A Study to Evaluate Daratumumab in Transplant Eligible Participants With Previously Untreated Multiple Myeloma

Study at a glance

From the registry record, last updated by the sponsor on 13 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title

Study of Daratumumab in Combination With Bortezomib (VELCADE), Thalidomide, and Dexamethasone (VTD) in the First Line Treatment of Transplant Eligible Subjects With Newly Diagnosed Multiple Myeloma

ClinicalTrials.gov ID

NCT02541383

Acronym / sponsor ID

Cassiopeia / IFM 2015-01

Conditions

Multiple Myeloma

Keywords

Untreated Multiple Myeloma, daratumumab

Phase

Phase 3

Study type

Interventional

Recruitment status

Completed

Enrolment

1,085 participants (actual)

Lead sponsor

Intergroupe Francophone du MyelomeResearch network

Collaborators

HOVON - Dutch Haemato-Oncology Association, Janssen Research & Development, LLC

Study start

Sep 2015 (actual)

Primary completion

27 Aug 2020 (actual)

Study completion

1 Sep 2023 (actual)

First posted

4 Sep 2015 (estimated)

Results

Posted 13 Apr 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose

Treatment

Allocation

Randomised

Intervention model

Parallel groups

Masking

None (open label)

Number of arms

4

Who may qualify

Ages

18 to 65 years

Sex

All

Healthy volunteers

Not accepted

Age groups

Adult, Older adult

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Primary outcome

1. Post-Consolidation Stringent Complete Response (sCR) Rate

   Time frame: At day 100 post Autologous Stem Cell Transplant (ASCT), up to 114 days post ASCT

   Post-consolidation sCR rate is defined as the percentage of ITT subjects who achieved or maintained sCR status within 30 days of Day 100 post Autologous Stem Cell Transplant (ASCT). The sCR status is assessed using the computerized algorithm according to IMWG response criteria, and must be achieved on or prior to start of subsequent therapies. Subjects must not die or progress by Day 100 post ASCT. According to the IMWG consensus recommendations for multiple myeloma treatment response criteria from 2006, the stringent complete response (sCR) was defined by a negative immunofixation on the serum and urine, and a disappearance of any soft tissue plasmacytomas, and < 5% plasma cells in bone marrow, plus normal free-light chain ratio and the absence of clonal bone marrow plasma cells by immunohistochemistry, immunofluorescence or 2- to 4-color flow cytometry.

2. Progression Free Survival (PFS) Post Completion of Maintenance Therapy

   Time frame: From the date of second randomization to either progressive disease or death which ever occurred first, with a median follow-up time of 35.4 months (cut-off for analysis was 26 months after the last rando 2 date).

   Progression Free Survival (PFS) post completion of maintenance therapy is defined as the duration from the date of second randomization to either progressive disease (according to the IMWG criteria specified in the protocol), or death, whichever occurs first (=all these considered as events) at the completion of Maintenance therapy.

Results and safety

Loading the posted results from ClinicalTrials.gov…

Research links

• Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2025.
• Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
• Results publication: PubMed 31171419Moreau P, Attal M, Hulin C, Arnulf B, Belhadj K, Benboubker L, Bene MC, Broijl A, Caillon H, Caillot D, Corre J, Delforge M, Dejoie T, Doyen C, Facon T, Sonntag C, Fontan J, Garderet L, Jie KS, Karlin L, Kuhnowski F, Lambert J, Leleu X, Lenain P, Macro M, Mathiot C, Orsini-Piocelle F, Perrot A, Stoppa AM, van de Donk NW, Wuilleme S, Zweegman S, Kolb B, Touzeau C, Roussel M, Tiab M, Marolleau JP, Meuleman N, Vekemans MC, Westerman M, Klein SK, Levin MD, Fermand JP, Escoffre-Barbe M, Eveillard JR, Garidi R, Ahmadi T, Zhuang S, Chiu C, Pei L, de Boer C, Smith E, Deraedt W, Kampfenkel T, Schecter J, Vermeulen J, Avet-Loiseau H, Sonneveld P. Bortezomib, thalidomide, and dexamethasone with or without daratumumab before and after autologous stem-cell transplantation for newly diagnosed multiple myeloma (CASSIOPEIA): a randomised, open-label, phase 3 study. Lancet. 2019 Jul 6;394(10192):29-38. doi: 10.1016/S0140-6736(19)31240-1. Epub 2019 Jun 3.
• Results publication: PubMed 34529931Moreau P, Hulin C, Perrot A, Arnulf B, Belhadj K, Benboubker L, Bene MC, Zweegman S, Caillon H, Caillot D, Corre J, Delforge M, Dejoie T, Doyen C, Facon T, Sonntag C, Fontan J, Mohty M, Jie KS, Karlin L, Kuhnowski F, Lambert J, Leleu X, Macro M, Orsini-Piocelle F, Roussel M, Stoppa AM, van de Donk NWCJ, Wuilleme S, Broijl A, Touzeau C, Tiab M, Marolleau JP, Meuleman N, Vekemans MC, Westerman M, Klein SK, Levin MD, Offner F, Escoffre-Barbe M, Eveillard JR, Garidi R, Ahmadi T, Krevvata M, Zhang K, de Boer C, Vara S, Kampfenkel T, Vanquickelberghe V, Vermeulen J, Avet-Loiseau H, Sonneveld P. Maintenance with daratumumab or observation following treatment with bortezomib, thalidomide, and dexamethasone with or without daratumumab and autologous stem-cell transplant in patients with newly diagnosed multiple myeloma (CASSIOPEIA): an open-label, randomised, phase 3 trial. Lancet Oncol. 2021 Oct;22(10):1378-1390. doi: 10.1016/S1470-2045(21)00428-9. Epub 2021 Sep 13.
• Results publication: PubMed 38889735Moreau P, Hulin C, Perrot A, Arnulf B, Belhadj K, Benboubker L, Zweegman S, Caillon H, Caillot D, Avet-Loiseau H, Delforge M, Dejoie T, Facon T, Sonntag C, Fontan J, Mohty M, Jie KS, Karlin L, Kuhnowski F, Lambert J, Leleu X, Macro M, Orsini-Piocelle F, Roussel M, Schiano de Colella JM, van de Donk NW, Wuilleme S, Broijl A, Touzeau C, Tiab M, Marolleau JP, Meuleman N, Vekemans MC, Westerman M, Klein SK, Levin MD, Offner F, Escoffre-Barbe M, Eveillard JR, Garidi R, Hua W, Wang J, Tuozzo A, de Boer C, Rowe M, Vanquickelberghe V, Carson R, Vermeulen J, Corre J, Sonneveld P; Intergroupe Francophone du Myelome, the Dutch-Belgian Cooperative Trial Group for Hematology Oncology and the CASSIOPEIA Investigators. Bortezomib, thalidomide, and dexamethasone with or without daratumumab and followed by daratumumab maintenance or observation in transplant-eligible newly diagnosed multiple myeloma: long-term follow-up of the CASSIOPEIA randomised controlled phase 3 trial. Lancet Oncol. 2024 Aug;25(8):1003-1014. doi: 10.1016/S1470-2045(24)00282-1. Epub 2024 Jun 15.
• Derived from this study: PubMed 42607072Dejoie T, Rebouh N, Corre J, Wuilleme S, Kraeber-Bodere F, Hulin C, Perrot A, Touzeau C, Leleu XP, Arnulf B, Karlin L, Moreau P, Caillon H. Blood-based MALDI-TOF mass spectrometry versus bone marrow MRD for monitoring multiple myeloma: CASSIOPEIA study results. Blood. 2026 Aug 17:blood.2026033773. doi: 10.1182/blood.2026033773. Online ahead of print.
• Derived from this study: PubMed 41894685Jamet B, Ahrari S, Zweegman S, Perrot A, Hulin C, Caillot D, Facon T, Leleu X, Belhadj K, Itti E, Karlin L, Bailly C, Levin MD, Minnema MC, Bodet-Milin C, de Keizer B, Corre J, Sonneveld P, Mateus D, Moreau P, Touzeau C, Kraeber-Bodere F, Carlier T. FDG-PET medullary total tumor volume highlights high-risk patients with newly diagnosed multiple myeloma in CASSIOPEIA trial. Blood Adv. 2026 Jun 9;10(11):3787-3798. doi: 10.1182/bloodadvances.2025019465.
