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Evaluation of Efficacy and Safety of Belantamab Mafodotin, Bortezomib and Dexamethasone Versus Daratumumab, Bortezomib and Dexamethasone in Participants With Relapsed/Refractory Multiple Myeloma (DREAMM 7)

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ClinicalTrials.gov Identifier: NCT04246047
Recruitment Status : Recruiting
First Posted : January 29, 2020
Last Update Posted : December 10, 2020
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Study Description
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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.

Condition or disease Intervention/treatment Phase
Multiple Myeloma Drug: Belantamab mafodotin Drug: Daratumumab Drug: Bortezomib Drug: Dexamethasone Phase 3

Expanded Access : An investigational treatment associated with this study is available outside the clinical trial.   More info ...

Detailed Description:
Approximately 478 participants will be randomized 1:1 to Arm A (B-Vd) or Arm B (D-Vd). Treatment will continue in both arms until progressive disease, death, unacceptable toxicity, withdrawal of consent or end of study, whichever occurs first.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 478 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Masking Description: This is an open-label study; therefore, no blinding of treatment identity is needed.
Primary Purpose: Treatment
Official Title: DREAMM 7: A Multicenter, Open-Label, Randomized Phase III Study to Evaluate the Efficacy and Safety of the Combination of Belantamab Mafodotin, Bortezomib, and Dexamethasone (B-Vd) Compared With the Combination of Daratumumab, Bortezomib and Dexamethasone (D-Vd) in Participants With Relapsed/Refractory Multiple Myeloma
Actual Study Start Date : May 7, 2020
Estimated Primary Completion Date : June 21, 2023
Estimated Study Completion Date : August 13, 2026

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Multiple Myeloma

Arms and Interventions
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Arm Intervention/treatment
Experimental: Belantamab mafodotin and Bortezomib plus Dexamethasone (Arm A) Drug: Belantamab mafodotin
Humanized anti-B-cell maturation antigen (BCMA) antibody/drug conjugate

Drug: Bortezomib
Proteasome Inhibitor

Drug: Dexamethasone
Synthetic glucocorticoid with anti-tumor activity
Active Comparator: Daratumumab and Bortezomib plus Dexamethasone (Arm B) Drug: Daratumumab
Anti-cluster of differentiation 38 [CD-38] monoclonal antibody

Drug: Bortezomib
Proteasome Inhibitor

Drug: Dexamethasone
Synthetic glucocorticoid with anti-tumor activity


Outcome Measures
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Primary Outcome Measures :
  1. Progression-free survival [ Time Frame: Up to an average of 34 months ]
    Time from start of study treatment to the first documented disease progression or death due to any cause, whichever occurs first.


Secondary Outcome Measures :
  1. Complete response rate (CRR) [ Time Frame: Up to 74 months ]
    Percentage of participants with a confirmed complete response or better.

  2. Overall response rate (ORR) [ Time Frame: Up to 74 months ]
    Percentage of participants with a confirmed partial response or better.

  3. Duration of response (DoR) after administration of study treatment [ Time Frame: Up to 74 months ]
    Time from first documented evidence of partial response or better to date of first documented progression or death, whichever occurs first.

  4. Time to response (TTR) after administration of study treatment [ Time Frame: Up to 74 months ]
    Time from the start of study treatment to the first documented evidence of response among participants who achieve partial response or better.

  5. Time to Progression (TTP) after administration of study treatment [ Time Frame: Up to 74 months ]
    Time from the start of study treatment until the first documented date of disease progression or death, whichever occurs first.

  6. Overall survival (OS) [ Time Frame: Up to 74 months ]
    Time from randomization to death due to any cause.

  7. Progression-free survival on subsequent line of therapy (PFS2) [ Time Frame: Up to 74 months ]
    Time from start of study treatment to disease progression after initiation of new anti-cancer therapy or death from any cause, whichever occurs first.

