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C1071032 - MAGNETISMM-32 A PHASE 3, OPEN-LABEL STUDY OF ELRANATAMAB MONOTHERAPY VERSUS ELOTUZUMB, POMALIDOMIDE, DEXAMETHASONE (EPd) OR POMALIDOMIDE, BORTEZOMIB, DEXAMETHASONE (PVd) OR CARFILZOMIB, DEXAMETHASONE (Kd) IN PARTICIPANTS WITH RELAPSED REFRACTORY MULTIPLE MYELOMA WHO RECEIVED PRIOR ANTI-CD38 DIRECTED THERAPY
EU CTIS ID: 2023-507871-23-00
What this study is testing
To compare the efficacy of elranatamab (Arm A) vs EPd or PVd or Kd (Arm B)
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Participants aged 18 years or older (or the minimum age of consent in accordance with local regulations if ≥18) at screening.
- Prior diagnosis of MM (multiple myeloma) per IMWG criteria and previously received at least 1 but not more than 4 prior lines of therapy for MM including: • At least 2 consecutive cycles of an anti-CD38 antibody-containing regimen in any prior line AND • At least 2 consecutive cycles of a lenalidomide-containing regimen in any prior line
- Documented evidence of progressive disease or failure to achieve a response to last line of MM therapy based on investigator's determination of response by IMWG criteria.
- Measurable disease based on IMWG criteria as defined by at least 1 of the following (assessed by central laboratory): • Serum M-protein (myeloma protein) ≥0.5 g/dL; • Urinary M-protein excretion ≥200 mg/24 hours; • Serum involved immunoglobulin FLC (free light chain) ≥10 mg/dL (≥100 mg/L) AND abnormal serum immunoglobulin kappa to lambda FLC ratio (<0.26 or >1.65).
- Corrected serum calcium ≤14 mg/dL (≤3.5 mmol/L), or free ionized calcium ≤6.5 mg/dL (≤1.6 mmol/L)
- Adequate bone marrow function (ANC, platelets, hemoglobin)
You likely can't join if
- Plasma cell leukemia, Smoldering MM, Waldenström’s macroglobulinemia, Amyloidosis, POEMS (Polyneuropathy, Organomegaly, Endocrinopathy, Monoclonal gammopathy and Skin abnormalities) Syndrome, known CNS (central nervous system) involvement or clinical signs of myelomatous meningeal involvement, stem cell transplant within 12 weeks prior to enrollment, active GVHD (graft versus host disease) (other than Grade 1 skin involvement) or GVHD requiring treatment.
- Unable to receive a control therapy (must be able and willing to adhere to any applicable requirements per Single Reference Safety Document [SRSD] for at least one choice of control therapy, including contraceptive requirements, and must not meet the exclusions listed below for the choice of control therapy): • unable to receive PVd if any of the following are present: • Received prior pomalidomide therapy • Does not meet criteria for bortezomib retreatment, (ie, must not have progressive disease during treatment or within 60 days of the last dose of a bortezomib-containing regimen) • Grade 1 peripheral neuropathy with pain or Grade ≥2 peripheral neuropathy as defined by NCI-CTCAE v5.0 • Received a strong cytochrome P (CYP) 3A4 inducer within 5 half-lives prior to enrollment • Active inflammatory gastrointestinal disease, chronic diarrhea, known diverticular disease or previous gastric resection or lap band surgery (gastroesophageal reflux disease under treatment with proton pump inhibitors is allowed, assuming no drug interaction potential). • unable to receive Kd if any of the following are present: • Received prior carfilzomib therapy • Uncontrolled hypertension • unable to receive EPd if any of the following are present: • Received prior pomalidomide therapy • Received prior elotuzumab therapy
- Active inflammatory gastrointestinal disease, chronic diarrhea, known diverticular disease or previous gastric resection or lap band surgery (gastroesophageal reflux disease under treatment with proton pump inhibitors is allowed, assuming no drug interaction potential).
- Live attenuated vaccines within 4 weeks of the first dose of study intervention;
- Cumulative dose of corticosteroids equivalent to ≥140 mg of prednisone (≥21 mg of dexamethasone) within the 14-day period before the first dose of study intervention, and administered for reasons other than anti-myeloma therapy
- Anti-myeloma drug therapy, within 14 days of the initiation of study intervention (includes dexamethasone). Bisphosphonate use permitted.
See the full eligibility criteria
Who can join
- Participants aged 18 years or older (or the minimum age of consent in accordance with local regulations if ≥18) at screening.
- Prior diagnosis of MM (multiple myeloma) per IMWG criteria and previously received at least 1 but not more than 4 prior lines of therapy for MM including: • At least 2 consecutive cycles of an anti-CD38 antibody-containing regimen in any prior line AND • At least 2 consecutive cycles of a lenalidomide-containing regimen in any prior line
- Documented evidence of progressive disease or failure to achieve a response to last line of MM therapy based on investigator's determination of response by IMWG criteria.
