Multiple MyelomaPhase 1NCT03091257
A Study of Dabrafenib and/or Trametinib in Patients With Relapsed and/or Refractory Multiple Myeloma
A Phase 1 study testing Dabrafenib and Trametinib in people with Multiple Myeloma, run by Massachusetts General Hospital at 2 sites in United States.
Trial summary
This research study is studying a targeted therapy as a possible treatment for multiple myeloma. The names of the study drugs involved in this study are: Trametinib Dabrafenib Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Myeloma
- What is being tested?
- Dabrafenib and Trametinib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 2 sitesUnited States
- Study dates
- 21 Jun 2017to 15 Sep 2026
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
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
- Participants must have a confirmed diagnosis of multiple myeloma as defined by the following criteria:
- Monoclonal plasma cells in the bone marrow greater than or equal to 10% and/or presence of a biopsy-proven plasmacytoma
- Monoclonal protein present in the serum and/or urine
- Measurable disease as defined by the following:
- IgG multiple myeloma: Serum monoclonal paraprotein (M-protein) level greater than or equal to 0.5 g/dL or urine M-protein level greater than or equal to 200 mg/24 hours
- IgA multiple myeloma: Serum M-protein level greater than or equal to 0.5 g/dL or urine M-protein level greater than or equal to 200 mg/24 hours
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- IgD multiple myeloma: Serum M-protein level greater than or equal to 0.5 g/dL or urine M-protein level greater than or equal to 200 mg/24 hours
- Light chain multiple myeloma: Serum immunoglobulin free light chain ≥ 10 mg/dL and abnormal serum immunoglobulin kappa lambda free light chain ratio
- Participants must have myeloma that is measurable by either serum or urine evaluation of the monoclonal component or by assay of serum free light chains. Measurable disease is defined as one or more of the following: serum M-protein ≥0.5 g/dL, urine M-protein ≥200 mg/24 h, and/or serum FLC assay: involved FLC level ≥10 mg/dL with abnormal serum FLC ratio.
- Relapsed disease after at least 2 line of therapy
- Age ≥ 18 years years at the time of signing the informed consent form.
- ECOG performance status ≤2 (Karnofsky ≥60%, see Appendix A)
- Participants must have sufficient organ and marrow function as defined below:
- Participants with platelet level ≥50,000/mm3, within 21 days of initiation of protocol therapy for patients in whom <50% of bone marrow nucleated cells are plasma cells; or platelet count ≥30,000/mm3 for participants in whom >50% of bone marrow nucleated cells are plasma cells. Transfusion within 7 days of screening is not allowed to meet platelet eligibility criteria.
- Participants with an absolute neutrophil count (ANC) ≥1000/mm3, within 21 days of initiation of protocol therapy. Growth factor within 7 days of screening is not allowed to meet ANC eligibility criteria.
- Participants with hemoglobin level ≥ 8 g/dL, within 21 days of initiation of protocol therapy. Transfusion may be used to meet hemoglobin eligibility criteria.
- Hepatic impairment, defined as total bilirubin ≤ 1.5 x institutional ULN (patients with benign hyperbilirubinemia (e.g., Gilbert's syndrome) are eligible.) or AST (SGOT), or ALT (SGPT), or alkaline phosphatase ≤ 2 x institutional ULN, within 21 days of initiation of protocol therapy.
- PT/INR and PTT ≤ 1.3 x institutional upper limit of normal. Subjects receiving anticoagulation treatment may be allowed to participate with INR established within the therapeutic range prior to alternate assignment.
- Total bilirubin ≤ 1.5 × institutional upper limit of normal, except subjects with known Gilbert's syndrome.
