RECRUITING

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

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Conditions

ISS Stage III Plasma Cell MyelomaMultiple Myeloma

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2022-09-22
Study Completion:2028-11-20
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05497804

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 80 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * PRE-REGISTRATION-
  1. * PRE-REGISTRATION EXCLUSION:
  2. * Monoclonal gammopathy of undetermined significance (MGUS), smoldering myeloma, light chain amyloidosis with organ involvement.
  3. * 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.
  4. * NOTE: Subjects with nonmelanoma skin cancer or carcinoma in situ of any type are not excluded if they have undergone complete resection.
  5. * Other co-morbidity which would interfere with subject's ability to participate in trial, e.g. uncontrolled infection, uncompensated heart or lung disease.
  6. * Other concurrent chemotherapy, or any ancillary therapy considered investigational. NOTE: Concurrent chemotherapy is any treatment not related to multiple myeloma.
  7. * NOTE: Concurrent chemotherapy is any treatment not related to multiple myeloma
  8. * NOTE: Bisphosphonates are considered to be supportive care rather than therapy, and are thus allowed while on protocol treatment.
  9. * Peripheral neuropathy \>= grade 3 on clinical examination or grade 2 with pain =\< 30 days prior to registration.
  10. * Major surgery =\< 14 days prior to pre-registration.
  11. * Evidence of current uncontrolled cardiovascular conditions, including hypertension, cardiac arrhythmias, congestive heart failure, unstable angina, or myocardial infarction within the past 6 months.
  12. * Note: Prior to trial entry, any electrocardiogram (ECG) abnormality at screening must be documented by the investigator as not medically relevant.
  13. * New York Heart Association (NYHA) II, III, IV heart failure.
  14. * Known human immunodeficiency virus (HIV) positive.
  15. * 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.
  16. * 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.
  17. * Known or suspected active hepatitis C infection.
  18. * Any medical or psychiatric illness that could, in the investigator's opinion, potentially interfere with the completion of treatment according to this protocol.
  19. * 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.
  20. * Inability to comply with protocol/procedures.
  21. * REGISTRATION-

Contacts and Locations

Principal Investigator

Shaji K. Kumar, M.D.
PRINCIPAL_INVESTIGATOR
Mayo Clinic in Rochester

Study Locations (Sites)

Mayo Clinic in Arizona
Scottsdale, Arizona, 85259
United States
Mayo Clinic
Jacksonville, Florida, 32224-9980
United States
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
United States

Collaborators and Investigators

Sponsor: Mayo Clinic

  • Shaji K. Kumar, M.D., PRINCIPAL_INVESTIGATOR, Mayo Clinic in Rochester

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-09-22
Study Completion Date2028-11-20

Study Record Updates

Study Start Date2022-09-22
Study Completion Date2028-11-20

Terms related to this study

Additional Relevant MeSH Terms

  • ISS Stage III Plasma Cell Myeloma
  • Multiple Myeloma