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ISS Stage III Plasma Cell MyelomaPhase 2NCT05497804

Combination Treatment Therapy Approaches for the Treatment of High-Risk Multiple Myeloma, REACH Trial

A Phase 2 study testing Bone Marrow Aspiration and Biopsy, Carfilzomib and Computed Tomography in people with ISS Stage III Plasma Cell Myeloma and Multiple Myeloma, run by Mayo Clinic at 3 sites in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial summary

This phase II trial test whether combination chemotherapy works to improve blood test results in patients with high-risk multiple myeloma. Chemotherapy drugs, such as carfilzomib, daratumumab, lenalidomide, and dexamethasone, work in different ways to stop the growth of cancer cells, either by killing the cells, by… Read more about this study

Who is it for?
Ages 18 to 80 years
What is being tested?
Bone Marrow Aspiration and Biopsy, Carfilzomib and Computed Tomography
Could I receive a placebo?
No, everyone receives an active treatment
How many people
17 participants
Where
3 sitesUnited States
Study dates
22 Sep 2022to 4 Sep 2028
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • PRE-REGISTRATION-INCLUSION CRITERIA:
  • Age >= 18 years and =< 80 years.
  • Patient must have suspected or confirmed newly diagnosed multiple myeloma by International Myeloma Working Group (IMWG) criteria.
  • Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1.
  • Provide informed written consent.
  • Willing to return to enrolling institution for follow-up during the active treatment phase of the trial.
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  • Willing to provide blood and bone marrow samples for planned research.
  • Life expectancy > 6 months.
  • Able to take aspirin (325 mg) daily as prophylactic anticoagulation.
  • Note: subjects intolerant to aspirin may use warfarin, novel oral anticoagulants, or low dose molecular weight heparin.
  • Patients must have monoclonal protein studies (serum free light chain assay, serum immunofixation or serum matrix-assisted laser desorption ionization time-of-flight mass-spectrometry [MASS-FIX]) at time of diagnosis before induction therapy initiated and available for review to be enrolled. Note: Patients are allowed to participate in this study if urine electrophoresis immunofixation study was not done at time of diagnosis or cannot be obtained
  • REGISTRATION-INCLUSION CRITERIA:
  • High risk myeloma, which is untreated, defined as any two of:
  • Beta-2 microglobulin >5.5
  • Gain or amplification of chr1q
  • del17p or monosomy 17 or TP53 mutation (if known)
  • t(4;14) or t(14;16)
  • >= 5% circulating plasma cells
  • presence of extramedullary disease (does not include bone contiguous disease)
  • Creatinine clearance >= 30 mL/min (using Cockroft-Gault equation) (obtained =< 14 days prior to registration).
  • Absolute neutrophil count (ANC) >= 1000/mm^3 (without the use of growth factors) (obtained =< 14 days prior to registration).
  • Platelet count >= 75000/mm^3 (obtained =< 14 days prior to registration).
  • Hemoglobin >= 8.0 g/dL.
  • Total bilirubin =< 1.5 x upper limit of normal (ULN) (obtained =< 14 days prior to registration).
  • Alanine transaminase (ALT) and aspartate aminotransferase (AST) =< 3 x ULN (obtained =< 14 days prior to registration).
  • Registration must be completed =< 30 days after pre-registration.
  • Patients must not have received more than one cycle of treatment between pre-registration and registration.
  • All 4 drugs in the study regimen approved by insurance.
  • Left ventricular ejection fraction (LVEF) >= 40% =< 30 days prior to pre-registration

