Teclistamab + RVd for Multiple Myeloma

Recruiting at 6 trial locations

Overseen By Neha Korde, MD

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: Memorial Sloan Kettering Cancer Center

Disqualifiers: Plasma cell leukemia, Active malignancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Breakthrough Therapy This drug has been fast-tracked for approval by the FDA given its high promise

Compensation: Varies

Number of Visits: Unknown

65 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new combination of treatments for individuals with newly diagnosed multiple myeloma, a type of blood cancer. Researchers aim to determine if alternating between two treatment regimens, including drugs like teclistamab (a new potential drug) and daratumumab, is safe and effective. The study will initially assess safety and then evaluate the treatment's effectiveness in eliminating cancer cells. Ideal participants are those diagnosed with multiple myeloma who have not yet received significant treatment beyond basic supportive care. As a Phase 1 trial, this research seeks to understand how the treatment works in people, offering participants the opportunity to be among the first to receive this new potential drug.

Do I have to stop taking my current medications for the trial?

The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor to get specific guidance based on your situation.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that patients generally tolerate teclistamab well. Studies have found no major safety issues, even for those with serious health conditions, indicating it manages side effects effectively for people with multiple myeloma.

Similarly, daratumumab has proven safe, with no new safety concerns after years of use. Patients generally accept it well when used alongside other treatments for multiple myeloma.

Both treatments have undergone research and appear to be safe choices for those considering joining this trial. However, discussing any concerns with a doctor is always advisable. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about Teclistamab because it offers a new approach to treating multiple myeloma by engaging the body's immune system in a unique way. Unlike traditional treatments like proteasome inhibitors or immunomodulatory drugs, Teclistamab is a bispecific antibody that targets both BCMA on myeloma cells and CD3 on T-cells, potentially enhancing the immune system's ability to attack cancer cells directly. This dual-targeting mechanism sets it apart from existing therapies and holds promise for improved outcomes in patients. Daratumumab, another component of the study, is a monoclonal antibody that targets CD38, adding another layer of immune system activation against the cancer cells. Together, these treatments could offer a more robust attack on multiple myeloma than current options.

What evidence suggests that this trial's treatments could be effective for multiple myeloma?

Research shows that teclistamab, one of the treatments in this trial, holds promise for treating multiple myeloma, with 63% of patients responding well, even those who have tried many treatments before. Teclistamab may help patients who couldn't join other trials, suggesting it could be widely useful. In this trial, some participants will receive teclistamab in combination with RVd.

Adding daratumumab, another treatment option in this trial, to standard treatments for multiple myeloma has helped patients live longer without their cancer worsening. Various studies have shown that daratumumab achieves a 52.6% response rate and improves survival times. Both treatments are being evaluated in this trial to effectively address multiple myeloma, offering hope for those newly diagnosed. ^{6 7 8 9 10}

Who Is on the Research Team?

Neha Korde, MD

Principal Investigator

Memorial Sloan Kettering Cancer Center

Are You a Good Fit for This Trial?

This trial is for individuals newly diagnosed with multiple myeloma. Participants should meet specific health criteria and not have received prior treatments for their condition. Detailed eligibility will be based on certain medical parameters set by the researchers.

Inclusion Criteria

My organs and blood counts are healthy.

I am 18 years old or older.

All study participants must be able to tolerate thromboprophylaxis strategies

Exclusion Criteria

Significant uncontrolled comorbid conditions likely to interfere with the study procedures

Pregnant or lactating patients

Unwilling or unable to give written, informed consent or comply with the protocol

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Phase I Treatment

Evaluate the safety and toxicity of Tec-RVd

up to 4 months

Phase II Treatment

Evaluate MRD negativity rate of alternating Dara-RVd/Tec-RVd after 6 cycles of induction therapy

up to 6 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4-8 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Daratumumab
• Teclistamab

Trial Overview The study tests if Tec-RVd (teclistamab combined with lenalidomide, bortezomib, and dexamethasone) following Dara-RVd (daratumumab with the same combination) is effective and safe as an initial treatment for multiple myeloma over three treatment cycles.

How Is the Trial Designed?

Group I: Phase II, Stage 2 Experimental Treatment 2 Interventions

The phase II part of the study evaluates MRD negativity (MRD-) rate of alternating Dara-RVd/Tec-RVd after 6 cycles of induction therapy.

Group II: Phase II, Stage 1 Experimental Treatment 2 Interventions

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

Group III: Phase I Experimental Treatment 2 Interventions

The phase 1 part of the study evaluates the safety and toxicity of Tec-RVd

Who Is Running the Clinical Trial?

Memorial Sloan Kettering Cancer Center

Lead Sponsor

Trials

1,998

Recruited

602,000+

Citations

1. esmoopen.com esmoopen.com/article/S2059-7029(24)01854-4/fulltext

Outcomes and prognostic indicators in daratumumab ... With an overall response rate (ORR) of 39.5% and a median PFS of 4.56 months, the outcomes were comparable to other salvage regimens used in ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10532632/

Clinical Outcomes of Patients with Multiple Myeloma after ... Survival after daratumumab progression was better in patients treated with an anti-CD38 MoAB as a first line compared to those who received ...

3. cancer.gov cancer.gov/news-events/cancer-currents-blog/2024/multiple-myeloma-darzalex-plus-vrd

Daratumumab Plus Standard Therapy for Multiple Myeloma Adding daratumumab (Darzalex) to standard VRD treatment helped people with newly diagnosed multiple myeloma live longer without their cancer ...

4. ashpublications.org ashpublications.org/blood/article/144/Supplement%201/7831/526813/Real-World-Efficacy-and-Patient-Reported-Quality

Real-World Efficacy and Patient-Reported Quality of Life ... 31 (53.4%) patients achieved a very good partial response or better per IMWG response assessment criteria, 49 (84.5%) achieved a partial ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S2059702924018544

Outcomes and prognostic indicators in daratumumab ... The overall response rate was 52.6%, with a median PFS and OS of 6.6 and 17.0 months, respectively. The International Staging System (ISS) stages II and III, ...

6. ashpublications.org ashpublications.org/blood/article/145/15/1658/534407/Efficacy-and-safety-of-daratumumab-in-intermediate

Efficacy and safety of daratumumab in intermediate/high-risk ... No new safety concerns were observed after extended follow-up of ∼7 years, highlighting the tolerability of daratumumab. Subjects: Clinical Trials and ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10519573/

Efficacy and safety of daratumumab in the treatment of ... Our results suggest that daratumumab-based regimens are effective in the treatment of RRMM, improving progression-free survival, minimal residual disease, and ...

8. jnj.com jnj.com/media-center/press-releases/darzalex-faspro-is-the-first-and-only-treatment-approved-by-the-u-s-fda-for-patients-with-high-risk-smoldering-multiple-myeloma

DARZALEX FASPRO® is the first and only treatment ... Phase 3 AQUILA study showed DARZALEX FASPRO® significantly reduced the risk of progression to active multiple myeloma or death by 51 percent ...

9. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0006497124112827

Efficacy and safety of daratumumab in intermediate/high- ... No new safety concerns were observed after extended follow-up of ∼7 years, highlighting the tolerability of daratumumab. Abstract. Early ...

10. nejm.org nejm.org/doi/full/10.1056/NEJMoa2312054

Daratumumab, Bortezomib, Lenalidomide, and ... Daratumumab has been approved for use in combination with various regimens for the treatment of patients with newly diagnosed multiple myeloma, ...