AzTrials
AzTrials

Relapsed Refractory Multiple MyelomaPhase 1/2MyDRUGNCT03732703

Myeloma-Developing Regimens Using Genomics (MyDRUG)

A Phase 1/2 study testing Abemaciclib, dexamethasone, ixazomib, pomalidomide, Enasidenib, dexamethasone, ixazomib, pomalidomide and Cobimetinib, dexamethasone, ixazomib, pomalidomide in people with Relapsed Refractory Multiple Myeloma, run by Multiple Myeloma Research Consortium at 16 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Relapsed Refractory Multiple Myeloma
What is being tested?
Abemaciclib, dexamethasone, ixazomib, pomalidomide, Enasidenib, dexamethasone, ixazomib, pomalidomide and Cobimetinib, dexamethasone, ixazomib, pomalidomide
Could I receive a placebo?
No, everyone receives an active treatment
How many people
103 participants
Where
16 sitesUnited States
Study dates
1 Apr 2019to 31 Dec 2024
Phase
Phase 1/2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 28Show fewer
  • had early relapse after initial treatment Early relapse as defined by at least one of the following: (Relapse is defined as the IMWG uniform response)
  • Relapse within 3 years of initiation of induction chemo therapy for post autologous stem cell transplantation (ASCT) followed by maintenance, or 18 months if unmaintained after ASCT
  • 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 upper limit of normal (ULN) or if total bilirubin is >1.5 x ULN, the direct bilirubin must be ≤ 2.0 mg/dL
  • Aspartate aminotransferase (AST) <3 x ULN
  • Creatinine Clearance ≥ 30 mL/min
  • Measurable disease of Multiple Myeloma (MM) as defined by at least one of the following:
  • Serum monoclonal protein ≥ 0.5 g by protein electrophoresis
  • ≥200 mg of monoclonal protein in the urine on 24-hour electrophoresis
  • Serum immunoglobulin free light chain (FLC) ≥10 mg/dL AND abnormal serum immunoglobulin kappa to lambda FLC ratio
  • Monoclonal bone marrow plasmacytosis ≥30% (evaluable disease)
  • Eastern Cooperative Oncology Group (ECOG) Performance Status 0, 1, or 2
  • Ability to take aspirin, warfarin, or low molecular weight heparin
  • Sub-Protocol Inclusion Criteria:
  • Refer to each respective Sub Protocol for additional inclusion criteria.

Who cannot join

  • Patients will be ineligible for this study if they meet any one of the following criteria:
  • Aggressive multiple myeloma requiring immediate treatment as defined by:
  • Lactate dehydrogenase (LDH) > 2 times ULN
  • Presence of symptomatic extramedullary disease or central nervous system involvement
  • Hypercalcemia >11.5 mg/dl
  • Acute worsening of renal function (CrCl < 30 ml/min) directly related to myeloma relapse
Show all 27Show fewer
  • Any neurological emergency related to myeloma
  • Clinical symptoms of hyperviscosity related to monoclonal protein
  • Involved serum free light chain > 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.

Trial locations and contacts

16 sites in 1 country.

16 sites in 1 country

United States16 sites

  • University of Michigan Health System

    Ann Arbor, Michigan, 48109

  • Emory University

    Atlanta, Georgia, 30322

  • Massachusetts General Hospital Cancer Center

    Boston, Massachusetts, 02114

  • Beth Israel Deaconess

    Boston, Massachusetts, 02215

  • Dana Farber Cancer Institute

    Boston, Massachusetts, 02215

  • Levine Cancer Institute

    Charlotte, North Carolina, 28204

  • Ohio State University College of Medicine

    Columbus, Ohio, 43210

  • UT Southwestern Medical Center

    Dallas, Texas, 75390

  • Karmanos Cancer Center

    Detroit, Michigan, 48201

  • City of Hope

    Duarte, California, 91010

  • Hackensack University Medical Center

    Hackensack, New Jersey, 07610

  • Mount Sinai School of Medicine

    New York, New York, 10029

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10065

  • Mayo Clinic - Arizona

    Phoenix, Arizona, 85054

  • Mayo Clinic - Minnesota

    Rochester, Minnesota, 55905

  • Washington University School of Medicine Division of Medical Oncology

    St Louis, Missouri, 63110

Other trials in United States

About this study

Official title: Myeloma-Developing Regimens Using Genomics (MyDRUG) (Genomics Guided Multi-arm Trial of Targeted Agents Alone or in Combination With a Backbone Regimen)

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 25% 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 25% 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).