- Creatinine ≤ 2.0 mg/dl
- Serum calcium or albumin-adjusted serum calcium ≥ 2.0 mmol/L (8.0 mg/dL) and ≤ 2.9 mmol/L (11.5 mg/dL)
- Left Ventricular Ejection Fraction (LVEF) ≥ LLN by ECHO. --- Abbreviations: ALT = alanine transaminase; ANC = absolute neutrophil count; AST = aspartate aminotransferase; INR = international normalized ratio; LLN = lower limit of normal; PT = prothrombin time; PTT = partial thromboplastin time;
- Harboring a mutation in the BRAF oncogene or the KRAS or the NRAS oncogene
- Women of child-bearing potential must have a negative serum pregnancy test within 14 days prior to enrollment and agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation and for 4 months after the last dose of study treatment. Should a woman become pregnant or suspect she is pregnant while she is participating in this study, she should inform her treating physician immediately. A pregnancy test is not required for female participants over age 60 who have been postmenopausal for at least 24 months. Male participants, even if surgically sterilized (i.e., status post vasectomy) must agree to 1 of the following: practice effective barrier contraception during the entire study treatment period and through a minimum of 30 days after the last dose of study drug, or completely abstain from heterosexual intercourse.
- Ability to understand and the willingness to sign a written informed consent document.
- Participant must be able to swallow pills and retain oral medication and must not have clinically significant gastrointestinal abnormalities that may alter absorption such as malabsorption syndrome or major resection of the stomach or bowels.
Who cannot join
- Prior treatment with a BRAF inhibitor or a MEK inhibitor. Treatment by localized radiotherapy is not an exclusion criterion if an interval of at least two weeks between the end of radiotherapy and initiation of protocol therapy is observed.
- Primary amyloidosis (AL) or myeloma complicated by amyloidosis
- Nonsecretory multiple myeloma based upon standard M-component criteria (ie, measurable serum/urine M-component) unless the baseline serum free light chain level is elevated. Patients with plasmacytomas with biopsy proven known mutations may be included as long as they have evaluable disease by imaging.
- Participants receiving any other investigational agents within 2 weeks of the start of this trial and throughout the duration of this trial. Participants receiving anti-cancer treatment (chemotherapy, immunotherapy, biologic therapy, vaccine therapy, or investigational treatment) within 3 weeks prior to first dose of dabrafenib or trametinib. Participants receiving proteasome inhibitors or immunomodulatory drugs (-imid), or chemotherapy without delayed toxicity within 2 weeks prior to first dose of dabrafenib or trametinib. Treatment by localized radiotherapy is not an exclusion criterion if an interval of at least two weeks between the end of radiotherapy and initiation of protocol therapy is observed.
- Current use of a prohibited medication as described in Section 6.4.
- Participants with platelet level <50,000/mm3, within 21 days of initiation of protocol therapy for patients in whom <50% of bone marrow nucleated cells are plasma cells; or platelet count <30,000/mm3 for participants in whom >50% of bone marrow nucleated cells are plasma cells. Transfusion within 7 days of screening is not allowed to meet platelet eligibility criteria.
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- Participants with an absolute neutrophil count (ANC) <1000/mm3, within 21 days of initiation of protocol therapy. Growth factor within 7 days of screening is not allowed to meet ANC eligibility criteria.
- Participants with hemoglobin level < 8 g/dL, within 21 days of initiation of protocol therapy. Transfusion may be used to meet hemoglobin eligibility criteria.
- Hepatic impairment, defined as total bilirubin > 1.5 x institutional ULN (patients with benign hyperbilirubinemia (e.g., Gilbert's syndrome) are eligible.) or AST (SGOT), or ALT (SGPT), or alkaline phosphatase > 2 x institutional ULN, within 21 days of initiation of protocol therapy.
- Renal insufficiency, defined as serum creatinine >2.0 mg/dL.
- Participant had myocardial infarction within 6 months prior to enrollment or has New York Heart Association (NYHA) Class II, III or IV heart failure (see Appendix G), uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities, or treatment refractory hypertension defined as a blood pressure of systolic >140mmHg and/ or diastolic > 90 mmHg which cannot be controlled by anti-hypertensive therapy. Prior to study entry, any ECG abnormality at screening must be documented by the investigator as not medically relevant.
