Multiple Myeloma in RelapsePhase 1/2NCT03136653
A Phase 2 Trial of MP0250 Plus Bortezomib + Dexamethasone in Patients With Multiple Myeloma
A Phase 1/2 study testing MP0250 plus BOR+DEX in people with Multiple Myeloma in Relapse, run by Molecular Partners AG at 24 sites in 6 countries.
Trial summary
The purpose of this study is to assess the efficacy, safety, tolerability, pharmacokinetics (PK), immunogenicity and efficacy of MP0250 in combination with bortezomib + dexamethasone in patients with refractory and relapsed multiple myeloma (RRMM). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Myeloma in Relapse
- What is being tested?
- MP0250 plus BOR+DEX
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 24 sitesin 6 countries
- Study dates
- 23 May 2017to 13 Jan 2021
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
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
- Patients with MM who have received:
- Part 1 ≥2 lines of therapy (including bortezomib and an IMiD) and have shown no response (i.e. stable disease) to, have progressed on the most recent treatment or have progressed within 60 days of the most recent therapy
- Part 2 ≥2 lines of prior therapy that included a proteasome inhibitor (bortezomib, carfilzomib or both) and an IMiD (thalidomide, lenalidomide and/or pomalidomide) either alone or in combination and a response no better than SD lasting at least 4 months on a bortezomib- or carfilzomib-based regimen as last line of therapy or progression on treatment or within 60 days of stopping a bortezomib- or carfilzomib-based regimen as last line of therapy. Note: For transplant-eligible patients enrolled to Part 1 or Part 2, induction plus conditioning chemotherapy/ASCT +/- maintenance therapy constitute one regimen.
- Presence of a measurable disease with at least one of the following criteria:
- Serum M protein ≥0.5 g/dL, or
- Urine M protein ≥200 mg/24 h, or
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- Involved serum free light chain (FLC) levels >100 mg/L and abnormal kappa/lambda (κ/λ) ratio in patients without detectable serum or urine M protein, or
- For patients with immunoglobulin A (IgA) myeloma whose disease can only be reliably measured by quantitative immunoglobulin measurement, a serum IgA level ≥0.5g/dL.
- Eastern Cooperative Oncology Group (ECOG) performance status (0 to 1)
- Life expectancy >3 months
- Adequate hepatic function at Screening, with aspartate aminotransferase (AST) and alanine aminotransferase (ALT) <3x ULN and total bilirubin <2 x upper limit of normal (ULN). For patients with Gilbert's syndrome (Gilbert-Meulengracht syndrome), higher bilirubin of 5 x ULN is acceptable
- Absolute neutrophil count (ANC) ≥1000/mm3 at Screening. Screening ANC must be independent of growth factor support for ≥1 week
- Hemoglobin ≥8.0 g/dL at Screening. Use of erythropoietic stimulating factors and red blood cell (RBC) transfusions per institutional guidelines is allowed, however most recent RBC transfusion must not have been done within 7 days prior to obtaining screening hemoglobin
- Platelet count ≥50 000/mm3 at Screening. Patients must not have received platelet transfusions for at least 1 week prior to obtaining the screening platelet count
- Calculated or measured creatinine clearance (CrCl) of ≥ 45 mL/min at Screening based on the Cockcroft and Gault formula
- Serum albumin concentration ≥ 25 g/L. Note: Patients with lower levels of serum albumin at baseline may receive albumin supplementation to comply with this criterion
- Males and females ≥18 years of age
- Male Participants: A male participant must agree to use a highly effective contraception
- Female Participants: A female participant is eligible to participate if she is not pregnant, not breastfeeding, and at least one of the following conditions applies:
- Not a woman of childbearing potential (WOCBP) OR
- A WOCBP who agrees to follow contraceptive guidance from the Screening visit, during the treatment period and for at least 3 months after the last dose of study treatment
- Capable of giving signed informed consent
Who cannot join
- Patients with the following diseases:
- Monoclonal gammopathy of undetermined significance (MGUS) of non- immunoglobulin (Ig)M and IgM subtypes,
- Light chain MGUS,
- Solitary plasmacytoma (alone or with minimal marrow involvement),
- Systemic Ig light chain amyloidosis,
- Waldenstrom's Macroglobulinemia,
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- Myelodysplastic syndrome,
- Plasma cell leukemia defined as a plasma cell count >2000/mm3
- Polyneuropathy, organomegaly endocrinopathy, monoclonal protein, and skin changes (POEMS) syndrome
- Peripheral neuropathy Grade 2 or higher at Screening or patients with a history of Grade 3/4 neuropathy or Grade 2 with pain
- Prior or concurrent malignancy, except for: Adequately treated basal cell or squamous cell skin cancer, carcinoma in-situ of the cervix or breast or very low and low risk prostate cancer in active surveillance or any other cancer from which the patient has been disease-free for >5 years
