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NCT05288062 · OUTCOME

Response Rates (RR) at First Assessment

Immunomodulatory Drugs (Lenalidomide With or Without Pomalidomide) in Combination With a Corticosteroid Drug (Dexamethasone) for the Treatment of Multiple Myeloma · Source last updated 2025-08-20

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure
COUNT_OF_PARTICIPANTS
Unit
Participants
Interval / dispersion
Not reported
Time frame
21 days

What was measured

RR is defined as a binary variable. A success will be defined as patient who achieve a response of a partial response (PR) or better using the International Myeloma Working Group (IMWG) criteria. Biomarkers of interest will be identified and categorized into clinically relevant groups (e.g. positive vs. negative) by evaluating baseline and post treatment (after cycle one) biospecimens. RR will be estimated within each biomarker. Each cohort (A-D) will be evaluated separately and independently.

Analysis population: Only patients that completed the study were included in analysis

Groups in this outcome

Cohort A (Lenalidomide, Dexamethasone)

Patients with smoldering multiple myeloma receive lenalidomide PO QD alone on days 1-14 OR in combination with dexamethasone PO QD on days 1, 8 and 15. Treatment for cycle 1 continues for 21 days in the absence of disease progression or unacceptable toxicity. Patients then receive lenalidomide PO QD on days 1-21 alone or in combination with dexamethasone PO QD on days 1, 8, 15, and 22, or in combination with another drug. Treatment repeats every 28 days for up to 5 cycles in the absence of disease progression or unacceptable toxicity. Bone Marrow Biopsy: Undergo bone marrow aspirate/biopsy Dexamethasone: Given orally Lenalidomide: Given orally

Cohort B (Lenalidomide, Dexamethasone)

Patients with newly diagnosed multiple myeloma receive treatment as in Cohort A. Bone Marrow Biopsy: Undergo bone marrow aspirate/biopsy Dexamethasone: Given orally Lenalidomide: Given orally

Cohort C (Lenalidomide, Dexamethasone, Pomalidomide)

Patients with relapsed or refractory multiple myeloma receive lenalidomide PO QD on days 1-14 in combination with dexamethasone PO QD on days 1, 8 and 15 OR pomalidomide PO QD on days 1-21 in combination with dexamethasone PO QD on days 1, 8 and 15. Treatment for cycle 1 continues for 21 days in the absence of disease progression or unacceptable toxicity. Patients then receive lenalidomide PO QD on days 1-21 in combination with dexamethasone PO QD on days 1, 8, 15, and 22 OR pomalidomide PO QD on days 1-21 in combination with dexamethasone PO QD on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 5 cycles in the absence of disease progression or unacceptable toxicity. Bone Marrow Biopsy: Undergo bone marrow aspirate/biopsy Dexamethasone: Given orally Lenalidomide: Given orally Pomalidomide: Given orally

Cohort D (Lenalidomide, Dexamethasone, Pomalidomide)

Patients with relapsed multiple myeloma after lenalidomide maintenance receive treatment as in Cohort C. Bone Marrow Biopsy: Undergo bone marrow aspirate/biopsy Dexamethasone: Given orally Lenalidomide: Given orally Pomalidomide: Given orally

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
Cohort A (Lenalidomide, Dexamethasone)0
Cohort B (Lenalidomide, Dexamethasone)5
Cohort C (Lenalidomide, Dexamethasone, Pomalidomide)10
Cohort D (Lenalidomide, Dexamethasone, Pomalidomide)0

Reported measurements

Source class 1
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Cohort B (Lenalidomide, Dexamethasone)1Not reportedNot reportedNot reportedNot reported
Cohort C (Lenalidomide, Dexamethasone, Pomalidomide)4Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG001
        value
        1
      2. group Id
        OG002
        value
        4
denoms
  1. counts
    1. group Id
      OG000
      value
      0
    2. group Id
      OG001
      value
      5
    3. group Id
      OG002
      value
      10
    4. group Id
      OG003
      value
      0
    units
    Participants
description
RR is defined as a binary variable. A success will be defined as patient who achieve a response of a partial response (PR) or better using the International Myeloma Working Group (IMWG) criteria. Biomarkers of interest will be identified and categorized into clinically relevant groups (e.g. positive vs. negative) by evaluating baseline and post treatment (after cycle one) biospecimens. RR will be estimated within each biomarker. Each cohort (A-D) will be evaluated separately and independently.
groups
  1. description
    Patients with smoldering multiple myeloma receive lenalidomide PO QD alone on days 1-14 OR in combination with dexamethasone PO QD on days 1, 8 and 15. Treatment for cycle 1 continues for 21 days in the absence of disease progression or unacceptable toxicity. Patients then receive lenalidomide PO QD on days 1-21 alone or in combination with dexamethasone PO QD on days 1, 8, 15, and 22, or in combination with another drug. Treatment repeats every 28 days for up to 5 cycles in the absence of disease progression or unacceptable toxicity. Bone Marrow Biopsy: Undergo bone marrow aspirate/biopsy Dexamethasone: Given orally Lenalidomide: Given orally
    id
    OG000
    title
    Cohort A (Lenalidomide, Dexamethasone)
  2. description
    Patients with newly diagnosed multiple myeloma receive treatment as in Cohort A. Bone Marrow Biopsy: Undergo bone marrow aspirate/biopsy Dexamethasone: Given orally Lenalidomide: Given orally
    id
    OG001
    title
    Cohort B (Lenalidomide, Dexamethasone)
  3. description
    Patients with relapsed or refractory multiple myeloma receive lenalidomide PO QD on days 1-14 in combination with dexamethasone PO QD on days 1, 8 and 15 OR pomalidomide PO QD on days 1-21 in combination with dexamethasone PO QD on days 1, 8 and 15. Treatment for cycle 1 continues for 21 days in the absence of disease progression or unacceptable toxicity. Patients then receive lenalidomide PO QD on days 1-21 in combination with dexamethasone PO QD on days 1, 8, 15, and 22 OR pomalidomide PO QD on days 1-21 in combination with dexamethasone PO QD on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 5 cycles in the absence of disease progression or unacceptable toxicity. Bone Marrow Biopsy: Undergo bone marrow aspirate/biopsy Dexamethasone: Given orally Lenalidomide: Given orally Pomalidomide: Given orally
    id
    OG002
    title
    Cohort C (Lenalidomide, Dexamethasone, Pomalidomide)
  4. description
    Patients with relapsed multiple myeloma after lenalidomide maintenance receive treatment as in Cohort C. Bone Marrow Biopsy: Undergo bone marrow aspirate/biopsy Dexamethasone: Given orally Lenalidomide: Given orally Pomalidomide: Given orally
    id
    OG003
    title
    Cohort D (Lenalidomide, Dexamethasone, Pomalidomide)
param Type
COUNT_OF_PARTICIPANTS
population Description
Only patients that completed the study were included in analysis
reporting Status
POSTED
time Frame
21 days
title
Response Rates (RR) at First Assessment
type
PRIMARY
unit Of Measure
Participants

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice