Can a One-Time CAR-T therapy outsmart myeloma and replace lifelong treatment?
NCT ID NCT07764978
First seen Aug 14, 2026 · Last updated Aug 14, 2026
Summary
This Phase III trial is testing whether a single infusion of AZD0120, a CAR-T therapy that targets two proteins on myeloma cells, can keep the cancer at bay better than continuous standard treatment. It enrolls adults newly diagnosed with multiple myeloma who are not eligible for a stem cell transplant. Participants first receive standard induction therapy, then are randomly assigned to either AZD0120 or ongoing standard care. The study measures how long people live without the cancer progressing and whether the treatment can achieve deep remissions.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- AZD0120, a dual-targeting BCMA/CD19 CAR-T cell therapy given intravenously
- What this could lead to
- If successful, this could offer a one-time cellular therapy that may lead to deep, durable remissions and potentially a cure for multiple myeloma patients who cannot undergo stem cell transplant.
- What could go wrong
- This is an early-stage test in a large trial; CAR-T therapy carries risks like cytokine release syndrome and neurological side effects. It may not prove superior to continuous standard therapy, and long-term durability is unknown.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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About 750 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jun 2026
- Expected to finish
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May 2034
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
INCLUSION CRITERIA: 1. Participants must be 18 years or older, at the time of signing the ICF. 2. Participant must have documented diagnosis of MM according to the IMWG diagnostic criteria. 3. Participant must have one or more of the following measurable disease criteria: (a) Serum M-protein level ≥1.0 g/dL, (b) Urine M-protein level ≥ 200 mg/24 h, (c)Serum immunoglobulin FLC ≥ 10 mg/dL (100 mg/L) and abnormal serum immunoglobulin kappa lambda FLC ratio. 4. Participant must be deemed ineligible for ASCT while also having adequate organ function for CAR-T cell treatment. 5. Participant is a candidate to receive at least one of the regimens (IsaVRd or DRd) as determined by the Investigator. 6. ECOG performance status Grade of 0 to 2. 7. Participant must have adequate organ and bone marrow function. EXCLUSION CRITERIA: 1. Participant has active or prior CNS or meningeal involvement of MM. 2. Participant has primary amyloidosis, active plasma cell leukemia (≥5% circulating plasma cells), Waldenström macroglobulinemia, or POEMS syndrome. 3. Participant has significant neurological or psychiatric condition posing risk or impairing evaluation. 4. Participant has any other significant medical condition that increases unacceptable risk, interferes with therapy delivery, or confounds evaluation. 5. Participant has a history of a prior non-haematologic malignancy unless the participant has been disease-free with no evidence of recurrence for ≥ 2 years. 6. Participant has a history of haematologic malignancies, other than MM, regardless of remission status. 7. Participant is positive for any of the following: 1. HIV: Known to be seropositive for HIV (including any history of HIV). 2. Chronic or active hepatitis B. 3. Active hepatitis C: Hepatitis C infection. 4. Additional local requirements for the testing for infectious diseases and exclusions of applicable participants should be followed per local regulations. 8. Participant has clinically significant cardiovascular disease. 9. Participant has COPD with an FEV1 \< 50% of predicted normal. 10. Additional exclusion for participants who are planned to receive IsaVRd as induction: Participant has peripheral neuropathy Grade 4, Grade 3, Grade 2, or Grade 1 with pain.