- Measurable disease based on IMWG criteria as defined by at least 1 of the following (assessed by central laboratory): • Serum M-protein (myeloma protein) ≥0.5 g/dL; • Urinary M-protein excretion ≥200 mg/24 hours; • Serum involved immunoglobulin FLC (free light chain) ≥10 mg/dL (≥100 mg/L) AND abnormal serum immunoglobulin kappa to lambda FLC ratio (<0.26 or >1.65).
- Corrected serum calcium ≤14 mg/dL (≤3.5 mmol/L), or free ionized calcium ≤6.5 mg/dL (≤1.6 mmol/L)
- Adequate bone marrow function (ANC, platelets, hemoglobin)
- ECOG (Eastern Cooperative Oncology Group) performance status <2.
What rules you out
- Plasma cell leukemia, Smoldering MM, Waldenström’s macroglobulinemia, Amyloidosis, POEMS (Polyneuropathy, Organomegaly, Endocrinopathy, Monoclonal gammopathy and Skin abnormalities) Syndrome, known CNS (central nervous system) involvement or clinical signs of myelomatous meningeal involvement, stem cell transplant within 12 weeks prior to enrollment, active GVHD (graft versus host disease) (other than Grade 1 skin involvement) or GVHD requiring treatment.
- Unable to receive a control therapy (must be able and willing to adhere to any applicable requirements per Single Reference Safety Document [SRSD] for at least one choice of control therapy, including contraceptive requirements, and must not meet the exclusions listed below for the choice of control therapy): • unable to receive PVd if any of the following are present: • Received prior pomalidomide therapy • Does not meet criteria for bortezomib retreatment, (ie, must not have progressive disease during treatment or within 60 days of the last dose of a bortezomib-containing regimen) • Grade 1 peripheral neuropathy with pain or Grade ≥2 peripheral neuropathy as defined by NCI-CTCAE v5.0 • Received a strong cytochrome P (CYP) 3A4 inducer within 5 half-lives prior to enrollment • Active inflammatory gastrointestinal disease, chronic diarrhea, known diverticular disease or previous gastric resection or lap band surgery (gastroesophageal reflux disease under treatment with proton pump inhibitors is allowed, assuming no drug interaction potential). • unable to receive Kd if any of the following are present: • Received prior carfilzomib therapy • Uncontrolled hypertension • unable to receive EPd if any of the following are present: • Received prior pomalidomide therapy • Received prior elotuzumab therapy
- Active inflammatory gastrointestinal disease, chronic diarrhea, known diverticular disease or previous gastric resection or lap band surgery (gastroesophageal reflux disease under treatment with proton pump inhibitors is allowed, assuming no drug interaction potential).
- Live attenuated vaccines within 4 weeks of the first dose of study intervention;
- Cumulative dose of corticosteroids equivalent to ≥140 mg of prednisone (≥21 mg of dexamethasone) within the 14-day period before the first dose of study intervention, and administered for reasons other than anti-myeloma therapy
- Anti-myeloma drug therapy, within 14 days of the initiation of study intervention (includes dexamethasone). Bisphosphonate use permitted.
- Impaired hepatic or renal function.
- Previous administration with an investigational product (drug or vaccine) within 30 days (or as determined by the local requirement) or 5 half lives preceding the first dose of study intervention used in this study (whichever is longer). Participation in studies of other investigational products (drug or vaccine) at any time during their participation in this study.
- Active HBV (Hepatitis B virus), HCV (Hepatitis C virus), SARS-CoV-2 (severe acute respiratory syndrome coronavirus 2), HIV [human immunodeficiency virus], or any active, uncontrolled bacterial, fungal, or viral infection. Active infections must be resolved at least 21 days prior to enrollment. Treatment with systemic anti-infective agents must have completed at least 28 days prior to enrollment. Prophylactic use of systemic anti-infective agents is permitted.
- Ongoing Grade ≥3 peripheral sensory or motor neuropathy; history of GBS (Guillain-Barré syndrome) or GBS variants; history of any Grade ≥3 peripheral motor polyneuropathy.
- Impaired cardiovascular function or clinically significant cardiovascular diseases within 6 months prior to enrollment, including LVEF (left ventricular ejection fraction) <40% as determined by a MUGA (multigated acquisition) scan or ECHO (echocardiogram) at screening.
- Any other active malignancy within 3 years prior to enrollment, except for adequately treated basal cell or squamous cell skin cancer, or carcinoma in situ or Stage 0/1 malignancy with minimal risk of recurrence per investigator
- Known or suspected hypersensitivity to the study interventions or any of their excipients.
- Unresolved acute effects (excluding alopecia) of any prior therapy (not resolved to baseline severity or CTCAE Grade ≤ 1).
- Previous treatment with a BCMA-directed or CD3 (cluster of differentiation 3) redirecting therapy.
- Individuals who have never achieved a response (partial response [PR] or better) with any treatment during the disease course.
The study team makes the final eligibility decision.
Where it's taking place
- United Kingdom
- Canada
- Argentina
- Israel
- Chile
- Australia
- Taiwan
- Japan
- Brazil
- Korea, Republic of
- United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include United Kingdom; Canada; Argentina; Israel; Chile; Australia and 5 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.