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Relapsed Multiple MyelomaPhase 1/2NCT05060627

Study of Belantamab Mafodotin in Combination With Kd for the Treatment of Relapsed Myeloma Patients, Refractory to Lenalidomide

A Phase 1/2 study testing Belantamab mafodotin, Carfilzomib and Dexamethasone in people with Relapsed Multiple Myeloma, run by PETHEMA Foundation at 15 sites in Spain.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

This is a phase I-II open-label, multicenter, non-randomized study aiming to evaluate the efficacy and safety of belantamab mafodotin in combination with carfilzomib (Kyprolis®) and dexamethasone (Kd). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Relapsed Multiple Myeloma
What is being tested?
Belantamab mafodotin, Carfilzomib and Dexamethasone
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
15 sitesSpain
Study dates
20 Dec 2021to 30 May 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

  • Participant must be able to understand the study procedures
  • Patient is, in the investigator's opinion, willing and able to comply with the protocol requirements.
  • Patient has given voluntary written informed consent before performance of any study-related procedure nor part of normal medical care, with the understanding that consent may be withdrawn by the patient at any time without prejudice to their future medical care.
  • Relapse multiple myeloma patients that have received at least 1 and no more than 3 prior lines of therapy. Induction, intensification with high-dose melphalan and stem cell transplant and maintenance is considered one line of treatment.
  • Patients must be refractory to lenalidomide. Refractoriness is defined as progression while receiving lenalidomide or in the first 60 days after the last dose of lenalidomide.
  • Refractoriness would be defined regardless of the dose of lenalidomide received, and the schedule or whether it was given alone or in combination.
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  • Patients can have received prior treatment with proteasome inhibitors. Patients with prior bortezomib treatment are eligible regardless of refractory status. Prior carfilzomib treatment is allowed, provided that the patients achieve at least a partial response to prior carfilzomib, and that there is a treatment free interval of at least 6 months.
  • Participant must have a measurable secretory disease defined as either serum monoclonal protein of ≥ 0,5 g/dl or urine monoclonal (light chain) protein ≥ 200 mg/24 h. For patients whose disease is only measurable by serum FLC, the involved FLC should be ≥ 10mg/L (100 mg/dl), with an abnormal serum FLC ratio.
  • Participant must have an Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2
  • Participant must be ≥ 18 years of age
  • Participant must have adequate organ function. Laboratory values that define adequate organ function for inclusion in study are as follow:
  • HEMATOLOGIC Absolute neutrophil count (ANC) ≥1.5 X 109/L Hemoglobin ≥8.0 g/dL (prior red blood cell (RBC) transfusion or recombinant human erythropoietin use is permitted) Platelets ≥75 x 109/L for subjects in whom <50% of bone marrow nucleated cells are plasma cells; otherwise platelet count >50 × 109/L (prior platelet transfusion is permitted up to 7 days before the screening phase) Calcium corrected serum calcium <14 mg/dL (<3.5 mmol/L); or free ionized calcium <6.5 mg/dL (<1.6 mmol/L); HEPATIC Total bilirubin ≤1.5X ULN (Isolated bilirubin ≥1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin <35%) ALT ≤2.5 X ULN AST ≤2.5 X ULN
  • RENAL eGFRa ≥40 mL/min/ 1.73 m2 Spot urine (albumin/creatinine ratios) <500 mg/g (56 mg/mmol) OR Negative/trace (if ≥1+ only eligible if confirmed ≥ 500 mg/g (56 mg/mmol) by albumin/creatinine ratio (spot urine from first void) Urine Dipstick
  • CARDIAC LVEF (echo) ≥ 40%
  • Female participants: contraceptive use should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. 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 (with a failure rate of <1% per year), preferably with low user dependency, during the intervention period and for at least 4 months after the last dose of study intervention and agrees not to donate eggs (ova, oocytes) for the purpose of reproduction during this period. The investigator should evaluate the effectiveness of the contraceptive method in relationship to the first dose of study intervention.
  • A WOCBP must have a negative highly sensitive serum pregnancy test (as required by local regulations) within 72 hours before the first dose of study intervention.
  • The investigator is responsible for review of medical history, menstrual history, and recent sexual activity to decrease the risk for inclusion of a woman with a nearly undetected pregnancy.
  • Nonchildbearing potential is defined as follows (by other than medical reasons):
  • ≥45 years of age and has not had menses for >1 year
  • Patients who have been amenorrhoeic for >2 years without history of a hysterectomy and oophorectomy must have a follicle stimulating hormone value in the postmenopausal range upon screening evaluation
  • Post-hysterectomy, post-bilateral oophorectomy, or post-tubal ligation.Documented hysterectomy or oophorectomy must be confirmed with medical records of the actual procedure or confirmed by an ultrasound. Tubal ligation must be confirmed with medical records of the actual procedure.
  • Male participants: contraceptive use should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
  • Male participants are eligible to participate if they agree to the following from the time of first dose of study until 6 months after the last dose of belantamab mafodotin to allow for clearance of any altered sperm:
  • Refrain from donating sperm
  • PLUS either:
  • Be abstinent from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long term and persistent basis) and agree to remain abstinent OR
  • Must agree to use contraception/barrier as detailed below:
  • Agree to use a male condom, even if they have undergone a successful vasectomy and female partner to use an additional highly effective contraceptive method with a failure rate of <1% per year when having sexual intercourse with a WOCBP (including pregnant females).
  • All prior treatment-related toxicities (defined by National Cancer Institute- Common Toxicity Criteria for Adverse Events (NCI-CTCAE), version 4.0 must be ≤ Grade 1 at the time of enrolment except for alopecia
  • Participant must be able to understand the study procedures and agree to participate in the study by providing written informed consent

