Renal ImpairmentPhase 2BRIDGENCT03639610
PK of Melphalan During Treatment With Melflufen and Dexamethasone in Patients With RRMM and Impaired Renal Function
A Phase 2 study testing Melflufen and Dexamethasone in people with Renal Impairment and Multiple Myeloma, run by Oncopeptides AB at 10 sites in 3 countries.
Trial summary
This was a multicenter study of the pharmacokinetics (PK) of melphalan during treatment with melflufen and dexamethasone in patients with relapsed refractory multiple myeloma (RRMM) and impaired renal function. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Renal Impairment, Multiple Myeloma
- What is being tested?
- Melflufen 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
- 35 participants
- Where
- 10 sitesin 3 countries
- Study dates
- 28 Aug 2018to 22 Dec 2021
- Phase
- Phase 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, age 18 years or older, at the time of signing the informed consent;
- A prior diagnosis of multiple myeloma (MM) with documented disease progression in need of treatment at time of screening;
- Received at least 2 prior lines of therapy;
- Measurable disease defined as any of the following:
- Serum monoclonal protein ≥0.5 g/dL by serum protein electrophoresis (SPEP).
- ≥200 mg/24 hours of monoclonal protein in the urine on 24-hour urine electrophoresis (UPEP)
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- Serum free light chain (SFLC) ≥10 mg/dL AND abnormal serum kappa to lambda free light chain ratio
- Life expectancy of ≥6 months;
- Eastern Cooperative Oncology Group (ECOG) performance status ≤2. (Patients with lower performance status based solely on bone pain secondary to MM may be eligible following consultation and approval of the medical monitor);
- Patient is a female of childbearing potential (FCBP)* with a negative serum or urine pregnancy test prior to initiation of therapy and agrees to practice appropriate methods of birth control, or the patient is male and agrees to practice appropriate methods of birth control;
- Ability to understand the purpose and risks of the study and provide signed and dated informed consent;
- 12-lead electrocardiogram (ECG) with QT interval calculated by Fridericia Formula (QTcF) interval of ≤470 msec;
- Renal function: Estimated glomerular filtration rate (eGFR) by Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula on 2 consecutive screening evaluations. Patients meeting criteria for Screening 1, must also meet criteria for Screening 2 following optimal hydration (as determined by the investigator). Screening 2 must be on or as close as possible to treatment start date (preferably <24-48 hours) but cannot exceed 72 hours.
- Cohort 1 (a and b): Screening 1: eGFR between ≥25 mL/min/1.73m² to <45 mL/min/1.73m². Screening 2: eGFR between ≥30 mL/min/1.73m² to <45 mL/min/1.73m².
- Cohort 2 (a and b): Screening 1: eGFR between ≥10 mL/min/1.73m² to <35 mL/min/1.73m². Screening 2: eGFR between ≥15 mL/min/1.73m² to <30 mL/min/1.73m².
- Cohort 2b will only be enrolled following approval of Data Safety Monitoring Committee (DSMC) after evaluating data from Cohort 1a, 1b and 2a.
- Patients with fluctuating values of eGFR may be eligible following consideration of additional assessments in consultation with the medical monitor.
- The following laboratory results must be met during screening (within 21 days) and immediately before study drug administration on Cycle 1 Day 1:
- Absolute neutrophil count (ANC) ≥1,000 cells/mm³ (1.0 x 10⁹/L) (Growth factors cannot be used within 10 days [14 days for pegfilgrastim] prior to initiation of therapy)
- Platelet count ≥75,000 cells/mm³ (75 x 10⁹/L) (without required transfusions during the 10 days prior to initiation of therapy)
- Hemoglobin ≥8.0 g/dL (red blood cell [RBC] transfusions are permitted)
- Total Bilirubin ≤1.5 x upper limit of normal (ULN), or higher in patients diagnosed with Gilbert's syndrome, that have been reviewed and approved by the medical monitor
- Aspartate transaminase / serum glutamic oxaloacetic transaminase (AST / SGOT) and alanine transaminase / serum glutamic pyruvic transaminase (ALT / SGPT) ≤3.0 x ULN;
- Must have, or be willing to have, an acceptable central catheter. (Port a cath, peripherally inserted central catheter [PICC] line, or central venous catheter).