Read the detailed description

The study will enroll 228 patients enrolled to one of eight 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
Being tested
Abemaciclib, dexamethasone, ixazomib, pomalidomide, Enasidenib, dexamethasone, ixazomib, pomalidomide, Cobimetinib, dexamethasone, ixazomib, pomalidomide, Erdafitinib, dexamethasone, ixazomib, pomalidomide, Venetoclax, dexamethasone, ixazomib, pomalidomide
Keywords
Multiple Myeloma, Relapsed Refractory, Multiple Myeloma Research Consortium (MMRC), Genomic Profile, My Drug, Multiple Myeloma Research Foundation
Medical subject headings
Multiple Myeloma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Abemaciclib, dexamethasone, ixazomib, pomalidomideDrug

    Also called abemaciclib: Verzenio, LY2835219, ixazomib: Ninlaro, MLN2238, pomalidomide: Pomalyst

    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.

  • Enasidenib, dexamethasone, ixazomib, pomalidomideDrug

    Also called enasidenib: AG221, IDHIFA, ixazomib: Ninlaro, MLN2238, pomalidomide: Pomalyst

    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.

  • Cobimetinib, dexamethasone, ixazomib, pomalidomideDrug

    Also called cobimetinib: Cotellic, GDC-0973, RG7420, ixazomib: Ninlaro, MLN2238, pomalidomide: Pomalyst

    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.

  • Erdafitinib, dexamethasone, ixazomib, pomalidomideDrug

    Also called erdafitinib: G-024, JNJ-42756493, JNJ-493, ixazomib: Ninlaro, MLN2238, pomalidomide: Pomalyst

    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.

  • Venetoclax, dexamethasone, ixazomib, pomalidomideDrug

    Also called venetoclax: Venclexta: ABT-199, ixazomib: Ninlaro, MLN2238, pomalidomide: Pomalyst

    Patients with t(11;14) translocation will be enrolled in arm E1 and randomized to the venetoclax or the IPd control arm. Patients with relapsed Multiple Myeloma will receive Venetoclax, Ixazomib, Pomalidomide and Dexamethasone every cycle. Each cycle is 28 days long.

  • Daratumumab, dexamethasone, ixazomib, pomalidomideDrug

    Also called daratumumab: Darzalex, ixazomib: Ninlaro, MLN2238, pomalidomide: Pomalyst

    Patients with relapsed Multiple Myeloma will receive Daratumumab, Ixazomib, Pomalidomide and Dexamethasone every cycle. Each cycle is 28 days long.

  • Belantamab mafodotin, dexamethasone, ixazomib, pomalidomideDrug

    Also called Belantamab mafodotin: BLENREP, GSK2857916

    Patients with relapsed Multiple Myeloma will receive Belantamab mafodotin, Ixazomib, Pomalidomide and Dexamethasone every cycle. Each cycle is 28 days long.

  • Selinexor, dexamethasone, ixazomib, pomalidomideDrug

    Also called Selinexor: XPOVIO

    Patients with relapsed Multiple Myeloma will receive Selinexor, Ixazomib, Pomalidomide and Dexamethasone every cycle. Each cycle is 28 days long.