Who cannot join

  • Participant has a diagnosis of primary amyloidosis, monoclonal gammopathy of undetermined significance (MGUS), smoldering multiple myeloma (SMM), plasma cell leukemia or active POEMS syndrome at the time of screening.
  • Participant has invasive malignancies other than disease under study, unless the second malignancy has been medically stable for at least 2 years and, in the opinion of the principal investigators, will not affect the evaluation of the effects of clinical trial treatments on the currently targeted malignancy. Participants with curatively treated non-melanoma skin cancer may be enrolled without a 2-year restriction.
  • Participant has meningeal involvement of multiple myeloma.
  • Pregnant or breastfeeding females.
  • Participant is simultaneously enrolled in other interventional clinical trial.
  • Participant has used a systemic anti-myeloma drug within 14 days or five half-lives, whichever is shorter, preceding the first dose of study drug.
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  • Participant has used an investigational drug within 14 days or five half-lives, whichever is shorter, preceding the first dose of study drug.
  • Prior treatment with a monoclonal antibody within 30 days of receiving the first dose of study drug.
  • Participant has received prior treatment with anti-BCMA agents.
  • Received plasmapheresis within 7 days prior to the first dose of study drug.
  • Participant has received prior radiotherapy within 2 weeks of start of study therapy.
  • Participants must have recovered from all radiation-related toxicities, not require corticosteroids, and not have had radiation pneumonitis. A 1-week washout is permitted for palliative radiation (≤2 weeks of radiotherapy) to non-central nervous system (CNS) disease.
  • Participant has a known immediate or delayed hypersensitivity reaction or idiosyncratic reactions to belantamab mafodotin or drugs chemically related to belantamab mafodotin, or any of the components of the study treatment.
  • Participant has a known immediate or delayed hypersensitivity reaction or idiosyncrasy to other molecular antibodies.
  • Major surgery (except kyphoplasty) ≤ 4 weeks prior to initiating protocol therapy.
  • Participant has current corneal epithelial disease except mild changes in corneal epithelium
  • Participant has peripheral neuropathy or neuropathic pain grade ≥2, as defined by the National Cancer Institute Terminology Criteria for Adverse Events (NCI CTCAE) Version 4.0.
  • Participant evidence of cardiovascular risk including any of the following:
  • QTcF interval QTcF > 480 msec (the QT interval values must be corrected for heart rate by Fridericia's formula [QTcF])
  • Evidence of current clinically significant uncontrolled arrhythmias, including clinically significant ECG abnormalities such as 2nd degree (Type II) or 3rd degree atrioventricular (AV) block.
  • History of myocardial infarction, acute coronary syndromes (including unstable angina), coronary angioplasty, or stenting or bypass grafting within six months of Screening.
  • Class III or IV heart failure as defined by the New York Heart Association functional classification system [NYHA, 1994]
  • Uncontrolled hypertension, defined as an average systolic blood pressure ≥ 160 mmHg or diastolic ≥ 100 mmHg despite optimal treatment.
  • Participant has current unstable liver or biliary disease defined by the presence of ascites, encephalopathy, coagulopathy, hypoalbuminemia, esophageal or gastric varices, persistent jaundice, or cirrhosis. Note: Stable chronic liver disease (including Gilbert's syndrome or asymptomatic gallstones) or hepatobiliary involvement of malignancy is acceptable if otherwise meets entry criteria.
  • Presence of active renal condition (infection, requirement for dialysis or any other condition that could affect patient's safety). Participants with isolated proteinuria resulting from MM are eligible, provided they fulfil inclusion criteria.
  • Evidence of active mucosal or internal bleeding.
  • Use of contact lenses while participating in this study.
  • Any serious medical condition or psychiatric illness that would interfere in understanding of the informed consent form.
  • Uncontrolled endocrine diseases (i.e. diabetes mellitus, hypothyroidism or hyperthyroidism) (i.e. requiring relevant changes in medication within the last month, or hospital admission within the last 3 months).
  • Patients with acute diffuse infiltrative pulmonary disease and/or pericardial disease.
  • Patients with severe chronic obstructive pulmonary disease (COPD) or asthma with forced expiratory volume in the first minute (FEV1) less than 50%.
  • History of interstitial lung disease or ongoing interstitial lung disease. aa. Participant has an active infection requiring antibiotic, antiviral, or antifungal treatment bb. Participant has known HIV infection cc. Participant has presence of hepatitis B surface antigen (HBsAg), or hepatitis B core antibody (HBcAb at screening or within 3 months prior to first dose of study treatment.
  • dd. Participant has positive hepatitis C antibody test result or positive hepatitis C RNA test result at screening or within 3 months prior to first dose of study treatment.
  • Note: Participants with positive Hepatitis C antibody due to prior resolved disease can be enrolled, only if a confirmatory negative Hepatitis C RNA test is obtained.
  • Note: Hepatitis RNA testing is optional and participants with negative Hepatitis C antibody test are not required to also undergo Hepatitis C RNA testing.

