A Trial Comparing Ramantamig and Daratumumab (Ramantamig-D) Versus Daratumumab, Bortezomib, Lenalidomide, and Dexamethasone in Participants With Newly Diagnosed Multiple Myeloma Who Are Transplant Eligible

Browse trials for

• Multiple Myeloma 3,717

Multiple Myeloma

3,717 studies on the registry are indexed under Multiple Myeloma; 754 are open to participants now.

This study's planned enrollment of 1,000 is above the median of 41 across 2,967 interventional studies indexed under Multiple Myeloma.

Lead sponsor

Janssen Research & Development, LLC is the lead sponsor of 930 studies on the registry; 77 are open to participants now.

Of its 283 completed or terminated interventional studies of FDA-regulated products, 134 (47%) have results posted.

Study arms

• Experimental
  Arm A: Ramantamig and Daratumumab (Ramantamig-D)

  Participants will receive subcutaneous (SC) dose of ramantamig-D.

  Drug: Ramantamig · Drug: Daratumumab

• Active comparator
  Arm B: DVRd+ HDT+ ASCT+ DR

  Participants will receive Daratumumab, Bortezomib, Lenalidomide, and Dexamethasone (DVRd) along with High-Dose Therapy (HDT), Autologous Stem Cell Transplantation (ASCT) and Daratumumab and Lenalidomide (DR) maintenance for 2 years or until progressive disease (PD) or intolerable toxicity whichever occurs first. Participants will have the option to continue lenalidomide and/or daratumumab maintenance therapy beyond 2 years, until PD, at the investigator's discretion and sponsor approval.

  Drug: Daratumumab · Drug: Bortezomib · Drug: Lenalidomide · Drug: Dexamethasone · Drug: HDT+ASCT

Interventions

• DrugRamantamig

  Ramantamig will be administered as subcutaneous (SC) injection.

  Also known as: JNJ-79635322

• DrugDaratumumab

  Daratumumab will be administered as SC injection.

  Also known as: JNJ-54767414

• DrugBortezomib

  Bortezomib will be administered as SC injection.

• DrugLenalidomide

  Lenalidomide will be administered orally.

• DrugDexamethasone

  Dexamethasone will be administered orally or intravenously (IV).

• DrugHDT+ASCT

  HDT and ASCT will be performed as per standard of care.

Primary outcomes

1. Progression-Free Survival (PFS)

   PFS is defined as the duration from the date of randomization to either confirmed progressive disease (PD) or death, whichever occurs first. PD will be determined according to international myeloma working group (IMWG) response criteria.

   Time frame: Up to approximately 10 years

2. Percentage of Participants Achieving 12-Month Minimal Residual Disease (MRD)-Negative Complete Response (CR)

   12-month MRD-negative CR is defined as participants who achieve MRD-negative status at 12 months (plus minus \[+-\] 3 months) from randomization, as determined by next-generation sequencing (NGS), prior to PD or subsequent antimyeloma therapy (including autologous stem cell transplantation \[ASCT\]).

   Time frame: Up to approximately 12 months

Secondary outcomes

1. Overall Survival (OS)

   OS is defined as the time from the date of randomization to the date of the participant's death due to any cause. If the participant is alive or the vital status is unknown, then the participant's data will be censored at the date the participant was last known to be alive.

   Time frame: Up to approximately 10 years

2. Percentage of Participants Achieving 24-Month Sustained MRD-Negative CR

   24-month sustained MRD-negative CR is defined as participants who achieve MRD-negative CR status, as determined by NGS, for at least 24 months without any examination showing MRD positive status in between, and prior to PD or subsequent antimyeloma therapy (including ASCT).

   Time frame: Up to 5 years

3. Percentage of Participants with Very Good Partial Response (VGPR) or Better

   VGPR or better is defined as participants who achieve VGPR, CR, or stringent complete response (sCR) prior to subsequent antimyeloma therapy, in accordance with the IMWG criteria, during or after the trial intervention.

   Time frame: Up to 5 years

4. Percentage of Participants with Complete Response (CR) or Better

   CR or better is defined as participants who achieve CR or sCR prior to subsequent antimyeloma therapy, in accordance with the IMWG criteria, during or after the trial intervention.

   Time frame: Up to 5 years

5. Percentage of Participants with Overall Response (ORR)

   Overall response rate is defined as percentage of participants who achieve partial response (PR) or better prior to subsequent antimyeloma therapy, in accordance with the IMWG criteria, during or after the trial intervention.

   Time frame: Up to 5 years

6. Percentage of Participants with Overall MRD-Negative CR

   Overall MRD-negative CR is defined as participants who achieve MRD negative status, as determined by NGS, at any time point after randomization and prior to PD or subsequent antimyeloma therapy and who achieve CR or better.

   Time frame: Up to 5 years

7. Percentage of Participants Achieving 12-Month Sustained MRD-Negative CR

   12-month sustained MRD-negative CR is defined as participants who achieve MRD-negative CR status, as determined by NGS, for at least 12 months without any examination showing MRD positive status in between, and prior to PD or subsequent antimyeloma therapy (including ASCT).

   Time frame: Up to 5 years

8. Progression-Free Survival 2 (PFS2)

   PFS2 is defined as the time interval between the date of randomization and date of event, which is defined as PD, as assessed by investigator, on the first subsequent line of antimyeloma therapy or death from any cause, whichever occurs first.

   Time frame: Up to approximately 10 years

9. Number of Participants With Treatment-Emergent Adverse Event (TEAE) by Severity

   An AE is any untoward medical occurrence in a clinical study participant administered a pharmaceutical (investigational or non investigational) product. Any new or worsening AE occurring at or after the initial administration of study treatment through the day of last dose plus 30 days or prior to the start of subsequent anticancer therapy will be considered treatment-related regardless of the start date of the event. TEAEs will be graded according to the National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 6.0. Severity scale ranges from Grade 1= mild, Grade 2= moderate, Grade 3= severe, Grade 4= life-threatening, Grade 5= death related to adverse event.

