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

Description

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.

Conditions

Multiple Myeloma

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Study Overview

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Study Details

Study overview

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.

S1803, Phase III Study of Daratumumab/rHuPH20 (NSC-810307) + Lenalidomide or Lenalidomide as Post-Autologous Stem Cell Transplant Maintenance Therapy in Patients With Multiple Myeloma (MM) Using Minimal Residual Disease to Direct Therapy Duration (DRAMMATIC Study)

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

Condition
Multiple Myeloma
Intervention / Treatment

-

Contacts and Locations

Anchorage

Anchorage Associates in Radiation Medicine, Anchorage, Alaska, United States, 98508

Anchorage

Anchorage Radiation Therapy Center, Anchorage, Alaska, United States, 99504

Anchorage

Alaska Breast Care and Surgery LLC, Anchorage, Alaska, United States, 99508

Anchorage

Alaska Oncology and Hematology LLC, Anchorage, Alaska, United States, 99508

Anchorage

Alaska Women's Cancer Care, Anchorage, Alaska, United States, 99508

Anchorage

Anchorage Oncology Centre, Anchorage, Alaska, United States, 99508

Anchorage

Katmai Oncology Group, Anchorage, Alaska, United States, 99508

Anchorage

Providence Alaska Medical Center, Anchorage, Alaska, United States, 99508

Fairbanks

Fairbanks Memorial Hospital, Fairbanks, Alaska, United States, 99701

Kingman

Kingman Regional Medical Center, Kingman, Arizona, United States, 86401

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * Patients must have completed ASCT within 180 days prior to registering to Step 2.
  • * Patients must have one of the following performed within 60 days prior to registration for disease assessment: diagnostic quality skeletal survey, whole body CT scan, MRI, or PET.
  • * Patients must have Zubrod Performance Status \</= 2
  • * Patients must have adequate bone marrow function as evidenced by platelets \>/= 75,000/mm3 and ANC \>/= 1,000/mm3 within 28 days prior to first randomization:
  • * Patients must have adequate hepatic function defined by the following within 28 days prior to first randomization:
  • * Total bilirubin \</=1.5 x IULN (institutional upper limit of the norm) AND AST and ALT \</=3.0 x IULN
  • * Patients must have evidence of adequate renal function, as defined by creatinine clearance (CrCl) \>/= 30 mL/min., as measured by a 24-hour urine collection, or estimated by the Cockcroft and Gault formula, or have a serum creatinine \< 2.5 mg/dL within 28 days prior to first randomization.
  • * All ASCT-related toxicities must have recovered to \</=Grade 1 (except for alopecia, fatigue and amenorrhea) prior to first randomization.
  • * Mucositis and gastrointestinal symptoms must have resolved to \</=Grade 1.
  • * Females of childbearing potential (FCBP) must have a negative serum or urine pregnancy test with a sensitivity of at least 25 mIU/mL within 10-14 days prior to registration.
  • * FCBP must agree to have a second pregnancy test within 24 hours prior to starting Cycle 1. Further, FCBP must either commit to continued abstinence from heterosexual intercourse or begin TWO acceptable methods of birth control: one highly effective method and one additional effective method AT THE SAME TIME, at least 28 days before starting lenalidomide. FCBP must also agree to ongoing pregnancy testing and must agree to not become pregnant for at least 3 months after the last dose of study treatment.
  • * Men must agree to use a latex condom during sexual contact with a FCBP, even if they have had a successful vasectomy, during the study treatment and for 3 months after the last dose of study treatment.
  • * Patients must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines.
  • * Patients must not have received any other maintenance therapy post-ASCT and prior to Step 2 registration.
  • * Patients must not have had progressive disease between induction and registration to Registration Step 2. (See Section 10.1b).

Ages Eligible for Study

18 Years to 75 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

SWOG Cancer Research Network,

Amrita Krishnan, MD, FACP, PRINCIPAL_INVESTIGATOR, City of Hope Medical Center

Parameswaran Hari, MD, PRINCIPAL_INVESTIGATOR, Medical College of Wisconsin

Study Record Dates

2040-07-01