Trial locations and contacts

15 sites in 1 country.

15 sites in 1 country

Spain15 sites

  • Hospital Germans Trias i Pujol (ICO BADALONA)

    Badalona

  • Hospital Clinic

    Barcelona

  • ICO Duran i Reynals

    L'Hospitalet de Llobregat

  • H. Gregorio Marañón

    Madrid

  • Hospital Universitario 12 de Octubre

    Madrid

  • H. Morales Meseguer

    Murcia

  • HUCA

    Oviedo

  • H. Son Llatzer

    Palma de Mallorca

  • Clínica Universidad de Navarra (CUN)

    Pamplona

  • Hospital Universitario de Salamanca

    Salamanca

  • H. Universitario de Canarias

    Santa Cruz de Tenerife

  • H. Universitario Marqués de Valdecilla

    Santander

  • Complejo Hospitalario Santiago (CHUS)

    Santiago de Compostela

  • Complejo Hospitalario Virgen del Rocío

    Seville

  • H.U. La Fe

    Valencia

Other trials in Spain

About this study

Official title: An Open Label, Multicenter, Phase I/II Study of Belantamab Mafodotin in Combination With Kd for the Treatment of Relapsed Myeloma Patients, Refractory to Lenalidomide.

This is a phase I-II open-label, multicenter, non-randomized study aiming to evaluate the efficacy and safety of belantamab mafodotin in combination with carfilzomib (Kyprolis®) and dexamethasone (Kd). Since this is the first time that this combination is being evaluated in a clinical trial, a first dose escalation part will be developed following the classic 3+3 design, to establish the maximum tolerated dose (MTD) of the combination. Once the MTD will be defined, a dose expansion phase will be open to recruit up to 60 patients.

