Targeted Therapy + Standard Treatment for Multiple Myeloma

(MyDRUG Trial)

Recruiting in Palo Alto (17 mi)

+15 other locations

Overseen by Hearn J Cho, M.D., Ph.D.

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1 & 2

Waitlist Available

Sponsor: Multiple Myeloma Research Consortium

No Placebo Group

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?

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).

Research Team

Hearn J Cho, M.D., Ph.D.

Principal Investigator

Multiple Myeloma Research Consortium

Eligibility Criteria

This trial is for adults with Multiple Myeloma who have specific gene mutations, have had at least one but no more than three prior treatments, and are not currently pregnant or breastfeeding. They must be able to take blood thinners and have an ECOG status of 0-2, indicating they can perform daily activities with varying degrees of assistance.

Inclusion Criteria

I have been cancer-free for over 3 years, except for minor skin cancers or early-stage cervical, breast, or prostate cancer.

My multiple myeloma can be measured for its progress.

You have more than 30% of a specific type of cells in your bone marrow.

Exclusion Criteria

You have a serious medical or mental health condition, or struggle with alcoholism or drug addiction that could make it hard for you to follow the study guidelines.

I have amyloidosis or plasma cell leukemia with symptoms.

I do not have any uncontrolled heart conditions.

Treatment Details

Interventions

• Abemaciclib (CDK4/6 Inhibitor)
• Belantamab mafodotin (Monoclonal Antibodies)
• Cobimetinib (MEK Inhibitor)
• Daratumumab (Monoclonal Antibodies)
• Enasidenib (IDH2 Inhibitor)
• Erdafitinib (FGFR Inhibitor)
• Selinexor (Selective Inhibitor of Nuclear Export (SINE))
• Venetoclax (BCL-2 Inhibitor)

Trial Overview The MyDRUG study tests targeted drugs against mutated genes in Multiple Myeloma patients. It uses precision medicine to match treatments like Abemaciclib, Enasidenib, Cobimetinib, Erdafitinib, Venetoclax, Daratumumab, Belantamab mafodotin and Selinexor with the patient's specific genetic profile.

Participant Groups

Group I: Sub-Protocol Y3 Experimental Treatment 1 Intervention

Patients with Non-Actionable Genetic Abnormality receive Selinexor in combination with ixazomib, pomalidomide and dexamethasone (IPd)

Group II: Sub-Protocol Y2 Experimental Treatment 1 Intervention

Patients with Non-Actionable Genetic Abnormality receive Belantamab mafodotin in combination with ixazomib, pomalidomide and dexamethasone (IPd)

Group III: Sub-Protocol Y1 Experimental Treatment 1 Intervention

Patients with Non-Actionable Genetic Abnormality receive Daratumumab in combination with ixazomib, pomalidomide and dexamethasone (IPd)

Group IV: Sub-Protocol E1 Experimental Treatment 1 Intervention

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.

Group V: Sub-Protocol D1 Experimental Treatment 1 Intervention

Patients with presence of FGFR3 activating mutations receive Erdafitinib in combination with ixazomib, pomalidomide and dexamethasone (IPd)

Group VI: Sub-Protocol C1 Experimental Treatment 1 Intervention

Patients with the presence of RAF/RAS mutation receive Cobimetinib in combination with ixazomib, pomalidomide and dexamethasone (IPd)

Group VII: Sub-Protocol B1 Experimental Treatment 1 Intervention

Patients with IDH2 activating mutation receive Enasidenib in combination with ixazomib, pomalidomide and dexamethasone (IPd)

Group VIII: Sub-Protocol A1 Experimental Treatment 1 Intervention

Patients with CDK activating alteration receive Abemaciclib in combination with ixazomib, pomalidomide and dexamethasone (IPd)

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Levine Cancer Institute Charlotte, NC

City of Hope Duarte, CA

Dana Farber Cancer Institute Boston, MA

UT Southwestern Medical Center Dallas, TX

More Trial Locations

Who Is Running the Clinical Trial?

Multiple Myeloma Research Consortium

Lead Sponsor

Trials

21

Patients Recruited

1,200+

Takeda

Industry Sponsor

Trials

1255

Patients Recruited

4,219,000+

Eli Lilly and Company

Industry Sponsor

Trials

2708

Patients Recruited

3,720,000+

Genentech, Inc.

Industry Sponsor

Trials

1578

Patients Recruited

569,000+

Janssen, LP

Industry Sponsor

Trials

169

Patients Recruited

329,000+

Founded

1953

Headquarters

Beerse, Belgium

Known For

Mental Health Therapies

Top Products

Imodium, Remicade, Invega, Procrit

GlaxoSmithKline

Industry Sponsor

Trials

4834

Patients Recruited

8,389,000+

Headquarters

London, UK

Known For

Vaccines & Medicines

Top Products

**Advair (salmeterol, fluticasone propionate)**, **Shingrix (shingles vaccine)**, **Augmentin (amoxicillin/clavulanate potassium)**, **Ventolin (salbutamol sulfate)

Karyopharm Therapeutics Inc

Industry Sponsor

Trials

89

Patients Recruited

7,200+

AbbVie

Industry Sponsor

Trials

1079

Patients Recruited

535,000+

Founded

2013

Headquarters

North Chicago, USA

Known For

Immunology treatments

Top Products

Humira (adalimumab), Skyrizi (risankizumab), Rinvoq (upadacitinib)

Celgene Corporation

Industry Sponsor

Trials

446

Patients Recruited

58,500+

References