- Active congestive heart failure (New York Heart Association [NYHA] Class III to IV), symptomatic cardiac ischemia, or conduction abnormalities uncontrolled by conventional intervention. Myocardial infarction within 6 months prior to screening
- Uncontrolled hypertension (defined as systolic blood pressure (SBP) >150 mm Hg diastolic blood pressure (DBP) >100 mm Hg despite antihypertensive medication)
- Stroke, or transient ischemic attack within 6 months of Screening, clinically significant bleeding and vascular disease
- Abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within the past 6 months
- Significant concurrent, uncontrolled medical condition including, but not limited to, severe wound healing complication, renal (except related to MM), hepatic, hematological except MM, gastrointestinal, endocrine, pulmonary, neurological, cerebral or psychiatric disease
- Acute active infection requiring systemic antibiotics, antiviral (except antiviral therapy directed at hepatitis B) or antifungal agents within 14 days prior to screening
- Clinical signs of or documented leptomeningeal or cerebral involvement of MM
- Treatment with ixazomib as last line of therapy in Part 2
- Therapy with approved or investigational anticancer therapeutics within 21 days (or in the case of nitrosureas, within 6 weeks) prior to treatment (except anti-myeloma treatment with a carfilzomib- or bortezomib-based regimen in Part 2) Note: Patients must have recovered from pre-existing, treatment-related adverse events to Grade 1 or lower
- Autologous stem cell transplantation (ASCT) within 12 weeks before the date of enrollment
- Prior allogeneic stem cell transplantation with active graft-versus-host-disease
- Major surgery within 21 days prior to Screening
- Immunotherapy within 21 days prior to Screening
- Newly initiated therapy with bisphosphonate or RANKL (within two months prior to Screening). Patients on stable regimen with bisphosphonate or receptor activator of nuclear kappa-B ligand (RANKL)-inhibitor therapy over 2 months can continue these treatments at the same dose. No new therapy with bisphosphonate/RANKL inhibitor is allowed during the study
- Radiation therapy within 2 months of Cycle 1, Day 1 is not permitted Except for local low-dose, palliative radiation to bone lesions for pain control.
- Patients who have received treatment with any non-marketed product within 21 days prior to treatment start
- Current participation in any other interventional clinical study
- Patients known or suspected of not being able to comply with a study protocol (e.g. due to alcoholism, drug dependency or psychological disorder)
- Known infection with human immunodeficiency virus or serologic status reflecting active hepatitis B or hepatitis C virus infection as follows:
- Not receiving or not responding to anti-viral therapy.
- HCV RNA detected
- Patients with contraindication to dexamethasone or bortezomib according to the applicable local product label
- Known hypersensitivity to components of the investigational product, for example, histidine buffer or the Tween diluent
Trial locations and contacts
24 sites in 6 countries.
24 sites in 6 countries
Germany7 sites
Asklepios Klinik Altona
Altona, Free and Hanseatic City of Hamburg, 22763
Universitätsklinikum Dresden
Dresden, Saxony, 01307
Universitaetsklinikum Essen
Essen, 45147
Universitätsklinikum Heidelberg
Heidelberg, 69120
Universitätsklinikum Leipzig
Leipzig, 04103
Universitätsklinikum Münster
Münster, 48149
Universitätsklinikum Würzburg
Würzburg, 97080
Poland6 sites
Samodzielny Publiczny Zakład Opieki Zdrowotnej Zespół Szpitali Miejskich
Chorzów, Silesian Voivodeship, 41-500
Uniwersyteckie Centrum Kliniczne
Gdansk, 80-214
Szpital Uniwersytecki w Krakowie
Krakow, 31-501
Centrum Onkologii Ziemi Lubelskiej
Lublin, 20-090
Szpital Wojewódzki w Opolu
Opole, 45-061
Instytut Hematologii i Transfuzjologii
Warsaw, 02-776
Italy5 sites
Azienda Ospedaliera Policlinico di Bari
Bari, 70124
Azienda Ospedaliero Universitaria di Bologna Policlinico Sant'Orsola-Malpighi
Bologna, 40138
Arcispedale Santa Maria Nuova
Reggio Emilia, 42100
Fondazione Policlinico Universitario Agostino Gemelli
Roma, 00168
Azienda Ospedaliera Città della Salute e della Scienza di Torino
Torino, 10126
Austria2 sites
Landeskliniken Salzburg Saint Johanns-Spital
Salzburg, 5020
Hanusch Krankenhaus Wiener Gebietskrankenkasse
Vienna, State of Vienna, 1140
Czechia2 sites
Fakultní Nemocnice Brno
Brno, Jihormoravsky Krav, 625 00
Fakultní Nemocnice Ostrava
Ostrava - Poruba, Severomoravsky KRAJ, 708 52
Denmark2 sites
Odense University Hospital
Odense C, 5000
Vejle Sygehus
Vejle, 7100
About this study
Official title: A Phase 2 Open-label, Single-arm, Multicenter Trial of MP0250 Plus Bortezomib + Dexamethasone in Patients With Refractory and Relapsed Multiple Myeloma
The purpose of this study is to assess the efficacy, safety, tolerability, pharmacokinetics (PK), immunogenicity and efficacy of MP0250 in combination with bortezomib + dexamethasone in patients with refractory and relapsed multiple myeloma (RRMM).