Patients will receive treatment with belantamab-mafodotin + Kd, until unacceptable toxicity, disease progression, patient withdrawal, loss to follow-up, end of study, or death.

Read the detailed description

This is a phase I-II open-label, multicenter, non-randomized study aiming to evaluate the efficacy and safety of belantamab mafodotin in combination with carfilzomib (Kyprolis®) and dexamethasone (Kd). Since this is the first time that this combination is being evaluated in a clinical trial, a first dose escalation part will be developed following the classic 3+3 design, to establish the maximum tolerated dose (MTD) of the combination. Once the MTD will be defined, a dose expansion phase will be open to recruit up to 60 patients.

The study comprises the following phases:

Phase 1 (Lead-in): 3+3 Dose escalation

In the phase 1 of the study, aiming to establish the recommended phase 2 dose (RP2D), patients will be included following the classic 3 + 3 design. Dose levels will be as follows:

Dose level -1

  • Belantamab-Mafodotin 1.9 mg/kg day 1, Q8W
  • Carfilzomib 20/45 mg/m2 on days 1, 8, and 15, Q4W.
  • Dexamethasone 40 mg weekly (days 1, 8, 15 and 22) or 20 mg in patients > 75 years old, Q4W Dose level 1
  • Belantamab-Mafodotin 2.5 mg/kg day 1, Q8W
  • Carfilzomib 20/45 mg/m2 days 1, 8, and 15, Q4W.
  • Dexamethasone 40 mg weekly (days 1, 8, 15 and 22) or 20 mg in patients > 75 years old., Q4W Dose level 2
  • Belantamab-Mafodotin 2.5 mg/kg on day 1, Q8W
  • Carfilzomib 20/56 mg/m2 on days 1, 8, and 15, Q4W.
  • Dexamethasone 40 mg weekly (days 1, 8, 15 and 22) or 20 mg in patients > 75 years old, Q4W. Dose level 3
  • Belantamab-Mafodotin 2.5 mg/kg on day 1, every 4 weeks (Q8W)
  • Carfilzomib 20/70 mg/m2 on days 1, 8, and 15, Q4W.
  • Dexamethasone 40 mg weekly (days 1, 8, 15 and 22) or 20 mg in patients > 75 years old., Q4W

The rules applied for the Lead-in phase are as follows:

  1. An initial cohort of 3 subjects is enrolled at the first dose level (DL1).
  2. If 1/3 subjects develop a DLT, 3 additional patients will be included at the same dose level (DL1)
  3. If 0/3 subjects develop a DLT, 3 additional patients will be included at the next dose level (DL2, dose level 2).
  4. If 1/3 subjects develop a DLT, 3 additional patients will be included at the same dose level (DL2, dose level 2).
  5. If 0 of the 3 new subjects develops a DLT (for a total of 0-1/6 patients with a DLT at this dose level), 3 new subjects will be included in DL3 (dose level 3).
  6. If 1 of the 3 new subjects develops a DLT (for a total of 0-1/6 patients with a DLT at this dose level), 3 new subjects will be included at the same dose level (DL3, dose level 3)
  7. If 0 out of the 3 new subjects develops a DLT, 3 additional subjects will be included in the same dose level. If 0-1 out of 6 patients developed a DLT, this dose will be considered the maximum tolerated dose (MTD) and will be explored in the expansion phase (phase 2).
  8. If ≥2/3 subjects develop a DLT, dose level will be de-escalated (previous dose level) with the same rules as described above.

Dose limiting toxicities (DLTs) will be evaluated during the DLT evaluation period. The DLT evaluation period will be defined as the first 4-weeks treatment cycle for each cohort.

Patients participating in the Lead-In-Phase must undergo a complete ophthalmologic examination at the end of the DLT evaluation period (4-weeks) and before starting Cycle 2.

Subjects will be considered evaluable for the assessment of DLT if they:

  • Received at least 1 dose of belantamab mafodotin + Kd and experience a DLT, OR
  • Received at least 1 dose of belantamab mafodotin, 3 doses of Carfilzomib and 3 doses of Dexamethasone and complete the safety follow-up through the end of the DLT evaluation period.

