New drug cocktails show promise for multiple myeloma patients
NCT ID NCT02203643
First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study tested different combinations of cancer drugs (carfilzomib, cyclophosphamide, lenalidomide, and dexamethasone) in 477 adults newly diagnosed with multiple myeloma who were eligible for a stem cell transplant. The goal was to see which combination worked best before and after transplant, or as a longer treatment without transplant. The study also compared two maintenance therapies to keep the disease under control.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Carfilzomib, cyclophosphamide, lenalidomide, and dexamethasone
- What this could lead to
- If successful, this could point toward more effective treatment combinations for multiple myeloma, potentially improving response rates and delaying disease progression.
- What could go wrong
- This is a phase 2 trial, so results are preliminary. The drug combinations may cause significant side effects, and not all patients may benefit equally.
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 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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477 people
The number who actually took part.
- Start date
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Feb 2015
- Finished
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Mar 2026
- 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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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: Age ≥ 18 years Newly diagnosed MM based on standard CRAB criteria (see appendix B). Patient \< 65 years eligible for ASCT. Patient has measurable disease according to IMWG (International Myeloma Working Group) criteria. Patient has given voluntary written informed consent. Patient agrees to use acceptable methods for contraception. Patient has a Karnofsky performance status ≥ 60% Pretreatment clinical laboratory values within 30 days of enrolment: Platelet count ≥50 x 109/L (≥30 x 109 /L if myeloma involvement in the bone marrow is \> 50%) Absolute neutrophil count (ANC) ≥ 1 x 109/L without the use of growth factors Corrected serum calcium ≤14 mg/dL (3.5 mmol/L) Alanine transaminase (ALT): ≤ 3 x the Upper Limit Normal (ULN) Total bilirubin: ≤ 2 x the ULN Calculated or measured creatinine clearance: ≥ 30 mL/minute. LVEF≥40%. 2-D transthoracic echocardiogram (ECHO) is the preferred method of evaluation. Multigated Acquisition Scan (MUGA) is acceptable if ECHO is not available Life expectancy ≥ 3 months Exclusion Criteria: Previous treatment with anti-myeloma therapy (does not include radiotherapy, bisphosphonates, or a single short course of steroid \< to the equivalent of dexamethasone 40 mg/day for 4 days) Patients with non-secretory MM unless serum free-light chains are present and the ratio is abnormal or a plasmocytoma with minimum largest diameters of \> 2 cm Patients ineligible for autologous transplantation Pregnant or lactating females Presence of: Clinical active infectious hepatitis type A, B, C or HIV Acute active infection requiring antibiotics or infiltrative pulmonary disease Myocardial infarction or unstable angina ≤ 4 months or other clinically significant heart disease Peripheral neuropathy or neuropathic pain grade 2 or higher, as defined by National Cancer Institute Common Toxicity Criteria (NCI CTC) 4.0 Known history of allergy to Captisol ® (a cyclodextrin derivative used to solubilize carfilzomib) Contraindication to any of the required drugs or supportive treatments Invasive malignancy within the past 3 years Serious medical condition, laboratory abnormality or psychiatric illness that prevented the subject from the enrolment or place the subject at unacceptable risk.
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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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IRCCS--CROB --CROB di Rionero in di Rionero in Vulture
Rionero in Vulture, 85028, Italy
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Triple-Drug combo aims to deepen myeloma response before transplant
- Cell therapy targets a marker on myeloma cells
- Oral drug combo targets myeloma that escaped the bone marrow
- Can a Four-Drug combo tame Ultra-High-Risk myeloma?
- MRI scans may reveal hidden clues to myeloma relapse risk
- Can a dual immunotherapy erase hidden myeloma cells?