalidomide will be administered to patients orally 4 mg on days 1-21 of the 28-day cycle.
LenalidomideDrug
Lenalidomide will be administered to patients orally 25 mg on days 1-21 of the 28-day cycle.
| Study group | Role | What they receive |
|---|---|---|
| Phase 1 dose escalation | Experimental | 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. Receives: Drug: MOR03087 phase 1 dose escalation; Drug: Dexamethasone; Drug: Pomalidomide; Drug: Lenalidomide |
| Phase 2a confirmatory cohorts | Experimental | 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. Receives: Drug: MOR03087; Drug: Dexamethasone; Drug: Pomalidomide; Drug: Lenalidomide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determination of Maximum Tolerated Dose and / or Recommended Dose and Dosing Regimen of MOR03087
- as monotherapy
- in combination with dexamethasone
- in combination with pomalidomide + dexamethasone
- in combination with lenalidomide + dexamethasone
Measured: First cycle of treatment
Number of Participants Who Develop Anti-MOR03087 Antibodies
Number of participants who develop anti-MOR03087 antibodies, a measure of immunogenicity
Measured: during treatment period, maximum 3 years after 1st dose
Secondary outcomes (6)
Overall Response Rate
number (#) of patients responding (# stringent complete response + # complete response + # very good partial response + # partial response)
Measured: maximum 3 years after 1st dose
Time to Progression
Time to Progression (Kaplan Meier estimate)
Measured: patients were observed for up to 36 months
Progression-free Survival
Progression-free survival (Kaplan Meier estimates)
Measured: patients were observed up to 36 months
Duration of Response
Duration of response (Kaplan Meier estimates)
Measured: patients were observed up to 36 months
Pharmacokinetics: Cmax - Maximum Observed Serum Concentration for MOR202
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
Measured: up to 7 days after last MOR202 dose
Pharmacokinetics: AUC Cycle 1+2 - Area Under the Time/Concentration Curve for MOR202
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
Measured: 56 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2011 (estimated)
- Study startJul 2011
- Primary completionAug 2020
- Study completionAug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Multiple MyelomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 91 participants (actual)
Sponsor and investigators
- Lead sponsor
- MorphoSys AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01421186
- Sponsor's protocol ID
- MOR202C101
- Other IDs
- DRKS00003145
- Status last verified
- Jul 2021
- First submitted
- 29 Jul 2011
- Last updated
- 16 Nov 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
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.
PubMed 32171061
Study at a glance
From the registry record, last updated by the sponsor on 16 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1/2a, Open-Label, Multicentre, Dose-Escalation Study to Evaluate the Safety and Preliminary Efficacy of the Human Anti-CD 38 Antibody MOR03087 as Monotherapy and in Combination With Standard Therapy in Subjects With Relapsed/Refractory Multiple Myeloma
- ClinicalTrials.gov ID
- NCT01421186
- Acronym / sponsor ID
- MOR202C101
- Conditions
- Multiple Myeloma
- Keywords
- Multiple Myeloma, MOR03087 (MOR202), Lenalidomide, Pomalidomide, CD38
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 91 participants (actual)
- Lead sponsor
- MorphoSys AGIndustry (pharma, biotech, devices)
- Study start
- Jul 2011 (actual)
- Primary completion
- Aug 2020 (actual)
- Study completion
- Aug 2020 (actual)
- First posted
- 22 Aug 2011 (estimated)
- Results
- Posted 28 Oct 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Phase 1 dose escalation | Experimental | Drug: MOR03087 phase 1 dose escalation, Drug: Dexamethasone, Drug: Pomalidomide, Drug: LenalidomidePart 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. |
| Phase 2a confirmatory cohorts | Experimental | Drug: MOR03087, Drug: Dexamethasone, Drug: Pomalidomide, Drug: LenalidomideConfirmatory 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Male or female subjects 18 years and older
- Relapsed or refractory multiple myeloma defined as:
- 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
- Absolute neutrophil count (ANC) ≥ 1,000 / mm3
- Haemoglobin ≥ 8 g/dL
Key exclusion criteria (11 listed)
- Primary refractory multiple myeloma
- History of significant cerebrovascular disease or sensory or motor neuropathy of toxicity grade 3 or higher
- Treatment with systemic investigational agent within 28 days prior to first study treatment
- Solitary plasmacytoma or plasma cell leukaemia
- Previous allogenic stem cell transplant (SCT)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MOR03087 phase 1 dose escalationTreatment 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. | Drug | Phase 1 dose escalation |
| MOR03087MOR03087 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. | Drug | Phase 2a confirmatory cohorts |
| DexamethasoneDexamethasone 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. | Drug | Phase 1 dose escalation, Phase 2a confirmatory cohorts |
| PomalidomidePomalidomide will be administered to patients orally 4 mg on days 1-21 of the 28-day cycle. | Drug | Phase 1 dose escalation, Phase 2a confirmatory cohorts |
| LenalidomideLenalidomide will be administered to patients orally 25 mg on days 1-21 of the 28-day cycle. | Drug | Phase 1 dose escalation, Phase 2a confirmatory cohorts |
Primary outcome
Determination of Maximum Tolerated Dose and / or Recommended Dose and Dosing Regimen of MOR03087
Time frame: First cycle of treatment
1. as monotherapy 2. in combination with dexamethasone 3. in combination with pomalidomide + dexamethasone 4. in combination with lenalidomide + dexamethasone
Number of Participants Who Develop Anti-MOR03087 Antibodies
Time frame: during treatment period, maximum 3 years after 1st dose
Number of participants who develop anti-MOR03087 antibodies, a measure of immunogenicity
6 secondary outcomes
Overall Response Rate
Time frame: maximum 3 years after 1st dose
Time to Progression
Time frame: patients were observed for up to 36 months
Progression-free Survival
Time frame: patients were observed up to 36 months
Duration of Response
Time frame: patients were observed up to 36 months
Pharmacokinetics: Cmax - Maximum Observed Serum Concentration for MOR202
Time frame: up to 7 days after last MOR202 dose
Pharmacokinetics: AUC Cycle 1+2 - Area Under the Time/Concentration Curve for MOR202
Time frame: 56 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Nov 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 32171061Raab 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
10 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing MOR03087 phase 1 dose escalation, MOR03087 and Dexamethasone in people with Multiple Myeloma, run by MorphoSys AG at 10 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in Germany, Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 28 Oct 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Determination of Maximum Tolerated Dose and / or Recommended Dose and Dosing Regimen of MOR03087 (time frame: First cycle of treatment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01421186, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Nov 2021.