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Multiple MyelomaPhase 1/2BELI(E)VENCT05853965

Combination Treatment of Belantamab Mafodotin and Venetoclax in Treatment of Relapsed and Refractory t(11;14) Multiple Myeloma

A Phase 1/2 study testing Belantamab mafodotin, Venetoclax in people with Multiple Myeloma and Multiple Myeloma in Relapse, run by Universitätsklinikum Hamburg-Eppendorf at 5 sites in Germany.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

The goal of this clinical trial is to learn about the safety and efficacy of the drug combination belantamab mafodotin and venetoclax, with or without the addition of dexamethasone, in patients with relapsed/refractory multiple myeloma bearing the translocation t(11;14) Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Multiple Myeloma, Multiple Myeloma in Relapse
What is being tested?
Belantamab mafodotin, Venetoclax
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
45 participants
Where
5 sitesGermany
Study dates
28 Jun 2023to Dec 2028
Phase
Phase 1/2
Are there results?
Not yet: the study is under way

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

  • Subjects must be ≥ 18 years of age.
  • Subjects must have an Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2
  • Subjects must voluntarily sign and date an in-formed consent form
  • Subjects must have had documented multiple myeloma requiring treatment as defined by the criteria below:
  • Monoclonal plasma cells in the bone marrow > 10% and/or presence of a biopsy proven plasmacytoma at some point in their disease history requiring treatment according diag-nostic criteria (IMWG updated criteria 2014, Rajkumar et al. 2014) with measurable dis-ease at screening (serum M-protein > 500 mg/dL or urine M protein 200 mg/24h, in case of oligosecretory MM serum free light chain > 10mg/dL and abnormal kap-pa/lambda free light chain ratio)
  • Cytogenetics/FISH confirming t(11;14)
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  • Prior treatment requirements:
  • Prior treatment requirements:
  • Subjects must have received at least 1 prior treatment line (induction, high-dose, consolidation and maintenance is considered as one treatment line). All patients have to have received at least one proteasome inhibitor and at least one immunomodulatory agent and at least one anti-CD38 monoclonal antibody.
  • Subjects must have documented evidence of progressive disease on or after the last treatment line.
  • Subjects with a history of autologous SCT are eligible for study participation provided the following eligibility criteria are met: i. ASCT was >100 days prior to initiating study treatment, and ii. No active bacterial, viral, or fungal in-fection(s) present.
  • Subjects must have adequate organ function, defined as follows:
  • Hemoglobin ≥8.0 g/dL (without transfusion of red blood cells for the past 14 days) b. Absolute neutrophil count ≥ 1.5 x109/L (with-out growth factor support for the past 14 days) c. Platelet count more or equal 75 x109/L (with-out growth factor or platelet stimulating agents for the past 14 days) d. Adequate hepatic function per local laborato-ry reference range as follows: i. Aspartate aminotransferase (AST) ≤ 2,5 x upper limit of normal (ULN); ii. Alanine aminotransferase (ALT) ≤ 2.5 x ULN iii. Total bilirubin ≤ 1.5 x ULN, except in subjects with congenital bilirubinemia, such as Gilbert syndrome (direct bili-rubin ≤ 1.5 x ULN). Isolated bilirubin ≥1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin <35%.
  • Subjects must have adequate renal function as demonstrated by eGFR ≥30 mL/min/ 1.73 m2 as calculated by Modified Diet in Renal Disease (MDRD) formula f. Spot urine (albumin/creatinine ratios (spot urine) <500 mg/g (56 mg/mmol) OR Urine Dipstick Negative/trace (if 1+ only eligible if confirmed <500 mg/g (56 mg/mmol) by albumin/creatinine ratio (spot urine from first void) g. Corrected serum calcium ≤ 14 mg/dL (≤3,5 mmol/L); or free ionized calcium ˂ 6,5 mg/dL (˂1,6 mmol/L)
  • A female participant is eligible to participate if she is not pregnant or breastfeeding, and at least one of the following conditions applies:
  • Is not a woman of childbearing potential (WOCBP) OR
  • Is a WOCBP and using a contraceptive method that is highly effective
  • Male participants are eligible to participate if they agree to the refrain from donating sperm and either bei abstinent from heterosexual intercourse or agree to use a highly effective contraceptive method during the intervention period and for 6 months after the last dose of study treatment to allow for clearance of any altered sperm
  • All subjects must agree to refrain from donating blood while on study drug and for 28 days after discontinuation from this study treatment.
  • All subjects must agree not to share study medication.
  • All prior treatment-related toxicities (defined by National Cancer Institute- Common Toxicity Criteria for Adverse Events (NCI-CTCAE), version 5.0) must be ≤ Grade 1 at the time of en-rolment except for alopecia.