- Footnote
- FCBP is any sexually mature female who: 1) has not undergone a hysterectomy or bilateral oophorectomy or 2) has not been naturally postmenopausal (not having menstrual cycles due to cancer therapy does not rule out childbearing potential) for at least 24 consecutive months.
Who cannot join
- Primary refractory disease (i.e., never responded with ≥ minimal response [MR] to any prior therapy);
- Evidence of mucosal or internal bleeding and/or platelet transfusion refractory (platelet count fails to increase by >10,000 cells/mm³ [10.0 x 10⁹/L] after a transfusion of an appropriate dose of platelets);
- Any medical conditions that, in the Investigator's opinion, would impose excessive risk to the patient or would adversely affect his/her participating in this study. Examples of such conditions are: a significant history of cardiovascular disease (e.g., myocardial infarction, significant conduction system abnormalities, uncontrolled hypertension, ≥Grade 3 thromboembolic event in the last 6 months);
- Known active infection requiring parenteral or oral anti-infective treatment within 14 days of initiation of therapy;
- Other malignancy diagnosed or requiring treatment within the past 3 years with the exception of adequately treated basal cell carcinoma, squamous cell skin cancer, carcinoma in-situ of the cervix or breast or very low and low risk prostate cancer in active surveillance;
- Pregnant or breast-feeding females;
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- Serious psychiatric illness, active alcoholism, or drug addiction that may hinder or confuse compliance or follow-up evaluation;
- Known human immunodeficiency virus or active hepatitis B or C viral infection;
- Concurrent symptomatic amyloidosis or plasma cell leukemia;
- POEMS syndrome (plasma cell dyscrasia with polyneuropathy, organomegaly, endocrinopathy, monoclonal protein and skin changes);
- Previous cytotoxic therapies, including cytotoxic investigational agents, for MM within 3 weeks (6 weeks for nitrosoureas) prior to initiation of therapy. The use of live vaccines within 30 days before initiation of therapy. Immunomodulatory drugs (IMiDs), proteasome inhibitors (PIs) or corticosteroids within 2 weeks prior to initiation of therapy. Other investigational therapies and monoclonal antibodies (mAb) within 4 weeks of initiation of therapy. Prednisone up to but no more than 10 mg orally once daily (q.d.) or its equivalent for symptom management of comorbid conditions is permitted but dose should be stable for at least 7 days prior to initiation of therapy;
- Residual side effects to previous therapy >Grade 1 prior to initiation of therapy (Alopecia any grade and/or neuropathy Grade 2 without pain are permitted);
- Prior peripheral stem cell transplant within 12 weeks of initiation of therapy;
- Prior allogeneic stem cell transplantation with active graft-versus-host-disease;
- Prior major surgical procedure or radiation therapy within 4 weeks of initiation of study therapy (this does not include limited course of radiation used for management of bone pain to be completed within 7 days of initiation of study therapy). Plasmapheresis is not permitted within 14 days of initiation of therapy;
- Known intolerance to steroid therapy;
- Prior renal transplant;
- Currently in need of renal dialysis.
Trial locations and contacts
10 sites in 3 countries.
10 sites in 3 countries
Poland4 sites
Maria Sklodowska-Curie Institute of Oncology, Branch in Gliwice, Department of Bone Marrow Transplantation and Hematologic Oncology
Gliwice
Independent Public Healthcare Facility Municipal Hospitals, Department of Hematology
Katowice
Independent Public Teaching Hospital No.1 in Lublin, Department of Hematooncology, Bone Marrow Transplantation and Chemotherapy
Lublin
Nasz Lekarz Medical Outpatient Clinics Slawomir Jeka
Torun, Torun
Czechia3 sites
University Hospital Brno, Clinic of Internal Medicine - Hematology and Oncology
Brno
University Hospital Olomouc, Clinic of Hemato-Oncology
Olomouc
General University Hospital in Prague, 1st Internal Clinic - Clinic of Hematology
Prague
Greece3 sites
General Hospital of Athens "Evangelismos"
Athens
General Hospital of Athens Alexandra, Therapeutic Clinic
Athens
University General Hospital of Patras
Pátrai
About this study
Official title: A Study of the Pharmacokinetics of Melphalan During Treatment With Melflufen and Dexamethasone in Patients With Relapsed Refractory Multiple Myeloma and Impaired Renal Function
This was a multicenter study of the pharmacokinetics (PK) of melphalan during treatment with melflufen and dexamethasone in patients with relapsed refractory multiple myeloma (RRMM) and impaired renal function.
