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New cocktail aims to keep myeloma at bay longer

NCT ID NCT03004287

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 This study
Running, but no longer taking on new participants.
Completed
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 26, 2026 · Last updated Sep 16, 2026 · Updated 2 times

Summary

This phase 2 trial is testing whether adding the drug daratumumab to a standard treatment plan helps people with newly diagnosed multiple myeloma live longer without their cancer getting worse. The study involves 50 participants and uses a combination of daratumumab, carfilzomib, thalidomide, and dexamethasone. The goal is to improve progression-free survival, especially for those with high-risk disease.

What this could mean

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

Active substance
Daratumumab (Darzalex) plus carfilzomib, thalidomide, and dexamethasone
What this could lead to
If successful, this could offer a more effective treatment combination for newly diagnosed multiple myeloma, potentially extending the time patients live without their cancer worsening.
What could go wrong
This is a small, early-phase study (50 participants) and results may not apply to all patients. Adding more drugs can also increase side effects.

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 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 50 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jul 2017

Expected to finish

Oct 2028

An estimate. End dates often move.

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

18 to 75 years

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: * Patients must have newly diagnosed active Multiple Myeloma (MM) requiring treatment. Patients with a previous history of smoldering myeloma will be eligible if there is evidence of progressive disease requiring chemotherapy. * Patients must be either untreated or have not received more than four cycles of systemic MM therapy (e.g. Revlimid Dexamethasone (RD), Bortezomib Revlimid Dexamethasone (VRD). Prior bisphosphonates and localized radiation are allowed. * Participants must have high-risk disease, as defined by at least one of the following: * Myeloma Prognostic Risk Signature (MyPRS) risk score ≥ 50.4 * Lactate Dehydrogenase (LDH) ≥ 360 U/L (Rule out hemolysis and infection; contact PI if any doubt.) * Diagnosis of primary plasma cell leukemia. * Eastern Cooperative Oncology Group (ECOG) ≤ 2, unless solely due to symptoms of MM-related bone disease. * Patients must have a platelet count ≥ 50,000/μL, unless lower levels are explained by extensive bone marrow plasmacytosis. * Patients must be at least 18 years of age and not older than 75 years of age at the time of registration. * Participants must have a baseline serum creatinine level \< 3 mg/dL and baseline Alanine Aminotransferase (ALT) \< 3x Upper Limit of Normal (ULN). * Participants must have an ejection fraction by echocardiogram (ECHO) or Multiple-gated Acquisition Scan (MUGA) scan ≥ 45% * Patients must have adequate pulmonary function studies \> 50% of predicted on mechanical aspects (Forced Expiratory Volume 1 (FEV1), Forced Vital Capacity (FVC) and diffusion capacity (DLCO) \> 50% of predicted. If the patient is unable to complete pulmonary function tests due to MM related pain or other conditions, an exception may be granted if the principal investigator documents that the patient is a candidate for high dose therapy. * Patients must have signed an Institutional Review Board (IRB)-approved informed consent indicating their understanding of the proposed treatment and that the protocol has been approved by the Institutional Review Board (IRB). Exclusion Criteria: * No evidence of high-risk disease * Poorly controlled hypertension, diabetes mellitus, active or uncontrolled hepatitis, or other serious medical or psychiatric illness that could potentially interfere with the completion of treatment according to this protocol. * Patients must not have prior malignancy, except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or other cancer for which the patient has not received treatment for one year prior to enrollment. Other cancers will only be acceptable if the patient's life expectancy exceeds five years. * Pregnant or nursing women may not participate. Women of childbearing potential must have a negative pregnancy documented within one week of registration. * Subjects of reproductive potential may not participate unless they have agreed to use an effective contraceptive method.

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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

  • University of Arkansas for Medical Sciences

    Little Rock, Arkansas, 72205, United States

More trials for these conditions

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