  8. Minimal Residual Disease (MRD) negativity rate after administration of study treatment [ Time Frame: Up to 74 months ]
    Percentage of participants who are MRD negative by next-generation sequencing.

  9. Number of participants with adverse events (AEs) [ Time Frame: Up to 74 months ]
    AEs will be collected, including abnormal laboratory parameters.

  10. Number of participants with serious adverse events (SAEs) [ Time Frame: Up to 74 months ]
    SAEs will be collected.

  11. Number of participants with abnormal ocular findings on ophthalmic examination [ Time Frame: Up to 74 months ]
    Ophthalmic examination will assess abnormal findings.

  12. Plasma concentrations of belantamab mafodotin at indicated time points [ Time Frame: Up to 74 months ]
    Plasma concentrations of belantamab mafodotin in Arm A.

  13. Plasma concentrations of total monoclonal antibody (mAb) at indicated time points [ Time Frame: Up to 74 months ]
    Plasma concentrations of total mAb in Arm A.

  14. Plasma concentrations of monomethyl auristatin-F with a cysteine linker (cys-mcMMAF) at indicated time points [ Time Frame: Up to 74 months ]
    Plasma concentrations of cys-mcMMAF in Arm A.

  15. Number of participants with positive anti-drug antibodies (ADAs) against belantamab mafodotin [ Time Frame: Up to 74 months ]
    Plasma concentrations of belantamab mafodotin ADAs in Arm A.

  16. Titers of ADAs against belantamab mafodotin [ Time Frame: Up to 74 months ]
    Titers of ADAs in Arm A.

  17. Change from Baseline in symptoms as measured by Patient-Reported Outcome Version of the Common Term Criteria for Adverse Events (PRO-CTCAE) [ Time Frame: Baseline and Up to 74 months ]
    PRO-CTCAE questionnaire assesses side effect symptoms in cancer clinical trials using a PRO-CTCAE score.

  18. Change from Baseline in impacts as measured by PRO-CTCAE [ Time Frame: Baseline and Up to 74 months ]
    PRO-CTCAE questionnaire assesses side effect symptoms in cancer clinical trial. Impacts of the side effects will be assessed using PRO-CTCAE score.

  19. 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) [ Time Frame: Baseline and Up to 74 months ]
    EORTC Quality of Life questionnaire QLQ-C30 on a scale of 0-100. Lower scores correlate with worse quality of life and higher scores correlate with better quality of life.

  20. Change from Baseline in HRQoL as measured by EORTC, 20-Item Multiple Myeloma Module (QLQ-MY20) [ Time Frame: Baseline and Up to 74 months ]
    EORTC 20-item Multiple Myeloma Module QLQ-MY20 questionnaire: only Disease Symptoms Domain will be administered. A high score represents a high level of symptoms or problems.


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04246047


Contacts
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Contact: US GSK Clinical Trials Call Center 877-379-3718 GSKClinicalSupportHD@gsk.com
Contact: EU GSK Clinical Trials Call Center +44 (0) 20 89904466 GSKClinicalSupportHD@gsk.com

Locations
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Sponsors and Collaborators
GlaxoSmithKline
Investigators
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Study Director: GSK Clinical Trials GlaxoSmithKline
More Information
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Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT04246047    
Other Study ID Numbers: 207503
First Posted: January 29, 2020    Key Record Dates
Last Update Posted: December 10, 2020
Last Verified: December 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: IPD for this study will be made available via the Clinical Study Data Request site.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Time Frame: IPD will be made available within 6 months of publishing the results of the primary endpoints, key secondary endpoints and safety data of the study
Access Criteria: Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.
URL: http://clinicalstudydatarequest.com

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by GlaxoSmithKline:
Belantamab mafodotin
Relapsed/refractory multiple myeloma
Daratumumab
Bortezomib
Dexamethasone
Additional relevant MeSH terms:
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Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
 Dexamethasone
Bortezomib
Daratumumab
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents