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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 04/16/2021.

Myeloma-Developing Regimens Using Genomics (MyDRUG)

Clinicaltrials.gov identifier NCT03732703

Recruitment Status Recruiting

First Posted November 7, 2018

Last update posted September 25, 2020

Study Description

Brief summary:

The MyDRUG study is a type of Precision Medicine trial to treat patients with drugs targeted to affect specific genes that are mutated as part of the disease. Mutations in genes can lead to uncontrolled cell growth and cancer. Patients with a greater than 30% mutation to any of the following genes; CDKN2C, FGFR3, KRAS, NRAS, BRAF V600E, IDH2 or T(11;14) can be enrolled to one of the treatment arms. These arms have treatments specifically directed to the mutated genes. Patients that do not have a greater than 30% mutation to the genes listed can be enrolled to a non-actionable treatment arm. The genetic sequencing of the patient's tumor is required via enrollment to the MMRF002 study: Clinical-grade Molecular Profiling of Patients with Multiple Myeloma and Related Plasma Cell Malignancies. (NCT02884102).

  • Condition or Disease:Relapsed Refractory Multiple Myeloma
  • Intervention/Treatment: Drug: Abemaciclib, dexamethasone, ixazomib, pomalidomide
    Drug: Enasidenib, dexamethasone, ixazomib, pomalidomide
    Drug: Cobimetinib, dexamethasone, ixazomib, pomalidomide
    Drug: Erdafitinib, dexamethasone, ixazomib, pomalidomide
    Drug: Venetoclax, dexamethasone, ixazomib, pomalidomide
    Drug: Daratumumab, dexamethasone, ixazomib, pomalidomide
  • Phase: Phase 1/Phase 2
Detailed Description

The study will enroll 228 patients enrolled to one of six treatment arms. The study is open to patients relapsing with relapsed refractory multiple myeloma, who have - received at least one prior but no more than 3 prior therapies - exposed to both a PI and an IMiD - had early relapse after initial treatment. Relapse is defined as the IMWG uniform response criteria (Kumar et al, 2016). Early relapse as defined by at least one of the following: 1. Relapse within 3 years post autologous stem cell transplantation (ASCT) on maintenance, or 18 months if unmaintained 2. Relapse within 18 months of initial non-ASCT based therapy

Study Design
  • Study Type: Interventional
  • Estimated Enrollment: 228 participants
  • Allocation: Non-Randomized
  • Intervention Model: Parallel Assignment
  • Intervention Model Description: Six arms with 38 patients per arm
  • Masking: None (Open Label) ()
  • Primary Purpose: Treatment
  • Official Title: Myeloma-Developing Regimens Using Genomics (MyDRUG) (Genomics Guided Multi-arm Trial of Targeted Agents Alone or in Combination With a Backbone Regimen)
  • Actual Study Start Date: April 2019
  • Estimated Primary Completion Date: February 2022
  • Estimated Study Completion Date: February 2024
Arms and interventions
Arm Intervention/treatment
Experimental: Sub-Protocol A1
Patients with CDK activating alteration receive Abemaciclib in combination with ixazomib, pomalidomide and dexamethasone (IPd)
Drug: Abemaciclib, dexamethasone, ixazomib, pomalidomide
Patients with relapsed Multiple Myeloma will receive Abemaciclib and Dexamethasone for the first 2 cycles. Abemaciclib, Dexamethasone, Ixazomib and Pomalidomide from cycle 3 forward. Each cycle is 28 days long.
Experimental: Sub-Protocol B1
Patients with IDH2 activating mutation receive Enasidenib in combination with ixazomib, pomalidomide and dexamethasone (IPd)
Drug: Enasidenib, dexamethasone, ixazomib, pomalidomide
Patients with relapsed Multiple Myeloma will receive Enasidenib and Dexamethasone for the first 2 cycles. Enasidenib, Dexamethasone, Ixazomib and Pomalidomide from cycle 3 forward. Each cycle is 28 days long.
Experimental: Sub-Protocol C1
Patients with the presence of RAF/RAS mutation receive Cobimetinib in combination with ixazomib, pomalidomide and dexamethasone (IPd)
Drug: Cobimetinib, dexamethasone, ixazomib, pomalidomide
Patients with relapsed Multiple Myeloma will receive Cobimetinib and Dexamethasone for the first 2 cycles. Cobimetinib, Dexamethasone, Ixazomib and Pomalidomide from cycle 3 forward. Each cycle is 28 days long.
Experimental: Sub-Protocol D1
Patients with presence of FGFR3 activating mutations receive Erdafitinib in combination with ixazomib, pomalidomide and dexamethasone (IPd)
Drug: Erdafitinib, dexamethasone, ixazomib, pomalidomide
Patients with relapsed Multiple Myeloma will receive Erdafitinib and Dexamethasone for the first 2 cycles. Erdafitinib, Dexamethasone, Ixazomib and Pomalidomide from cycle 3 forward. Each cycle is 28 days long.
Experimental: Sub-Protocol E1
Patients with Plasma cell Fluorescence In Situ Hybridization (FISH) test demonstrating presence of t(11;14) receive Venetoclax in combination with ixazomib, pomalidomide and dexamethasone (IPd)
Drug: Venetoclax, dexamethasone, ixazomib, pomalidomide
Patients with relapsed Multiple Myeloma will receive Venetoclax, Ixazomib, Pomalidomide and Dexamethasone every cycle. Each cycle is 28 days long.
Experimental: Sub-Protocol Y1
Patients with Non-Actionable Genetic Abnormality receive Daratumumab in combination with ixazomib, pomalidomide and dexamethasone (IPd)
Drug: Daratumumab, dexamethasone, ixazomib, pomalidomide
Patients with relapsed Multiple Myeloma will receive Daratumumab, Ixazomib, Pomalidomide and Dexamethasone every cycle. Each cycle is 28 days long.
Outcome Measures
  • Primary Outcome Measures: 1. Overall Response Rate - Actionable Genetic Alteration [ Time Frame: Patients will be evaluated monthly for response from the start of the study until the date of documented disease progression, assessed up to 2 years ]
    • To evaluate the overall response rate (ORR) with targeted agents used in combination with backbone regimen ixazomib, pomalidomide and dexamethasone (IPd) in patients with an actionable genetic alteration per the International Myeloma Working Group [IMWG] consensus criteria (Kumar et al, 2016)
  • 2. Overall Response Rate - Non-Actionable Genetic Alteration [ Time Frame: Patients will be evaluated monthly for response from the start of the study until the date of documented disease progression, assessed up to 2 years ]
    • To evaluate the ORR with agents used in combination with backbone (or IPd) regimen in patients with no actionable genetic alteration per IMWG consensus criteria (Kumar et al, 2016).
Eligibility Criteria
  • Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
  • Sexes Eligible for Study: All
  • Accepts Healthy Volunteers: No
Criteria

