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New drug cocktail aims to deepen remissions in myeloma patients

NCT ID NCT01816971

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This phase 2 trial tested a combination of three drugs—carfilzomib, lenalidomide, and dexamethasone—given before and after a stem cell transplant in 76 people newly diagnosed with multiple myeloma. The goal was to see how many patients achieved a very deep remission (stringent complete response). The approach aims to kill more cancer cells by using targeted therapy, immune-modulating drugs, and chemotherapy together.

What this could mean

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

Active substance
carfilzomib, lenalidomide, and dexamethasone
What this could lead to
If successful, this drug combination could improve the chance of achieving a deep remission after stem cell transplant for multiple myeloma.
What could go wrong
This is a small, early-phase trial (76 people) with no control group, so results may not apply broadly. Side effects from the drugs and transplant can be serious.

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

76 people

The number who actually took part.

Start date

Jan 2013

Finished

Mar 2026

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 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: * Newly diagnosed, myeloma requiring systemic chemotherapy as per International Myeloma Working Group (IMWG) uniform criteria: * Prior treatment of hypercalcemia or spinal cord compression or active and/or aggressively progressing myeloma with corticosteroids or lenalidomide or bortezomib-based regimens does not disqualify the patient (the treatment dose should not exceed the equivalent of 160 mg of dexamethasone in a 4 week period or not more than 1 cycle) * Bisphosphonates are permitted * Suitable and interested to proceed to ASCT * Measurable disease, prior to initial treatment as indicated by one or more of the following: * Serum monoclonal (M)-protein \>= 0.5 g/dL * Urine M-protein \>= 200 mg/24 hours * If serum protein electrophoresis is felt to be unreliable for routine M-protein measurement, then quantitative immunoglobulin levels are acceptable * Life expectancy of more than 3 months * Eastern Cooperative Oncology Group (ECOG) performance status 0-2 * Bilirubin \< 1.5 times the upper limit of normal (ULN) * Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) \< 2.5 times ULN * Absolute neutrophil count (ANC) \>= 1.0 x 10\^9/L * Hemoglobin \>= 8 g/dL * Platelet count \>= 75 x 10\^9/L; subjects may receive red blood cell (RBC) transfusions or platelet transfusions, if clinically indicated in accordance with institutional guidelines; however, screening platelet count should be independent of platelet transfusions for at least 2 weeks * Calculated or measured creatinine clearance of \>= 50 mL/minute, calculated using the formula of Cockcroft and Gault * Written informed consent in accordance with federal, local, and institutional guidelines * Females of childbearing potential (FCBP) (defined as sexually mature females who: have not undergone a hysterectomy or bilateral oophorectomy; or have not been naturally postmenopausal for at least 24 consecutive months \[ie, has had menses at any time in the preceding 24 consecutive months\]) must agree to ongoing pregnancy testing * FCBP must have 2 negative pregnancy tests (sensitivity of at least 50 mIU/mL) prior to initiating lenalidomide; the first pregnancy test must be performed within 10-14 days before day 1 cycle 1 and the second pregnancy test must be performed within 24 hours of day 1 cycle 1; the subject may not receive lenalidomide until the treating investigator has verified that the results of these pregnancy tests are negative, and must agree to ongoing pregnancy tests as outlined in the protocol * FCBP must agree to use 2 reliable forms of contraception simultaneously or to practice complete abstinence from heterosexual intercourse during the following time periods related to this study: * For at least 28 days before starting lenalidomide * While participating in the study; and * For at least 28 days after discontinuation from the study; the 2 methods of reliable contraception must include a highly effective method (ie, intrauterine device (IUD), hormonal \[birth control pills, injections, or implants\], tubal ligation, partner's vasectomy) and an additional effective (barrier) method (ie, latex condom, diaphragm, cervical cap); FCBP must be referred to a qualified provider of contraceptive methods if needed * Male subjects must agree to use a latex condom during sexual contact with females of childbearing potential while participating in the study and for at least 28 days following discontinuation from the study even if he has undergone a successful vasectomy * Male subjects must agree to inform his physician if he has had unprotected sexual contact with a female who can become pregnant or if he thinks for any reason that his sexual partner may be pregnant * Male subjects must agree not to donate semen or sperm while taking lenalidomide * All study participants must be registered into the mandatory Rev Assist program and be willing and able to comply with the requirements of Rev Assist * The ability to take aspirin or other appropriate venous thromboembolism (VTE) prophylaxis * Subjects must agree to adhere to all study requirements, including birth control measures and pregnancy testing, visit schedule, outpatient treatment, required concomitant medications, and laboratory monitoring Exclusion Criteria: * Non-secretory or hyposecretory multiple myeloma, prior to initial treatment defined as \< 0.5 g/dL M-protein in serum, \< 200 mg/24 hr urine M-protein, or disease only measured by serum free light chain * POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes) * Waldenstrom's macroglobulinemia or immunoglobin (Ig)M myeloma * Radiotherapy to multiple sites or immunotherapy within 4 weeks before start of protocol treatment (localized radiotherapy to a single site at least 1 week before start is permissible) * Participation in an investigational therapeutic study within 3 weeks or within 5 drug half-lives (t1/2) prior to first dose, whichever time is greater * Pregnant or lactating females * History of allergy to mannitol * Major surgery within 3 weeks prior to first dose * Myocardial infarction within 6 months prior to enrollment, New York Heart Association (NYHA) class III or IV heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities * Uncontrolled hypertension or diabetes * Acute active infection requiring systemic antibiotics, antivirals, or antifungals within two weeks prior to first dose * Known or suspected human immunodeficiency virus (HIV) infection, known HIV seropositivity * Active hepatitis A, B, or C infection * Non-hematologic malignancy within the past 3 years except adequately treated basal cell, squamous cell skin cancer, thyroid cancer, carcinoma in situ of the cervix, or prostate cancer \< Gleason grade 6 with stable prostate specific antigen levels or cancer considered cured by surgical resection alone * Any clinically significant medical disease or condition that, in the investigator's opinion, may interfere with protocol adherence or a subject's ability to give informed consent * Significant neuropathy (grades 3-4, or grade 2 with pain) at the time of the first dose and/or within 14 days before enrollment * Contraindication to any of the required concomitant drugs, including proton-pump inhibitor (eg, lansoprazole), enteric-coated aspirin, allopurinol or if a history of prior thrombotic disease, warfarin or low molecular weight heparin * Subjects in whom the required program of PO and IV fluid hydration is contraindicated, eg, due to pre-existing pulmonary, cardiac, or renal impairment * Subjects with known or suspected amyloidosis of any organ * Subjects with pleural effusions requiring thoracentesis or ascites requiring paracentesis * No coverage or not-acceptable by patient co-pay for lenalidomide

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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

  • Dana Farber

    Boston, Massachusetts, 02215, United States

  • Princess Margaret

    Toronto, Ontario, M5T 2M9, Canada

  • Sarah Cannon Cancer Center

    Nashville, Tennessee, 37203, United States

  • University of Chicago Comprehensive Cancer Center

    Chicago, Illinois, 60637-1470, United States

  • Washington University in St Louis

    St Louis, Missouri, 63130, United States

More trials for these conditions

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