Skip to content
Triangle logo TriangleGet started
← Study library

NCT04246047 · CITED IN SOURCE DOCUMENTS

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

An NCI or FDA source cites this study. A citation does not establish that it applies to an individual diagnosis.

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

This is a Phase 3, randomized, open-label study designed to evaluate safety and efficacy of belantamab mafodotin in combination with bortezomib/dexamethasone (Arm A) versus daratumumab in combination with bortezomib/dexamethasone (Arm B) in the participants with relapsed recurrent 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

Complete Response Rate (CRR)

→

outcome · NOT POSTED

Overall Response Rate (ORR)

→

outcome · NOT POSTED

Clinical Benefit Rate (CBR)

→

outcome · NOT POSTED

Duration of Response (DoR)

→

outcome · NOT POSTED

Time to Response (TTR)

→

outcome · NOT POSTED

Time to Progression (TTP)

→

outcome · NOT POSTED

Overall Survival (OS)

→

outcome · NOT POSTED

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

→

outcome · NOT POSTED

Minimal Residual Disease (MRD) Negativity Rate

→

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) at Indicated Time Points

→

outcome · NOT POSTED

Plasma Concentrations of Belantamab Mafodotin (ADC) at Indicated Time Points

→

outcome · NOT POSTED

Plasma Concentrations of Monomethyl Auristatin-F With a Cysteine Linker (Cys-mcMMAF) at Indicated Time Points