Who cannot join

  • Subject has received prior Venetoclax and/or anti BCMA treatment.
  • Participant has used an investigational drug or approved systemic anti-myeloma therapy with-in 14 days or five half-lives, whichever is short-er, preceding the first dose of study drug. The only exception is emergency use of a short course of corticosteroids (equivalent of Dexa-methasone 40 mg/day for a maximum of 4 days) up to 7 days before treatment.
  • Participant has had plasmapheresis or radia-tion therapy within 7 days prior to first dose of study treatment
  • Participant has current corneal epithelial dis-ease except mild changes in corneal epitheli-um
  • Participant has current unstable liver or biliary disease
  • Participant has a presence of active renal con-dition (infection, requirement for dialysis or any other condition that could affect participant's safety).
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  • Participant has had major surgery ≤ 4 weeks prior to initiating study treatment. Kyphoplasty is not considered a major surgery.
  • Participant must not use contact lenses while participating in this study. Bandage contacts may be prescribed by an eye care professional if needed.
  • Participant has any evidence of active mucosal or internal bleeding or other gastrointestinal disease that may significantly alter the absorp-tion of oral drugs.
  • Participant has evidence of cardiovascular risk as defined in the protocol
  • Participant has known immediate or delayed hypersensitivity reaction or idiosyncratic reac-tions to IMPs or drugs chemically related to IMPs, or any of the components of the study treatment
  • Participant has an invasive malignancy other than disease under study within 5 years before trial inclusion, except
  • Adequately treated in situ carcinoma of the cervix uteri or the breast;
  • Basal cell carcinoma of the skin or localized squamous cell carcinoma of the skin;
  • Prostate cancer Gleason grade 6 or lower AND with stable Prostate Specific Antigen (PSA) levels off treatment;
  • Previous malignancy with no current evi-dence of disease, and which was confined and surgically resected (or treated with other mo-dalities) with curative intent and unlikely to im-pact survival during the duration of the study.
  • Participant is pregnant or lactating
  • Participants who have had prior allogeneic stem cell transplant.
  • Participants with symptomatic amyloidosis, ac-tive POEMS syndrome (polyneuropathy, or-ganomegaly, endocrinopathy, monoclonal plasmaproliferative disorder, skin changes) or active plasma cell leukaemia at the time of screening.
  • Participants with any serious and/or unstable pre-existing medical, psychiatric disorder or other conditions (including lab abnormalities) that could interfere with participant's safety, ob-taining informed consent or compliance to the study procedures.
  • Subject is known to be seropositive for human immunodeficiency virus (HIV) or hepatitis B (defined by a positive test for hepatitis B sur-face antigen (HBsAg) or antibodies to hepatitis B surface and core antigen (anti HBs and anti HBc respectively), or hepatitis C (anti-HCV an-tibody positive or HCV RNA quantitation posi-tive).
  • Current immune or inflammatory conditions re-quiring immunosuppressive treatment (e.g. systemic lupus erythematosus, rheumatoid ar-thritis).
  • Subject must not have received any live vac-cines within 8 weeks prior to first dose of study treatment.
  • Subject must not use or anticipate the use of prohibited medications or foods during study participation.
  • Subject does not have a history of or show any signs of known meningeal/central nervous sys-tem involvement by myeloma.
  • Evidence of other clinically significant uncon-trolled condition(s) that is likely to interfere with the study proce-dures or results, or that in the opinion of the investigator, would constitute a hazard for the participation in this study.
  • Subject is known or suspected of not being able to comply with the study protocol. Subject has any condition for which, in the opinion of the investigator, participation would not be in the best interest of the subject (e.g., compromise the well-being) or that could prevent, limit or confound the pro-tocol-specified assessments.
  • Treatment with any of the following within 7 days prior to the first dose of study drug:
  • moderate or strong cytochrome P450 3A (CYP3A) inhibitors
  • moderate or strong CYP3A inducers
  • Administration or consumption of any of the fol-lowing within 3 days prior to the first dose of study drug:
  • grapefruit or grapefruit products
  • Seville oranges (including marmalade con-taining Seville oranges)
  • star fruit
  • Participation in any other clinical trial (with the exclusion of observational studies)