Read the detailed description
This was a multicenter study assessing the safety, tolerability, and efficacy of melflufen given on Day 1 of a 28-day cycle, together with weekly dexamethasone, in patients with relapsed multiple myeloma or RRMM and impaired renal function, as well as the relationship between renal function and PK parameters for the active metabolite melphalan.
- Conditions
- Renal Impairment, Multiple Myeloma
- Being tested
- Melflufen, Dexamethasone
- Medical subject headings
- Renal Insufficiency, Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MelflufenDrug
Also called Melphalan flufenamide
Melflufen was distributed in the European Union (EU) as a powder for concentrate for solution for infusion; in the US, it was distributed as a powder for injection. Melflufen was administered as a 30-minute intravenous infusion on Day 1 of every 28-day cycle via a central catheter.
DexamethasoneDrug
Tablets. Administered orally on Days 1, 8, 15, and 22 of each 28-day cycle. Dose of 40 mg for patients aged <75 years. Dose of 20 mg for patients aged ≥75 years.
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1a | Experimental | Patients with moderate renal impairment (eGFR ≥30 to <45 mL/min/1.73m²) and a starting dose of melflufen of 40 mg Receives: Drug: Melflufen; Drug: Dexamethasone |
| Cohort 1b | Experimental | Patients with moderate renal impairment (eGFR ≥30 to <45 mL/min/1.73m²) and a starting dose of melflufen of 30 mg Receives: Drug: Melflufen; Drug: Dexamethasone |
| Cohort 2a | Experimental | Patients with severe renal impairment (eGFR ≥15 to <30 mL/min/1.73m²) and a starting dose of melflufen of 20 mg Receives: Drug: Melflufen; Drug: Dexamethasone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cmax of Melphalan
Maximum observed concentration (Cmax)
Measured: Samples were drawn 5-10 minutes after the end of infusion, 2-3 hours after the end of infusion, and 5-7 hours after the end of infusion.
Tmax of Melphalan
Time of maximum observed concentration (Tmax)
Measured: Samples were drawn 5-10 minutes after the end of infusion, 2-3 hours after the end of infusion, and 5-7 hours after the end of infusion.
Area Under the Curve (0-t) of Melphalan
Area under the concentration-time curve (AUC) from 0h to the last measurable concentration.
Measured: Samples were drawn 5-10 minutes after the end of infusion, 2-3 hours after the end of infusion, and 5-7 hours after the end of infusion.
Area Under the Curve (Inf) of Melphalan
Area under the concentration-time curve (AUC) from 0 hours to infinity
Measured: Samples were drawn 5-10 minutes after the end of infusion, 2-3 hours after the end of infusion, and 5-7 hours after the end of infusion.
T1/2 of Melphalan
Elimination half-life of melphalan
Measured: Samples were drawn 5-10 minutes after the end of infusion, 2-3 hours after the end of infusion, and 5-7 hours after the end of infusion.
Secondary outcomes (9)
Best Confirmed Response
Best confirmed response required 2 consecutive assessments with the same response result made at any time. In case at the second consecutive assessment (made at any time) the response is higher than the previous one, then confirmed response (linked to the first assessment visit) will be the first one (e.g., PR - VGPR consecutive pair will lead to a PR confirmed response at the first visit). In case the second consecutive response is lower than the first one, then confirmed response (linked to the first assessment visit) will be the second one (e.g. CR-VGPR consecutive pair will lead to a VGPR confirmed response at the first visit).
Measured: Patients were assessed for response after each cycle. After discontinuation of therapy, patients continued to be assessed until documented progression (confirmed on 2 consecutive assessments) or initiation of subsequent therapy (max duration 127.1 weeks).
