Skip to content
Triangle logo TriangleGet started
← Study library

NCT06868654 · REGISTRY CONDITION SEARCH

China Subpopulation: Evaluation of Efficacy and Safety of Belantamab Mafodotin, Bortezomib and Dexamethasone Versus Daratumumab, Bortezomib and Dexamethasone in Participants With Relapsed/Refractory Multiple Myeloma

Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.

Phase
PHASE3
Status at capture
ACTIVE NOT RECRUITING
Registry last update
2026-04-23

This study is designed to evaluate safety and efficacy of belantamab mafodotin in combination with bortezomib/dexamethasone versus daratumumab in combination with bortezomib/dexamethasone in the Chinese participants with relapsed/refractory multiple myeloma.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

→

baseline

Baseline characteristics

→

outcome · POSTED

Progression-free Survival (PFS)

→

outcome · NOT POSTED

Overall Survival (OS)

→

outcome · NOT POSTED

Duration of Response (DoR)

→

outcome · NOT POSTED

Minimal Residual Disease (MRD) Negativity Rate

→

outcome · NOT POSTED

Complete Response Rate (CRR)

→

outcome · NOT POSTED

Overall Response Rate (ORR)

→

outcome · NOT POSTED

Clinical Benefit Rate (CBR)

→

outcome · NOT POSTED

Time to Response (TTR)

→

outcome · NOT POSTED

Time to Progression (TTP)

→

outcome · NOT POSTED

Progression-free Survival on Subsequent Line of Therapy (PFS2)

→

outcome · NOT POSTED

Number of Participants With Adverse Events (AEs)

→

outcome · NOT POSTED

Number of Participants With Clinically Significant Changes in Hematology Parameters

→

outcome · NOT POSTED

Number of Participants With Clinically Significant Changes in Clinical Chemistry

→

outcome · NOT POSTED

Number of Participants With Clinically Significant Changes in Urine Dipstick

→

outcome · NOT POSTED

Number of Participants With Abnormal Ocular Findings on Ophthalmic Examination

→

outcome · NOT POSTED

Plasma Concentrations of Belantamab Mafodotin (Total Antibody)

→

outcome · NOT POSTED

Plasma Concentrations of Belantamab Mafodotin (ADC)

→

outcome · NOT POSTED

Plasma Concentrations of Monomethyl Auristatin-F With a Cysteine Linker (Cys-mcMMAF)

→

outcome · NOT POSTED

Number of Participants With Positive Anti-Drug Antibodies (ADAs) Against Belantamab Mafodotin

→

outcome · NOT POSTED

Titers of ADAs Against Belantamab Mafodotin

→

outcome · NOT POSTED

Number of Participants With Maximum Post-baseline Change From Baseline in Individual Items of Patient-reported Outcome Version of the Common Term Criteria for Adverse Events (PRO-CTCAE)

→

outcome · NOT POSTED

Change From Baseline in Health Related Quality of Life (HRQoL) as Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30)

