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Multiple Myeloma in RelapsePhase 2NCT06282978

Study of Elranatamab for Relapsed or Refractory Myeloma in Patients Previously Exposed to Three-drug Classes

A Phase 2 study testing Elranatamab (PF-06863135) in people with Multiple Myeloma in Relapse, run by PETHEMA Foundation at 13 sites in Spain.

Active, not recruiting

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

Official record
Search all trials

Trial summary

The goal of this phase II, open-label, single-arm, multicenter study is to evaluate i) the efficacy and ii) safety of elranatamab monotherapy at the dose of 76 mg subcutaneously in participants with RRMM after at least one or two prior lines of therapy who have received prior treatment with immunomodulatory drugs… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Multiple Myeloma in Relapse
What is being tested?
Elranatamab (PF-06863135)
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50 participants
Where
13 sitesSpain
Study dates
23 Nov 2023to Dec 2029
Phase
Phase 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

  • Male or female, 18 years or older (at the time consent is obtained).
  • Patient who, in the investigator's opinion, is able to comply with the protocol requirements.
  • Prior diagnosis of MM as defined according to IMWG criteria.
  • Patient has given voluntary written informed consent before performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the patient at any time without prejudice to their future medical care.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 or 2 prior lines of therapy including at least to one proteasome inhibitor (bortezomib, carfilzomib or ixazomib), one immunomodulatory drug (lenalidomide is mandatory and patients can be also have been exposed to pomalidomide) and at least one anti-CD38 monoclonal antibody (daratumumab or isatuximab).
  • Patients must be refractory to the last line of therapy, defined as progression while receiving treatment or in the first 60 days after the last dose of treatment.
  • Patient 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 in whom disease is only measurable by serum FLC, the involved FLC should be ≥ 10mg/dL (100 mg/L), with an abnormal serum FLC ratio.

Who cannot join

  • Subject has a diagnosis of primary amyloidosis, monoclonal gammopathy of undetermined significance (MGUS), smoldering multiple myeloma (SMM), POEMS syndrome (defined by the presence of peripheral neuropathy, organomegaly, endocrinopathy, monoclonal plasma-cells proliferative disorder, and skin changes) or plasma cell leukemia.
  • Prior anti-BCMA treatment.
  • Subject has peripheral neuropathy or neuropathic pain grade 2 or higher, as defined by the National Cancer Institute Terminology Criteria for Adverse Events (NCI CTCAE) Version 5.
  • History of Guillain-Barré syndrome (GBS) or GBS variants, or history of any Grade ≥3 peripheral motor polyneuropathy.
  • Stem cell transplant within 12 weeks prior to enrolment.

Trial locations and contacts

13 sites in 1 country.

13 sites in 1 country

Spain13 sites

  • Institut Catala d'Oncologia (ICO) Badalona - Hospital Universitari Germans Trias i Pujol

    Badalona, Barcelona, 08916

  • H. Clínic i Provincial de Barcelona

    Barcelona, 08036

  • Hospital Clínico Universitario Virgen de la Arrixaca

    El Palmar, Murcia, 30120

  • Hospital de Cabueñes

    Gijón, 33394

  • Hospital Universitario de Jerez de la Frontera

    Jerez de la Frontera, Cádiz, 11407

  • CHU de Gran Canaria Doctor Negrín

    Las Palmas de Gran Canaria, Las Palmas, 35010

  • Complejo Asistencial Universitario de León

    León

  • Hospital Universitario Lucus Augusti

    Lugo

  • Hospital Son Llàtzer

    Palma de Mallorca, Balearic Islands, 07198

  • Hospital Clínico Universitario Salamanca

    Salamanca, 37007

  • Hospital Universitario Marqués de Valdecilla

    Santander, Cantabria, 39008

  • Hospital Clínico Universitario de Santiago ~ CHUS

    Santiago de Compostela, A Coruña, 15706

  • C.H. de Toledo (Virgen de la Salud)

    Toledo, 45005

Other trials in Spain

About this study

Official title: An Open Label, Multicenter, Phase II Study of Elranatamab as Single Agent for the Treatment of Relapsed or Refractory Myeloma in Patients Previously Exposed to Three-drug Classes (GEM-RANTAB)

The goal of this phase II, open-label, single-arm, multicenter study is to evaluate i) the efficacy and ii) safety of elranatamab monotherapy at the dose of 76 mg subcutaneously in participants with RRMM after at least one or two prior lines of therapy who have received prior treatment with immunomodulatory drugs, protease inhibitors, and anti-CD38 therapy and were refractory to the last line of therapy, defined as progression while receiving treatment or in the first 60 days after the last dose of treatment.

Efficacy refers to the rate of Undetectable Measurable Residual Disease at 6 and 12 months as per International Myeloma Working Group (IMWG) criteria evaluated by the investigators.

Read more

Safety refers to the measurement of:

  1. Adverse events (AEs) and serious adverse events (SAEs) according to standard clinical and laboratory tests (hematology and chemistry, physical examination, vital sign measurements, and diagnostic tests). ii) Incidence and severity of Cytokine Release Syndrome (CRS) and Immune effector cell associated neurotoxicity syndrome (ICANS) according to the American Society for Transplantation and Cellular Therapy (ASTCT) criteria. iii) Incidence and severity of other neurotoxicities. iv) Incidence of cytopenias and infections

The study consists of a screening/baseline period, a treatment period, and a posttreatment follow-up period. The study includes a periodic review of safety data, that will be independently analyzed by the Data Safety Independent Committee (DSMC) and will recommend how to proceed with the study.

Read the detailed description

Treatment with elranatamab will be initiated using a 2-step-up priming regimen: the initial doses of elranatamab will be 12 mg (Cycle 1 Day 1) and 32 mg (Cycle1 Day 4). Participants should be hospitalized and monitored for toxicity (especially CRS/ICANS) for at least 2 days (~48 hours) beginning on Cycle 1 Day 1, and for 1 day (~24 hours) for Cycle1 Day 4. The dose of elranatamab should be increased to 76 mg on Cycle 1 Day 8 as long as the participant meets the redosing criteria or deferred until the criteria are met.

The scheme of administration includes weekly administrations for at least six 4-weeks cycles and, if patients have achieved at least PR (or better) persisting for at least 2 months, the dose interval should be changed from weekly to every other week. Treatment will be scheduled with a response-adapted duration and patients achieving undetectable measurable residual disease and maintained for 12 months will stop therapy. After stopping therapy, and if the patient is in sustained undetectable measurable residual disease for at least 12 months, it would be possible to re-start treatment with elranatamab in case the measurable residual disease will be detectable or relapse from CR will occur. Patients who will not achieve undetectable measurable residual disease sustained for 12 months will receive continuous treatment until progressive disease. In both situations, the occurrence of unacceptable toxicity might result into the treatment discontinuation.

Being tested
Elranatamab (PF-06863135)
Keywords
Relapsed Refractory Multiple Myeloma, Elranatamab
Medical subject headings
Multiple Myeloma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Elranatamab (PF-06863135)Drug

    The scheme of administration includes weekly administrations for at least six 4-weeks cycles and, if patients have achieved at least PR (or better) persisting for at least 2 months, the dose interval should be changed from weekly to every other week. Treatment will be scheduled with a response-adapted duration and patients achieving undetectable measurable residual disease (MRD) and maintained for 12 months will stop therapy. After stopping therapy, and if the patient is in sustained undetectable MRD for at least 12 months, it would be possible to re-start treatment with elranatamab in case the MRD will be detectable or relapse from CR will occur. Patients who will not achieve undetectable MRD sustained for 12 months will receive continuous treatment until progressive disease.

Study groups in NCT06282978
Study groupRoleWhat they receive
ElranatamabExperimentalElranatamab will be administered by subcutaneous (SC) injection
Receives: Drug: Elranatamab (PF-06863135)

What is being measured

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

  1. To evaluate the rate of Undetectable Measurable Residual Disease (uMRD) at 6 and 12 months as per International Myeloma Working Group (IMWG) criteria evaluated by the investigators of elranatamab in patients with relapsed/refractory multiple myeloma.

    To evaluate the rate of uMRD at 6 and 12 months (defined as the percentage of participants who are MRD negative by next generation flow cytometry (NGF) method and with a sensitivity level of at least 10-5) of elranatamab in patients with relapsed/refractory multiple myeloma. Next generation flow cytometry is a reproducible biomarker to detect the presence of phenotypically abnormal clonal plasma cells (Measurable Residual Disease). The presence of surface markers (CD138, CD27, CD38, CD56, CD45, CD19) and certain morphological characteristics (FSC and SSC) permit the specific identification of plasma cells (PC). This will permit unique, high specificity confirmation of the monoclonality of phenotypically abnormal plasma cells (by light chain restriction). Said cells will have been clearly identified by low antigen expression (CD19, CD27, CD38, CD45, CD81) or overexpression (CD56, CD117, CD138).

    Measured: 5 Years

Secondary outcomes (22)

  1. To evaluate annually by NGF until loss of response, the rate of Undetectable Measurable Residual Disease (% of patients with MRD negative by NGF method and with a sensitivity level of 10-5) of elranatamab in patients with R/R multiple myeloma.

    To evaluate annually by Next Generation Flow Cytometry until loss of response, the rate of Undetectable Measurable Residual Disease (defined as the percentage of participants who are MRD negative by next generation flow cytometry method and with a sensitivity level of at least 10-5) of elranatamab in patients with relapsed/refractory multiple myeloma. Next generation flow cytometry is a reproducible biomarker to detect the presence of phenotypically abnormal clonal plasma cells (Measurable Residual Disease). The presence of surface markers (CD138, CD27, CD38, CD56, CD45, CD19) and certain morphological characteristics (FSC and SSC) permit the specific identification of plasma cells (PC). This will permit unique, high specificity confirmation of the monoclonality of phenotypically abnormal plasma cells (by light chain restriction). Said cells will have been clearly identified by low antigen expression (CD19, CD27, CD38, CD45, CD81) or overexpression (CD56, CD117, CD138).

    Measured: 5 Years

  2. Incidence and severity Adverse Events (AEs) and Serious Adverse Event (SAEs) as assessed by changes in laboratory values in blood and biochemistry tests.

    Blood test will measure complete blood count, hemoglobin, white blood cell count with differential count and platelet count.

    Biochemistry test will measure urea, creatinine, uric acid, bilirubin, alkaline phosphatase, LDH, AST, ALT, sodium, chloride, calcium, potassium and, glucose, magnesium, GGT, CRP and CPK.

    Measured: 5 Years

  3. Incidence and severity Adverse Events (AEs) and Serious Adverse Event (SAEs) as assessed by changes in physical examination and ECOG performance status scale (0-5).

    Physical examination will include the examination of general appearance, skin, neck (including thyroid), eyes, ears, nose, throat, lungs, heart, absomen, back, lymph nodes, extremities, vascular and neurological.

    Heght in centimetres (cm), body weight (kg).

    ECOG performance status has scale from 0 (fully active) to 5 (dead).

    Measured: 5 Years

  4. Incidence and severity Adverse Events (AEs) and Serious Adverse Event (SAEs) as assessed by changes in vital sign measurements.

    Vital signs will include the systolic and diastolic blood pressure, temperature, pulse rate, respiratory rate and oxygen saturation. Vital signs must be measured after resting for at least 5 minutes. Vital signs must be measured more frequently if warranted by the clinical condition of the participant. Vital signs are to be monitored at least every 4 hours (± 15 min) during first 48 hours after the first dose of study intervention (C1D1) and 24 hours after second dose of study intervention (C1D4).

    Measured: 5 Years

  5. Incidence and severity Adverse Events (AEs) and Serious Adverse Event (SAEs) as assessed by pregnancy test.

    Pregnancy test will be assessed by Serum beta-human chorionic gonadotropin (β -HCG) pregnancy test for female participants of childbearing potential only.

    Measured: 5 Years

  6. Incidence and severity Adverse Events (AEs) and Serious Adverse Event (SAEs) as assessed by changes in 12-lead ECG.

    Electrocardiograms (ECG) must be recorded after 10 minutes rest in the supine position to ensure a table baseline. ECG will be performed at screening and end of treatment, but this test can be repeated throughout the study at the discretion of investigators.

    A standard 12-lead ECG will include a general diagnostic impression as well as measurement of the heart rate, PR interval, QRS duration, QT interval, and the Fridericia-corrected QT interval (QTcF). The QTcF must be used for clinical decisions. The investigator must calculate QTcF if its is not auto calculated by the ECG machine.

    Measured: 5 Years

  7. Incidence and severity Adverse Events (AEs) and Serious Adverse Event (SAEs) as assessed by changes in Echocardiogram / MUGA.

    This test will be will be performed at screening and end of treatment, but can be repeated when clinically indicated based on patient condition. A MUGA scan is also valid.

    Echocardiogram will include a Left ventricular ejection fraction (LVEF %).

    Measured: 5 Years

  8. To determine Circulating Tumor Cells (CTC) at baseline to evaluate its prognostic value.

    Counting of CTC by next generation flow cytometry and correlation of the number of CTC with MRD and survival will be done.

    Measured: 5 Years

  9. To determine serum BCMA levels and its correlation with response.

    Values of BCMA in blood samples (serum) will be correlated with MRD and survival.

    Measured: 5 Years

  10. To do gene expression techniques (RNA sequencing and single cell sequencing studies) coupled with intelligent clinical and molecular data analysis (i.e. machine learning) to identify factors that could predict response to elranatamab.

    Statistical analysis will be done to find significant changes in gene expression which identify markers of response (MRD negativity or positivity) to elranatamab.

    Measured: 5 Years

  11. To determine MRD value with alternative methods

    Mass spectrometry (alternative method) will be used to complement the evaluation of the response by the conventional techniques like electrophoresis, immunofixation and next generation flow cytometry.

    Measured: 5 Years

  12. To characterize patients' immune system

    Next generation flow cytometry (NGF) will be used to identify and characterize T, B, NK, monocytes and normal/clonal Plasma Cells (including BCMA antigen expression).

    NGF for the quantification of soluble factors: IL6, IL2, IFNγ and TNFα.

    Measured: 5 Years

  13. To define genomic determinants of response/resistance

    This determination will be done by next generation flow cytometry by Fluorescence-Activated Cell Sorting (FACS) sorting of T and Pathological Plasma Cells at inclusion and at progressive disease, and of T cells after the first dose.

    Measured: 5 Years

  14. To evaluate Overall Response Rate of elranatamab in patients with relapsed/refractory multiple myeloma.

    Measurement of Overall response rate and the different responses categories according to the IMWG criteria as evaluated by investigator

    Measured: 5 years

  15. To evaluate Duration of Response of elranatamab in patients with relapsed/refractory multiple myeloma.

    Duration of response refers to the time from Complete Remission achievement to loss of response/disease progression.

    Measured: 5 years

  16. To evaluate Time to first and best response of elranatamab in patients with relapsed/refractory multiple myeloma.

    Time to first and best response refers to the time from first Complete Remission achievement to disease progression. The degree of response is also assessed and correltaes with the level of MRD measured by Next Generation Flow Cytometry.

    Measured: 5 years

  17. To evaluate Progression-free survival (PFS) of elranatamab in patients with relapsed/refractory multiple myeloma.

    PFS is defined as the time from the date of first dose of study drug to the date of first documented disease progression, as defined in the International Myeloma Working Group (IMWG) criteria, or death due to any cause, whichever occurs first. For subjects who have not progressed and are alive, data will be censored at the last disease evaluation before the start of any subsequent anti-myeloma therapy. PFS is measured in months

    Measured: 5 years

  18. To evaluate Overall survival (OS) of elranatamab in patients with relapsed/refractory multiple myeloma.

    OS is defined as the time from the date of first dose of study drug to the date of the subject's death. If the subject is alive or the vital status is unknown, then the subject's data will be censored at the date the subject was last known to be alive. OS is measured in months.

    Measured: 5 years

  19. To evaluate PFS in those patients who stop treatment because of sustained MRD-positive for 12 months of elranatamab in patients with relapsed/refractory multiple myeloma.

    The same definitions used above but restricted to patients with poor response to therapy (sustained MRD-positive for 12 months)

    Measured: 5 yerars

  20. To evaluate OS in those patients who stop treatment because of sustained MRD-positive for 12 months of elranatamab in patients with relapsed/refractory multiple myeloma.

    The same definitions used above but restricted to patients with poor response to therapy (sustained MRD-positive for 12 months)

    Measured: 5 yerars

  21. To evaluate the Incidence of neurologic effects related to elranatamab in patients with relapsed/refractory multiple myeloma.

    Incidence and severity of Cytokine Release Syndrome (CRS) and Immune effector cell associated neurotoxicity syndrome (ICANS) will be collected according to the American Society for Transplantation and Cellular Therapy (ASTCT) criteria. Incidence and degree of other neurotoxicities.

    Measured: 5 years

  22. To evaluate the Incidence of cytopenias and infections related to elranatamab in patients with relapsed/refractory multiple myeloma.

