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Testing the Use of Combination Therapy in Adult Patients With Newly Diagnosed Multiple Myeloma, the EQUATE Trial

ConditionsPlasma Cell MyelomaRISS Stage I Plasma Cell MyelomaRISS Stage II Plasma Cell Myeloma
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorECOG-ACRIN Cancer Research Group

About this trial

This phase III trial compares the combination of four drugs (daratumumab, bortezomib, lenalidomide and dexamethasone) to the use of a three drug combination (daratumumab, lenalidomide and dexamethasone). Bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Chemotherapy drugs, such as lenalidomide, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Daratumumab is a monoclonal antibody that may interfere with the ability of cancer cells to grow and spread. Anti-inflammatory drugs, such as dexamethasone lower the body's immune response and are used with other drugs in the treatment of some types of cancer. Adding bortezomib to daratumumab, lenalidomide, and dexamethasone may be more effective in shrinking the cancer or preventing it from returning, compared to continuing on daratumumab, lenalidomide, and dexamethasone.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

STEP 0 - Patient must have an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0-2 (PS 3 allowed if secondary to pain)

STEP 0 - Patient must have newly diagnosed multiple myeloma (MM) by International Myeloma Working Group (IMWG) criteria

STEP 0 - Patient must agree to register to the mandatory REVLIMID Risk Evaluation and Mitigation Strategy (RevREMS) program and be willing and able to comply with the requirements of RevREMS

STEP 0 - Patient must be able to undergo diagnostic bone marrow aspirate following preregistration.

Disqualifiers

STEP 0 - Patient must not have any known allergies, hypersensitivity, or intolerance to corticosteroids, monoclonal antibodies or human proteins, or their excipients (refer to respective package inserts or Investigator's Brochure), or known sensitivity to mammalian-derived products

Has achieved menarche at some point,

Has not undergone a hysterectomy or bilateral oophorectomy; or

Has not been naturally postmenopausal (amenorrhea following cancer therapy does not rule out childbearing potential) for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months)

Trial design

Design model

Sequential

Treatments tested in this trial

  • Bortezomib

    Drug

    Given SC

  • Daratumumab and Hyaluronidase-fihj

    Biological/Vaccine

    Given SC

  • Dexamethasone

    Drug

    Given PO

  • Lenalidomide

    Drug

    Given PO

  • Quality-of-Life Assessment

    Other intervention

    Ancillary studies

Treatment groups

1,450 Participants
are divided into 3 treatment groups
Group A: Arm A (daratumumab, lenalidomide, dexamethasone)Active comparator 4 interventions
Group B: Arm B (bortezomib, daratumumab, lenalidomide, dexamethasone)Experimental treatment 5 interventions
Group C: Arm C (daratumumab, lenalidomide, dexamethasone)Active comparator 4 interventions

Trial outcomes

Primary outcomes

1

Consolidation overall survival

Will be estimated using the Kaplan-Meier (KM) method and compared using a stratified log-rank test. Stratified cox proportional hazards regression will produce treatment hazard ratio (bortezomib, daratumumab and hyaluronidase-fihj (daratumumab), lenalidomide and dexamethasone \[Btz-DRd\] then daratumumab, lenalidomide and dexamethasone \[DRd\] then daratumumab and lenalidomide \[DR\]).

Time frame
Time from Step 2 randomization at the start of consolidation to death or to the date last known alive, assessed up to 15 years

Secondary outcomes

1

Consolidation progression-free survival

Patients alive without disease progression will be censored at date of last disease evaluation. Only deaths that occur within 3 months of the last disease evaluation are considered events.

Time frame
Time from Step 2 randomization at the start of consolidation until the earlier of progression or death due to any cause, assessed up to 15 years
2

Incidence of adverse events

Time frame
During induction, consolidation, and maintenance; a period of up to 42 months (9 months of induction, 9 months of consolidation, and up to 2 years of maintenance).
3

Incidence of grade 3 or higher non-hematologic adverse events

Time frame
During induction, consolidation, and maintenance; a period of up to 42 months (9 months of induction, 9 months of consolidation, and up to 2 years of maintenance).
4

Incidence of grade 3 or higher adverse events

Time frame
During induction, consolidation, and maintenance; a period of up to 42 months (9 months of induction, 9 months of consolidation, and up to 2 years of maintenance).

Other outcomes

1

Change in Functional Assessment of Cancer Therapy - Neurotoxicity Trial Outcome Index (FACT-Ntx TOI) score (Patient reported outcome)

Calculated as the difference after completion of 9 cycles of consolidation therapy from end of induction. Scores can range from a minimum of 0 and a maximum of 44. A higher score on this assessment means a worse outcome.

Time frame
From end of induction to after completion of 9 cycles of consolidation, a period of approximately 36 weeks (9 months)
2

Levels and changes of FACT-General (G) (physical well-being [PWB] + functional well-being [FWB]) score (PRO)

The FACT-G is a single outcome measure made up of the PWB and FWB components. Scores range from a minimum of 0 and a maximum of 56. For this assessment, a higher score means a better outcome.

Time frame
From the end of induction through 1 year of maintenance, 21 weeks
3

Presence, frequency, interference, amount and/or severity of select PRO- Common Terminology Criteria for Adverse Events (CTCAEs) (PRO)

Presence, frequency, interference, amount and/or severity of select PRO-CTCAEs tabulated at each measurement.

Time frame
Up to 15 years
4

Comparison of selected PRO-CTCAEs with provider obtained assessment of same CTCAE items (PRO)

Time frame
Up to 15 years

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

ECOG-ACRIN Cancer Research Group

Lead sponsor

National Cancer Institute (NCI)

Collaborator

Source ClinicalTrials.gov
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