Sequential Therapy in Multiple Myeloma Guided by MRD Assessments

Conditions

• Multiple Myeloma

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Dara-VRd intensification, Dara-R maintenance — DRUG
  Eligible patients are enrolled in arm M for induction therapy, corresponding to 6 cycles of Dara-VRd. Upon confirmation of adequate hematopoietic cell collection and result of MRD1 patients will undergo 1:1 randomization according to the MRD-assigned cohort • MRD negative cohort - Patients will be randomized between arm A (3 cycles of Dara-VRd intensification followed by 13 cycles of Dara-R maintenance) and arm B (AHCT intensification followed by 13 cycles of Dara-R maintenance) for intensification and maintenance
• AHCT intensification, Dara-R maintenance — DRUG
  Eligible patients are enrolled in arm M for induction therapy, corresponding to 6 cycles of Dara-VRd. Upon confirmation of adequate hematopoietic cell collection and result of MRD1 patients will undergo 1:1 randomization according to the MRD-assigned cohort • MRD negative cohort - Patients will be randomized between arm A (3 cycles of Dara-VRd intensification followed by 13 cycles of Dara-R maintenance) and arm B (AHCT intensification followed by 13 cycles of Dara-R maintenance) for intensification and maintenance
• AHCT intensification, Tec-Dara consolidation, Tec-Dara maintenance — DRUG
  Eligible patients are enrolled in arm M for induction therapy, corresponding to 6 cycles of Dara-VRd. Upon confirmation of adequate hematopoietic cell collection and result of MRD1 patients will undergo 1:1 randomization according to the MRD-assigned cohort. MRD positive cohort - Patients will be randomized between arm C (AHCT intensification, 3 cycles of Dara-Tec consolidation and 13 cycles of Dara-Tec maintenance) and arm D (AHCT intensification, 3 cycles of Dara-R consolidation and 13 cycles of Dara-R maintenance) for intensification, consolidation and maintenance.
• AHCT intensification, Dara-R consolidation, Dara-R maintenance — DRUG
  Eligible patients are enrolled in arm M for induction therapy, corresponding to 6 cycles of Dara-VRd. Upon confirmation of adequate hematopoietic cell collection and result of MRD1 patients will undergo 1:1 randomization according to the MRD-assigned cohort. MRD positive cohort - Patients will be randomized between arm C (AHCT intensification, 3 cycles of Dara-Tec consolidation and 13 cycles of Dara-Tec maintenance) and arm D (AHCT intensification, 3 cycles of Dara-R consolidation and 13 cycles of Dara-R maintenance) for intensification, consolidation and maintenance.
• Dara-VRd induction — DRUG
  Patients undergo induction therapy with 6 cycles of daratumumab, bortezomib, lenalidomide and dexamethasone

Study Details

This research study will determine the proportion of patients with lowest minimal residual disease (MRD) response obtainable after receiving 6 cycles of study treatment. Minimal residual disease is multiple myeloma cells below the level of 1 cancer cell out of 100,000 in the bone marrow. For patients who become MRD "negative" (i.e. less than 1 cancer cell out of 100,000) at the end of 6 cycles of therapy, this study will study if that good response can be maintained with 3 additional cycles of treatment instead of use of autologous hematopoietic cell transplantation (AHCT). For patients who are MRD "positive" at the end of 6 cycles of therapy, this study will answer whether more patients can become and remain MRD "negative" with AHCT plus teclistamab in combination with daratumumab when compared with patients who undergo AHCT followed by lenalidomide (an established anti-myeloma drug) plus daratumumab.

Key Dates

Start date

Dec 13, 2023

Status verified

May 2026

Primary completion

Dec 31, 2027

Completion

Dec 31, 2029

Study Design

Enrollment

300 participants (estimated)

Allocation

RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

TREATMENT

Arms

• Experimental: Arm A
  3 cycles of Dara-VRd intensification followed by 13 cycles of Dara-R maintenance in MRD negative patients
• Active Comparator: Arm B
  AHCT intensification followed by 13 cycles of Dara-R maintenance in MRD negative patients
• Experimental: Arm C
  AHCT intensification, 3 cycles of Dara-Tec consolidation and 13 cycles of Dara-Tec maintenance in MRD positive patients
• Active Comparator: Arm D
  AHCT intensification, 3 cycles of Dara-R consolidation and 13 cycles of Dara-R maintenance in MRD positive patients
• Other: Arm M
  Induction - 6 cycles of Dara-VRd in all participants

Primary Outcome Measure

Depth of response obtained with 6 cycles of Dara-VRd [ Time Frame: 6 months ]

Central Contacts

• Luciano Costa, MD
  205-934-9695
  [email protected]
• Margaret A Thomas, MPH
  [email protected]

Locations (10)

Find similar trials in Birmingham, AL

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