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Newly diagnosed multiple myeloma are added.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
123 sites in 15 countries. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Research Site
NOT_YET_RECRUITINGGilbert, Arizona, 85234, United States
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NOT_YET_RECRUITINGPhoenix, Arizona, 85054, United States
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NOT_YET_RECRUITINGTucson, Arizona, 85719, United States
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NOT_YET_RECRUITINGOrange, California, 92868, United States
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NOT_YET_RECRUITINGSanta Monica, California, 90404, United States
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NOT_YET_RECRUITINGAurora, Colorado, 80045, United States
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NOT_YET_RECRUITINGDenver, Colorado, 80218, United States
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NOT_YET_RECRUITINGNew Haven, Connecticut, 06510, United States
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NOT_YET_RECRUITINGCoral Gables, Florida, 33156, United States
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NOT_YET_RECRUITINGTampa, Florida, 33606, United States
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NOT_YET_RECRUITINGAtlanta, Georgia, 30322, United States
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NOT_YET_RECRUITINGChicago, Illinois, 60607, United States
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NOT_YET_RECRUITINGIowa City, Iowa, 52242, United States
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NOT_YET_RECRUITINGWichita, Kansas, 67214, United States
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NOT_YET_RECRUITINGLouisville, Kentucky, 40207, United States
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NOT_YET_RECRUITINGBaton Rouge, Louisiana, 70809, United States
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NOT_YET_RECRUITINGBaltimore, Maryland, 21201, United States
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NOT_YET_RECRUITINGDetroit, Michigan, 48201, United States
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NOT_YET_RECRUITINGSt Louis, Missouri, 63110, United States
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NOT_YET_RECRUITINGEast Brunswick, New Jersey, 08816, United States
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NOT_YET_RECRUITINGAlbany, New York, 12208, United States
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NOT_YET_RECRUITINGNew Hyde Park, New York, 11042, United States
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NOT_YET_RECRUITINGNew York, New York, 10016, United States
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NOT_YET_RECRUITINGNew York, New York, 10029, United States
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NOT_YET_RECRUITINGNew York, New York, 10032, United States
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NOT_YET_RECRUITINGThe Bronx, New York, 10467, United States
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NOT_YET_RECRUITINGChapel Hill, North Carolina, 27599, United States
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NOT_YET_RECRUITINGCharlotte, North Carolina, 28203, United States
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NOT_YET_RECRUITINGDurham, North Carolina, 27705, United States
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NOT_YET_RECRUITINGWinston-Salem, North Carolina, 27103, United States
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NOT_YET_RECRUITINGWinston-Salem, North Carolina, 27157, United States
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NOT_YET_RECRUITINGCincinnati, Ohio, 45236, United States
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NOT_YET_RECRUITINGCleveland, Ohio, 44195, United States
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NOT_YET_RECRUITINGColumbus, Ohio, 43210, United States
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NOT_YET_RECRUITINGMontgomery, Ohio, 45242, United States
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NOT_YET_RECRUITINGPortland, Oregon, 97239, United States
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NOT_YET_RECRUITINGNashville, Tennessee, 37203, United States
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NOT_YET_RECRUITINGNashville, Tennessee, 37219, United States
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NOT_YET_RECRUITINGDallas, Texas, 75235, United States
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NOT_YET_RECRUITINGHouston, Texas, 77030, United States
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NOT_YET_RECRUITINGFairfax, Virginia, 22031, United States
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NOT_YET_RECRUITINGPuyallup, Washington, 98373, United States
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NOT_YET_RECRUITINGSeattle, Washington, 98101, United States
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NOT_YET_RECRUITINGSeattle, Washington, 98104, United States
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WITHDRAWNMilwaukee, Wisconsin, 53226, United States
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NOT_YET_RECRUITINGConcord, 2139, Australia
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NOT_YET_RECRUITINGDarlinghurst, 2010, Australia
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NOT_YET_RECRUITINGEast Melbourne, 3002, Australia
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RECRUITINGFitzroy, VIC3065, Australia
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NOT_YET_RECRUITINGLiverpool, 2170, Australia
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NOT_YET_RECRUITINGMelbourne, 3004, Australia
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NOT_YET_RECRUITINGMurdoch, 6150, Australia
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NOT_YET_RECRUITINGWaratah, 2298, Australia
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NOT_YET_RECRUITINGSalvador, 41253-190, Brazil
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NOT_YET_RECRUITINGSão Paulo, 01525-001, Brazil
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NOT_YET_RECRUITINGSão Paulo, 05651-901, Brazil
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NOT_YET_RECRUITINGCalgary, Alberta, T2N 5G2, Canada
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NOT_YET_RECRUITINGVancouver, British Columbia, V5Z 4E6, Canada
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NOT_YET_RECRUITINGHalifax, Nova Scotia, B3H 2Y9, Canada