   Time frame: Up to approximately 10 years

10. Number of Participants With Adverse Events by Severity

    An AE is any untoward medical occurrence in a clinical trial participant administered a pharmaceutical (investigational or non investigational) product. An AE does not necessarily have a causal relationship with the treatment.

    Time frame: Up to approximately 10 years

11. Number of Participants with Significant Abnormalities in Laboratory Parameters

    Number of participants with abnormalities in laboratory parameters (serum chemistry and hematology) will be reported.

    Time frame: Up to approximately 10 years

12. Change from Baseline in Health-related Quality of Life (HRQoL), Symptoms and Functioning Using the Multiple Myeloma Symptom and Impact Questionnaire (MySIm-Q) Scale Scores

    The MySIm-Q is a disease-specific patient reported outcome (PRO) assessment with established content validity for participants with newly diagnosed multiple myeloma (NDMM). It is included to be complementary to the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30). It includes 17 items resulting in a symptom subscale and an impact subscale. The recall period is the "past 7 days" and responses are reported on a 5-point verbal rating scale. Higher scores indicate greater severity/impact.

    Time frame: From Baseline up to approximately 10 years

13. Change from Baseline in HRQoL, Symptoms and Functioning Using the EORTC QLQ C30 Scale Scores

    The EORTC QLQ-C30 Version 3 includes 30 items that make up 5 functional scales (physical, role, emotional, cognitive, and social); 1 global health status scale; 3 symptom scales (pain, fatigue, and nausea/vomiting); 5 single symptom items (dyspnea, insomnia, appetite loss, constipation, and diarrhea); and a single impact item (financial difficulties). The item and scale scores are transformed to a 0 to 100 scale. A higher score represents greater HRQoL, better functioning, and more (worse) symptoms.

    Time frame: From Baseline up to approximately 10 years

14. Change from Baseline in HRQoL, Symptoms and Functioning Using European Quality of Life 5-Dimensions 5-Level Version (EQ-5D-5L) Scale Scores

    The EQ-5D-5L is a self-administered, generic health status measure, consisting of a descriptive system and a visual analogue scale (EQ-VAS). The descriptive system covers 5 dimensions of health (mobility, self-care, usual activities, pain or discomfort, and anxiety or depression), each with 5 levels of severity (no problems, slight problems, moderate problems, severe problems, and unable to perform or extreme problems). Higher scores indicate worse HRQoL.

    Time frame: From Baseline up to approximately 10 years

15. Time to Worsening in HRQoL, Symptoms and Functioning Using the MySIm-Q Scale Scores

    Time to worsening in HRQoL, symptoms and functioning using the MySIm-Q scale scores will be reported. The recall period is the "past 7 days" and responses are reported on a 5-point verbal rating scale. Higher scores indicate greater severity/impact.

    Time frame: Up to approximately 10 years

16. Time to Worsening in HRQoL, Symptoms and Functioning Using the EORTC-QLQ-C30 Scale Scores

    Time to worsening in HRQoL, symptoms and functioning using the EORTC-QLQ-C30 scale scores will be reported. The item and scale scores are transformed to a 0 to 100 scale. A higher score represents greater HRQoL, better functioning, and more (worse) symptoms.

    Time frame: Up to approximately 10 years

17. Time to Worsening in HRQoL, Symptoms and Functioning Using the EQ-5D-5L Scale Scores

    Time to worsening in HRQoL, symptoms and functioning using the EQ-5D-5L scale scores will be reported. The EQ-5D-5L descriptive system covers 5 dimensions of health each with 5 levels of severity with higher scores indicating worse HRQoL.

    Time frame: Up to approximately 10 years

18. Percentage of Participants With Meaningful Improvement in HRQoL, Symptoms and Functioning Using the MySIm-Q Scale Scores

    Percentage of participants with meaningful improvement in HRQoL, symptoms and functioning using MySIm-Q scale score will be reported. The recall period is the "past 7 days" and responses are reported on a 5-point verbal rating scale. Higher scores indicate greater severity/impact.

    Time frame: Up to approximately 10 years

19. Percentage of Participants With Meaningful Improvement in HRQoL, Symptoms and Functioning Using the EORTC-QLQ-C30 Scale Scores

    Percentage of participants with meaningful improvement in HRQoL, symptoms and functioning as assessed by EORTC-QLQ-C30 scale score will be reported. he item and scale scores are transformed to a 0 to 100 scale. A higher score represents greater HRQoL, better functioning, and more (worse) symptoms.

    Time frame: Up to approximately 10 years

20. Percentage of Participants With Meaningful Improvement in HRQoL, Symptoms and Functioning Using the EQ-5D-5L Scale Scores

    Percentage of participants with meaningful improvement in HRQoL, symptoms and functioning using EQ-5D-5L scale score will be reported. The EQ-5D-5L descriptive system covers 5 dimensions of health each with 5 levels of severity with higher scores indicating worse HRQoL.

    Time frame: Up to approximately 10 years

21. Percentage of Participants Who Report Side Effect Burden as Assessed by the European Organization for Research and Treatment of Cancer Item List (EORTC IL) 46

    The EORTC IL46 consists of a single question that measures global impression of burden due to treatment-related symptoms. The response options range from "not at all" to "very much" on a 4 point scale.

    Time frame: Up to approximately 10 years

Individual participant data

Plan to share: Yes — The data sharing policy of Johnson \& Johnson Innovative Medicine is available at www.innovativemedicine.jnj.com/our-innovation/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu.

Data sharing details ↗ · innovativemedicine.jnj.com