S1803, Lenalidomide +/- Daratumumab/rHuPh20 as Post-ASCT Maintenance for MM w/MRD to Direct Therapy Duration

Conditions

• Multiple Myeloma

Eligibility Criteria

Sex

ALL

Age

18 Years - 75 Years

Healthy Volunteers

Not accepted

Interventions

• Lenalidomide — DRUG
  Commercially available intervention
• Daratumumab/rHuPH20 — DRUG
  SWOG-Held IND

Study Details

Patients are enrolled to screening (Reg Step 1) prior to or after ASCT but prior to Reg Step 2. Patients are followed until they will begin Maintenance and then registered to Reg Step 2 (first randomization). Patients are randomized between Lenalidomide for 2 years and Lenalidomide + Daratumumab/rHuPH20. After 2 years of Maintenance, MRD is assessed to guide further therapy. MRD-positive patients will continue with the assigned treatment. MRD-negative patients will be further randomized (Reg Step 3) to either continue or discontinue the assigned treatment. Patients are treated for up to 7 years from Step 2 reg and followed for up to 15 years.

Key Dates

Start date

Aug 13, 2019

Status verified

Sep 2025

Primary completion

Jul 1, 2029

Completion

Jul 1, 2040

Study Design

Enrollment

1,100 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• No Intervention: Study Entry / Screening
  Study entry/screening to follow patient until Maintenance.
• Active Comparator: Arm 1: Lenalidomide
  Lenalidomide 10 mg/day, D1-28, q28 days for 3 cycles, then 15 mg/day, D1-28 for up to 2 years from starting treatment.
• Experimental: Arm 2: Lenalidomide + Daratumumab/rHuPH20
  Lenalidomide 10 mg/day, D1-28, q28 days for 3 cycles, then 15 mg/day, D1-28 for up to 2 years from starting treatment. Plus Daratumumab/rHuPH20 1800 mg/30,000 units D1, 8, 15, 22 q 28 days for 2 cycles, then D 1 and 15 q 28 days for cycles 3-6 then D1 q 28 days for subsequent cycles for up to 2 years from starting treatment.
• Active Comparator: Arm 1a: Continue Lenalidomide
  MRD+ or MRD- and randomized to Arm 1a: Lenalidomide 10 mg/day, D1-28, q28 days for 3 cycles, then 15 mg/day, D1-28 for up to 7 years from starting treatment.
• No Intervention: Arm 1b: Stop Lenalidomide
  MRD- and randomized to Arm 1b: Discontinue protocol therapy.
• Active Comparator: Arm 2a: Continue Lenalidomide + Daratumumab/rHuPH20
  MRD+ or MRD- and randomized to Arm 2a: Lenalidomide 10 mg/day, D1-28, q28 days for 3 cycles, then 15 mg/day, D1-28 for up to 7 years from starting treatment. Plus Daratumumab/rHuPH20 1800 mg/30,000 units D1, 8, 15, 22 q 28 days for 2 cycles, then D 1 and 15 q 28 days for cycles 3-6 then D1 q 28 days for subsequent cycles for up to 7 years from starting treatment.
• No Intervention: Arm 2b: Stop Lenalidomide + Daratumumab/rHuPH20
  MRD- and randomized to Arm 2b: Discontinue protocol therapy.

Primary Outcome Measure

Overall Survival [ Time Frame: From date of intial randomization until death due to any cause, assessed up to 15 years ]

Locations (837)

Find similar trials in Anchorage, AK

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