RECRUITING

A Study of Dara-RVd and Teclistamab-RVd in People With Multiple Myeloma

Conditions

Multiple Myeloma ALTITUDE Dara-RVd Teclistamab-RVd Memorial Sloan Kettering Cancer Center 24-288

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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

The purpose of this study is to find out whether Tec-RVd (teclistamab, lenalidomide, bortezomib, and dexamethasone) after 3 treatment Cycles of Dara-RVd (daratumumab, lenalidomide, bortezomib, and dexamethasone) is a safe treatment for people with newly diagnosed multiple myeloma (MM).

Official Title

ALTITUDE - ALTernating Induction Therapies to Achieve Undetectable Disease Endpoints: A Phase 1/2 Alternating Dara-RVd/Teclistamab-RVd in Transplant Eligible Standard-risk Newly Diagnosed Multiple Myeloma

Quick Facts

Study Start:2025-07-24

Study Completion:2029-07-24

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT07099391

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

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
1. Documented multiple myeloma satisfying the International Myeloma Working Group (IMWG) diagnostic criteria36 (evidence of myeloma defining event attributed to underlying plasma cell disorder) with measurable disease defined as: 1. Clonal plasma cells in the bone marrow ≥ 10% or presence of a biopsy proven plasmacytoma 2. Measurable disease within the past 4 weeks defined by any of the following: * IgG myeloma: Serum monoclonal protein ≥ 1.0 g/dL or urine monoclonal protein ≥ 200 mg/24 hr; or * IgA, IgM, IgD, IgE multiple myeloma: serum M-protein ≥ 0.5 g/dL or urine monoclonal protein ≥ 200 mg/24 hr; or * Light chain multiple myeloma: Involved serum immunoglobulin free light chain ≥ 10 mg/dL AND abnormal serum free kappa/lambda light chain ratio * Measurable plasmacytomas seen on imaging (≥ 1 lesion that has a single diameter ≥ 2 cm). If this is the primary marker of measurable disease, patients will need a biopsy at screening. * Bone marrow plasma cells ≥ 30% as determined by CD138 immunohistochemistry staining. 2. Standard risk multiple myeloma - excluding patients with high risk cytogenetic abnormality (HRCA) according to the IMS/IMWG 2024 Consensus Definition: 1. TP53 mutation and/or del(17p) with cancer clonal function (CCF) \>20% by analyses conducted on CD138+ purified cells 2. t(4;14), t(14;16), or t(14;20) co-occurring with +1q (gain/amp 1q) and/or del(1p) 3. Monoallelic del(1p32) with +1q or biallelic del(1p32) 4. High Beta-2 microglobulin (\>5.5 mg/dL) with normal creatinine (\<1.2 mg/dL) 3. Newly diagnosed patient considered a candidate for high-dose chemotherapy and autologous stem cell transplant 4. Age ≥18 years. 5. Eastern Cooperative Oncology Group (ECOG) performance status 0-2 6. Have adequate organ and hematologic function: 1. Hemoglobin ≥ 7.5 g/dL (prior RBC transfusion or recombinant human erythropoietin use is permitted); 2. Absolute neutrophil count (ANC) ≥ 1.0 x 109/L (G-CSF use is permitted); 3. Platelet count ≥ 75 x 109/L 4. Creatinine Clearance ≥ 30 ml/min. CrCl can be measured or estimated using Cockcroft-Gault method, MDRD, or CKD-EPI formula 5. Total bilirubin ≤ 2 x ULN (≤ 3 x ULN if documented Gilbert's syndrome); 6. AST ≤ 2.5 x ULN; 7. ALT ≤ 2.5 x ULN 7. All study participants must be able to tolerate one of the following thromboprophylaxis strategies: aspirin, low molecular weight heparin or warfarin (coumadin) or alternative anti-coagulant. 8. All study participants must be able to tolerate one of the following thromboprophylaxis strategies: aspirin, low molecular weight heparin or warfarin (Coumadin), or direct-acting oral anticoagulants (DOACs). 9. All study participants must be registered into the mandatory REMS® program and be willing and able to comply with the requirements of REMS®, including compliance with contraception methods (Appendix A).	1. Patients who have received \> 1 cycle of prior treatment or concurrent systemic therapy for multiple myeloma (excluding corticosteroids or radiation therapy) 2. Patients with diagnosis of plasma cell leukemia, primary light chain amyloidosis, monoclonal gammopathy of undetermined significance, smoldering multiple myeloma, POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, M-protein, and skin changes), Waldentröm's macroglobulinemia 3. History of another active primary malignancy within 2 years prior to enrollment, except for adequately treated basal cell carcinoma or squamous cell skin cancer or carcinoma in situ. 4. Significant, uncontrolled comorbid conditions that is likely to interfere with the study procedures or results, or that in the opinion of the investigator, would constitute a hazard for participating in the study. Examples include, but are not limited to 1. Chronic obstructive pulmonary disease (COPD) with a forced expiratory volume in 1 second (FEV1) \< 50% of predicted normal. Note that FEV1 testing is required for participants suspected of having COPD and participants must be excluded if FEV1 is \< 50% of predicted normal. 2. Moderate or severe persistent asthma within the past 2 years or uncontrolled asthma of any classification. Note that participants who currently have controlled intermittent asthma or controlled mild persistent asthma are allowed to participate. 3. Infiltrative pulmonary disease 4. Active autoimmune disease requiring systemic immunosuppressive therapy within 6 months before start of study treatment. Exception of vitiligo, type 1 diabetes, and prior autoimmune thyroiditis that is currently euthyroid 5. Disabling psychiatric conditions (e.g., alcohol or drug abuse)., severe dementia, or altered mental status 6. Known history of human immunodeficiency virus (HIV) 7. Seropositive for hepatitis B (defined by a positive test for hepatitis B surface antigen \[HBsAg\]). 5. Pregnant or lactating patients 6. Unwilling to give written, informed consent, unwilling to participate, or unable to comply with the protocol for the duration of the study