Non-evaluable subjects will be replaced.

Phase 2 (Expansion Phase, n= up to 60 patients)

Combination treatment will be administered at the RP2D based on the results of the phase 1 dose escalation part of the study:

  • Belantamab mafodotin on day 1 at the RP2D, every 8 weeks, intravenously (IV).
  • Carfilzomib will be given at the RP2D weekly IV on days: 1, 8, and 15 of every 4-week cycle (Q4W).
  • Dexamethasone will be given at the dose of 40 mg (or 20 mg if patient > 75 years old) on days: 1, 8, 15 and 22 Q4W.

From month 13 onwards carfilzomib treatment will be given on day 1 and 15 of every 4-weeks cycles. Belantamab will be given at the RP2D every 8 weeks and Dexamethasone 40mg on days 1, 8, and 15 of every 4-week cycle.

The trial has the following objectives:

Primary objectives (PO):

Phase 1 PO1: To determine the maximum tolerated dose, and the recommended phase 2 dose of belantamab mafodotin in combination with carfilzomib and dexamethasone.

Phase 2 PO2: To evaluate the efficacy in terms of complete response rate and rates of minimal residual negativity after 12 months of therapy with belantamab mafodotin combined with carfilzomib and dexamethasone.

PO3: To evaluate safety and tolerability of the combination of belantamab mafodotin plus carfilzomib and dexamethasone.

Secondary Objectives (SO):

SO1: To determine time to event data of the combinations: Progression-free survival, progression-free survival at 12 months, duration of response, time to response, and overall survival.

SO2: Evaluate deepening of response during continuous therapy at 12, and 24 months.

SO3: Evaluate sustained MRD rate at 1 and 2 years. SO4: Evaluate the rate of conversion from MRD positivity to MRD negativity during the treatment (yearly).

SO5: To assess the safety of the combination of belantamab mafodotin + Kd, as well as the incidence of corneal and ophthalmologic adverse events.

Being tested
Belantamab mafodotin, Carfilzomib, Dexamethasone
Keywords
Relapsed multiple myeloma, Refractoriness to lenalidomide
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 mafodotinDrug

    In phase 1:

    • Dose level -1: Belantamab-Mafodotin 1.9 mg/kg day 1, Q8W
    • Dose level 1,2,3: Belantamab-Mafodotin 2.5 mg/kg day 1, Q8W In phase 2: maximum tolerated dose (MTD) of the combination

  • CarfilzomibDrug

    In phase 1:

    • Dose level -1, 1: Carfilzomib 20/45 mg/m2 days 1, 8, and 15, Q4W.
    • Dose level 2: Carfilzomib 20/56 mg/m2 on days 1, 8, and 15, Q4W
    • Dose level 3: Carfilzomib 20/70 mg/m2 on days 1, 8, and 15, Q4W.

    In phase 2: maximum tolerated dose (MTD) of the combination

  • DexamethasoneDrug

    Description: Dexamethasone 40 mg weekly (days 1, 8, 15 and 22) or 20 mg in patients > 75 years old., Q4W

Study groups in NCT05060627
Study groupRoleWhat they receive
Belantamab-Mafodotin + Carfilzomib+ dexametasonaExperimentalIn the phase 1 of the study, aiming to establish the recommended phase 2 dose (RP2D), patients will be included following the classic 3 + 3 design. Once the DLT assessment period is completed and the MTD is defined, the recruitment will continue in the expansion phase 2. Combination treatment will be administered at the recommended Phase 2 dose (RP2D) based on the results of the phase 1 dose escalation part of the study: * Belantamab mafodotin on day 1 at the RP2D, every 8 weeks, intravenously (IV). * Carfilzomib will be given at the RP2D weekly IV on days: 1, 8, and 15 of every 4-week cycle (Q4W). * Dexamethasone will be given at the dose of 40 mg (or 20 mg if patient > 75 years old) on days: 1, 8, 15 and 22 Q4W. From month 13 onwards carfilzomib treatment will be given on day 1 and 15 of every 4-weeks cycles. Belantamab will be given at the RP2D every 8 weeks and Dexamethasone 40mg on days 1, 8, and 15 of every 4-week cycle.
Receives: Drug: Belantamab mafodotin; Drug: Carfilzomib; Drug: Dexamethasone

What is being measured

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

  1. Number of participants with adverse events (AEs) during the triplet-therapy in phase I.

    To determine the maximum tolerated dose, and the recommended phase 2 dose of belantamab mafodotin in combination with carfilzomib and dexamethasone, number of participants with adverse events (AEs) during the triplet-therapy in phase 1 will be evaluated.

