Multiple MyelomaPhase 1/2NCT07099391
A Study of Dara-RVd and Teclistamab-RVd in People With Multiple Myeloma
A Phase 1/2 study testing Dara-RVd and Tec-RVd in people with Multiple Myeloma, run by Memorial Sloan Kettering Cancer Center at 7 sites in United States.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Myeloma
- What is being tested?
- Dara-RVd and Tec-RVd
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 65 participants
- Where
- 7 sitesUnited States
- Study dates
- 24 Jul 2025to 24 Jul 2029
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
- Clonal plasma cells in the bone marrow ≥ 10% or presence of a biopsy proven plasmacytoma
- 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
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- 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.
- Standard risk multiple myeloma - excluding patients with high risk cytogenetic abnormality (HRCA) according to the IMS/IMWG 2024 Consensus Definition:
- TP53 mutation and/or del(17p) with cancer clonal function (CCF) >20% by analyses conducted on CD138+ purified cells
- t(4;14), t(14;16), or t(14;20) co-occurring with +1q (gain/amp 1q) and/or del(1p)
- Monoallelic del(1p32) with +1q or biallelic del(1p32)
- High Beta-2 microglobulin (>5.5 mg/dL) with normal creatinine (<1.2 mg/dL)
- Newly diagnosed patient considered a candidate for high-dose chemotherapy and autologous stem cell transplant
- For patients who received one complete cycle of Dara-RVd at MSK, patients can enter treatment at cycle 2 at the discretion of treating investigator and PI
- Age ≥18 years.
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2
- Have adequate organ and hematologic function:
- Hemoglobin ≥ 7.5 g/dL (prior RBC transfusion or recombinant human erythropoietin use is permitted);
- Absolute neutrophil count (ANC) ≥ 1.0 x 109/L (G-CSF use is permitted);
- Platelet count ≥ 75 x 109/L
- Creatinine Clearance ≥ 30 ml/min. CrCl can be measured or estimated using Cockcroft-Gault method, MDRD, or CKD-EPI formula
- Total bilirubin ≤ 2 x ULN (≤ 3 x ULN if documented Gilbert's syndrome);
- AST ≤ 2.5 x ULN;
- ALT ≤ 2.5 x ULN
- 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.
- 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).
- 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).
Who cannot join
- Patients who have received > 1 cycle of prior treatment or concurrent systemic therapy for multiple myeloma (excluding corticosteroids or radiation therapy). For patients who received one complete cycle of Dara-RVd at MSK, patients can enter treatment at cycle 2 at the discretion of treating investigator and PI
- 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
- 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.
- 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
- 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.
- 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.
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- Infiltrative pulmonary disease
- 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
- Disabling psychiatric conditions (e.g., alcohol or drug abuse)., severe dementia, or altered mental status
- Known history of human immunodeficiency virus (HIV)
- Seropositive for hepatitis B (defined by a positive test for hepatitis B surface antigen [HBsAg]).
- Subjects with resolved infection (i.e., subjects who are HBsAg negative with antibodies to total hepatitis B core antigen [anti-HBc] with or without the presence of hepatitis B surface antibody [anti-HBs]) must be screened using real-time polymerase chain reaction (PCR) measurement of hepatitis B virus (HBV) 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 HBV vaccination, do not need to be testing for HBV DNA by PCR.
- Seropositive for hepatitis C i. Except in the setting of a sustained virologic response [SVR], defined as a viremia at least 12 weeks after completion of antiviral therapy.
- Clinically significant cardiac disease, including: i. Myocardial infarction within 6 months before enrollment, or unstable or uncontrolled disease/condition related to or affection cardiac function (e.g., unstable angina, congestive heart failure, New York Heart Association Class III-IV) ii. Uncontrolled cardiac arrhythmia
- Pregnant or lactating patients
- Unwilling to give written, informed consent, unwilling to participate, or unable to comply with the protocol for the duration of the study
Trial locations and contacts
7 sites in 1 country. Contact the study team or a site near you to ask about taking part.
7 sites in 1 country
United States7 sites, 7 recruiting
- Recruiting
Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)
Basking Ridge, New Jersey, 07920
Neha Korde, MD, 646-608-3708
- Recruiting
Memorial Sloan Kettering Cancer Center @ Suffolk - Commack (Limited Protocol Activities)
Commack, New York, 11725
Neha Korde, MD, 646-608-3708
- Recruiting
Memorial Sloan Kettering Westchester (Limited Protocol Activities)
Harrison, New York, 10604
Neha Korde, MD, 646-608-3708
- Recruiting
Memorial Sloan Kettering Monmouth (Limited Protocol Activities)
Middletown, New Jersey, 07748
Neha Korde, MD, 646-608-3708
- Recruiting
Memorial Sloan Kettering Bergen (Limited Protocol Activities)
Montvale, New Jersey, 07645
Neha Korde, MD, 646-608-3708
- Recruiting
Memorial Sloan Kettering Cancer Center (All Protocol Activities)
New York, New York, 10065
Neha Korde, MD, 646-608-3708
- Recruiting
Memorial Sloan Kettering Nassau (Limited Protocol Activities)
Uniondale, New York, 11553
Neha Korde, MD, 646-608-3708
About this study
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
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).