Inclusion Criteria

Exclusion Criteria

1. Documented multiple myeloma satisfying the International Myeloma Working Group (IMWG) diagnostic criteria36 (evidence of myeloma defining event attributed to underlying plasma cell disorder) with measurable disease defined as:
1. Clonal plasma cells in the bone marrow ≥ 10% or presence of a biopsy proven plasmacytoma
2. Measurable disease within the past 4 weeks defined by any of the following:
* IgG myeloma: Serum monoclonal protein ≥ 1.0 g/dL or urine monoclonal protein ≥ 200 mg/24 hr; or
* IgA, IgM, IgD, IgE multiple myeloma: serum M-protein ≥ 0.5 g/dL or urine monoclonal protein ≥ 200 mg/24 hr; or
* Light chain multiple myeloma: Involved serum immunoglobulin free light chain ≥ 10 mg/dL AND abnormal serum free kappa/lambda light chain ratio
* Measurable plasmacytomas seen on imaging (≥ 1 lesion that has a single diameter ≥ 2 cm). If this is the primary marker of measurable disease, patients will need a biopsy at screening.
* Bone marrow plasma cells ≥ 30% as determined by CD138 immunohistochemistry staining.
2. Standard risk multiple myeloma - excluding patients with high risk cytogenetic abnormality (HRCA) according to the IMS/IMWG 2024 Consensus Definition:
1. TP53 mutation and/or del(17p) with cancer clonal function (CCF) \>20% by analyses conducted on CD138+ purified cells
2. t(4;14), t(14;16), or t(14;20) co-occurring with +1q (gain/amp 1q) and/or del(1p)
3. Monoallelic del(1p32) with +1q or biallelic del(1p32)
4. High Beta-2 microglobulin (\>5.5 mg/dL) with normal creatinine (\<1.2 mg/dL)
3. Newly diagnosed patient considered a candidate for high-dose chemotherapy and autologous stem cell transplant
4. Age ≥18 years.
5. Eastern Cooperative Oncology Group (ECOG) performance status 0-2
6. Have adequate organ and hematologic function:
1. Hemoglobin ≥ 7.5 g/dL (prior RBC transfusion or recombinant human erythropoietin use is permitted);
2. Absolute neutrophil count (ANC) ≥ 1.0 x 109/L (G-CSF use is permitted);
3. Platelet count ≥ 75 x 109/L
4. Creatinine Clearance ≥ 30 ml/min. CrCl can be measured or estimated using Cockcroft-Gault method, MDRD, or CKD-EPI formula
5. Total bilirubin ≤ 2 x ULN (≤ 3 x ULN if documented Gilbert's syndrome);
6. AST ≤ 2.5 x ULN;
7. ALT ≤ 2.5 x ULN
7. All study participants must be able to tolerate one of the following thromboprophylaxis strategies: aspirin, low molecular weight heparin or warfarin (coumadin) or alternative anti-coagulant.
8. All study participants must be able to tolerate one of the following thromboprophylaxis strategies: aspirin, low molecular weight heparin or warfarin (Coumadin), or direct-acting oral anticoagulants (DOACs).
9. All study participants must be registered into the mandatory REMS® program and be willing and able to comply with the requirements of REMS®, including compliance with contraception methods (Appendix A).