- A history or evidence of cardiovascular risk including any of the following:
- A QT interval corrected for heart rate using the Bazett's formula (QTcB; Appendix E) ≥ 480 msec;
- A history or evidence of current clinically significant uncontrolled arrhythmias; Clarification: Subjects with atrial fibrillation controlled for >30 days prior to dosing are eligible.
- A history of acute coronary syndromes (including myocardial infarction or unstable angina), coronary angioplasty, or stenting within 6 months prior to alternate assignment.
- A history or evidence of current ≥ Class II congestive heart failure as defined by the New York Heart Association (NYHA) guidelines (Appendix G);
- Patients with intra-cardiac defibrillators;
- Abnormal cardiac valve morphology (≥grade 2) documented by echocardiogram (subjects with grade 1 abnormalities [i.e., mild regurgitation/stenosis] can be entered on study). Subjects with moderate valvular thickening should not be entered on study.
- Treatment refractory hypertension defined as a blood pressure of systolic> 140 mmHg and/or diastolic > 90 mm Hg which cannot be controlled by anti-hypertensive therapy;
- Any serious or unstable pre-existing medical conditions (aside from malignancy exceptions specified above), psychiatric disorders, or other conditions that could interfere with the subject's safety, obtaining informed consent, or compliance with study procedures.
- A history of Hepatitis B Virus (HBV), or Hepatitis C Virus (HCV) infection (subjects with laboratory evidence of cleared HBV and/or HCV will be permitted.
- Diagnosed or treated for another malignancy within 2 years of enrollment, with the exception of complete resection of basal cell carcinoma or squamous cell carcinoma of the skin, an in situ malignancy, or low-risk prostate cancer after curative therapy or subjects with indolent second malignancies.
- Female participants pregnant or breast-feeding. Pregnant women are excluded from this study because dabrafenib, and trametinib may have teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with the study drugs, breastfeeding should be discontinued if the mother is treated with the study drugs. Dabrafenib was teratogenic and embryotoxic in rats at doses three times greater than the human exposure at the recommended clinical dose.
- A history or current evidence of retinal vein occlusion (RVO)
- History of interstitial lung disease or pneumonitis
- Patients with known human immunodeficiency virus (HIV) on combination antiretroviral therapy are ineligible because of the potential for pharmacokinetic interactions with dabrafenib and trametinib. In addition, these participants are at increased risk of lethal infections when treated with marrow-suppressive therapy.
- Known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs chemically related to the study treatments, their excipients, and/or dimethyl sulfoxide (DMSO).
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Massachusetts General Hospital
Boston, Massachusetts, 02115
Karmanos Cancer Institute
Detroit, Michigan, 48201
About this study
Official title: An Open-label, Pilot Study of Dabrafenib and/or Trametinib in Patients With Relapsed and/or Refractory Multiple Myeloma
This research study is studying a targeted therapy as a possible treatment for multiple myeloma.
The names of the study drugs involved in this study are:
- Trametinib
- Dabrafenib
Read the detailed description
This research study is a Pilot Study, which is the first time investigators are examining this study drug in this disease. "Investigational" means that the combination of drugs is being studied. It also means that the FDA (U.S. Food and Drug Administration) has not approved the drugs for your type of cancer.
The FDA has not approved Trametinib or Dabrafenib for your specific disease but they have been approved for other uses.
Some cancers have changes (mutations) in a gene called BRAF or other genes, called KRAS or NRAS. These three genes tell the body to make a protein called BRAF, KRAS, or NRAS, respectively, which are all involved in sending signals in cells that can lead to cell growth. Certain mutations in these three genes cause a change in these proteins that can increase the growth and spread of cancer cells.
Dabrafenib and trametinib work to prevent these altered proteins from working and sending signals in cancer cells, and thereby may block the growth and spread of cancer cells in people with cancers with BRAF, KRAS, or NRAS gene mutations. Dabrafenib and trametinib have been used in the treatment for other cancers in other research studies, and information from those research studies suggest that these agents may help to kill multiple myeloma cells.