Overall Response Rate
Overall response rate (ORR) is the percentage of patients who achieved a confirmed response of stringent complete response (sCR), complete response (CR), very good partial response (VGPR), or partial response (PR) as best response, as assessed by the Investigator.
Measured: Patients were assessed for response after each cycle. After discontinuation of therapy, patients continued to be assessed until disease progression (confirmed on 2 consecutive assessments) (maximum duration 127.1 weeks).
Clinical Benefit Rate
Clinical benefit rate (CBR) is the proportion of patients who achieved a confirmed minimal response (MR) or better (stringent complete response [sCR], complete response [CR], very good partial response [VGPR], partial response [PR], and MR) as their best response, as assessed by the Investigator.
Measured: Patients were assessed for response after each cycle (maximum duration 127.1 weeks).
Progression-free Survival
Progression-free survival (PFS) was defined as the time from the date of first study drug (the earliest of melflufen and dexamethasone start date) initiation to the date of first documentation of confirmed PD or death due to any cause, whichever occurred first. Participants were deemed 'progressed' in case of i) unconfirmed progressive disease (PD) as the final response assessment, ii) death after at least one response assessment or PD based on at least two consecutive response assessments at any time, or iii) death before the first response assessment. The distribution of PFS was summarized using the Kaplan-Meier (K-M) method. The median PFS was estimated from the 50th percentile of the corresponding K-M estimates. The 95% confidence interval for median PFS was constructed using the method of Brookmeyer (Brookmeyer, 1982).
Measured: Patients were assessed from the initiation of therapy until documented disease progression or initiation of new therapy (maximum duration 127.1 weeks).
Duration of Response
Duration of response (DOR) is defined as the time from the first evidence of confirmed assessment of stringent complete response (sCR), complete response (CR), very good partial response (VGPR), or partial response (PR) to first confirmed disease progression, or to death due to any cause. The distribution of DOR was summarized using the Kaplan-Meier (K-M) method. The median DOR was estimated from the 50th percentile of the corresponding K-M estimates. The 95% confidence interval for median DOR was constructed using the method of Brookmeyer (Brookmeyer, 1982).
Measured: Patients were assessed for response from the first measure of a confirmed response (PR or better) until confirmed progression, death, or initiation of subsequent therapy (maximum duration 127.1 weeks).
Duration of Clinical Benefit
Duration of clinical benefit (DOCB) was calculated as time in months from the first evidence of confirmed assessment of stringent complete response (sCR), complete response (CR), very good partial response (VGPR), partial response (PR), or minimal response (MR) to first confirmed disease progression, or to death due to any cause. DOCB was defined only for patients with a confirmed MR or better. DOCB was summarized using the Kaplan-Meier (K-M) method. The median DOCB was estimated from the 50th percentile of the corresponding K-M estimates. The 95% confidence interval for median DOCB was constructed using the method of Brookmeyer (Brookmeyer, 1982).
Measured: Patients were assessed from the first measure of a confirmed MR or better until confirmed progression, death, or initiation of subsequent therapy (maximum duration 127.1 weeks).
Time to Response
Time from first dose of therapy to first documented confirmed response of partial response (PR) or better.
Measured: From initiation of therapy until documented disease response (maximum duration 127.1 weeks).
Time to Clinical Benefit
Time to clinical benefit was defined as the time from first dose of therapy to first documented confirmed response of minimal response (MR) or better.
Measured: Patients were assessed for response after each cycle. After discontinuation of therapy, patients continued to be assessed until documented progression (confirmed on 2 consecutive assessments) or initiation of subsequent therapy (max duration 127.1 weeks).
Overall Survival
Overall survival was defined as the time in months from initiation of therapy to death due to any cause. Patients still alive at the end of the study, or lost to follow up, were censored at last day known alive.
Measured: Patients were followed for overall survival until death or until the last patient in the study had documented progression (confirmed on 2 consecutive assessments) or initiation of subsequent therapy (maximum of 39.2 months).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2018
- Study start28 Aug 2018
- Primary completion22 Dec 2021
- Study completion22 Dec 2021
Why it stopped: The sponsor decided to terminate the study following an FDA request of a partial clinical hold.