1. Patients who have received \> 1 cycle of prior treatment or concurrent systemic therapy for multiple myeloma (excluding corticosteroids or radiation therapy)
2. Patients with diagnosis of plasma cell leukemia, primary light chain amyloidosis, monoclonal gammopathy of undetermined significance, smoldering multiple myeloma, POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, M-protein, and skin changes), Waldentröm's macroglobulinemia
3. History of another active primary malignancy within 2 years prior to enrollment, except for adequately treated basal cell carcinoma or squamous cell skin cancer or carcinoma in situ.
4. Significant, uncontrolled comorbid conditions that is likely to interfere with the study procedures or results, or that in the opinion of the investigator, would constitute a hazard for participating in the study. Examples include, but are not limited to
1. Chronic obstructive pulmonary disease (COPD) with a forced expiratory volume in 1 second (FEV1) \< 50% of predicted normal. Note that FEV1 testing is required for participants suspected of having COPD and participants must be excluded if FEV1 is \< 50% of predicted normal.
2. Moderate or severe persistent asthma within the past 2 years or uncontrolled asthma of any classification. Note that participants who currently have controlled intermittent asthma or controlled mild persistent asthma are allowed to participate.
3. Infiltrative pulmonary disease
4. Active autoimmune disease requiring systemic immunosuppressive therapy within 6 months before start of study treatment. Exception of vitiligo, type 1 diabetes, and prior autoimmune thyroiditis that is currently euthyroid
5. Disabling psychiatric conditions (e.g., alcohol or drug abuse)., severe dementia, or altered mental status
6. Known history of human immunodeficiency virus (HIV)
7. Seropositive for hepatitis B (defined by a positive test for hepatitis B surface antigen \[HBsAg\]).
5. Pregnant or lactating patients
6. Unwilling to give written, informed consent, unwilling to participate, or unable to comply with the protocol for the duration of the study

Contacts and Locations

Study Contact

Neha Korde, MD

CONTACT

646-608-3708

korden@mskcc.org

Carlyn Rose Tan, MD

CONTACT

646-608-3778

TanC4@mskcc.org

Principal Investigator

Neha Korde, MD

PRINCIPAL_INVESTIGATOR

Memorial Sloan Kettering Cancer Center

Study Locations (Sites)

Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)

Basking Ridge, New Jersey, 07920

United States

Memorial Sloan Kettering Monmouth (Limited Protocol Activities)

Middletown, New Jersey, 07748

United States

Memorial Sloan Kettering Bergen (Limited Protocol Activities)

Montvale, New Jersey, 07645

United States

Memorial Sloan Kettering Cancer Center @ Suffolk - Commack (Limited Protocol Activities)

Commack, New York, 11725

United States

Memorial Sloan Kettering Westchester (Limited Protocol Activities)

Harrison, New York, 10604

United States

Memorial Sloan Kettering Cancer Center (All Protocol Activities)

New York, New York, 10065

United States

Memorial Sloan Kettering Nassau (Limited Protocol Activities)

Uniondale, New York, 11553

United States

Collaborators and Investigators

Sponsor: Memorial Sloan Kettering Cancer Center

Neha Korde, MD, PRINCIPAL_INVESTIGATOR, Memorial Sloan Kettering Cancer Center

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 Date2025-07-24

Study Completion Date2029-07-24

Study Record Updates

Study Start Date2025-07-24

Study Completion Date2029-07-24

Terms related to this study

Keywords Provided by Researchers

Multiple Myeloma
ALTITUDE
Dara-RVd
Teclistamab-RVd
Memorial Sloan Kettering Cancer Center
24-288

Additional Relevant MeSH Terms

Multiple Myeloma