→

outcome · NOT POSTED

Change From Baseline in HRQoL as Measured by EORTC IL52

→

adverse events

Adverse events

→

more info

Limitations, agreements, and source contact

→
Who could take part
eligibility Criteria
Inclusion Criteria: * Confirmed diagnosis of multiple myeloma as defined by the International Myeloma Working Group (IMWG) criteria. * Previously treated with at least 1 prior line of multiple myeloma (MM) therapy and must have documented disease progression during or after their most recent therapy. * Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2. * Must have at least 1 aspect of measurable disease, defined as one of the following; 1. Urine M-protein excretion \>=200 mg per 24-hour, or 2. Serum M-protein concentration \>=0.5 grams per deciliter (g/dL), or 3. Serum free light chain (FLC) assay: involved FLC level \>=10 mg per dL (\>=100 mg per liter) and an abnormal serum free light chain ratio (\<0.26 or \>1.65). * 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 enrollment, except for alopecia. * Adequate organ function Exclusion Criteria: * Intolerant to daratumumab. * Refractory to daratumumab or any other anti-CD38 therapy (defined as progressive disease during treatment with anti-CD38 therapy, or within 60 days of completing that treatment). * Intolerant to bortezomib, or refractory to bortezomib (defined as progressive disease during treatment with a bortezomib-containing regimen of 1.3 mg/m\^2 twice weekly, or within 60 days of completing that treatment). Note: participants with progressive disease during treatment with a weekly bortezomib regimen are allowed. * Ongoing Grade 2 or higher peripheral neuropathy or neuropathic pain. * Prior treatment with anti-B-cell maturation antigen (anti-BCMA) therapy. * Prior allogenic stem cell transplant. * Any serious and/or unstable pre-existing medical, psychiatric disorder or other conditions, including renal, liver, cardiovascular, or certain prior malignancies. * Corneal epithelial disease
healthy Volunteers
false
minimum Age
18 Years
sex
ALL
std Ages
  1. ADULT
  2. OLDER_ADULT
Treatment arms and interventions
arm Groups
  1. intervention Names
    1. Drug: Belantamab mafodotin
    2. Drug: Bortezomib
    3. Drug: Dexamethasone
    label
    Belantamab mafodotin and Bortezomib plus Dexamethasone
    type
    EXPERIMENTAL
  2. intervention Names
    1. Drug: Daratumumab
    2. Drug: Bortezomib
    3. Drug: Dexamethasone
    label
    Daratumumab and Bortezomib plus Dexamethasone
    type
    ACTIVE_COMPARATOR
interventions
  1. arm Group Labels
    1. Belantamab mafodotin and Bortezomib plus Dexamethasone
    description
    Humanized anti-B-cell maturation antigen (BCMA) antibody/drug conjugate
    name
    Belantamab mafodotin
    type
    DRUG
  2. arm Group Labels
    1. Daratumumab and Bortezomib plus Dexamethasone
    description
    Anti-cluster of differentiation 38 \[CD-38\] monoclonal antibody
    name
    Daratumumab
    type
    DRUG
  3. arm Group Labels
    1. Belantamab mafodotin and Bortezomib plus Dexamethasone
    2. Daratumumab and Bortezomib plus Dexamethasone
    description
    Proteasome Inhibitor
    name
    Bortezomib
    type
    DRUG
  4. arm Group Labels
    1. Belantamab mafodotin and Bortezomib plus Dexamethasone
    2. Daratumumab and Bortezomib plus Dexamethasone
    description
    Synthetic glucocorticoid with anti-tumor activity
    name
    Dexamethasone
    type
    DRUG
Study design
allocation
RANDOMIZED
intervention Model
PARALLEL
masking Info
masking
NONE
primary Purpose
TREATMENT
Enrollment
count
72
type
ACTUAL
Registered outcome plans (not posted results)
primary Outcomes
  1. description
    PFS is defined as time from randomization until earliest date of disease progression (PD), determined by Independent Review Committee (IRC), according to the International Myeloma Working Group (IMWG) Response Criteria, or death due to any cause. PD= increase of \>=25% from lowest value in \>=1 of following (serum M-protein \[absolute increase \>=0.5 grams per deciliter {g/dL}\]; serum M-protein increase \>=1g/dL \[when lowest M-protein \>=5g/dL\]; urine M-protein \[absolute increase \>=200 milligrams per 24 hours {mg/24h}\]; participants without measurable serum \& urine M-protein levels, difference between involved \& uninvolved serum free light chains (sFLC) levels \[absolute increase \>10mg/dL\]; appearance of new lesion,\>=50% increase from nadir in Sum of the products of the maximal perpendicular diameters of measured lesions (SPD) of \>1 lesion, or \>=50% increase in longest diameter of previous lesion \>1 centimeter (cm) in short axis.
    measure
    Progression-free Survival (PFS)
    time Frame
    Up to approximately 32 months
secondary Outcomes
  1. description
    OS is defined as time from the date of randomization until the date of death due to any cause.
    measure
    Overall Survival (OS)
    time Frame
    Up to 255 weeks
  2. description
    DOR is defined as time from first documented evidence of partial response or better until first documented progression or death, whichever occurs first.
    measure
    Duration of Response (DoR)
    time Frame
    Up to 255 weeks
  3. description
    Minimal Residual Disease (MRD) negativity rate is defined as the percentage of participants who are MRD negative by next generation sequencing (NGS).
    measure