    Measured: At the end of the first 4-week cycle following a 3+3 design.

  2. Overall Response Rate (ORR)

    Percentage of participants with a confirmed partial response (PR) or better (PR, VGPR, CR, sCR).

    Measured: 12 months.

  3. Minimal Residual Disease (MRD) negativity rate

    The percentage of participants who are MRD negative by next-generation flow cytometry (NGF).

    Measured: At the time of CR/VGPR, and in all patients at month 12, 18, and 24, and yearly thereafter.

  4. Complete Response Rate (CRR)

    The percentage of participants with a confirmed complete response (CR) or better (stringent complete response (CR, sCR)).

    Measured: 12 months.

  5. Incidence of deaths and primary cause of death.

    Frequency and percentage of deaths and primary cause of death.

    Measured: Throughout the study. Approximately 60 months.

  6. Incidence of adverse events (AEs).

    Frequency and percentage of AEs

    Measured: Throughout the study. Approximately 60 months.

  7. % of patients with changes in hematologic laboratory parameters

    Percentage of patients who present differences in hematologic laboratory parameters from baseline values .

    Measured: Throughout the study. Approximately 60 months.

  8. % of patients with changes in blood chemistry laboratory parameters

    Percentage of patients who present differences in blood chemistry panel from baseline values.

    Measured: Throughout the study. Approximately 60 months.

  9. Frequency of ocular findings on ophthalmic exam

    Ocular findings on ophthalmic exam

    Measured: Throughout the study. Approximately 60 months.

Secondary outcomes (11)

  1. Duration of Response (DoR)

    Time from first documented evidence of PR or better until progressive disease (PD) or death due to PD among participants who achieved PR or better.

    Measured: Throughout the study. Approximately 60 months.

  2. Progression-Free Survival (PFS)

    Time from the start of treatment until the earliest date of documented disease progression or death due to any cause.

    Measured: Throughout the study. Approximately 60 months.

  3. Progression-Free Survival (PFS) at 12 months.

    Time from the start of treatment until the earliest date of documented disease progression or death due to any cause.

    Measured: 12 months

  4. Time to Response (TTR)

    Time from the start of treatment and the first documented evidence of response (PR or better) among participants who achieve confirmed PR or better.

    Measured: Throughout the study. Approximately 60 months.

  5. Overall Survival (OS)

    Time from the start of treatment until the date of death due to any cause

    Measured: Throughout the study. Approximately 60 months.

  6. Percentage of patients upgrading the response category

    Percentage of patients upgrading/deepening the response (converting from partial response to VGPR, etc.)

    Measured: At 12 and 24 months

  7. Percentage of patients achieving minimal residual disease negativity using EuroFlow Panel with a sensitivity of 10*(-6).

    Percentage of patients achieving minimal residual disease negativity using EuroFlow Panel with a sensitivity of 10*(-6)

    Measured: At 12, 18 and 24 months

  8. Percentage of patients converting from positive MRD to undetectable MRD following EuroFlow panel with a sensitivity of 10*(-6)

    Percentage of patients converting from positive MRD to undetectable MRD following EuroFlow panel with a sensitivity of 10-6

    Measured: At 12, 24, 36, 48 and 60 months.

  9. Incidence of Treatment related adverse events

    Frequency and percentage of Treatment related adverse events

    Measured: Throughout the study. Approximately 60 months.

  10. Percentage of patients discontinuing therapy due to AEs.

    Percentage of patients discontinuing therapy due to AEs.

    Measured: Throughout the study. Approximately 60 months.

  11. Percentage of patients requiring dose modifications.

    Percentage of patients requiring dose modifications.