MP0250 is a multi-DARPin® drug candidate with three specificities, able to simultaneously neutralize the activities of vascular endothelial growth factor (VEGF) and hepatocyte growth factor (HGF) and also to bind to human serum albumin (HSA) to give an increased plasma half-life and potentially enhanced tumor penetration.
- Conditions
- Multiple Myeloma in Relapse
- Being tested
- MP0250 plus BOR+DEX
- Keywords
- DARPin, MP0250, VEGF, HGF, RRMM
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MP0250 plus BOR+DEXBiological
6 mg/kg or 8 mg/kg or 12 mg/kg of MP0250, IV (in the vein,) on day 1 of each 21 day cycle. Bortezomib and Dexamethasone according to label.
Number of Cycles: until progression or unacceptable toxicity develops.
| Study group | Role | What they receive |
|---|---|---|
| Single arm Study MP0250 plus BOR + DEX | Experimental | Single arm study of MP0250 plus bortezomib + dexamethasone Receives: Biological: MP0250 plus BOR+DEX |
What is being measured
The primary outcome is the main question the study is designed to answer.
Part 1: Overall Response Rate (ORR)
Defined as the number of participants achieving a complete response (CR), very good partial response (VGPR), or partial response (PR) during treatment with MP0250 plus bortezomib+dexamethasone determined by the Investigator in part 1.
Measured: 24 months
Part 2: ORR
Defined as the number of participants achieving a confirmed, stringent complete response (sCR), very good partial response (VGPR), or partial response (PR) during treatment with MP0250 plus bortezomib+dexamethasone determined by the Investigator in part 2.
Measured: 24 months
Secondary outcomes (11)
Number of Participants Who Experienced One or More Treatment-Emergent Adverse Events
Measured: 24 months
Number of Participants who Experienced One or More Treatment-Emergent SAEs
Measured: 24 months
Number of Participants Who Experienced One or More Common Terminology Criteria for Adverse Events (CTCAE) Grade ≥ 3 Adverse Events
Measured: 24 months
Number of Participants with a Clinical Significant Change from Baseline in Laboratory Results
Measured: 24 months
Number of Participants with a Clinically Significant Change from Baseline in Vital Signs
Measured: 24 months
Number of Participants with a Clinically Significant Change from Baseline in Electrocardiogram (ECG) Results
Measured: 24 months
Number of Participants with a Positive Anti-drug Antibody (ADA) Result
Measured: 24 months
Titer of Anti-drug Antibodies (ADA)
Measured: 24 months
Time Course of Anti-drug Antibodies
Measured: 24 months
Duration of Response (DOR)
DOR is defined as the duration from first observation of partial response (PR) or better until disease progression, or death from myeloma.
Measured: 24 months
Progression Free Survival (PFS)
PFS is determined as the time from first study treatment until progression or death from myeloma.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2017
- Study start23 May 2017
- Primary completion12 Oct 2020
- Study completion13 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple Myeloma in RelapseStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Molecular Partners AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03136653
- Sponsor's protocol ID
- MP0250-CP201
- Other IDs
- 2016-002771-10, 2016
- Status last verified
- Aug 2021
- First submitted
- 18 Apr 2017
- Last updated
- 25 Aug 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2 Open-label, Single-arm, Multicenter Trial of MP0250 Plus Bortezomib + Dexamethasone in Patients With Refractory and Relapsed Multiple Myeloma
- ClinicalTrials.gov ID
- NCT03136653
- Acronym / sponsor ID
- MP0250-CP201
- Conditions
- Multiple Myeloma in Relapse
- Keywords
- DARPin, MP0250, VEGF, HGF, RRMM
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Molecular Partners AGIndustry (pharma, biotech, devices)
- Study start
- 23 May 2017 (actual)
- Primary completion
- 12 Oct 2020 (actual)
- Study completion
- 13 Jan 2021 (actual)
- First posted
- 2 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to assess the efficacy, safety, tolerability, pharmacokinetics (PK), immunogenicity and efficacy of MP0250 in combination with bortezomib + dexamethasone in patients with refractory and relapsed multiple myeloma (RRMM).