Dabrafenib and trametinib, which are investigated in this research study may or may not kill myeloma cells effectively. We would like to see if these drugs given alone or in combination safely and effectively kill these cancer cells.
- Conditions
- Multiple Myeloma
- Being tested
- Dabrafenib, Trametinib
- Keywords
- Multiple Myeloma
- Medical subject headings
- Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DabrafenibDrug
Also called Tafinlar
Administered Orally BID
TrametinibDrug
Also called Mekinist
Administered Orally once daily
| Study group | Role | What they receive |
|---|---|---|
| Dabrafenib | Experimental | Determine if mutation in BRAF, KRAS, NRAS
* BRAF V600 mutated
* Treat cohort with Dabrafenib
* Analysis
* Treat cohort with Dabrafenib Receives: Drug: Dabrafenib |
| Dabrafenib and Trametinib | Experimental | Determine if mutation in BRAF, KRAS, NRAS
* BRAF V600 mutated, BRAF/KRAS mutated, or BRAF/NRAS mutated, or BRAF non-V600 mutated
* Treat cohort with Dabrafenib and Trametinib
* Analysis
* Treat cohort with Dabrafenib and Trametinib Receives: Drug: Dabrafenib; Drug: Trametinib |
| Trametinib | Experimental | Determine if mutation in BRAF, KRAS, NRAS
* KRAS or NRAS mutated
* Treat cohort with Trametinib
* Analysis
* Treat cohort with Trametinib Receives: Drug: Trametinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Response Rate
Response rate by IMWG criteria
Measured: 100 weeks
Secondary outcomes (1)
Number of Participants with Severe Adverse Events
NCI Toxicity
Measured: 100 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2017
- Study start21 Jun 2017
- Primary completion15 Jul 2026
- Study completion15 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple MyelomaStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Novartis, Multiple Myeloma Research Consortium, Barbara Ann Karmanos Cancer Institute
- Responsible party
- Principal investigator, Noopur Raje, Massachusetts General Hospital
- Investigators
- Noopur S Raje, MD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03091257
- Sponsor's protocol ID
- 16-352
- Status last verified
- Jul 2026
- First submitted
- 17 Feb 2017
- Last updated
- 31 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Pilot Study of Dabrafenib and/or Trametinib in Patients With Relapsed and/or Refractory Multiple Myeloma
- ClinicalTrials.gov ID
- NCT03091257
- Acronym / sponsor ID
- 16-352
- Conditions
- Multiple Myeloma
- Keywords
- Multiple Myeloma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- Novartis, Multiple Myeloma Research Consortium, Barbara Ann Karmanos Cancer Institute
- Study start
- 21 Jun 2017 (actual)
- Primary completion
- 15 Jul 2026 (actual)
- Study completion
- 15 Sep 2026 (estimated)
- First posted
- 27 Mar 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This research study is studying a targeted therapy as a possible treatment for multiple myeloma.
The names of the study drugs involved in this study are:
- Trametinib
- Dabrafenib
Detailed description
This research study is a Pilot Study, which is the first time investigators are examining this study drug in this disease. "Investigational" means that the combination of drugs is being studied. It also means that the FDA (U.S. Food and Drug Administration) has not approved the drugs for your type of cancer.
The FDA has not approved Trametinib or Dabrafenib for your specific disease but they have been approved for other uses.
Some cancers have changes (mutations) in a gene called BRAF or other genes, called KRAS or NRAS. These three genes tell the body to make a protein called BRAF, KRAS, or NRAS, respectively, which are all involved in sending signals in cells that can lead to cell growth. Certain mutations in these three genes cause a change in these proteins that can increase the growth and spread of cancer cells.
Dabrafenib and trametinib work to prevent these altered proteins from working and sending signals in cancer cells, and thereby may block the growth and spread of cancer cells in people with cancers with BRAF, KRAS, or NRAS gene mutations. Dabrafenib and trametinib have been used in the treatment for other cancers in other research studies, and information from those research studies suggest that these agents may help to kill multiple myeloma cells.