    Measured: Throughout the study. Approximately 60 months.

Timeline

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

  1. First posted29 Sep 2021
  2. Study start20 Dec 2021
  3. Primary completion23 Oct 2024
  4. Study completion30 May 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
Not applicable
Intervention model
Sequential
Model description
A phase I classic 3+3 design, to establish the maximum tolerated dose (MTD) of the combination. Once the MTD will be defined, a dose expansion phase II will be open to recruit up to 60 patients.
Masking
None (open label)
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05060627
Sponsor's protocol ID
GEM-BELMA
Other IDs
2021-002125-15
Status last verified
May 2026
First submitted
17 Sep 2021
Last updated
11 May 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Berenson JR, Cartmell A, Bessudo A, Lyons RM, Harb W, Tzachanis D, Agajanian R, Boccia R, Coleman M, Moss RA, Rifkin RM, Patel P, Dixon S, Ou Y, Anderl J, Aggarwal S, Berdeja JG. CHAMPION-1: a phase 1/2 study of once-weekly carfilzomib and dexamethasone for relapsed or refractory multiple myeloma. Blood. 2016 Jun 30;127(26):3360-8. doi: 10.1182/blood-2015-11-683854. Epub 2016 May 12.

    PubMed 27207788

  • Chari A, Martinez-Lopez J, Mateos MV, Blade J, Benboubker L, Oriol A, Arnulf B, Rodriguez-Otero P, Pineiro L, Jakubowiak A, de Boer C, Wang J, Clemens PL, Ukropec J, Schecter J, Lonial S, Moreau P. Daratumumab plus carfilzomib and dexamethasone in patients with relapsed or refractory multiple myeloma. Blood. 2019 Aug 1;134(5):421-431. doi: 10.1182/blood.2019000722. Epub 2019 May 21.

    PubMed 31113777

  • Cowan AJ, Allen C, Barac A, Basaleem H, Bensenor I, Curado MP, Foreman K, Gupta R, Harvey J, Hosgood HD, Jakovljevic M, Khader Y, Linn S, Lad D, Mantovani L, Nong VM, Mokdad A, Naghavi M, Postma M, Roshandel G, Shackelford K, Sisay M, Nguyen CT, Tran TT, Xuan BT, Ukwaja KN, Vollset SE, Weiderpass E, Libby EN, Fitzmaurice C. Global Burden of Multiple Myeloma: A Systematic Analysis for the Global Burden of Disease Study 2016. JAMA Oncol. 2018 Sep 1;4(9):1221-1227. doi: 10.1001/jamaoncol.2018.2128.

    PubMed 29800065

  • Dimopoulos MA, Moreau P, Palumbo A, Joshua D, Pour L, Hajek R, Facon T, Ludwig H, Oriol A, Goldschmidt H, Rosinol L, Straub J, Suvorov A, Araujo C, Rimashevskaya E, Pika T, Gaidano G, Weisel K, Goranova-Marinova V, Schwarer A, Minuk L, Masszi T, Karamanesht I, Offidani M, Hungria V, Spencer A, Orlowski RZ, Gillenwater HH, Mohamed N, Feng S, Chng WJ; ENDEAVOR Investigators. Carfilzomib and dexamethasone versus bortezomib and dexamethasone for patients with relapsed or refractory multiple myeloma (ENDEAVOR): a randomised, phase 3, open-label, multicentre study. Lancet Oncol. 2016 Jan;17(1):27-38. doi: 10.1016/S1470-2045(15)00464-7. Epub 2015 Dec 5.

    PubMed 26671818

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Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Belantamab mafodotin, Carfilzomib and Dexamethasone in people with Relapsed Multiple Myeloma, run by PETHEMA Foundation at 15 sites in Spain.

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 32 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: under way, not looking for participants, as of the sponsor's last update on 11 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 15 sites in Spain. 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?

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?

Number of participants with adverse events (AEs) during the triplet-therapy in phase I. (time frame: At the end of the first 4-week cycle following a 3+3 design.). The study lists 9 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 NCT05060627, which also lists 10 linked publications.

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 11 May 2026.

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