→

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 EuropeanOrganization 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 (Arm A)
    type
    EXPERIMENTAL
  2. intervention Names
    1. Drug: Daratumumab
    2. Drug: Bortezomib
    3. Drug: Dexamethasone
    label
    Daratumumab and Bortezomib plus Dexamethasone (Arm B)
    type
    ACTIVE_COMPARATOR
interventions
  1. arm Group Labels
    1. Belantamab mafodotin and Bortezomib plus Dexamethasone (Arm A)
    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 (Arm B)
    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 (Arm A)
    2. Daratumumab and Bortezomib plus Dexamethasone (Arm B)
    description
    Proteasome Inhibitor
    name
    Bortezomib
    type
    DRUG
  4. arm Group Labels
    1. Belantamab mafodotin and Bortezomib plus Dexamethasone (Arm A)
    2. Daratumumab and Bortezomib plus Dexamethasone (Arm B)
    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
494
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 41 months
secondary Outcomes
  1. description
    CRR is defined as percentage of participants with a confirmed complete response or better.
    measure
    Complete Response Rate (CRR)
    time Frame
    Up to 73 months
  2. description
    ORR is defined as percentage of participants with a confirmed partial response or better.
    measure
    Overall Response Rate (ORR)
    time Frame
    Up to 73 months
  3. description
    CBR is defined as percentage of participants with a confirmed minimal response (MR) or better
    measure
    Clinical Benefit Rate (CBR)
    time Frame
    Up to 73 months
  4. 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 73 months
  5. 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 73 months
  6. description
    TTP is defined as time from the date of randomization until the earliest date of documented date of disease progression or death, whichever occurs first.
    measure
    Time to Progression (TTP)
    time Frame
    Up to 73 months
  7. 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 73 months
  8. description
    Progression-free survival on subsequent line of therapy is defined as time from randomization to disease progression after initiation of new anti-myeloma therapy or death from any cause, whichever occurs first. If disease progression after new antimyeloma 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 73 months
  9. description
    Minimal Residual Disease (MRD) negativity rate is defined as the percentage of participants who are MRD negative status by next generation sequencing (NGS).
    measure
    Minimal Residual Disease (MRD) Negativity Rate
    time Frame
    Up to 73 months
  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.
    measure
    Number of Participants With Adverse Events (AEs)
    time Frame
    Up to 73 months
  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 73 months
  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 73 months
Full study description
brief Summary
This is a Phase 3, randomized, open-label study designed to evaluate safety and efficacy of belantamab mafodotin in combination with bortezomib/dexamethasone (Arm A) versus daratumumab in combination with bortezomib/dexamethasone (Arm B) in the participants with relapsed recurrent multiple myeloma.
Source references
references
  1. citation
    Mateos MV, Trudel S, Quach H, Robak P, Beksac M, Pour L, Hus M, Kim K, Zherebtsova V, Delimpasi S, Jelinek T, Ward C, Ho PJ, Vorobyev V, Pitombeira de Lacerda M, Aparecida-Martinez G, Spicka I, Radocha J, Cavo M, Cerchione C, Fu C, Suzuki K, Rogers R, Phillips-Jones A, Wang Z, Baig H, Wilkes J, Zhou XL, Lewis E, Eccersley L, Sule N, Paka P, Opalinska JB, Mukhopadhyay P, Hungria V, Dimopoulos MA. Modification of belantamab mafodotin dosing to balance efficacy and tolerability in the DREAMM-7 and DREAMM-8 trials. Blood Adv. 2025 Nov 25;9(22):5708-5719. doi: 10.1182/bloodadvances.2025016949.
    pmid
    40763276
    type
    DERIVED
  2. citation
    Hungria V, Robak P, Hus M, Zherebtsova V, Ward C, Ho PJ, Hajek R, Kim K, Grosicki S, Sia H, Bryant A, Pitombeira de Lacerda M, Martinez GA, Sureda Balari A, Sandhu I, Cerchione C, Ganly P, Dimopoulos MA, Fu C, Garg M, Abdallah AO, Gatt ME, Oriol Rocafiguera A, Cavo M, Rifkin R, Fujisaki T, Mielnik M, Ficek J, Mantero A, Pirooz N, Varghese S, Lee J, McKeown A, Rogers R, Baig H, Eccersley L, Roy-Ghanta S, Mukhopadhyay P, Nielsen J, Opalinska J, Mateos MV; DREAMM-7 study investigators. Belantamab mafodotin plus bortezomib and dexamethasone in patients with relapsed or refractory multiple myeloma (DREAMM-7): updated overall survival analysis from a global, randomised, open-label, phase 3 trial. Lancet Oncol. 2025 Aug;26(8):1067-1080. doi: 10.1016/S1470-2045(25)00330-4. Epub 2025 Jul 15.
    pmid
    40680754
    type
    DERIVED
  3. citation
    Hungria V, Hus M, Fu C, Zherebtsova V, Ward C, Ho PJ, Mikulski D, Muronova L, Cerchione C, Loubert A, Bunod L, M'Hari M, Pirooz N, Rogers R, Lin CP, Roy-Ghanta S, Opalinska JB, Purser M, McKeown A, McNamara S, Baig H, Eccersley L, Pompilus F, Mateos MV; DREAMM-7 trial study group. Patient-reported outcomes with belantamab mafodotin, bortezomib, and dexamethasone versus daratumumab, bortezomib, and dexamethasone in patients with relapsed or refractory multiple myeloma (DREAMM-7): results from a phase 3, open-label, randomised controlled trial. Lancet Haematol. 2025 Aug;12(8):e599-e610. doi: 10.1016/S2352-3026(25)00163-2. Epub 2025 Jul 15.
