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Up-front transplant should be offered to all transplant-eligible patients. Delayed initial SCT may be considered in select patients Type: evidence based; Evidence quality: high, benefit outweighs harm; Strength of recommendation: strong. Ample stem-cell collection sufficient for more than one SCT should be considered up front, due to concern for limited ability for future stem-cell collection after prolonged treatment exposure Type: evidence based; Evidence quality: intermediate, benefit outweighs harm; Strength of recommendation: moderate.

The level of minimal response required to proceed to SCT is not established for patients receiving induction therapy—patients should be referred for SCT independent of depth of response Type: evidence based; Evidence quality: intermediate, benefit outweighs harm; Strength of recommendation: moderate. High-dose melphalan is the recommended conditioning regimen for ASCT Type: evidence based; Evidence quality: high, benefit outweighs harm; Strength of recommendation: strong.

Tandem ASCT should not be routinely recommended Type: evidence based; Evidence quality: intermediate, benefit equals harm; Strength of recommendation: strong. Salvage or delayed SCT may be used as consolidation at first relapse for those not choosing to proceed to transplant initially Type: evidence based; Evidence quality: intermediate, benefit outweighs harm; Strength of recommendation: moderate.

Allogeneic transplant for multiple myeloma is not routinely recommended but may be considered in select high-risk patients or in the context of a clinical trial Type: evidence based; Evidence quality: intermediate, harm outweighs benefit; Strength of recommendation: strong.

Recommendation 3. Consolidation therapy is not routinely recommended but may be considered in the context of a clinical trial.

Additional information

For patients ineligible or unwilling to consider maintenance therapy, consolidation therapy for at least two cycles may be considered Type: evidence based; Evidence quality: intermediate, benefit outweighs harm; Strength of recommendation: moderate. Lenalidomide maintenance therapy should be routinely offered to standard-risk patients starting at approximately day 90 to at 10 to 15 mg daily until progression. A minimum of 2 years of maintenance therapy is associated with improved survival, and efforts to maintain therapy for at least this duration are recommended Type: evidence based; Evidence quality: high, benefit outweighs harm; Strength of recommendation: strong.

Recommendation 4. The quality and depth of response should be assessed by International Myeloma Working Group IMWG criteria Type: evidence based; Evidence quality: high, benefit outweighs harm; Strength of recommendation: strong. The goal of initial therapy for transplant-eligible patients should be achievement of the best depth of remission. MRD-negative status has been associated with improved outcomes, but it should not be used to guide treatment goals outside the context of a clinical trial Type: evidence based; Evidence quality: high, benefit outweighs harm; Strength of recommendation: moderate.

It is recommended that depth of response be assessed with each cycle. Frequency of assessment once best response is attained or on maintenance therapy may be assessed less frequently but at minimum every 3 months Type: evidence based; Evidence quality: low, benefit outweighs harm; Strength of recommendation: weak. Whole-body low-dose computed tomography CT scan has been shown to be superior to skeletal survey done with plain x-rays and is the preferred method for baseline and routine bone surveillance.

They may also be used in select situations eg, risk-stratifying smoldering myeloma, for monitoring response of nonsecretory and oligosecretory myeloma, and if CT or skeletal survey is inconclusive Type: evidence based; Evidence quality: high, benefit outweighs harm; Strength of recommendation: moderate. Recommendation 5. Initial treatment recommendations for patients with multiple myeloma who are transplant ineligible should be individualized based on shared decision making between physicians and patients. Multiple factors should be considered; disease-specific factors such as stage and cytogenetic abnormalities, and patient-specific factors including age, comorbidities, functional status, frailty status, and patient preferences should also be considered Type: evidence based; Evidence quality: intermediate, benefit outweighs harm; Strength of recommendation: strong.

Initial treatment of patients with multiple myeloma who are transplant ineligible should include at minimum a novel agent immunomodulatory drug or PI and a steroid if possible Type: evidence based; Evidence quality: high, benefit outweighs harm; Strength of recommendation: strong. Triplet therapies for patients with multiple myeloma who are transplant ineligible, including bortezomib, lenalidomide, dexamethasone, should be considered.

Multiple Myeloma - A New Era of Treatment Strategies

Daratumumab plus bortezomib plus melphalan plus prednisone may also be considered Type: evidence based; Evidence quality: high, benefit outweighs harm; Strength of recommendation: strong. Initial dosing should be individualized based on patient age, renal function, comorbidities, functional status, and frailty status. Subsequent dosing may be tailored based on initial response and tolerability Type: evidence based; Evidence quality: intermediate, benefit outweighs harm; Strength of recommendation: moderate. Continuous therapy should be offered over fixed-duration therapy when initiating an immunomodulatory drug or PI-based regimen Type: evidence based; Evidence quality: high, benefit outweighs harm; Strength of recommendation: strong.

Recommendation 6.

The goal of initial therapy for transplant-ineligible patients should be achievement of the best quality and depth of remission Type: evidence based; Evidence quality: intermediate, benefit outweighs harm; Strength of recommendation: moderate. Depth of response for all patients should be assessed by IMWG criteria Table 6 regardless of transplant eligibility Type: evidence based; Evidence quality: high, benefit outweighs harm; Strength of recommendation: moderate. There is insufficient evidence to support change in type and length of therapy based on depth of response as measured by conventional IMWG approaches or MRD Type: informal consensus; Evidence quality: low, harm outweighs benefit; Strength of recommendation: moderate.