- Conditions
- Multiple Myeloma
- Being tested
- Dara-RVd, Tec-RVd
- Keywords
- Multiple Myeloma, ALTITUDE, Dara-RVd, Teclistamab-RVd, Memorial Sloan Kettering Cancer Center, 24-288
- Medical subject headings
- Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dara-RVdDrug
This study is a phase 1/2 study design of alternating 6 cycles of Dara-RVd/Tec-RVd induction therapy
Tec-RVdDrug
This study is a phase 1/2 study design of alternating 6 cycles of Dara-RVd/Tec-RVd induction therapy
| Study group | Role | What they receive |
|---|---|---|
| Phase I | Experimental | The phase 1 part of the study evaluates the safety and toxicity of Tec-RVd Receives: Drug: Dara-RVd; Drug: Tec-RVd |
| Phase II, Stage 1 | Experimental | The phase II part of the study evaluates MRD negativity (MRD-) rate of alternating Dara-RVd/Tec-RVd after 6 cycles of induction therapy. If 4 or less participants achieve a MRD- after 6 cycles evaluation the trial will be stopped. If 5 or more participants accomplish a MRD- the trial will move on to stage 2 Receives: Drug: Dara-RVd; Drug: Tec-RVd |
| Phase II, Stage 2 | Experimental | The phase II part of the study evaluates MRD negativity (MRD-) rate of alternating Dara-RVd/Tec-RVd after 6 cycles of induction therapy. Receives: Drug: Dara-RVd; Drug: Tec-RVd |
What is being measured
The primary outcome is the main question the study is designed to answer.
Phase I: Toxicity
Evaluate the safety and toxicity of Tec-RVd for Phase I participants by the number of Dose Limiting Toxicities experienced within the DLT window
Measured: up to 4 months
Phase II: MRD Negativity
The primary endpoint is MRD negativity (MRD-) rate upon completion of 6 cycles of alternating Dara-RVd with Tec-RVd.
Measured: up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2025
- Study start24 Jul 2025
- Primary completion24 Jul 2029 (estimated)
- Study completion24 Jul 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple MyelomaStudies of the same condition, open and under way.
- More trials run by Memorial Sloan Kettering Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 65 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Neha Korde, MD, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07099391
- Sponsor's protocol ID
- 24-288
- Status last verified
- Oct 2026
- First submitted
- 25 Jul 2025
- Last updated
- 2 Nov 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made following one year after publication and for up to 36 months later. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07099391
- Acronym / sponsor ID
- 24-288
- Conditions
- Multiple Myeloma
- Keywords
- Multiple Myeloma, ALTITUDE, Dara-RVd, Teclistamab-RVd, Memorial Sloan Kettering Cancer Center, 24-288
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 65 participants (estimated)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Study start
- 24 Jul 2025 (actual)
- Primary completion
- 24 Jul 2029 (estimated)
- Study completion
- 24 Jul 2029 (estimated)
- First posted
- 1 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Phase I | Experimental | Drug: Dara-RVd, Drug: Tec-RVdThe phase 1 part of the study evaluates the safety and toxicity of Tec-RVd |
| Phase II, Stage 1 | Experimental | Drug: Dara-RVd, Drug: Tec-RVdThe phase II part of the study evaluates MRD negativity (MRD-) rate of alternating Dara-RVd/Tec-RVd after 6 cycles of induction therapy. If 4 or less participants achieve a MRD- after 6 cycles evaluation the trial will be stopped. If 5 or more participants accomplish a MRD- the trial will move on to stage 2 |
| Phase II, Stage 2 | Experimental | Drug: Dara-RVd, Drug: Tec-RVdThe phase II part of the study evaluates MRD negativity (MRD-) rate of alternating Dara-RVd/Tec-RVd after 6 cycles of induction therapy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (28 listed)
- 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:
- Standard risk multiple myeloma - excluding patients with high risk cytogenetic abnormality (HRCA) according to the IMS/IMWG 2024 Consensus Definition:
- Newly diagnosed patient considered a candidate for high-dose chemotherapy and autologous stem cell transplant
- Age ≥18 years.
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2
Key exclusion criteria (17 listed)
- Patients who have received > 1 cycle of prior treatment or concurrent systemic therapy for multiple myeloma (excluding corticosteroids or radiation therapy). For patients who received one complete cycle of Dara-RVd at MSK, patients can enter treatment at cycle 2 at the discretion of treating investigator and PI
- 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
- 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.
- 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
- Pregnant or lactating patients
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dara-RVdThis study is a phase 1/2 study design of alternating 6 cycles of Dara-RVd/Tec-RVd induction therapy | Drug | Phase I, Phase II, Stage 1, Phase II, Stage 2 |
| Tec-RVdThis study is a phase 1/2 study design of alternating 6 cycles of Dara-RVd/Tec-RVd induction therapy | Drug | Phase I, Phase II, Stage 1, Phase II, Stage 2 |
Primary outcome
Phase I: Toxicity
Time frame: up to 4 months
Evaluate the safety and toxicity of Tec-RVd for Phase I participants by the number of Dose Limiting Toxicities experienced within the DLT window
Phase II: MRD Negativity
Time frame: up to 6 months
The primary endpoint is MRD negativity (MRD-) rate upon completion of 6 cycles of alternating Dara-RVd with Tec-RVd.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2026.
- Memorial Sloan Kettering Cancer CenterLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made following one year after publication and for up to 36 months later. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Neha Korde, MD principal investigator
Memorial Sloan Kettering Cancer Center
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Dara-RVd and Tec-RVd in people with Multiple Myeloma, run by Memorial Sloan Kettering Cancer Center at 7 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 28 inclusion and 17 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: looking for participants now, 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 7 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Neha Korde, MD (646-608-3708, korden@mskcc.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Phase I: Toxicity (time frame: up to 4 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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.