    Incidence and degree of cytopenias and infections according to the American Society for Transplantation and Cellular Therapy (ASTCT) criteria.

    Measured: 5 years

Timeline

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

  1. First posted28 Feb 2024
  2. Study start23 Nov 2023
  3. Primary completion30 May 2025
  4. Study completionDec 2029 (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 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
This is an open label, multicenter, phase II study of Elranatamab as single agent. The primary aiming is to evaluate the efficacy of elranatamab monotherapy in participants with relapsed refractory multiple myeloma (RRMM) who had received prior treatment with immunomodulatory drugs, protease inhibitors, and anti-CD38 therapy and were refractory to the last line of therapy as evaluated with the rate of complete Response and Undetectable Measurable Residual Disease. Efficacy refers to the rate of Undetectable Measurable Residual Disease at 6 and 12 months as per International Myeloma Working Group (IMWG) criteria evaluated by the investigators.
Masking
None (open label)
Enrolment
50 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06282978
Sponsor's protocol ID
GEM-RANTAB
Other IDs
2023-504273-21, 2023
Status last verified
May 2026
First submitted
23 Nov 2023
Last updated
4 Jun 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No: All participant data relating to the study will be recorded on electronic CRF unless transmitted to the sponsor or designee electronically (e.g., laboratory data). The investigator is responsible for verifying that data entries are accurate and correct by physically or electronically signing the eCRF. Results of this clinical trial, positive or negative, will be presented at scientific conferences and published in scientific journals.

Publications

  • van de Donk NWCJ, Pawlyn C, Yong KL. Multiple myeloma. Lancet. 2021 Jan 30;397(10272):410-427. doi: 10.1016/S0140-6736(21)00135-5.

    PubMed 33516340

  • Dimopoulos MA, Moreau P, Terpos E, Mateos MV, Zweegman S, Cook G, Delforge M, Hajek R, Schjesvold F, Cavo M, Goldschmidt H, Facon T, Einsele H, Boccadoro M, San-Miguel J, Sonneveld P, Mey U; EHA Guidelines Committee. Electronic address: guidelines@ehaweb.org; ESMO Guidelines Committee. Electronic address: clinicalguidelines@esmo.org. Multiple myeloma: EHA-ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-updagger. Ann Oncol. 2021 Mar;32(3):309-322. doi: 10.1016/j.annonc.2020.11.014. Epub 2021 Feb 3. No abstract available.

    PubMed 33549387

  • Moreau P, Kumar SK, San Miguel J, Davies F, Zamagni E, Bahlis N, Ludwig H, Mikhael J, Terpos E, Schjesvold F, Martin T, Yong K, Durie BGM, Facon T, Jurczyszyn A, Sidana S, Raje N, van de Donk N, Lonial S, Cavo M, Kristinsson SY, Lentzsch S, Hajek R, Anderson KC, Joao C, Einsele H, Sonneveld P, Engelhardt M, Fonseca R, Vangsted A, Weisel K, Baz R, Hungria V, Berdeja JG, Leal da Costa F, Maiolino A, Waage A, Vesole DH, Ocio EM, Quach H, Driessen C, Blade J, Leleu X, Riva E, Bergsagel PL, Hou J, Chng WJ, Mellqvist UH, Dytfeld D, Harousseau JL, Goldschmidt H, Laubach J, Munshi NC, Gay F, Beksac M, Costa LJ, Kaiser M, Hari P, Boccadoro M, Usmani SZ, Zweegman S, Holstein S, Sezer O, Harrison S, Nahi H, Cook G, Mateos MV, Rajkumar SV, Dimopoulos MA, Richardson PG. Treatment of relapsed and refractory multiple myeloma: recommendations from the International Myeloma Working Group. Lancet Oncol. 2021 Mar;22(3):e105-e118. doi: 10.1016/S1470-2045(20)30756-7.

    PubMed 33662288

  • Casanova M, Mateos MV, de Arriba F, al. e. Determination of the Value Contribution of Belantamab Mafodotin (Belamaf; BLENREP®) for the Treatment of Triple-Class Refractory Multiple Myeloma in Spain through Reflective Multi-Criteria Decision Analysis. Rev Esp Econ Salud. 2021;16(3):58-69.

  • European Medicines Agency. NEXPOVIO. Summary of Product Characteristics. Available at: https://www.ema.europa.eu/en/documents/product-information/nexpovio-epar-product-informat ion_es.pdf . 2022.