Recommendations 6. Upon initiation of therapy, one should define patient-specific goals of therapy. Redefining the goals prospectively, based on response, symptoms, and quality of life, is recommended Type: informal consensus; Evidence quality: low, benefit outweighs harm; Strength of recommendation: moderate.

Type: informal consensus; Evidence quality: low, benefit outweighs harm; Strength of recommendation: moderate. Recommendation 7. Treatment of biochemically relapsed myeloma should be individualized. All clinically relapsed patients with symptoms due to myeloma should be treated immediately Type: evidence based; Evidence quality: high, benefit outweighs harm; Strength of recommendation: strong. A triplet is defined as a regimen with two novel agents PIs, immunomodulatory drugs, or monoclonal antibodies Type: evidence based; Evidence quality: high, benefit outweighs harm; Strength of recommendation: strong.

Treatment of relapsed multiple myeloma may be continued until disease progression. There are not enough data to recommend risk-based versus response-based duration of treatment such as MRD Type: evidence-based; Evidence quality: intermediate, benefit outweighs harm; Strength of recommendation: moderate.

Prior therapies should be taken into consideration when selecting the treatment at first relapse. Triplet regimens are preferred based on tolerability and comorbidities Type: evidence-based; Evidence quality: low, benefit outweighs harm; Strength of recommendation: moderate. ASCT, if not received after primary induction therapy, should be offered to transplant-eligible patients with relapsed multiple myeloma. Repeat SCT may be considered in relapsed multiple myeloma if progression-free survival after first transplant is 18 months or greater Type: evidence-based; Evidence quality: low, benefit outweighs harm; Strength of recommendation: weak.

Recommendation 8.

Introduction

The risk status of the patients should be assessed using the Revised International Staging System for all patients at the time of diagnosis Type: evidence based; Evidence quality: high, benefit outweighs harm; Strength of recommendation: strong. Repeat risk assessment at the time of relapse should be performed and should include bone marrow with fluorescence in situ hybridization for myeloma abnormalities seen with progression, including 17p and 1q abnormalities. Fluorescence in situ hybridization for primary abnormalities translocations and trisomies , if seen in the initial diagnostic marrow, does not need to be repeated Type: evidence based; Evidence quality: high, benefit outweighs harm; Strength of recommendation: strong.

In patients with genetic high-risk disease, a triplet combination of PI, immunomodulatory drug, and a steroid should be the initial treatment, followed by one or two ASCTs, followed by a PI-based maintenance until progression Type: evidence based; Evidence quality: high, benefit outweighs harm; Strength of recommendation: strong. In patients with renal insufficiency, drugs should be modified based on renal clearance Type: evidence based; Evidence quality: high, benefit outweighs harm; Strength of recommendation: strong.

Highlights

In patients with plasma cell leukemia or extramedullary disease, cytotoxic chemotherapy may have a role Type: evidence based; Evidence quality: intermediate, benefit outweighs harm; Strength of recommendation: moderate. Recommendation 9. The IMWG revised response criteria should be used for response assessment Type: evidence based; Evidence quality: high, benefit outweighs harm; Strength of recommendation: strong.

All measurable parameters need to be followed, including light and heavy chain analysis Type: evidence based; Evidence quality: high, benefit outweighs harm; Strength of recommendation: strong. All responses excluding marrow and imaging should be confirmed as per IMWG criteria Type: evidence based; Evidence quality: high, benefit outweighs harm; Strength of recommendation: strong.

Response assessment should be performed after one cycle of therapy, and once a response trend is observed, it may be done every other cycle and less frequently once patient is in a plateau Type: evidence based; Evidence quality: high, benefit outweighs harm; Strength of recommendation: strong. More information, including a Data Supplement with additional evidence tables, a Methodology Supplement with information about evidence quality and strength of recommendations, slide sets, and clinical tools and resources, is available at www.

Posttransplant maintenance therapy in multiple myeloma: the changing landscape

ASCO believes that cancer clinical trials are vital to inform medical decisions and improve cancer care, and that all patients should have the opportunity to participate. This clinical practice guideline addresses several overarching clinical questions: In transplant-eligible patients: What criteria are used to assess eligibility for autologous stem-cell transplant ASCT? What are the response goals for the transplant-eligible patient?

In transplant-ineligible patients:. What are the response goals following initial therapy for transplant-ineligible patients, and in patients with relapsed disease? This systematic review-based guideline product was developed by a multidisciplinary Expert Panel, which included a patient representative and an ASCO guidelines staff member with health research methodology expertise. The Expert Panel also included representatives from Cancer Care Ontario, in an effort to avoid duplication of guidelines on topics of mutual interest Appendix Table A1 , online only. The Expert Panel, co-chaired by T.

Based on the consideration of the evidence, the authors were asked to contribute to the development of the guideline, provide critical review, and finalize the guideline recommendations.