    pmid
    40680752
    type
    DERIVED
  4. citation
    Hungria V, Robak P, Hus M, Zherebtsova V, Ward C, Ho PJ, Ribas de Almeida AC, Hajek R, Kim K, Grosicki S, Sia H, Bryant A, Pitombeira de Lacerda M, Aparecida Martinez G, Sureda Balari AM, Sandhu I, Cerchione C, Ganly P, Dimopoulos M, Fu C, Garg M, Abdallah AO, Oriol A, Gatt ME, Cavo M, Rifkin R, Fujisaki T, Mielnik M, Pirooz N, McKeown A, McNamara S, Zhou X, Nichols M, Lewis E, Rogers R, Baig H, Eccersley L, Roy-Ghanta S, Opalinska J, Mateos MV; DREAMM-7 Investigators. Belantamab Mafodotin, Bortezomib, and Dexamethasone for Multiple Myeloma. N Engl J Med. 2024 Aug 1;391(5):393-407. doi: 10.1056/NEJMoa2405090. Epub 2024 Jun 1.
    pmid
    38828933
    type
    DERIVED
Source notices and limitations
    Discovery and provenance
    1. release id
      ctgov-registry-7ad944f6deaf1f5cd6122126
      edge id
      nct-edge-58fce20299555b0fe04e
      requested nct id
      NCT04246047
      primary nct id
      NCT04246047
      source kind
      nci_explicit_reference_or_link
      source record id
      Source null
      source file sha256
      d6d5c80c67e5b4a0e31dcb23f10af8ee613bf3cdea28b12cf6edeec4e8cb5efd
      payload sha256
      d97bd12e9cf531331fc12f478d5c9fb9727fea583f202898a0007cf422b12999
      payload
      clinical indication matching status
      not_inferred
      end exclusive
      true
      id
      nct-edge-58fce20299555b0fe04e
      link basis
      explicit_NCT_identifier_in_acquired_source
      nct id
      NCT04246047
      occurrences
      1. context exact
        x="-1">Evidence (belantamab mafodotin):</p> <div class="pdq-content-list"><ol id="_1298"><li>A prospective randomized trial (<a href="/clinicaltrials/NCT04246047">NCT04246047</a>) included 494 patients with relapsed or refractory myeloma. Patients received either belantamab mafodotin plus Vd or DVd.[<a href="#cit/sectio
        end
        350171
        exact text
        NCT04246047
        start
        350160
      2. context exact
        ce (belantamab mafodotin):</p> <div class="pdq-content-list"><ol id="_1298"><li>A prospective randomized trial (<a href="/clinicaltrials/NCT04246047">NCT04246047</a>) included 494 patients with relapsed or refractory myeloma. Patients received either belantamab mafodotin plus Vd or DVd.[<a href="#cit/section_10.74">74</
        end
        350184
        exact text
        NCT04246047
        start
        350173
      offset unit
      unicode_code_points
      source file
      /tmp/cancer-full-research/nci/raw/f296c0ceec7921f192.html
      source file sha256
      d6d5c80c67e5b4a0e31dcb23f10af8ee613bf3cdea28b12cf6edeec4e8cb5efd
      source json pointer
      Source null
      source kind
      nci_explicit_reference_or_link
      source record id
      Source null
      source retrieved at
      2026-09-09T23:22:07.301466+00:00
      source string basis
      UTF-8_text_with_universal_newline_translation
      source string sha256
      06d77adc5701fe0c36d2266d613a483252a6113e6a22b8858db2d23882bdc33b
      source title
      Plasma Cell Neoplasms (Including Multiple Myeloma) Treatment (PDQ®)–Health Professional Version
      source update dates
      1. context
        Updated: April 25, 2025
        datetime
        2025-04-25T12:00:00Z
        display
        April 25, 2025
    2. release id
      ctgov-registry-7ad944f6deaf1f5cd6122126
      edge id
      nct-edge-ba1959324ebde6a19971
      requested nct id
      NCT04246047
      primary nct id
      NCT04246047
      source kind
      fda_approval_notice
      source record id
      fda-29d861b96a3e37e4
      source file sha256
      09b4a24794027cf54dafd19e27baa5afcb5f9950bc420463fee9fd9648b51029
      payload sha256
      dfed2b77aca5ee605fb3158dbd6130cf6f79b08049df437df268b259ac2f1edf
      payload
      clinical indication matching status
      not_inferred
      end exclusive
      true
      id
      nct-edge-ba1959324ebde6a19971
      link basis
      explicit_NCT_identifier_in_acquired_source
      nct id
      NCT04246047
      occurrences
      1. context exact
        tion for Blenrep will be posted on <a href="https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm">Drugs@FDA</a>.</p><p>Efficacy was evaluated in DREAMM-7 (NCT04246047), an open-label, randomized, multicenter trial in adults with relapsed or refractory multiple myeloma who had received at least one line of prior therapy. The
        end
        25186
        exact text
        NCT04246047
        start
        25175
      offset unit
      unicode_code_points
      source event date
      2025-10-23
      source file
      /tmp/cancer-full-research/updates/pages/fda-approves-belantamab-mafodotin-blmf-relapsed-or-refractory-multiple-myeloma.html
      source file sha256
      09b4a24794027cf54dafd19e27baa5afcb5f9950bc420463fee9fd9648b51029
      source json pointer
      Source null
      source kind
      fda_approval_notice
      source record id
      fda-29d861b96a3e37e4
      source string basis