Study groups in NCT03732703
Study groupRoleWhat they receive
Sub-Protocol A1ExperimentalPatients with CDK activating alteration receive Abemaciclib in combination with ixazomib, pomalidomide and dexamethasone (IPd)
Receives: Drug: Abemaciclib, dexamethasone, ixazomib, pomalidomide
Sub-Protocol B1ExperimentalPatients with IDH2 activating mutation receive Enasidenib in combination with ixazomib, pomalidomide and dexamethasone (IPd)
Receives: Drug: Enasidenib, dexamethasone, ixazomib, pomalidomide
Sub-Protocol C1ExperimentalPatients with the presence of RAF/RAS mutation receive Cobimetinib in combination with ixazomib, pomalidomide and dexamethasone (IPd)
Receives: Drug: Cobimetinib, dexamethasone, ixazomib, pomalidomide
Sub-Protocol D1ExperimentalPatients with presence of FGFR3 activating mutations receive Erdafitinib in combination with ixazomib, pomalidomide and dexamethasone (IPd)
Receives: Drug: Erdafitinib, dexamethasone, ixazomib, pomalidomide
Sub-Protocol E1ExperimentalPatients with t(11;14) translocation will be enrolled in arm E1 and randomized to the venetoclax or the IPd control arm. Patients with relapsed Multiple Myeloma will receive Venetoclax, Ixazomib, Pomalidomide and Dexamethasone every cycle. Each cycle is 28 days long.
Receives: Drug: Venetoclax, dexamethasone, ixazomib, pomalidomide
Sub-Protocol Y1ExperimentalPatients with Non-Actionable Genetic Abnormality receive Daratumumab in combination with ixazomib, pomalidomide and dexamethasone (IPd)
Receives: Drug: Daratumumab, dexamethasone, ixazomib, pomalidomide
Sub-Protocol Y2ExperimentalPatients with Non-Actionable Genetic Abnormality receive Belantamab mafodotin in combination with ixazomib, pomalidomide and dexamethasone (IPd)
Receives: Drug: Belantamab mafodotin, dexamethasone, ixazomib, pomalidomide
Sub-Protocol Y3ExperimentalPatients with Non-Actionable Genetic Abnormality receive Selinexor in combination with ixazomib, pomalidomide and dexamethasone (IPd)
Receives: Drug: Selinexor, dexamethasone, ixazomib, pomalidomide

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Overall Response Rate - Actionable Genetic Alteration

    • 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)

    Measured: 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

  2. Overall Response Rate - Non-Actionable Genetic Alteration

    • 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).

    Measured: 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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Nov 2018
  2. Study start1 Apr 2019
  3. Primary completion31 Dec 2024
  4. Study completion31 Dec 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Model description
Eight Arms with 38 patients per arm
Masking
None (open label)
Enrolment
103 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03732703
Sponsor's protocol ID
MyDRUG (MMRC-085)
Acronym
MyDRUG
Status last verified
Feb 2025
First submitted
29 Oct 2018
Last updated
14 Feb 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Kumar S, Paiva B, Anderson KC, Durie B, Landgren O, Moreau P, Munshi N, Lonial S, Blade J, Mateos MV, Dimopoulos M, Kastritis E, Boccadoro M, Orlowski R, Goldschmidt H, Spencer A, Hou J, Chng WJ, Usmani SZ, Zamagni E, Shimizu K, Jagannath S, Johnsen HE, Terpos E, Reiman A, Kyle RA, Sonneveld P, Richardson PG, McCarthy P, Ludwig H, Chen W, Cavo M, Harousseau JL, Lentzsch S, Hillengass J, Palumbo A, Orfao A, Rajkumar SV, Miguel JS, Avet-Loiseau H. International Myeloma Working Group consensus criteria for response and minimal residual disease assessment in multiple myeloma. Lancet Oncol. 2016 Aug;17(8):e328-e346. doi: 10.1016/S1470-2045(16)30206-6.

    PubMed 27511158

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Abemaciclib, dexamethasone, ixazomib, pomalidomide, Enasidenib, dexamethasone, ixazomib, pomalidomide and Cobimetinib, dexamethasone, ixazomib, pomalidomide in people with Relapsed Refractory Multiple Myeloma, run by Multiple Myeloma Research Consortium at 16 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 28 inclusion and 27 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 16 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03732703, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Feb 2025.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in