Who cannot join

  • PRE-REGISTRATION EXCLUSION:
  • Monoclonal gammopathy of undetermined significance (MGUS), smoldering myeloma, light chain amyloidosis with organ involvement.
  • Diagnosed or treated for another malignancy =< 1 year prior to pre- registration or previously diagnosed with another malignancy and have any evidence of residual disease.
  • NOTE: Subjects with nonmelanoma skin cancer or carcinoma in situ of any type are not excluded if they have undergone complete resection.
  • Other co-morbidity which would interfere with subject's ability to participate in trial, e.g. uncontrolled infection, uncompensated heart or lung disease.
  • Other concurrent chemotherapy, or any ancillary therapy considered investigational. NOTE: Concurrent chemotherapy is any treatment not related to multiple myeloma.
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  • NOTE: Concurrent chemotherapy is any treatment not related to multiple myeloma
  • NOTE: Bisphosphonates are considered to be supportive care rather than therapy, and are thus allowed while on protocol treatment.
  • Peripheral neuropathy >= grade 3 on clinical examination or grade 2 with pain =< 30 days prior to registration.
  • Major surgery =< 14 days prior to pre-registration.
  • Any medical or psychiatric illness that could, in the investigator's opinion, potentially interfere with the completion of treatment according to this protocol.
  • Known allergies, hypersensitivity, or intolerance to corticosteroids, monoclonal antibodies or human proteins, or their excipients (refer to respective package inserts or investigator's brochure) or known sensitivity to mammalian-derived products. Known allergies, hypersensitivity, or intolerance to trial drugs.
  • Inability to comply with protocol/procedures.
  • Received prior treatment for multiple myeloma prior to pre-registration. Note: results can still be pending as long as the tests have been performed
  • REGISTRATION-EXCLUSION CRITERIA:
  • If any of the following exist at screening, subject will not be eligible for trial because this trial involves an investigational agent whose genotoxic, mutagenic and teratogenic effects on the developing fetus and newborn are unknown:
  • Pregnant women
  • Nursing women
  • Men or women of childbearing potential who are unwilling to employ adequate contraception (per protocol).
  • Evidence of current uncontrolled cardiovascular conditions, including hypertension, cardiac arrhythmias, congestive heart failure, unstable angina, or myocardial infarction within the past 6 months.
  • Note: Prior to trial entry, any electrocardiogram (ECG) abnormality at screening must be documented by the investigator as not medically relevant.
  • New York Heart Association (NYHA) II, III, IV heart failure.
  • Known human immunodeficiency virus (HIV) positive.
  • Seropositive for hepatitis B (defined by a positive test for hepatitis B surface antigen [HBsAg]). Subjects with resolved infection (ie., subjects who are HBsAg negative but positive for antibodies to hepatitis B core antigen [anti-HBc] and/or antibodies to hepatitis B surface antigen [anti-HBs]) must be screened using real-time polymerase chain reaction (PCR) measurement of hepatitis B virus (HBV) deoxyribonucleic acid (DNA) levels. Those who are PCR positive will be excluded.
  • EXCEPTION: subjects with serologic findings suggestive of HBV vaccination (anti-HBs positivity as the only serologic marker) AND a known history of prior HBV vaccination, do not need to be tested for HBV DNA by PCR.
  • Known or suspected active hepatitis C infection.

Trial locations and contacts

3 sites in 1 country.

United States3 sites

  • Mayo Clinic

    Jacksonville, Florida, 32224-9980

  • Mayo Clinic in Rochester

    Rochester, Minnesota, 55905

  • Mayo Clinic in Arizona

    Scottsdale, Arizona, 85259

Other trials in United States

About this study

Official title: REsponse Adapted Combination Therapy Approaches for High-Risk Multiple Myeloma (REACH)

This phase II trial test whether combination chemotherapy works to improve blood test results in patients with high-risk multiple myeloma. Chemotherapy drugs, such as carfilzomib, daratumumab, lenalidomide, and dexamethasone, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. This trial may help determine if patients who have a small amount of cancer left after the initial treatment, called minimal residual disease, will benefit from the drug combination.

Read the detailed description

PRIMARY OBJECTIVE:

  1. To estimate the rate of sustained minimal residual disease (MRD) negativity (MRD negative status at any point, with a repeated MRD negative status one year later) in subjects with high-risk multiple myeloma.

SECONDARY OBJECTIVES:

  1. To describe the toxicities associated with this treatment approach in subjects with high-risk multiple myeloma (MM).

II. To estimate the overall response rate, very good partial response (VGPR) or better rate and complete response (CR) rate at the end of induction, end of consolidation, end of maintenance and at two years after the completion of treatment.

III. To estimate the progression-free survival and overall survival rate.

CORRELATIVE RESEARCH OBJECTIVES:

  1. To describe the clonal architecture through a combination of genomic, epigenomic, proteomic and metabolomic studies before and after treatment, in subjects with high-risk MM.

II. To describe the bone marrow microenvironment through various stages of treatment and the time of MRD negative state and at time of relapse.

OUTLINE:

INDUCTION: Patients receive carfilzomib intravenously (IV) on days 1, 2, 8, and 15 of cycle 1 and days 1, 8, and 15 of cycles 2-12, lenalidomide orally (PO) days 1-21 of each cycle, daratumumab subcutaneously (SC) days 1, 8, 15, and 22 of cycles 1 and 2, days 1 and 15 of cycles 3-6, and day 1 of subsequent cycles, and dexamethasone PO or IV on days 1, 8, 15, and 22 of each cycle. Treatment repeats every 28 days for 12 cycles in the absence of disease progression or unacceptable toxicity.

CONSOLIDATION: Patients receive carfilzomib IV on days 1, 8, and 15, lenalidomide PO days 1-21, daratumumab SC day 1 of each cycle. Treatment repeats every 28 days for 12 cycles in the absence of disease progression or unacceptable toxicity.

MAINTENANCE: Patients receive carfilzomib IV on day 1, lenalidomide PO days 1-21, daratumumab SC day 1 of each cycle. Treatment repeats every 28 days for 12 cycles in the absence of disease progression or unacceptable toxicity.

Additionally, patients undergo bone marrow aspirate and biopsy, blood sample collection, echocardiography (ECHO) or multigated acquisition (MUGA) scan, and magnetic resonance imaging (MRI), computed tomography (CT), or positron emission tomography (PET)/CT throughout the study. Patients also undergo chest radiography (x-ray) during screening.

After completion of study treatment, patients are followed up every 6 months for up to 10 years.

Being tested
Bone Marrow Aspiration and Biopsy, Carfilzomib, Computed Tomography, Daratumumab, Dexamethasone
Medical subject headings
Multiple Myeloma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Bone Marrow Aspiration and BiopsyProcedure or surgery

    Undergo bone marrow aspiration and biopsy

  • CarfilzomibDrug

    Also called Kyprolis, PR-171

    Given IV

  • Computed TomographyProcedure or surgery

    Also called CAT, CAT Scan, Computed Axial Tomography, Computerized Axial Tomography

    Undergo CT or PET/CT

  • DaratumumabBiological

    Also called Darzalex, HuMax-CD38, JNJ-54767414, Daratumumab Biosimilar HLX15

    Given SC

  • DexamethasoneDrug

    Also called Aacidexam, Adexone, Aknichthol Dexa, Alba-Dex

    Given IV/PO

  • LenalidomideDrug

    Also called CC-5013, CC5013, CDC 501, Revlimid

    Given PO

  • Magnetic Resonance ImagingProcedure or surgery

    Also called Magnetic Resonance Imaging Scan, Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance, MR, MR Imaging

    Undergo MRI

  • Positron Emission TomographyProcedure or surgery

    Also called Medical Imaging, Positron Emission Tomography, PET, PET Scan, Positron Emission Tomography Scan

    Undergo PET/CT

  • Multigated Acquisition ScanProcedure or surgery

    Also called Blood Pool Scan, Equilibrium Radionuclide Angiography, Gated Blood Pool Imaging, Gated Heart Pool Scan

    Undergo MUGA scan

  • Biospecimen CollectionProcedure or surgery

    Also called Biological Sample Collection, Biospecimen Collected, Specimen Collection