MP0250 is a multi-DARPin® drug candidate with three specificities, able to simultaneously neutralize the activities of vascular endothelial growth factor (VEGF) and hepatocyte growth factor (HGF) and also to bind to human serum albumin (HSA) to give an increased plasma half-life and potentially enhanced tumor penetration.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single arm Study MP0250 plus BOR + DEX | Experimental | Biological: MP0250 plus BOR+DEXSingle arm study of MP0250 plus bortezomib + dexamethasone |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (22 listed)
- Patients with MM who have received:
- Presence of a measurable disease with at least one of the following criteria:
- Eastern Cooperative Oncology Group (ECOG) performance status (0 to 1)
- Life expectancy >3 months
- Adequate hepatic function at Screening, with aspartate aminotransferase (AST) and alanine aminotransferase (ALT) <3x ULN and total bilirubin <2 x upper limit of normal (ULN). For patients with Gilbert's syndrome (Gilbert-Meulengracht syndrome), higher bilirubin of 5 x ULN is acceptable
Key exclusion criteria (34 listed)
- Patients with the following diseases:
- Peripheral neuropathy Grade 2 or higher at Screening or patients with a history of Grade 3/4 neuropathy or Grade 2 with pain
- Prior or concurrent malignancy, except for: Adequately treated basal cell or squamous cell skin cancer, carcinoma in-situ of the cervix or breast or very low and low risk prostate cancer in active surveillance or any other cancer from which the patient has been disease-free for >5 years
- Active congestive heart failure (New York Heart Association [NYHA] Class III to IV), symptomatic cardiac ischemia, or conduction abnormalities uncontrolled by conventional intervention. Myocardial infarction within 6 months prior to screening
- Uncontrolled hypertension (defined as systolic blood pressure (SBP) >150 mm Hg diastolic blood pressure (DBP) >100 mm Hg despite antihypertensive medication)
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 |
|---|---|---|
| MP0250 plus BOR+DEX6 mg/kg or 8 mg/kg or 12 mg/kg of MP0250, IV (in the vein,) on day 1 of each 21 day cycle. Bortezomib and Dexamethasone according to label. Number of Cycles: until progression or unacceptable toxicity develops. | Biological | Single arm Study MP0250 plus BOR + DEX |
Primary outcome
Part 1: Overall Response Rate (ORR)
Time frame: 24 months
Defined as the number of participants achieving a complete response (CR), very good partial response (VGPR), or partial response (PR) during treatment with MP0250 plus bortezomib+dexamethasone determined by the Investigator in part 1.
Part 2: ORR
Time frame: 24 months
Defined as the number of participants achieving a confirmed, stringent complete response (sCR), very good partial response (VGPR), or partial response (PR) during treatment with MP0250 plus bortezomib+dexamethasone determined by the Investigator in part 2.
11 secondary outcomes
Number of Participants Who Experienced One or More Treatment-Emergent Adverse Events
Time frame: 24 months
Number of Participants who Experienced One or More Treatment-Emergent SAEs
Time frame: 24 months
Number of Participants Who Experienced One or More Common Terminology Criteria for Adverse Events (CTCAE) Grade ≥ 3 Adverse Events
Time frame: 24 months
Number of Participants with a Clinical Significant Change from Baseline in Laboratory Results
Time frame: 24 months
Number of Participants with a Clinically Significant Change from Baseline in Vital Signs
Time frame: 24 months
Number of Participants with a Clinically Significant Change from Baseline in Electrocardiogram (ECG) Results
Time frame: 24 months
Number of Participants with a Positive Anti-drug Antibody (ADA) Result
Time frame: 24 months
Titer of Anti-drug Antibodies (ADA)
Time frame: 24 months
Time Course of Anti-drug Antibodies
Time frame: 24 months
Duration of Response (DOR)
Time frame: 24 months
Progression Free Survival (PFS)
Time frame: 24 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2021.
- Individual participant dataSharing planned: No
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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.
24 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing MP0250 plus BOR+DEX in people with Multiple Myeloma in Relapse, run by Molecular Partners AG at 24 sites in 6 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 22 inclusion and 34 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 25 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 24 sites in Germany, Poland, Italy, Austria, Czechia and 1 more country. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Part 1: Overall Response Rate (ORR) (time frame: 24 months). 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?
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 25 Aug 2021.