Authorised Therapeutic use (Phase IV) Newly diagnosed MM patients >= 65 years old or ineligible for autologous stem cell transplant

STUDY COMPARING TWO STANDARD TREATMENTS IN AUTOLOGOUS STEM CELL TRANSPLANTATION INELIGIBLE POPULATION AFFECTED BY MULTIPLE MYELOMA (Dara-VMP vs Dara-Rd)

EU CTIS ID: 2024-512049-17-00

What this study is testing

The primary objective is to compare the progression-free survival (PFS) of bortezomib-melphalan-prednisone (VMP) vs lenalidomide-dexamethasone (Rd) treatments with or without daratumumab (Dara-VMP, Dara-Rd) in real life unselected patient population.

  • Therapeutic use (Phase IV)

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

  • Patients has given voluntary written informed consent before the performance of any study related procedure
  • 1.2.1) Clonal bone marrow plasma cell percentage ≥60% (clonality should be established by showing κ/λ-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)
  • 1.2.2) 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)
  • 1.2.3) >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

You likely can't join if

  • 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))
  • Administration of prophylactic vaccine from 8 to 2 weeks before starting treatment
  • 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
See the full eligibility criteria
Who can join
  • Patients has given voluntary written informed consent before the performance of any study related procedure
  • 1.2.1) Clonal bone marrow plasma cell percentage ≥60% (clonality should be established by showing κ/λ-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)
  • 1.2.2) 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)
  • 1.2.3) >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: • 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.
  • Patients with newly diagnosed symptomatic multiple myeloma (NDMM) based on standard IMWG (International Myeloma Working Group) criteria:
  • 1) 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:
  • 1.1) Evidence of end organ damage that can be attributed to the underlying plasma cell proliferative disorder, specifically
  • 1.1.1) Hypercalcemia: serum calcium >0.25 mmol/L (>1mg/dL) higher than the upper limit of normal or >2.75 mmol/L (>11mg/dL)
  • 1.1.2) Renal insufficiency: creatinine clearance (CLcr)<40 mL per minute (measured or estimated by validated equations) or serum creatinine > 177 µmol/L (>2mg/dL)
  • 1.1.3) Anemia: hemoglobin value of >20g/L below the lower limit of normal, or a hemoglobin value <100g/L
  • 1.1.4) 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
  • 1.2) Any one or more of the following biomarkers of malignancy:
What rules you out
  • 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))
  • Administration of prophylactic vaccine from 8 to 2 weeks before starting treatment
  • 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

The study team makes the final eligibility decision.

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, 65+ years. The study team makes the final eligibility decision.

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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.