• Derived from this study: PubMed 40991848Kraeber-Bodere F, Jamet B, Zweegman S, Perrot A, Hulin C, Caillot D, Facon T, Leleu X, Belhadj K, Itti E, Karlin L, Bailly C, Levin MD, Minnema MC, Bodet-Milin C, de Keizer B, Corre J, Sonneveld P, Moreau P, Carlier T, Touzeau C. Prognostic value of premaintenance FDG PET/CT response in patients with newly diagnosed myeloma from the CASSIOPEIA trial. Blood. 2025 Dec 18;146(25):3050-3058. doi: 10.1182/blood.2025030084.
• Derived from this study: PubMed 40127397Corre J, Vincent L, Moreau P, Hebraud B, Hulin C, Bene MC, Broijl A, Caillot D, Delforge M, Dejoie T, Facon T, Lambert J, Leleu X, Macro M, Perrot A, Zweegman S, Filleron T, Cabarrou B, van de Donk NWCJ, Maheo S, Hua W, Wang J, Krevvata M, Vanquickelberghe V, de Boer C, Tuozzo A, Borgsten F, Rowe M, Carson R, Wuilleme S, Sonneveld P. Daratumumab-bortezomib-thalidomide-dexamethasone for newly diagnosed myeloma: CASSIOPEIA minimal residual disease results. Blood. 2025 Aug 7;146(6):679-692. doi: 10.1182/blood.2024027620.
• Derived from this study: PubMed 36263839Kraeber-Bodere F, Zweegman S, Perrot A, Hulin C, Caillot D, Facon T, Leleu X, Belhadj K, Itti E, Karlin L, Bailly C, Levin MD, Minnema MC, Jamet B, Bodet-Milin C, De Keizer B, Bene MC, Avet-Loiseau H, Sonneveld P, Pei L, Rigat F, De Boer C, Vermeulen J, Kampfenkel T, Lambert J, Moreau P. Prognostic value of positron emission tomography/computed tomography in transplant-eligible newly diagnosed multiple myeloma patients from CASSIOPEIA: the CASSIOPET study. Haematologica. 2023 Feb 1;108(2):621-626. doi: 10.3324/haematol.2021.280051. No abstract available.
• Derived from this study: PubMed 35086897Alberge JB, Kraeber-Bodere F, Jamet B, Touzeau C, Caillon H, Wuilleme S, Bene MC, Kampfenkel T, Sonneveld P, van Duin M, Avet-Loiseau H, Corre J, Magrangeas F, Carlier T, Bodet-Milin C, Cherel M, Moreau P, Minvielle S, Bailly C. Molecular Signature of 18F-FDG PET Biomarkers in Newly Diagnosed Multiple Myeloma Patients: A Genome-Wide Transcriptome Analysis from the CASSIOPET Study. J Nucl Med. 2022 Jul;63(7):1008-1013. doi: 10.2967/jnumed.121.262884. Epub 2022 Jan 27.
• Derived from this study: PubMed 33657786Hulin C, Offner F, Moreau P, Roussel M, Belhadj K, Benboubker L, Caillot D, Facon T, Garderet L, Kuhnowski F, Stoppa AM, Kolb B, Tiab M, Jie KS, Westerman M, Lambert J, Pei L, Vanquickelberghe V, De Boer C, Vermeulen J, Kampfenkel T, Sonneveld P, Van de Donk NWCJ. Stem cell yield and transplantation in transplant-eligible newly diagnosed multiple myeloma patients receiving daratumumab + bortezomib/thalidomide/dexamethasone in the phase 3 CASSIOPEIA study. Haematologica. 2021 Aug 1;106(8):2257-2260. doi: 10.3324/haematol.2020.261842. No abstract available.
• Derived from this study: PubMed 33242444Roussel M, Moreau P, Hebraud B, Laribi K, Jaccard A, Dib M, Slama B, Dorvaux V, Royer B, Frenzel L, Zweegman S, Klein SK, Broijl A, Jie KS, Wang J, Vanquickelberghe V, de Boer C, Kampfenkel T, Gries KS, Fastenau J, Sonneveld P. Bortezomib, thalidomide, and dexamethasone with or without daratumumab for transplantation-eligible patients with newly diagnosed multiple myeloma (CASSIOPEIA): health-related quality of life outcomes of a randomised, open-label, phase 3 trial. Lancet Haematol. 2020 Dec;7(12):e874-e883. doi: 10.1016/S2352-3026(20)30356-2.

Related trials for Multiple Myeloma

• Not yet recruitingPhase 2

  Study of YKST02 in Adults With Relapsed or Refractory Multiple Myeloma

  Relapsed or Refractory Multiple Myeloma (RRMM)

• RecruitingPhase 2

  Engaging T-cells to Eliminate MRD in Newly Diagnosed Myeloma Optimizing Response With Talquetmab and Teclistamab (ROTATE)

  Multiple Myeloma

• Active, not recruitingPhase 3

  A Phase III Study of Eque-cel in Subjects With Len-refractory RRMM (FUMANBA-03)

  Multiple Myeloma

• Active, not recruitingPhase 1/2

  A Window of Opportunity Trial to Learn if Linvoseltamab is Safe and Well Tolerated, and How Well it Works in Adult Participants With Recently Diagnosed Multiple Myeloma Who Have Not Already Received Treatment

  Multiple Myeloma

• Active, not recruitingPhase 2

  Testing AZD5363 as a Potential Targeted Treatment in Cancers With AKT Genetic Changes (MATCH-Subprotocol Y)

  Advanced Lymphoma, Advanced Malignant Solid Neoplasm

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

107 sites in 3 countries: see every site and its status.