    Undergo blood sample collection

  • EchocardiographyProcedure or surgery

    Also called EC

    Undergo ECHO

  • Chest RadiographyProcedure or surgery

    Also called chest x-ray

    Undergo chest x-ray

Study groups in NCT05497804
Study groupRoleWhat they receive
Treatment (combination chemotherapy)ExperimentalINDUCTION: Patients receive carfilzomib IV on days 2, 8, and 15 of cycle 1 and days 1, 8, and 15 of cycles 2-12, lenalidomide PO days 1-21 of each cycle, daratumumab SC days 1, 8, 15, and 22 of cycles 1 and 2, days 1 and 15 of cycles 3-6, and day 1 of subsequent cycles, and dexamethasone PO or IV on days 1, 8, 15, and 22 of each cycle. Treatment repeats every 28 days for 12 cycles in the absence of disease progression or unacceptable toxicity. CONSOLIDATION: Patients receive carfilzomib IV on days 1, 8, and 15, lenalidomide PO days 1-21, daratumumab SC day 1 of each cycle. Treatment repeats every 28 days for 12 cycles in the absence of disease progression or unacceptable toxicity. MAINTENANCE: Patients receive carfilzomib IV on day 1, lenalidomide PO days 1-21, daratumumab day 1 of each cycle. Treatment repeats every 28 days for 12 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo bone marrow aspirate and biopsy, MRI and, CT/PET.
Receives: Procedure: Bone Marrow Aspiration and Biopsy; Drug: Carfilzomib; Procedure: Computed Tomography; Biological: Daratumumab; Drug: Dexamethasone; Drug: Lenalidomide; Procedure: Magnetic Resonance Imaging; Procedure: Positron Emission Tomography; Procedure: Multigated Acquisition Scan; Procedure: Biospecimen Collection; Procedure: Echocardiography; Procedure: Chest Radiography

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Rate of Sustained Minimal Residual Disease (MRD) Negativity

    MRD negative status at any point, with a repeated MRD negative status one year later. All subjects meeting the eligibility criteria who have signed a consent form and have begun treatment will be evaluable, with the exception of subjects determined to be a major violation. The International Myeloma Working Group (IMWG) uniform response criteria (Kumar et al, >>> 2016) was used for response assessment.

    Measured: 1 year

Secondary outcomes (4)

  1. Overall Response Rate

    The overall response rate will be defined as the percentage of patients that achieved confirmed very good partial response (VGPR) or better by The International Myeloma Working Group (IMWG) uniform response criteria (Kumar et al, 2016) at the designated timepoint.

    Measured: At the end of induction (up to 1 year after start of induction treatment) and at the end of consolidation (up to 3 years after start of induction treatment)

  2. Overall Survival

    Defined as the time from registration to death due to any cause. The distribution of overall survival will be estimated using the method of Kaplan-Meier.

    Measured: 3 years

  3. Progression-Free Survival

    Defined as the time from registration to the earliest date of documentation of disease progression or death due to any cause. The distribution of progression-free survival will be estimated using the method of Kaplan-Meier.

    Measured: 3 years

  4. Incidence of Adverse Events

    Adverse Events: All eligible subjects that have initiated treatment will be considered evaluable for assessing adverse event rate(s). The maximum grade for each type of adverse event will be recorded for each subject, and frequency tables will be reviewed to determine patterns. Additionally, the relationship of the adverse event(s) to the trial treatment will be taken into consideration. AEs will be summarized overall, as well as by treatment phase (induction, consolidation, maintenance with carfilzomib and lenalidomide and daratumumab). The percent of patients with a grade 3 or higher event will be reported for both the Induction and Consolidation timepoints.

    Measured: Monthly up to 3 years after start of induction treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Aug 2022
  2. Study start22 Sep 2022
  3. Primary completion12 Feb 2026
  4. Study completion4 Sep 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
17 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05497804
Sponsor's protocol ID
MC210811
Other IDs
P50CA186781, 22-002687
Status last verified
Oct 2026
First submitted
3 Aug 2022
Last updated
2 Nov 2026
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Bone Marrow Aspiration and Biopsy, Carfilzomib and Computed Tomography in people with ISS Stage III Plasma Cell Myeloma and Multiple Myeloma, run by Mayo Clinic at 3 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 29 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 2 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 2 Nov 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Rate of Sustained Minimal Residual Disease (MRD) Negativity (time frame: 1 year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05497804.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2026.

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