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Can a new drug combo improve myeloma treatment for older adults?

NCT ID NCT01279694

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Sep 14, 2026 · Last updated Sep 15, 2026 · Updated 1 time

Summary

Researchers are testing a combination of carfilzomib, melphalan, and prednisone in adults over 65 with newly diagnosed multiple myeloma. The trial first aims to find the highest dose of carfilzomib that people can tolerate without severe side effects. Then it will measure how well the combination shrinks the cancer. Participants receive the drugs in cycles over several months.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
carfilzomib, a proteasome inhibitor, combined with melphalan and prednisone
What this could lead to
If it works, this combination could offer a new treatment option for older adults with multiple myeloma who have not yet received therapy.
What could go wrong
This is an early-phase trial with a small number of participants, so the results may not apply broadly. The drug combination can cause serious side effects, including low blood counts and nerve damage.

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

Phase 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

72 people

The number who actually took part.

Start date

Oct 2010

Finished

Feb 2014

Lead sponsor

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

65 years and older

Sex

Anyone

Healthy volunteers

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

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Karnofsky performance status (KPS) of at least 60% * Life expectancy of more than 3 months. * Must understand and voluntarily sign an informed consent form * Age \>65 years at the time of signing consent * Previously untreated, symptomatic multiple myeloma as defined by the 2 criteria below:○ MM diagnostic criteria (all 3 required):· Monoclonal plasma cells in the bone marrow ≥10% and/or presence of a biopsy-proven plasmacytoma· Monoclonal protein present in the serum and/or urine· Myeloma-related organ dysfunction (at least 1 of the following) \[C\] Calcium elevation in the blood (serum calcium \>10.5 mg/L or upper limit of normal)\[R\] Renal insufficiency (serum creatinine \> 2 mg/dL)\[A\] Anemia (hemoglobin \<10 g/dL or 2 g \< normal)\[B\] Lytic bone lesions or osteoporosisAND have measurable disease by protein electrophoresis analyses as defined by one or more of the following:· IgG multiple myeloma: Serum monoclonal paraprotein (M protein) level by SPEP ³ 0.5 g/dL or urine M-protein level ³ 200 mg/24 hours· IgA multiple myeloma: Serum M-protein level ³ 0.5 mg/dL or urine M-protein level ³ 200 mg/24 hours· IgM multiple myeloma (IgM M-protein plus lytic bone disease documented by skeletal survey plain films): Serum M-protein level ≥ 1.0 g/dL or urine M-protein level ≥ 200 mg/24 hours· IgD multiple myeloma: Serum M-protein level ³ 0.05 g/dL or urine M-protein level ³ 200 mg/24 hours Light chain multiple myeloma: Patients with serum free light chain disease in whom the involved light chain measures ≥ 10 mg/dL * ECOG performance status of 0, 1, or 2 * Able to adhere to the study visit schedule and other protocol requirements * Affiliation number to National Health Care System Exclusion Criteria: * Patients are ineligible if they meet any of the following criteria: 1 Previous treatment with antimyeloma therapy (does not include radiotherapy, bisphosphonates, or a single short course of steroid \[i.e., less than or equal to the equivalent of dexamethasone 40 mg/day for 4 days; such a short course of steroid treatment must not have been given within 28 days (4 weeks) of consent\]). * Any serious medical condition that places the patient at an unacceptable risk if he or she participates in this study. * Female of childbearing potential * Any of the following laboratory abnormalities:· Absolute neutrophil count (ANC) \< 1,000 cells/mL (1.0 × 109/L) · Platelet count \< 50,000 cells/mL (50 × 109/L) for patients in whom \< 50% of bone marrow nucleated cells are plasma cells; but platelet count \<30,000 cells/mL for patients in whom ³ 50% of bone marrow nucleated cells are plasma cells · Serum SGPT/ALT \> 3.0 × upper limit of normal (ULN); Bilirubin \>2 × ULN \[ALT more specific to liver\]· Creatinine clearance ≤ 30 mL/min (Cockcroft-Gault calculation)5 Prior history of malignancies, other than multiple myeloma, unless the subject has been free of the disease for ³ 3 years. Exceptions include the following:o Basal cell carcinoma of the skin Squamous cell carcinoma of the skin Carcinoma in situ of the cervix Carcinoma in situ of the breast6 Incidental histological finding of prostate cancer (TNM stage of T1a or T1b) Peripheral neuropathy of \> grade 2 severity. * Known HIV positivity or active infectious hepatitis, type A, B, or C. * Myocardial infarction within 3 months of enrollment, unstable angina within 2 months or New York Heart Association class III or IV heart failure. * Oral or IV fluid hydration contraindicated

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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

  • CHU de Nantes

    Nantes, 44000, France

More trials for these conditions

Other studies related to the condition(s) this trial covers.