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.
- Other trials for Renal ImpairmentStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Arms differed based on patients' level of renal function (moderate or severe impairment) and starting dose of melflufen.
- Masking
- None (open label)
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oncopeptides AB
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03639610
- Sponsor's protocol ID
- OP-107
- Other IDs
- 2018-000478-31, 2018
- Acronym
- BRIDGE
- Status last verified
- Mar 2023
- First submitted
- 14 Aug 2018
- Last updated
- 10 Mar 2023
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study of the Pharmacokinetics of Melphalan During Treatment With Melflufen and Dexamethasone in Patients With Relapsed Refractory Multiple Myeloma and Impaired Renal Function
- ClinicalTrials.gov ID
- NCT03639610
- Acronym / sponsor ID
- BRIDGE / OP-107
- Conditions
- Renal Impairment, Multiple Myeloma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The sponsor decided to terminate the study following an FDA request of a partial clinical hold.
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Oncopeptides ABIndustry (pharma, biotech, devices)
- Study start
- 28 Aug 2018 (actual)
- Primary completion
- 22 Dec 2021 (actual)
- Study completion
- 22 Dec 2021 (actual)
- First posted
- 21 Aug 2018 (actual)
- Results
- Posted 9 Mar 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This was a multicenter study of the pharmacokinetics (PK) of melphalan during treatment with melflufen and dexamethasone in patients with relapsed refractory multiple myeloma (RRMM) and impaired renal function.
Detailed description
This was a multicenter study assessing the safety, tolerability, and efficacy of melflufen given on Day 1 of a 28-day cycle, together with weekly dexamethasone, in patients with relapsed multiple myeloma or RRMM and impaired renal function, as well as the relationship between renal function and PK parameters for the active metabolite melphalan.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Arms differed based on patients' level of renal function (moderate or severe impairment) and starting dose of melflufen.
| Arm | Type | Receives |
|---|---|---|
| Cohort 1a | Experimental | Drug: Melflufen, Drug: DexamethasonePatients with moderate renal impairment (eGFR ≥30 to <45 mL/min/1.73m²) and a starting dose of melflufen of 40 mg |
| Cohort 1b | Experimental | Drug: Melflufen, Drug: DexamethasonePatients with moderate renal impairment (eGFR ≥30 to <45 mL/min/1.73m²) and a starting dose of melflufen of 30 mg |
| Cohort 2a | Experimental | Drug: Melflufen, Drug: DexamethasonePatients with severe renal impairment (eGFR ≥15 to <30 mL/min/1.73m²) and a starting dose of melflufen of 20 mg |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (26 listed)
- Male or female, age 18 years or older, at the time of signing the informed consent;
- A prior diagnosis of multiple myeloma (MM) with documented disease progression in need of treatment at time of screening;
- Received at least 2 prior lines of therapy;
- Measurable disease defined as any of the following:
- Life expectancy of ≥6 months;
Key exclusion criteria (18 listed)
- Primary refractory disease (i.e., never responded with ≥ minimal response [MR] to any prior therapy);
- Evidence of mucosal or internal bleeding and/or platelet transfusion refractory (platelet count fails to increase by >10,000 cells/mm³ [10.0 x 10⁹/L] after a transfusion of an appropriate dose of platelets);
- Any medical conditions that, in the Investigator's opinion, would impose excessive risk to the patient or would adversely affect his/her participating in this study. Examples of such conditions are: a significant history of cardiovascular disease (e.g., myocardial infarction, significant conduction system abnormalities, uncontrolled hypertension, ≥Grade 3 thromboembolic event in the last 6 months);
- Known active infection requiring parenteral or oral anti-infective treatment within 14 days of initiation of therapy;
- Other malignancy diagnosed or requiring treatment within the past 3 years with the exception of adequately treated basal cell carcinoma, squamous cell skin cancer, carcinoma in-situ of the cervix or breast or very low and low risk prostate cancer in active surveillance;
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 |
|---|---|---|
| MelflufenAlso: Melphalan flufenamideMelflufen was distributed in the European Union (EU) as a powder for concentrate for solution for infusion; in the US, it was distributed as a powder for injection. Melflufen was administered as a 30-minute intravenous infusion on Day 1 of every 28-day cycle via a central catheter. | Drug | Cohort 1a, Cohort 1b, Cohort 2a |
| DexamethasoneTablets. Administered orally on Days 1, 8, 15, and 22 of each 28-day cycle. Dose of 40 mg for patients aged <75 years. Dose of 20 mg for patients aged ≥75 years. | Drug | Cohort 1a, Cohort 1b, Cohort 2a |
Primary outcome
Cmax of Melphalan
Time frame: Samples were drawn 5-10 minutes after the end of infusion, 2-3 hours after the end of infusion, and 5-7 hours after the end of infusion.
