New study aims to find best myeloma treatment for seniors
NCT ID NCT03829371
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study looks at which treatment works best for older adults (65+) with multiple myeloma who cannot have a stem cell transplant. It compares standard drug combinations with or without daratumumab, a targeted antibody. The goal is to find the best balance of benefits, side effects, and quality of life for this group.
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 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Participants
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About 450 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jan 2019
- Expected to finish
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Jan 2030
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
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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65 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: * Patients has given voluntary written informed consent before the performance of any study related procedure; * Patients with newly diagnosed symptomatic multiple myeloma (NDMM) based on standard IMWG (International Myeloma Working Group) criteria: * Clonal bone marrow plasma cells \>=10% or biopsy-proven bony or extramedullary plasmacytoma and any one or more of the following CRAB features and myeloma-defining events: * evidence of end organ damage that can be attributed to the underlying plasma cell proliferative disorder, specifically * Hypercalcemia: serum calcium \>0.25 mmol/L (\>1mg/dL) higher than the upper limit of normal or \>2.75 mmol/L (\>11mg/dL) * Renal insufficiency: creatinine clearance (CLcr)\<40 mL per minute (measured or estimated by validated equations) or serum creatinine \> 177 micro mol/L (\>2mg/dL) * Anemia: hemoglobin value of \>20g/L below the lower limit of normal, or a hemoglobin value \<100g/L * Bone lesions: one or more osteolytic lesion on skeletal radiography, CT, or PET/CT. If bone marrow has \<10% clonal plasma cells, more than one bone lesion is required to distinguish from solitary plasmacytoma with minimal marrow involvement * Any one or more of the following biomarkers of malignancy: * Clonal bone marrow plasma cell percentage \>=60% (clonality should be established by showing kappa/lambda-light-chain restriction on flow cytometry, immunohistochemistry, or immunofluorescence. Bone marrow plasma cell percentage should preferably be estimated from a core biopsy specimen; in case of a disparity between the aspirate and core biopsy, the highest value should be used) * Involved:uninvolved serum free light chain ratio \>=100 (values based on the serum Freelite assay. The involved free light chain must be \>=100 mg/L) * \>1 focal lesion detected by MRI (magnetic resonance imaging) studies (each focal lesion must be 5 mm or more in size * According to physician's opinion, patients can undergo either one of the two standard treatments and procedures; * Females of childbearing potential (FBCP) must use an effective contraceptive method for 28 days before the study treatment, during the treatment and for at least 3 months after the last dose of study drugs; * Male subjects must use an effective barrier method if sexually active with FCBP during treatment and for at least 6 months after the last dose of study drug; * Patients should be ineligible for ASCT, defined as: * \>= 65 years old * younger than 65 years but who reject the transplant procedure or with abnormal cardiac, pulmonary, hepatic and renal function defined as \[1\]: * LVEF (left ventricular ejection fraction) \< 40% * FEV1 (forced expiratory volume-1 second) \< 40% * Bilirubin \> 1.5 UNL, AST/ALT \>2.5 UNL Creatinine clearance \< 60 mL/min. Exclusion Criteria: * Hypersensitivity to any active substance or to any of the excipients (lactose, microcrystalline cellulose, croscarmellose sodium, magnesium stearate, boron, mannitol, nitrogen, crospovidone, colloidal anhydrous silica, hypromellose, titanium dioxide, macrogol, talc, sodium starch glycolate, sodium benzoate, propylene glycol, sodium dihydrogen phosphate, hydroxypropyl beta cyclodextrin, sodium saccharin, sodium EDTA, sodium hydroxide, L-histidine, L-histidine hydrochloride monohydrate, L-methionine, polysorbate 20, sorbitol (E420), recombinant human hyaluronidase (rHuPH20)); * Hereditary intolerance to fructose; * Pregnant and lactating women; * FBCP that do not follow the Pregnancy Prevention Plan requirements; * Acute diffuse infiltrative pulmonary and pericardial disease; * Acute viral infections (e.g. herpes simplex or ocular herpes simplex, herpes zoster, varicella); * Systemic mycotic or bacterial infections, unless specific anti-infectious therapy is ongoing; * Peptic ulcer; * Psychosis; * Administration of prophylactic vaccine from 8 to 2 weeks before starting treatment.
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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.
Contacts and locations
Locations
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Dipartimento di Biotecnologie Molecolari e Scienze per la Salute
Torino, TO, 10126, Italy
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Bispecific antibody combo aims to deepen myeloma responses
- Can a stronger drug cocktail give older myeloma patients a better start?
- Cheap blood count ratios eyed as window into Myeloma's inflammatory grip
- Can a t-cell engager rescue myeloma that outsmarted CAR-T?
- Can myeloma treatment work without steroids?
- Double-Drug attack on Hard-to-Treat lymphomas