  • European Medicines Agency. BLENREP. Summary of Product Characteristics. Available at: https://www.ema.europa.eu/en/documents/product-information/blenrep-epar-product-informa tion_es.pdf . 2022.

  • Yang Q, Li X, Zhang F, Yang Q, Zhou W, Liu J. Efficacy and Safety of CAR-T Therapy for Relapse or Refractory Multiple Myeloma: A systematic review and meta-analysis. Int J Med Sci. 2021 Feb 18;18(8):1786-1797. doi: 10.7150/ijms.46811. eCollection 2021.

    PubMed 33746596

  • Zhang L, Shen X, Yu W, Li J, Zhang J, Zhang R, Li J, Chen L. Comprehensive meta-analysis of anti-BCMA chimeric antigen receptor T-cell therapy in relapsed or refractory multiple myeloma. Ann Med. 2021 Dec;53(1):1547-1559. doi: 10.1080/07853890.2021.1970218.

    PubMed 34459681

  • Cho SF, Yeh TJ, Anderson KC, Tai YT. Bispecific antibodies in multiple myeloma treatment: A journey in progress. Front Oncol. 2022 Oct 18;12:1032775. doi: 10.3389/fonc.2022.1032775. eCollection 2022.

    PubMed 36330495

  • Food and Drug Administration. FDA approves idecabtagene vicleucel for multiple myeloma. Available at: https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-idecabtagenevicleucel- multiple-myeloma . 2022.

  • European Medicines Agency. Abecma. Summary of Product Characteristics. Available at: https://www.ema.europa.eu/en/documents/product-information/abecma-epar-product-informati on_en.pdf . 2022.

  • Food and Drug Administration. FDA approves ciltacabtagene autoleucel for relapsed or refractory multiple myeloma. Available at: https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-ciltacabtageneautoleucel- relapsed-or-refractory-multiple-myeloma . 2022.

  • European Medicines Agency. CARVYKTI. Summary of Product Characteristics. Available at: https://www.ema.europa.eu/en/documents/product-information/carvykti-epar-product-informatio n_en.pdf . 2022.

  • Munshi NC, Anderson LD Jr, Shah N, Madduri D, Berdeja J, Lonial S, Raje N, Lin Y, Siegel D, Oriol A, Moreau P, Yakoub-Agha I, Delforge M, Cavo M, Einsele H, Goldschmidt H, Weisel K, Rambaldi A, Reece D, Petrocca F, Massaro M, Connarn JN, Kaiser S, Patel P, Huang L, Campbell TB, Hege K, San-Miguel J. Idecabtagene Vicleucel in Relapsed and Refractory Multiple Myeloma. N Engl J Med. 2021 Feb 25;384(8):705-716. doi: 10.1056/NEJMoa2024850.

    PubMed 33626253

  • Berdeja JG, Madduri D, Usmani SZ, Jakubowiak A, Agha M, Cohen AD, Stewart AK, Hari P, Htut M, Lesokhin A, Deol A, Munshi NC, O'Donnell E, Avigan D, Singh I, Zudaire E, Yeh TM, Allred AJ, Olyslager Y, Banerjee A, Jackson CC, Goldberg JD, Schecter JM, Deraedt W, Zhuang SH, Infante J, Geng D, Wu X, Carrasco-Alfonso MJ, Akram M, Hossain F, Rizvi S, Fan F, Lin Y, Martin T, Jagannath S. Ciltacabtagene autoleucel, a B-cell maturation antigen-directed chimeric antigen receptor T-cell therapy in patients with relapsed or refractory multiple myeloma (CARTITUDE-1): a phase 1b/2 open-label study. Lancet. 2021 Jul 24;398(10297):314-324. doi: 10.1016/S0140-6736(21)00933-8. Epub 2021 Jun 24.

    PubMed 34175021

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Elranatamab (PF-06863135) in people with Multiple Myeloma in Relapse, run by PETHEMA Foundation at 13 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 7 inclusion and 5 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 4 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 13 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 phase mean?

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?

To evaluate the rate of Undetectable Measurable Residual Disease (uMRD) at 6 and 12 months as per International Myeloma Working Group (IMWG) criteria evaluated by the investigators of elranatamab in patients with relapsed/refractory multiple myeloma. (time frame: 5 Years). 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 NCT06282978, which also lists 43 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 4 Jun 2026.

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