Trial locations and contacts

5 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Katja Weisel contact

+4940741051410

k.weisel@uke.de

Lisa Leypoldt contact

l.leypoldt@uke.de

5 sites in 1 country

Germany5 sites, 5 recruiting

  • Klinikum Chemnitz

    Chemnitz

    Mathias Hänel, m.haenel@skc.de

    Recruiting

  • University Medical Center Hamburg-Eppendorf

    Hamburg, Ham, 20246

    Katja Weisel, MD

    Lisa Leypoldt, MD

    Recruiting

  • Uniklinik Heidelberg

    Heidelberg

    Elias Mai, Elias.Mai@med.uni-heidelberg.de

    Recruiting

  • UKSH Lübeck

    Lübeck

    Cyrus Khandanpour, Cyrus.Khandanpour@uksh.de

    Recruiting

  • Uniklinkum Ulm

    Ulm

    Miriam Kull, Miriam.Kull@uniklinik-ulm.de

    Recruiting

Other trials in Germany

About this study

Official title: Combination Treatment of Belantamab Mafodotin and Venetoclax in Treatment of Relapsed and Refractory t(11;14) Multiple Myeloma (Phase I/IIa) The BELI(E)VE-Trial

The goal of this clinical trial is to learn about the safety and efficacy of the drug combination belantamab mafodotin and venetoclax, with or without the addition of dexamethasone, in patients with relapsed/refractory multiple myeloma bearing the translocation t(11;14)

Being tested
Belantamab mafodotin, Venetoclax
Keywords
t(11;14), venetoclax, belantamab mafodotin, multiple myeloma
Medical subject headings
Multiple Myeloma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Belantamab mafodotin, VenetoclaxDrug

    Belantamab mafodotin (IV) Venetoclax (PO)

Study groups in NCT05853965
Study groupRoleWhat they receive
Cohort 1ExperimentalBelantamab Mafodotin 1.9 mg/kg Q6W Venetoclax 400mg QD
Receives: Drug: Belantamab mafodotin, Venetoclax
Cohort 2ExperimentalBelantamab Mafodotin 1.9 mg/kg Q6W Venetoclax 800mg QD
Receives: Drug: Belantamab mafodotin, Venetoclax
Cohort 3ExperimentalBelantamab Mafodotin 1.9 mg/kg Q6W Venetoclax 400mg QD Dexamethasone 40mg Q1W (20mg for subjects ≥ 75 years)
Receives: Drug: Belantamab mafodotin, Venetoclax
Cohort 4ExperimentalBelantamab Mafodotin 1.9 mg/kg Q6W Venetoclax 800mg QD Dexamethasone 40mg Q1W (20mg for subjects ≥ 75 years)
Receives: Drug: Belantamab mafodotin, Venetoclax

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Recommended Phase II dose (RP2D)

    Establishment of Recommended Phase II dose (RP2D), Evaluation of safety profile, including maximum tolerated dose

    Measured: approx. 9 months

Secondary outcomes (4)

  1. Overall Response Rate

    Overall Response Rate

    Measured: through study completion, an average of 2 years

  2. Minimal residual disease (MRD) negativity

    Minimal residual disease (MRD) negativity rate and duration

    Measured: through study completion, an average of 2 years

  3. Progression free survival (PFS)

    Progression free survival (PFS)

    Measured: through study completion, an average of 2 years

  4. Duration of response (DOR)

    Duration of response (DOR)

    Measured: through study completion, an average of 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 May 2023
  2. Study start28 Jun 2023
  3. Primary completionApr 2027 (estimated)
  4. Study completionDec 2028 (estimated)

Resources

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
Sequential
Model description
Phase I: 3+3 Fibonacci design Phase II: single group
Masking
None (open label)
Enrolment
45 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05853965
Sponsor's protocol ID
BELI(E)VE Trial
Other IDs
2021-001413-37
Acronym
BELI(E)VE
Status last verified
May 2026
First submitted
22 Apr 2023
Last updated
18 May 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Schaefers C, Khandanpour C, Hanel M, Kull M, Alsdorf W, Kamili A, Kosch R, Kruger W, Bohl S, Mai EK, Scheid C, Einsele H, Bruggemann M, Suling A, Zapf A, Bokemeyer C, Weisel K, Leypoldt L. Belantamab mafodotin plus venetoclax in t(11;14)-positive relapsed or refractory multiple myeloma - the BELI(E)VE trial. BMC Cancer. 2026 Sep 16;26(1):1141. doi: 10.1186/s12885-026-16905-3.

    PubMed 42786443

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Belantamab mafodotin, Venetoclax in people with Multiple Myeloma and Multiple Myeloma in Relapse, run by Universitätsklinikum Hamburg-Eppendorf at 5 sites in Germany.

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 21 inclusion and 35 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: looking for participants now, as of the sponsor's last update on 18 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in Germany. 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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Katja Weisel (+4940741051410, k.weisel@uke.de), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Recommended Phase II dose (RP2D) (time frame: approx. 9 months). 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 NCT05853965, 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 18 May 2026.

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