Maximum observed concentration (Cmax)
Tmax of Melphalan
Time frame: Samples were drawn 5-10 minutes after the end of infusion, 2-3 hours after the end of infusion, and 5-7 hours after the end of infusion.
Time of maximum observed concentration (Tmax)
Area Under the Curve (0-t) of Melphalan
Time frame: Samples were drawn 5-10 minutes after the end of infusion, 2-3 hours after the end of infusion, and 5-7 hours after the end of infusion.
Area under the concentration-time curve (AUC) from 0h to the last measurable concentration.
Area Under the Curve (Inf) of Melphalan
Time frame: Samples were drawn 5-10 minutes after the end of infusion, 2-3 hours after the end of infusion, and 5-7 hours after the end of infusion.
Area under the concentration-time curve (AUC) from 0 hours to infinity
T1/2 of Melphalan
Time frame: Samples were drawn 5-10 minutes after the end of infusion, 2-3 hours after the end of infusion, and 5-7 hours after the end of infusion.
Elimination half-life of melphalan
9 secondary outcomes
Best Confirmed Response
Time frame: Patients were assessed for response after each cycle. After discontinuation of therapy, patients continued to be assessed until documented progression (confirmed on 2 consecutive assessments) or initiation of subsequent therapy (max duration 127.1 weeks).
Overall Response Rate
Time frame: Patients were assessed for response after each cycle. After discontinuation of therapy, patients continued to be assessed until disease progression (confirmed on 2 consecutive assessments) (maximum duration 127.1 weeks).
Clinical Benefit Rate
Time frame: Patients were assessed for response after each cycle (maximum duration 127.1 weeks).
Progression-free Survival
Time frame: Patients were assessed from the initiation of therapy until documented disease progression or initiation of new therapy (maximum duration 127.1 weeks).
Duration of Response
Time frame: Patients were assessed for response from the first measure of a confirmed response (PR or better) until confirmed progression, death, or initiation of subsequent therapy (maximum duration 127.1 weeks).
Duration of Clinical Benefit
Time frame: Patients were assessed from the first measure of a confirmed MR or better until confirmed progression, death, or initiation of subsequent therapy (maximum duration 127.1 weeks).
Time to Response
Time frame: From initiation of therapy until documented disease response (maximum duration 127.1 weeks).
Time to Clinical Benefit
Time frame: Patients were assessed for response after each cycle. After discontinuation of therapy, patients continued to be assessed until documented progression (confirmed on 2 consecutive assessments) or initiation of subsequent therapy (max duration 127.1 weeks).
Overall Survival
Time frame: Patients were followed for overall survival until death or until the last patient in the study had documented progression (confirmed on 2 consecutive assessments) or initiation of subsequent therapy (maximum of 39.2 months).
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
10 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Melflufen and Dexamethasone in people with Renal Impairment and Multiple Myeloma, run by Oncopeptides AB at 10 sites in 3 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 26 inclusion and 18 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: stopped early, as of the sponsor's last update on 10 Mar 2023. 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 Poland, Czechia, Greece. 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 phase mean?
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 9 Mar 2023). 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?
Cmax of Melphalan (time frame: Samples were drawn 5-10 minutes after the end of infusion, 2-3 hours after the end of infusion, and 5-7 hours after the end of infusion.). The study lists 5 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 10 Mar 2023; AzTrials last refreshed its copy on 8 Nov 2026.