    Minimal Residual Disease (MRD) Negativity Rate
    time Frame
    Up to 255 weeks
  4. description
    CRR is defined as percentage of participants with a confirmed complete response (CR) or better (i.e., CR, stringent Complete Response (sCR)).
    measure
    Complete Response Rate (CRR)
    time Frame
    Up to 255 weeks
  5. description
    ORR is defined as percentage of participants with a confirmed partial response (PR) or better (i.e. PR, Very Good Partial Response \[VGPR\], CR or sCR).
    measure
    Overall Response Rate (ORR)
    time Frame
    Up to 255 weeks
  6. description
    CBR is defined as percentage of participants with a confirmed minimal response (MR) or better per International Myeloma Working Group (IMWG).
    measure
    Clinical Benefit Rate (CBR)
    time Frame
    Up to 255 weeks
  7. description
    TTR is defined as time from the date of randomization and the first documented evidence of response (PR or better) among participants who achieve partial response or better.
    measure
    Time to Response (TTR)
    time Frame
    Up to 255 weeks
  8. description
    TTP is defined as the time from the date of randomization until the earliest date of documented PD or death due to PD. PD= increase of \>=25% from lowest value in \>=1 of following (serum M-protein \[absolute increase \>=0.5 grams per deciliter {g/dL}\]; serum M-protein increase \>=1g/dL \[when lowest M-protein \>=5g/dL\]; urine M-protein \[absolute increase \>=200 milligrams per 24 hours {mg/24h}\]; participants without measurable serum \& urine M-protein levels, difference between involved \& uninvolved serum free light chains (sFLC) levels \[absolute increase \>10mg/dL\]; appearance of new lesion,\>=50% increase from nadir in Sum of the products of the maximal perpendicular diameters of measured lesions (SPD) of \>1 lesion, or \>=50% increase in longest diameter of previous lesion \>1 centimeter (cm) in short axis.
    measure
    Time to Progression (TTP)
    time Frame
    Up to 255 weeks
  9. description
    PFS2 is defined as time from randomization to disease progression after initiation of new anti-myeloma therapy or death from any cause, whichever is earlier. If disease progression after new anti-myeloma therapy cannot be measured, a PFS event is defined as the date of discontinuation of new anti-myeloma therapy, or death from any cause, whichever is earlier
    measure
    Progression-free Survival on Subsequent Line of Therapy (PFS2)
    time Frame
    Up to 255 weeks
  10. description
    An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. AEs will be coded using the Medical Dictionary for Regulatory Activities (MedDRA dictionary).
    measure
    Number of Participants With Adverse Events (AEs)
    time Frame
    Up to 255 weeks
  11. description
    Blood samples will be collected for the analysis of hematology parameters.
    measure
    Number of Participants With Clinically Significant Changes in Hematology Parameters
    time Frame
    Up to 255 weeks
  12. description
    Blood samples will be collected for the analysis of clinical chemistry parameters.
    measure
    Number of Participants With Clinically Significant Changes in Clinical Chemistry
    time Frame
    Up to 255 weeks
Full study description
brief Summary
This study is designed to evaluate safety and efficacy of belantamab mafodotin in combination with bortezomib/dexamethasone versus daratumumab in combination with bortezomib/dexamethasone in the Chinese participants with relapsed/refractory multiple myeloma.
Source references
Source notices and limitations
    Discovery and provenance
    1. release id
      ctgov-registry-1336d216cbd1bbff780dac70
      edge id
      nct-edge-a2f246f0f8a448b4378a
      requested nct id
      NCT06868654
      primary nct id
      NCT06868654
      source kind
      ctgov_condition_query
      source record id
      Source null
      source file sha256
      2314ce01316b2d7044d298c6d25eda12e99cc5f44273bc75efed6cd5e03a8c14
      payload sha256
      8d6c21ab456f27440c1938b3c431c1a2f4be3cd9dfa8c31afb21ec2408fd4d4e
      payload
      clinical indication matching status
      condition_index_match_asserted_by_registry_not_reviewed
      end exclusive
      true
      id
      nct-edge-a2f246f0f8a448b4378a
      link basis
      returned_by_explicit_condition_and_posted_results_filter_query
      nct id
      NCT06868654
      occurrences
      1. context exact
        NCT06868654
        end
        11
        exact text
        NCT06868654
        start
        0
      offset unit
      unicode_code_points
      query cond
      Plasma Cell Neoplasms
      query disease state id
      ds-plasma-cell-neoplasms
      source file
      /Users/arunverma/Documents/ChatGPT/Cancer Statistics Website/research-data/2026-09-10/clinicaltrials-condition/round-0000/raw/cond-plasma-cell-neoplasms-000.json
      source file sha256
      2314ce01316b2d7044d298c6d25eda12e99cc5f44273bc75efed6cd5e03a8c14
      source json pointer
      /studies/350/protocolSection/identificationModule/nctId
      source kind
      ctgov_condition_query
      source record id
      Source null
      source string basis
      parsed_JSON_string_unmodified
      source string sha256
      daeb9ba088f2642f9dd50356cdc8fb1df92755cd3450c5b39bbf0a38b5e44761

    Preserved source evidence · Not medical advice