Inclusion Criteria:

- Willing to be registered into the pomalidomide (POMALYST®) Risk Evaluation and
Mitigation Strategy (REMS®) program

- Enrolled in the MMRF002 Molecular Profiling Protocol (NCT02884102) with report less
than 120 days old

- Disease free of prior malignancies for ≥ 3 years with exception of currently treated
basal cell, squamous cell carcinoma of the skin, carcinoma "in situ" of the cervix or
breast, or prostate cancer not requiring therapy

- High risk patients with relapsed refractory multiple myeloma (RRMM), who have:

- received at least one prior but no more than 3 prior therapies

- exposed to both a PI and an IMiD

- had early relapse after initial treatmentEarly relapse as defined by at least one
of the following: (Relapse is defined as the IMWG uniform response)

1. Within 3 years post autologous stem cell transplantation (ASCT) on
maintenance, or 18 months if unmaintained

2. Within 18 months of initial non-ASCT based therapy

- Patients must have progressed after their most recent treatment and require therapy
for myeloma

- Females of reproductive potential must have a negative pregnancy test at baseline, be
non-lactating, and willing to adhere to scheduled pregnancy testing

- Females of reproductive potential and males must practice and acceptable method of
birth control

- Laboratory values obtained ≤ 14 days prior to registration:

- Absolute neutrophil count (ANC) ≥ 1000/ul

- Hemoglobin (Hgb) ≥ 8 g/dl

- Platelet (PLT) ≥ 75,000/ul

- Total bilirubin 1.5
x ULN, the direct bilirubin must be ≤ 2.0 mg/dL

- Aspartate aminotransferase (AST) 2 times ULN

- Presence of symptomatic extramedullary disease or central nervous system
involvement

- Hypercalcemia >11.5 mg/dl

- Acute worsening of renal function (CrCl 100 mg/dL (1000 mg/L) in the setting of prior
diagnosis of cast nephropathy

- Infection requiring systemic antibiotic therapy or other serious infection within 14
days of enrolment

- Known hypersensitivity or development of erythema nodosum if characterized by a
desquamating rash while taking thalidomide, lenalidomide, pomalidomide or similar
drug. Known allergy to any of the study medications, their analogues, or excipients in
the various formulations of the agents

- Prior Ixazomib/Pomalidomide/Dexamethasone combination therapy

- Pregnant or breast-feeding females

- Serious medical or psychiatric illness, active alcoholism, or drug addiction that may
hinder or confuse compliance, interfere in the completion of treatment per protocol,
or follow-up evaluation

- Active hepatitis A, B or C viral infection or known human immunodeficiency virus (HIV)
infection

- Concurrent symptomatic amyloidosis or plasma cell leukemia

- POEMS syndrome [plasma cell dyscrasia with polyneuropathy, organomegaly,
endocrinopathy, monoclonal protein (M-protein) and skin changes]

- Residual side effects to previous therapy > Grade 1 prior to initiation of therapy
(Alopecia any grade and/or neuropathy Grade 2 without pain are permitted)

- Prior allogeneic or ASCT within 12 weeks of initiation of therapy. Prior allogeneic
stem cell transplant with active graft-versus-host disease (GVHD)

- Prior experimental therapy within 14 days of protocol treatment or 5 half-lives of the
investigational drug, whichever is longer

- Prior anticancer therapy within 14 days of initiation of protocol therapy
(Dexamethasone/ 40mg/day) for a maximum of 4 days before screening is allowed

- Prior major surgical procedure or radiation therapy within 4 weeks of the initiation
of therapy (this does not include limited course of radiation used for management of
bone pain within 7 days of initiation of therapy).

- Known to have dysphagia, short-gut syndrome, gastroparesis, or other conditions that
limit the ingestion or Gastro Intestinal (GI) absorption of drugs administered orally

- Evidence of current uncontrolled cardiovascular conditions, including uncontrolled
hypertension, uncontrolled cardiac arrhythmias, symptomatic congestive heart failure,
unstable angina, or myocardial infarction within the past 6 months

- Other co-morbidity, which would interfere with patient's ability to participate in
trial or that confounds the ability to interpret data from the study

Sub-Protocol Exclusion Criteria:

Refer to each respective Sub Protocol for additional exclusion criteria.

Contacts and Locations
Contacts

Contact: MMRF Patient Support Center 866-603-6628 patientnavigator@themmrf.org

Locations
Show 17 Study Locations
Sponsors and Collaborators

Multiple Myeloma Research Consortium

AbbVie

Celgene Corporation

Eli Lilly and Company

Genentech, Inc.

Janssen, LP

Takeda

More Information