Dabrafenib and trametinib, which are investigated in this research study may or may not kill myeloma cells effectively. We would like to see if these drugs given alone or in combination safely and effectively kill these cancer cells.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Dabrafenib | Experimental | Drug: DabrafenibDetermine if mutation in BRAF, KRAS, NRAS * BRAF V600 mutated * Treat cohort with Dabrafenib * Analysis * Treat cohort with Dabrafenib |
| Dabrafenib and Trametinib | Experimental | Drug: Dabrafenib, Drug: TrametinibDetermine if mutation in BRAF, KRAS, NRAS * BRAF V600 mutated, BRAF/KRAS mutated, or BRAF/NRAS mutated, or BRAF non-V600 mutated * Treat cohort with Dabrafenib and Trametinib * Analysis * Treat cohort with Dabrafenib and Trametinib |
| Trametinib | Experimental | Drug: TrametinibDetermine if mutation in BRAF, KRAS, NRAS * KRAS or NRAS mutated * Treat cohort with Trametinib * Analysis * Treat cohort with Trametinib |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (26 listed)
- Participants must have a confirmed diagnosis of multiple myeloma as defined by the following criteria:
- Participants must have myeloma that is measurable by either serum or urine evaluation of the monoclonal component or by assay of serum free light chains. Measurable disease is defined as one or more of the following: serum M-protein ≥0.5 g/dL, urine M-protein ≥200 mg/24 h, and/or serum FLC assay: involved FLC level ≥10 mg/dL with abnormal serum FLC ratio.
- Relapsed disease after at least 2 line of therapy
- Age ≥ 18 years years at the time of signing the informed consent form.
- ECOG performance status ≤2 (Karnofsky ≥60%, see Appendix A)
Key exclusion criteria (27 listed)
- Prior treatment with a BRAF inhibitor or a MEK inhibitor. Treatment by localized radiotherapy is not an exclusion criterion if an interval of at least two weeks between the end of radiotherapy and initiation of protocol therapy is observed.
- Primary amyloidosis (AL) or myeloma complicated by amyloidosis
- Nonsecretory multiple myeloma based upon standard M-component criteria (ie, measurable serum/urine M-component) unless the baseline serum free light chain level is elevated. Patients with plasmacytomas with biopsy proven known mutations may be included as long as they have evaluable disease by imaging.
- Participants receiving any other investigational agents within 2 weeks of the start of this trial and throughout the duration of this trial. Participants receiving anti-cancer treatment (chemotherapy, immunotherapy, biologic therapy, vaccine therapy, or investigational treatment) within 3 weeks prior to first dose of dabrafenib or trametinib. Participants receiving proteasome inhibitors or immunomodulatory drugs (-imid), or chemotherapy without delayed toxicity within 2 weeks prior to first dose of dabrafenib or trametinib. Treatment by localized radiotherapy is not an exclusion criterion if an interval of at least two weeks between the end of radiotherapy and initiation of protocol therapy is observed.
- Current use of a prohibited medication as described in Section 6.4.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DabrafenibAlso: TafinlarAdministered Orally BID | Drug | Dabrafenib, Dabrafenib and Trametinib |
| TrametinibAlso: MekinistAdministered Orally once daily | Drug | Dabrafenib and Trametinib, Trametinib |
Primary outcome
Overall Response Rate
Time frame: 100 weeks
Response rate by IMWG criteria
1 secondary outcome
Number of Participants with Severe Adverse Events
Time frame: 100 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Noopur S Raje, MD principal investigator
Massachusetts General Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Dabrafenib and Trametinib in people with Multiple Myeloma, run by Massachusetts General Hospital at 2 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 26 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: under way, not looking for participants, as of the sponsor's last update on 31 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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 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.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
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 (time frame: 100 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 31 Jul 2026.