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NOT_YET_RECRUITINGOttawa, Ontario, K1H 8L6, Canada
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NOT_YET_RECRUITINGMontreal, Quebec, H1T 2M4, Canada
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NOT_YET_RECRUITINGSherbrooke, Quebec, J1G 2K7, Canada
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NOT_YET_RECRUITINGÅrhus N, 8200, Denmark
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NOT_YET_RECRUITINGLille, 59037, France
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NOT_YET_RECRUITINGNantes, 44093, France
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NOT_YET_RECRUITINGParis, 75010, France
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NOT_YET_RECRUITINGPoitiers, 86021, France
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NOT_YET_RECRUITINGToulouse, 31059, France
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NOT_YET_RECRUITINGBerlin, 13353, Germany
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NOT_YET_RECRUITINGCologne, 50937, Germany
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NOT_YET_RECRUITINGDresden, 01307, Germany
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NOT_YET_RECRUITINGEssen, 45122, Germany
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NOT_YET_RECRUITINGFreiburg im Breisgau, 79106, Germany
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NOT_YET_RECRUITINGHamburg, 20246, Germany
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NOT_YET_RECRUITINGKiel, 24105, Germany
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NOT_YET_RECRUITINGLeipzig, 04103, Germany
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NOT_YET_RECRUITINGMagdeburg, 39120, Germany
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NOT_YET_RECRUITINGMainz, 55131, Germany
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NOT_YET_RECRUITINGMünchen, 81675, Germany
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NOT_YET_RECRUITINGNuremberg, 90419, Germany
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NOT_YET_RECRUITINGWürzburg, 97080, Germany
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NOT_YET_RECRUITINGBologna, 40138, Italy
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NOT_YET_RECRUITINGMilan, 20133, Italy
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NOT_YET_RECRUITINGMilan, 20141, Italy
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NOT_YET_RECRUITINGRome, 00168, Italy
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NOT_YET_RECRUITINGRozzano, 20089, Italy
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NOT_YET_RECRUITINGTorino, 10100, Italy
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NOT_YET_RECRUITINGFukuoka, 812-8582, Japan
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NOT_YET_RECRUITINGKyoto, 602-8566, Japan
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NOT_YET_RECRUITINGNishinomiya-shi, 663-8501, Japan
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NOT_YET_RECRUITINGOkayama, 700-8558, Japan
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NOT_YET_RECRUITINGSapporo, 060-8648, Japan
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NOT_YET_RECRUITINGShibuya-ku, 150-8935, Japan
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NOT_YET_RECRUITINGShinjuku-ku, 160-8582, Japan
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NOT_YET_RECRUITINGSuita-shi, 565-0871, Japan
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NOT_YET_RECRUITINGGdansk, 80-952, Poland
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NOT_YET_RECRUITINGGliwice, 44-101, Poland
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NOT_YET_RECRUITINGKielce, 25-734, Poland
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NOT_YET_RECRUITINGLublin, 20-090, Poland
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NOT_YET_RECRUITINGPoznan, 60-569, Poland
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NOT_YET_RECRUITINGWroclaw, 50-367, Poland
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NOT_YET_RECRUITINGSeoul, 03080, South Korea
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NOT_YET_RECRUITINGSeoul, 06351, South Korea
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NOT_YET_RECRUITINGSeoul, 06591, South Korea
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NOT_YET_RECRUITINGSeoul, 3722, South Korea
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NOT_YET_RECRUITINGSeoul, 5505, South Korea
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NOT_YET_RECRUITINGBadalona, 8916, Spain
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NOT_YET_RECRUITINGBarcelona, 08036, Spain
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NOT_YET_RECRUITINGMadrid, 28007, Spain
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NOT_YET_RECRUITINGMadrid, 28041, Spain
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NOT_YET_RECRUITINGPamplona, 31008, Spain
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NOT_YET_RECRUITINGSalamanca, 37007, Spain
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NOT_YET_RECRUITINGSeville, 41013, Spain
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NOT_YET_RECRUITINGValencia, 46026, Spain
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NOT_YET_RECRUITINGGothenburg, 413 45, Sweden
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NOT_YET_RECRUITINGHuddinge, 141 57, Sweden
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NOT_YET_RECRUITINGLund, 22242, Sweden
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NOT_YET_RECRUITINGTaipei, 10002, Taiwan
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NOT_YET_RECRUITINGTaipei, 106, Taiwan
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NOT_YET_RECRUITINGTaipei, 112, Taiwan
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NOT_YET_RECRUITINGTaoyuan, 33305, Taiwan
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NOT_YET_RECRUITINGEdinburgh, EH4 2XU, United Kingdom
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NOT_YET_RECRUITINGLondon, SE5 9RS, United Kingdom
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NOT_YET_RECRUITINGManchester, M20 4BX, United Kingdom
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Triplet therapy aims to deepen myeloma remission around transplant
- New Four-Drug cocktail aims to wipe out Hard-to-Treat myeloma
- New cocktail of cancer drugs aims to wipe out myeloma before transplant
- New hope for frail myeloma patients: phase III trial tests smarter drug combos
- New drug combo aims to tailor myeloma treatment to each patient
- New cocktail aims to tame myeloma without transplant