      UTF-8_text_with_universal_newline_translation
      source string sha256
      09b4a24794027cf54dafd19e27baa5afcb5f9950bc420463fee9fd9648b51029
      source title
      FDA approves belantamab mafodotin-blmf for relapsed or refractory multiple myeloma
    3. release id
      ctgov-registry-7ad944f6deaf1f5cd6122126
      edge id
      nct-edge-f340915e7b8e770994fb
      requested nct id
      NCT04246047
      primary nct id
      NCT04246047
      source kind
      fda_spl_label
      source url
      https://api.fda.gov/drug/label.json?search=%28indications_and_usage%3Acancer+OR+indications_and_usage%3Acarcinoma+OR+indications_and_usage%3Acarcinomas+OR+indications_and_usage%3Alymphoma+OR+indications_and_usage%3Alymphomas+OR+indications_and_usage%3Aleukemia+OR+indications_and_usage%3Aleukaemia+OR+indications_and_usage%3Asarcoma+OR+indications_and_usage%3Asarcomas+OR+indications_and_usage%3Amelanoma+OR+indications_and_usage%3Amyeloma+OR+indications_and_usage%3Atumor+OR+indications_and_usage%3Atumors+OR+indications_and_usage%3Atumour+OR+indications_and_usage%3Atumours+OR+indications_and_usage%3Aneoplasm+OR+indications_and_usage%3Aneoplasms+OR+indications_and_usage%3Amalignant+OR+indications_and_usage%3Amalignancy+OR+indications_and_usage%3Amyelodysplastic+OR+indications_and_usage%3Amyelofibrosis+OR+indications_and_usage%3Amastocytosis+OR+indications_and_usage%3Aglioma+OR+indications_and_usage%3Aglioblastoma+OR+indications_and_usage%3Aneuroblastoma+OR+indications_and_usage%3Aretinoblastoma+OR+indications_and_usage%3Apheochromocytoma+OR+indications_and_usage%3Aparaganglioma+OR+indications_and_usage%3Amyeloproliferative+OR+indications_and_usage%3Awaldenstrom+OR+indications_and_usage%3Apolycythemia+OR+indications_and_usage%3Athrombocythemia+OR+indications_and_usage%3Adesmoid+OR+indications_and_usage%3Aneurofibromatosis+OR+indications_and_usage%3Ahistiocytosis%29+AND+%28openfda.application_number%3ANDA%2A+OR+openfda.application_number%3ABLA%2A%29&limit=100&skip=600&sort=id%3Aasc
      source record id
      aef7c34c-fef8-407c-99c0-a68aded53c60
      source file sha256
      a9df7a5786dc51557d38f2a0881b5b5e9ae02ae396a6798e39ac96f586bcc5e6
      payload sha256
      fe36808658e817a8a3a7af38d8c68d4d737f6755ec9eb76e856538d24af6d0ee
      payload
      application numbers
      1. BLA761440
      clinical indication matching status
      not_inferred
      end exclusive
      true
      id
      nct-edge-f340915e7b8e770994fb
      link basis
      explicit_NCT_identifier_in_acquired_source
      nct id
      NCT04246047
      occurrences
      1. context exact
        acy of BLENREP in combination with bortezomib and dexamethasone (BVd) compared with daratumumab, bortezomib, and dexamethasone (DVd) was evaluated in DREAMM‑7 (NCT04246047), an open‑label, randomized, multicenter study in adult patients with relapsed or refractory multiple myeloma. Patients received at least one prior line of the
        end
        289
        exact text
        NCT04246047
        start
        278
      offset unit
      unicode_code_points
      source file
      /tmp/cancer-full-research/indications/raw/labels-00600.json
      source file sha256
      a9df7a5786dc51557d38f2a0881b5b5e9ae02ae396a6798e39ac96f586bcc5e6
      source json pointer
      /results/2/clinical_studies/0
      source kind
      fda_spl_label
      source record id
      aef7c34c-fef8-407c-99c0-a68aded53c60
      source string basis
      parsed_JSON_string_unmodified
      source string sha256
      0ca630a5b86b2128775b891390a08ef9006845956c58352cc5d13eb6209d304f
      source url
      https://api.fda.gov/drug/label.json?search=%28indications_and_usage%3Acancer+OR+indications_and_usage%3Acarcinoma+OR+indications_and_usage%3Acarcinomas+OR+indications_and_usage%3Alymphoma+OR+indications_and_usage%3Alymphomas+OR+indications_and_usage%3Aleukemia+OR+indications_and_usage%3Aleukaemia+OR+indications_and_usage%3Asarcoma+OR+indications_and_usage%3Asarcomas+OR+indications_and_usage%3Amelanoma+OR+indications_and_usage%3Amyeloma+OR+indications_and_usage%3Atumor+OR+indications_and_usage%3Atumors+OR+indications_and_usage%3Atumour+OR+indications_and_usage%3Atumours+OR+indications_and_usage%3Aneoplasm+OR+indications_and_usage%3Aneoplasms+OR+indications_and_usage%3Amalignant+OR+indications_and_usage%3Amalignancy+OR+indications_and_usage%3Amyelodysplastic+OR+indications_and_usage%3Amyelofibrosis+OR+indications_and_usage%3Amastocytosis+OR+indications_and_usage%3Aglioma+OR+indications_and_usage%3Aglioblastoma+OR+indications_and_usage%3Aneuroblastoma+OR+indications_and_usage%3Aretinoblastoma+OR+indications_and_usage%3Apheochromocytoma+OR+indications_and_usage%3Aparaganglioma+OR+indications_and_usage%3Amyeloproliferative+OR+indications_and_usage%3Awaldenstrom+OR+indications_and_usage%3Apolycythemia+OR+indications_and_usage%3Athrombocythemia+OR+indications_and_usage%3Adesmoid+OR+indications_and_usage%3Aneurofibromatosis+OR+indications_and_usage%3Ahistiocytosis%29+AND+%28openfda.application_number%3ANDA%2A+OR+openfda.application_number%3ABLA%2A%29&limit=100&skip=600&sort=id%3Aasc
      spl effective time
      20251023
      spl set id
      aef7c34c-fef8-407c-99c0-a68aded53c60

    Preserved source evidence · Not medical advice